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NCT04065841 | 5.1 | Inclusion criteria | 5.1 Inclusion criteria Participants eligible for inclusion in this study must meet all of the following criteria: - 1. Signed informed consent must be obtained prior to participation in the study. - 2. Male and female participants 18 years or older (at the time of the screening visit) - 3. Presence of NASH with fibrosi... | [] |
NCT04065841 | 5.2 | Exclusion criteria | 5.2 Exclusion criteria Participants meeting any of the following criteria are not eligible for inclusion in this study. - 1. Taking medications prohibited by the protocol. (see [Section 6.2.2,](#page-78-4) [Table 6-3\)](#page-79-0) - 2. Pregnant or nursing (lactating) women. - 3. Weight at Baseline changed by > 5% sinc... | [] |
NCT04065841 | 7 | Diabetes related: | 7. Diabetes related: - a. Type 1 diabetes mellitus. - b. Uncontrolled type 2 diabetes defined as HbA1c ≥ 9.0% at screening. - c. HbA1c ULN (see Central laboratory manual). - c. ALT or AST > 5× ULN (in either of the 2 values during screening). - d. Total bilirubin > ULN (see Central laboratory manual) (in either of the ... | [] |
NCT04065841 | 10 | Other forms of chronic liver disease: | 10. Other forms of chronic liver disease: - a. Hepatitis B as defined by presence of hepatitis B surface antigen (HBsAg). - b. Hepatitis C as defined by presence of detectable hepatitis C virus (HCV) RNA. - c. Autoimmune liver disease. - d. Primary biliary cholangitis. - e. Primary sclerosing cholangitis - f. Wilson's ... | [
"6 Treatment",
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"6.1.3.1 Dosing with 3 capsule (10 + 30 + 100 μg) tropifexor supply",
"6.1.3.2 Dosing with single capsule (140 μg) tropifexor supply",
"6.1.4 Treatment du... |
NCT04065841 | 10 | Safety monitoring, reporting and committees | 10 Safety monitoring, reporting and committees | [] |
NCT04065841 | 10.1 | Definition of adverse events and reporting requirements | 10.1 Definition of adverse events and reporting requirements | [] |
NCT04065841 | 10.1.1 | Adverse events | 10.1.1 Adverse events An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in clinical investigation participant after providing written informed consent for participation in the study. In addition, all reports ... | [] |
NCT04065841 | 10.1.2 | Serious adverse events | 10.1.2 Serious adverse events An SAE is defined as any adverse event [appearance of (or worsening of any pre-existing)] undesirable sign(s), symptom(s), or medical conditions(s) which meets any one of the following criteria: - fatal - life-threatening Life-threatening in the context of an SAE refers to a reaction in wh... | [] |
NCT04065841 | 10.1.3 | SAE reporting | 10.1.3 SAE reporting To ensure participant safety, every SAE, regardless of causality, occurring after the participant has provided informed consent and until 30 days after the last dose of study treatment must be reported to Novartis safety immediately, without undue delay, under no circumstances later than 24 hours o... | [] |
NCT04065841 | 10.1.4 | Pregnancy reporting | 10.1.4 Pregnancy reporting
Pregnancies If a female trial participant becomes pregnant, the study treatment should be stopped, and the pregnancy consent form should be presented to the trial participant. The participant must be given adequate time to read, review and sign the pregnancy consent form, This consent form i... | [
"Pregnancies"
] |
NCT04065841 | 10.1.5 | Reporting of study treatment errors including misuse/abuse | 10.1.5 Reporting of study treatment errors including misuse/abuse Medication errors are unintentional errors in the prescribing, dispensing, administration or monitoring of a medicine while under the control of a healthcare professional, participant or consumer (EMA definition). Misuse refers to situations where the me... | [] |
NCT04065841 | 10.2 | Additional Safety Monitoring | 10.2 Additional Safety Monitoring | [] |
NCT04065841 | 10.2.1 | Liver safety monitoring | 10.2.1 Liver safety monitoring To ensure participant safety and enhance reliability in determining the hepatotoxic potential of an investigational drugs, a standardized process for identification, monitoring and evaluation of liver events has to be followed. The following two categories of abnormalities / adverse event... | [] |
NCT04065841 | 10.2.2 | Renal safety monitoring | 10.2.2 Renal safety monitoring Once a participant is exposed to study treatment, renal serum and urine laboratory values will be assessed routinely. Renal laboratory triggers and renal events are defined in [Table 16-3](#page-156-0) in [Section 16.3.](#page-156-1) These laboratory abnormalities should be followed up as... | [] |
NCT04065841 | 10.2.3 | Adverse events of special interest | 10.2.3 Adverse events of special interest | [] |
NCT04065841 | 10.2.3.1 | Pruritus | 10.2.3.1 Pruritus Pruritus is a common adverse event for the FXR-agonist class of drugs. Events will be captured during the study. Pruritus should be managed according to normal standard of care. If a participant experiences pruritus, an interruption in dosing of study medication can be considered. Although not specifi... | [] |
NCT04065841 | 10.2.3.2 | Dyslipidemia | 10.2.3.2 Dyslipidemia Management of dyslipidemia is critical in participants with NASH. Increases in LDL-C and decreases in HDL-C are observed with experimental treatments for NASH including the FXRagonist class of drugs, such as tropifexor. The participant's cardiovascular risk should be assessed by the investigator. ... | [] |
NCT04065841 | 10.2.3.3 | Diarrhea | 10.2.3.3 Diarrhea Osmotic diarrhea has been observed in participants treated with licogliflozin (inhibition of absorption of glucose and fructose in the gut). Events will be closely monitored and captured during the study. Participants with gastrointestinal disorders associated with chronic diarrhea are not included in... | [] |
NCT04065841 | 10.2.3.4 | Genital infections | 10.2.3.4 Genital infections In clinical studies with licogliflozin, a small number of participants experienced non-serious, mild genital infections (mainly mycotic) with AEs including balanitis and vulvovaginal infections. This is observed due to dose dependent glucosuria as a consequence of SGLT2 inhibition. All genit... | [] |
NCT04065841 | 10.2.3.5 | Hypoglycemia | 10.2.3.5 Hypoglycemia Participants with T2DM treated with antidiabetic medications (especially insulin and sulfonylureas) are at risk of hypoglycemia. Licogliflozin is effective in reducing glucose level and may lead to hypoglycemia in participants receiving other antidiabetic medications (especially insulin and insuli... | [] |
NCT04065841 | 10.2.3.6 | Pancreatitis | 10.2.3.6 Pancreatitis In the 2012 update to the diagnosis Atlanta classification of acute pancreatitis, 2 of the following 3 features are required for diagnosis: (1) abdominal pain consistent with acute pancreatitis (acute onset of a persistent, severe, epigastric pain often radiating to the back), (2) serum lipase (or... | [] |
NCT04065841 | 10.2.3.7 | Ketoacidosis | 10.2.3.7 Ketoacidosis Euglycemic ketoacidosis is a rare adverse event reported with SGLT-2 inhibitor class of drugs. Participants are advised to maintain hydration and avoid excessive alcohol consumption. Participants should seek medical attention immediately in case they develop any of the following symptoms: vomiting... | [] |
NCT04065841 | 10.2.3.8 | Fournier's Gangrene | 10.2.3.8 Fournier's Gangrene Fournier's gangrene is a rare adverse event reported with SGLT-2 inhibitor class of drugs. Participants are advised to pay attention to genital hygiene. Participants developing fever with pain or swelling in genital or anal region or any other signs/symptoms of infection of genitalia or per... | [] |
NCT04065841 | 10.3 | Committees | 10.3 Committees | [] |
NCT04065841 | 10.3.1 | Data Monitoring Committee | 10.3.1 Data Monitoring Committee This study will include an external Data Monitoring Committee (DMC) which will function independently of all other individuals associated with the conduct of this clinical trial, including the site investigators participating in the study. The committee will consist of at least two phys... | [] |
NCT04065841 | 11 | Data Collection and Database management | 11 Data Collection and Database management | [] |
NCT04065841 | 11.1 | Data collection | 11.1 Data collection Designated investigator staff will enter the data required by the protocol into the electronic Case Report Forms (eCRF). The eCRFs have been built using fully validated secure web-enabled software that conforms to 21 CFR Part 11 requirements, Investigator site staff will not be given access to the ... | [] |
NCT04065841 | 11.2 | Database management and quality control | 11.2 Database management and quality control Novartis personnel or designated contract research organization (CRO) will review the data entered by investigational staff for completeness and accuracy. Electronic data queries stating the nature of the problem and requesting clarification will be created for discrepancies... | [] |
NCT04065841 | 11.3 | Site monitoring | 11.3 Site monitoring Before study initiation, at a site initiation visit or at an investigator's meeting, a Novartis/delegated CRO representative will review the protocol and data capture requirements (i.e. eCRFs) with the investigators and their staff. During the study, Novartis employs several methods of ensuring pro... | [] |
NCT04065841 | 12 | Data analysis and statistical methods | 12 Data analysis and statistical methods A final analysis will be conducted after all participants finish the end of study or premature study discontinuation visit. No interim analysis for earlier statistical inference is planned for the study. Analyses for DMC review will be outlined in a separate DMC charter. Unless ... | [] |
NCT04065841 | 12.1 | Analysis sets | 12.1 Analysis sets Following analysis populations will be defined for the statistical analysis: Screened analysis set (SCR) comprises of all participants who signed the informed consent. Randomized Analysis set (RAN) comprises of all participants who received a randomization number, regardless of whether participants r... | [] |
NCT04065841 | 12.2 | Participant demographics and other baseline characteristics | 12.2 Participant demographics and other baseline characteristics Demographic and other baseline data including disease characteristics will be summarized descriptively by treatment group for the FAS. Categorical data will be presented as frequencies and percentages. For continuous data, the mean, standard deviation, me... | [] |
NCT04065841 | 12.3 | Treatments | 12.3 Treatments The Safety set will be used for the analyses below. Categorical data will be summarized as frequencies and percentages. For continuous data, mean, standard deviation, median, 25th and 75th percentiles, minimum, and maximum will be presented. The duration of exposure (days) to investigational treatment, ... | [] |
NCT04065841 | 12.4 | Analysis of the primary endpoint(s)/estimand(s) | 12.4 Analysis of the primary endpoint(s)/estimand(s) The two primary endpoints to be analyzed are: - 1. Whether the participant has at least one stage improvement in fibrosis without worsening of NASH at Week 48 compared with baseline; - 2. Whether the participant achieves resolution of NASH and no worsening of fibrosi... | [] |
NCT04065841 | 12.4.1 | Definition of primary endpoint(s)/estimand(s) | 12.4.1 Definition of primary endpoint(s)/estimand(s) [Section 2.1](#page-62-1) describes the primary estimands that contain the primary endpoints. This section defines the primary endpoints in detail.
The study uses two primary endpoints. The first primary endpoint is: Whether (yes or no) the participant achieves impr... | [
"The study uses two primary endpoints."
] |
NCT04065841 | 12.4.2 | Statistical model, hypothesis, and method of analysis | 12.4.2 Statistical model, hypothesis, and method of analysis The main goal of the study is to reveal the efficacy of the combination therapy (tropifexor + licogliflozin) compared with placebo in the two primary endpoints, so the two tests of combination therapy vs. placebo (one for each endpoint) will be conducted firs... | [] |
NCT04065841 | 12.4.3 | Handling of remaining intercurrent events of primary estimand | 12.4.3 Handling of remaining intercurrent events of primary estimand Intercurrent events of primary estimand will be addressed with various strategies (given that these events occur before the histological assessments at Week 48): - 1. Bariatric surgery: participants who have undergone bariatric surgeries during trial ... | [] |
NCT04065841 | 12.4.4 | Handling of missing values not related to intercurrent events | 12.4.4 Handling of missing values not related to intercurrent events While not possible to confirm missing completely at random (MCAR), the histological response status from the early termination visit after at least 24 weeks of study treatment will be used for the primary analysis in case of missing primary endpoint a... | [] |
NCT04065841 | 12.4.5 | Sensitivity analyses for primary endpoint(s)/estimand(s) | 12.4.5 Sensitivity analyses for primary endpoint(s)/estimand(s) Any sensitivity analysis of the primary efficacy estimands will be described in the SAP. | [] |
NCT04065841 | 12.5 | Analysis of secondary endpoints | 12.5 Analysis of secondary endpoints Summary tables of descriptive statistics will be presented by treatment group, and by scheduled visit where applicable, for secondary endpoints. Counts and percentages will be presented for categorical variables and the arithmetic mean, standard deviation, minimum, maximum, median a... | [] |
NCT04065841 | 12.5.1 | Efficacy endpoint(s) | 12.5.1 Efficacy endpoint(s) Secondary efficacy endpoints will be analyzed in the FAS and planned analyses are outlined in [Table 12-1](#page-139-0) below: | Endpoints | Analysis | |-------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT04065841 | 12.5.2 | Safety endpoints | 12.5.2 Safety endpoints For all safety analyses, the safety set will be used and will be presented by actual investigational treatment as participant first received after randomization. Safety summaries (tables, figures) include only data from the on-treatment period with the exception of baseline data which will also ... | [] |
NCT04065841 | 12.5.2.1 | Adverse Events | 12.5.2.1 Adverse Events The number (and percentage) of participants with treatment emergent adverse events (events started after the first dose of study medication or events present prior to start of double-blind treatment but increased in severity based on preferred term) will be summarized in the following ways: - by... | [] |
NCT04065841 | 12.5.2.2 | Clinical laboratory evaluation | 12.5.2.2 Clinical laboratory evaluation Summary statistics for standard laboratory test results will be provided by treatment and visit/time. Shift tables using the low/normal/high/ (low and high) classification will be used to compare baseline to the worst on-treatment value. Number (percent) of participants with post... | [] |
NCT04065841 | 12.5.2.3 | Vital signs | 12.5.2.3 Vital signs The change from baseline in vital sign parameters, including Anthropometric measurements, will be summarized at scheduled post-baseline visits by treatment group. Change from baseline will only be summarized for participants with both baseline and post-baseline values. Participants with clinically ... | [] |
NCT04065841 | 12.5.2.4 | ECG | 12.5.2.4 ECG PR, QRS, QT, QTcF, and RR intervals will be obtained from 12-lead ECGs for each participant during the study. ECG data will be read and interpreted centrally. Number of participants changing in normal or abnormal ECG will be summarized by treatment and scheduled visit. The Fridericia QT correction formula ... | [] |
NCT04065841 | 12.7 | Interim analyses | 12.7 Interim analyses No interim analysis is planned for the study. Analysis needed for safety review by DMC will be defined in a separate DMC charter. | [] |
NCT04065841 | 12.8 | Sample size calculation | 12.8 Sample size calculation Sample size and allocation are determined by three factors: - 1. Optimizing the power of passing at least one of the combination vs. placebo tests from the two primary endpoints; - 2. Optimizing the power of passing any monotherapy vs placebo test (given that at least one of the combination... | [] |
NCT04065841 | 12.8.1 | Primary endpoint(s) | 12.8.1 Primary endpoint(s) Assumptions about true histological response rates for various treatments and placebo are made for sample size calculation. Published studies so far [\(Table 12-2\)](#page-143-0) suggest unignorable placebo effect ranging from 8% to 18% for different populations and endpoints, but unpublished... | [] |
NCT04065841 | 12.8.2 | Secondary endpoint(s) | 12.8.2 Secondary endpoint(s) The tests of the key secondary endpoint are not used for sample size calculation. These tests are similar to the five tests of each primary endpoint and will be performed after the tests of primary endpoints succeed. | [] |
NCT04065841 | 13 | Ethical considerations and administrative procedures | 13 Ethical considerations and administrative procedures | [] |
NCT04065841 | 13.1 | Regulatory and ethical compliance | 13.1 Regulatory and ethical compliance This clinical study was designed and shall be implemented, executed and reported in accordance with the International Council for Harmonization (ICH) Harmonized Tripartite Guidelines for Good Clinical Practice, with applicable local regulations (including European Directive 2001/2... | [] |
NCT04065841 | 13.2 | Responsibilities of the investigator and IRB/IEC | 13.2 Responsibilities of the investigator and IRB/IEC Before initiating a trial, the investigator/institution must obtain approval/favorable opinion from the Institutional Review Board/Independent Ethics Committee (IRB/IEC) for the trial protocol, written informed consent form, consent form updates, participant recruit... | [] |
NCT04065841 | 13.3 | Publication of study protocol and results | 13.3 Publication of study protocol and results The protocol will be registered in a publicly accessible database such as clinicaltrials.gov and as required in EudraCT. In addition, after study completion (defined as last participant last visit) and finalization of the study report the results of this trial will be subm... | [] |
NCT04065841 | 13.4 | Quality Control and Quality Assurance | 13.4 Quality Control and Quality Assurance Novartis maintains a robust Quality Management System (QMS) that includes all activities involved in quality assurance and quality control, to ensure compliance with written Standard Operating Procedures as well as applicable global/local GCP regulations and ICH Guidelines. Au... | [] |
NCT04065841 | 14 | Protocol adherence | 14 Protocol adherence This protocol defines the study objectives, the study procedures and the data to be collected on study participants. Additional assessments required to ensure safety of participants should be administered as deemed necessary on a case by case basis. Under no circumstances including incidental coll... | [] |
NCT04065841 | 14.1 | Protocol amendments | 14.1 Protocol amendments Any change or addition to the protocol can only be made in a written protocol amendment that must be approved by Novartis, health authorities where required, and the IRB/IEC prior to implementation. Only amendments that are required for participant safety may be implemented immediately provided... | [] |
NCT04065841 | 15 | References | 15 References References are available upon request Banks PA, Bollen TL, Dervenis C, et al (2013) Classification of acute pancreatitis—2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013; 62:102–11. Bays H (2013) Sodium Glucose Co-transporter Type 2 (SGLT2) Inhibitors: Tar... | [] |
NCT04065841 | 16 | Appendices | 16 Appendices | [] |
NCT04065841 | 16.1 | Appendix 1: Clinically notable laboratory values and vital signs | 16.1 Appendix 1: Clinically notable laboratory values and vital signs The central laboratory will flag laboratory values falling outside of the normal ranges on the central laboratory reports. Investigators are responsible for reviewing these abnormal values for clinical significance, signing the laboratory reports to ... | [
"SEE [APPENDIX 16.2](#page-151-2) FOR SPECIFIC LIVER EVENT AND LABORATORY TEST TRIGGER DEFINITIONS AND FOLLOW-UP REQUIREMENTS."
] |
NCT04065841 | 16.2 | Appendix 2: Liver event and Laboratory trigger Definitions and Follow-up Requirements | 16.2 Appendix 2: Liver event and Laboratory trigger Definitions and Follow-up Requirements [Table 16-2 d](#page-151-0)escribes detailed thresholds and actions needed when elevations of liver parameters is observed or symptoms / adverse events indicative of liver toxicity appear. These symptoms could include jaundice, c... | [] |
NCT04065841 | 16.3 | Appendix 3: Specific Renal Alert Criteria and Actions and Event Follow-up | 16.3 Appendix 3: Specific Renal Alert Criteria and Actions and Event Follow-up Table 16-3 Specific Renal Alert Criteria and Actions | Serum Event | | | | |---------------------------------------------------------------------------|-----------------------------------------------------------------------------------------... | [
"For all renal events:",
"Event resolution:",
"Event stabilization:"
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NCT04065841 | 16.5 | Appendix 5: The American Heart Association (AHA) Recommended Diet | 16.5 Appendix 5: The American Heart Association (AHA) Recommended Diet Optimization of diet can result in a marked triglyceride-lowering effect that ranges between 20% and 50%. Good practices include weight loss, reducing simple carbohydrates at the expense of increasing dietary fiber, eliminating industrial-produced t... | [] |
NCT04080895 | A | Randomized, Open-Label Study to Evaluate Potential Pharmacokinetic Interactions of Orally Administered Artemether-lumefantrine and Amodiaquine in Healthy Adult Subjects | A Randomized, Open-Label Study to Evaluate Potential Pharmacokinetic Interactions of Orally Administered Artemether-lumefantrine and Amodiaquine in Healthy Adult Subjects Short Title: Pharmacokinetic study of artemether-lumefantrine and amodiaquine in Healthy Subjects > Protocol version: version 6.0 dated 22 June 2022 ... | [] |
NCT04080895 | A | Randomized, Open-Label Study to Evaluate Potential Pharmacokinetic Interactions of Orally Administered Artemether-lumefantrine and Amodiaquine in Healthy Adult Subjects | A Randomized, Open-Label Study to Evaluate Potential Pharmacokinetic Interactions of Orally Administered Artemether-lumefantrine and Amodiaquine in Healthy Adult Subjects Short Title: Pharmacokinetic study of artemether-lumefantrine and amodiaquine in Healthy Subjects OxTREC reference Number: 34-19 Registration number ... | [
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NCT04125368 | A | Feasibility Study of Integrating Maternal Nutrition Interventions into Antenatal Care Services in Ethiopia: A Cluster-Randomized Evaluation | A Feasibility Study of Integrating Maternal Nutrition Interventions into Antenatal Care Services in Ethiopia: A Cluster-Randomized Evaluation
Study Protocol International Food Policy Research Institute June 2, 2021 VERSION: 2 Clinicaltrials.gov: NCT04125368 Funding: We acknowledge funding support from the Bill & Melin... | [
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NCT04126031 | 1 | INTRODUCTION | 1. INTRODUCTION | [] |
NCT04126031 | 1.1 | Mechanism of Action/Indication | 1.1. Mechanism of Action/Indication Ceftazidime is a bactericidal third generation cephalosporin antibiotic with activity against clinically important Gram-negative Enterobacteriaceae and Pseudomonas aeruginosa. Ceftazidime is approved for the treatment of aerobic Gram-negative bacterial infections in adults and childr... | [] |
NCT04126031 | 1.2 | Background | 1.2. Background CAZ-AVI is currently being evaluated for use in pediatric patients. PK in pediatric subjects aged 3 months to 18 years was investigated in Study D4280C00014, a Phase 1, multicenter, open-label study. In that study pediatric subjects receiving other systemic antibiotic therapy for suspected or confirmed ... | [] |
NCT04126031 | 1.3 | Rationale for Conducting This Study | 1.3. Rationale for Conducting This Study The long-established efficacy and safety of ceftazidime in children including neonates (from birth), the mode of action of avibactam, and the available Phase 2 clinical data for CAZ-AVI in pediatrics provide a strong rationale for extending the evaluation of CAZ-AVI into the inf... | [] |
NCT04126031 | 1.4 | Dose Rationale | 1.4. Dose Rationale Dosing for this study is based on modelling and simulation study CAZ-MS-PED-02 (Study 7) which included data from the adult Phase 1, 2, and 3 studies including studies of cIAI, cUTI, and NP, and three prior pediatric studies: 1) D4280C00014, an open-label, single-dose study in hospitalized pediatric... | [] |
NCT04126031 | 1.5 | Benefit/Risk and Ethical Assessment | 1.5. Benefit/Risk and Ethical Assessment The potential benefit of the study, in general, is the identification of a novel antibiotic combination product that is an effective treatment for infections in infants and neonates, in the face of the changing pattern of antibiotic resistance. In Part A, CAZ-AVI will not be use... | [] |
NCT04126031 | 2 | STUDY OBJECTIVES AND ENDPOINTS | 2. STUDY OBJECTIVES AND ENDPOINTS | Part A Primary Objective: | Part A Primary Endpoints: | |-------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------... | [] |
NCT04126031 | 3 | STUDY DESIGN | 3. STUDY DESIGN This is a 2-part Phase 2a non-randomized, multicenter, open-label, single and multi-dose PK study to assess PK, safety, and tolerability of CAZ-AVI in neonates and young infants aged birth to <3 months. The efficacy of CAZ-AVI for the treatment of aerobic Gram-negative infection will be summarized descr... | [] |
NCT04126031 | 4 | SUBJECT ELIGIBILITY CRITERIA | 4. SUBJECT ELIGIBILITY CRITERIA This study can fulfill its objectives only if appropriate subjects are enrolled. The following eligibility criteria are designed to select subjects for whom participation in the study is considered appropriate. All relevant medical and nonmedical conditions should be taken into considera... | [] |
NCT04126031 | 4.1 | Inclusion Criteria | 4.1. Inclusion Criteria Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: | [] |
NCT04126031 | 4.1.1 | Inclusion Criteria for All Subjects | 4.1.1. Inclusion Criteria for All Subjects - 1. Evidence of a personally signed and dated informed consent document indicating that the subject's parent(s), legal guardian, or legally acceptable representative has been informed of all pertinent aspects of the study. - 2. Willing and able to comply with scheduled visits... | [] |
NCT04126031 | 4.1.2 | Inclusion Criteria for Part A Subjects Only | 4.1.2. Inclusion Criteria for Part A Subjects Only 1. Hospitalized and receiving intravenous antibacterial therapy for the treatment of a suspected or confirmed bacterial infection. | [] |
NCT04126031 | 4.1.3 | Inclusion Criteria for Part B Subjects Only | 4.1.3. Inclusion Criteria for Part B Subjects Only - 1. Hospitalized with suspected or confirmed aerobic Gram-negative bacterial infection requiring intravenous antibacterial therapy. - 2. Subjects must meet at least 1 clinical and 1 laboratory criterion or meet at least 2 of the clinical criteria:
Clinical Criteria: ... | [
"Clinical Criteria:",
"Laboratory Criteria:"
] |
NCT04126031 | 4.2 | Exclusion Criteria | 4.2. Exclusion Criteria Subjects with any of the following characteristics/conditions will not be included in the study: | [] |
NCT04126031 | 4.2.1 | Exclusion Criteria for All Subjects | 4.2.1. Exclusion Criteria for All Subjects - 1. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of t... | [] |
NCT04126031 | 4.2.2 | Exclusion Criteria for Part A Subjects Only | 4.2.2. Exclusion Criteria for Part A Subjects Only - 1. Subject received a blood or a blood component transfusion within 24 hours of the start of CAZ-AVI infusion. - 2. Subject is expected to be discharged less than 24 hours after the start of CAZ-AVI infusion. | [] |
NCT04126031 | 4.2.3 | Exclusion Criteria for Part B Subjects Only | 4.2.3. Exclusion Criteria for Part B Subjects Only - 1. At study entry, subject has confirmed or strongly suspected infection with a pathogen known to be resistant to CAZ-AVI or only a Gram-positive pathogen or viral, fungal, or parasitic pathogens as the sole cause of infection. - 2. Confirmed or suspected central ner... | [] |
NCT04126031 | 4.3 | Randomization Criteria | 4.3. Randomization Criteria This study is not randomized. All enrolled subjects will receive CAZ-AVI either as a single dose in Part A or multiple doses in Part B. | [] |
NCT04126031 | 4.4 | Cohort Enrollment Sequence | 4.4. Cohort Enrollment Sequence Enrollment for this study will begin with Cohort 1 of Part A. A Safety Review Committee (SRC) consisting of the study team physician, international coordinating Investigator or delegate, global safety/risk lead or delegate, therapeutic area director or delegate and the clinical pharmacol... | [] |
NCT04126031 | 4.5 | Procedures for Handling Incorrectly Enrolled Subjects | 4.5. Procedures for Handling Incorrectly Enrolled Subjects Where a subject does not meet all the eligibility criteria, but is enrolled in error and incorrectly started on study treatment, the Investigator should inform the Medical Monitor immediately, and a discussion should occur between the Medical Monitor and the In... | [] |
NCT04126031 | 4.6 | Sponsor's Qualified Medical Personnel | 4.6. Sponsor's Qualified Medical Personnel The contact information for the Sponsor's appropriately qualified medical personnel for the study is documented in the study contact list located in the supporting study documentation at each site. To facilitate access to appropriately qualified medical personnel on study rela... | [] |
NCT04126031 | 5 | STUDY TREATMENTS | 5. STUDY TREATMENTS For the purposes of this study, and per International Conference on Harmonization (ICH) guidelines, investigational product is defined as a pharmaceutical form of an active ingredient or placebo being tested or used as a reference/comparator in a clinical trial, including a product with a marketing ... | [] |
NCT04126031 | 5.1 | Allocation to Treatment | 5.1. Allocation to Treatment This is an unblinded, single treatment arm study. All subjects will receive CAZ-AVI. | [] |
NCT04126031 | 5.2 | Breaking the Blind | 5.2. Breaking the Blind This is an open-label study. Blinding procedures are not applicable. The Investigator's knowledge of the treatment should not influence the decision to enroll a particular subject or affect the order in which subjects are enrolled. | [] |
NCT04126031 | 5.3 | Subject Compliance | 5.3. Subject Compliance Qualified study center personnel will administer the IV study treatment and assure treatment compliance. At a minimum the dose, date, and exact start and stop time of administration of the IV study treatment will be recorded in the appropriate sections of the Case Report Form (CRF) and checked b... | [] |
NCT04126031 | 5.4 | Investigational Product Supplies | 5.4. Investigational Product Supplies All sites will be provided with an Investigational Product (IP) Manual containing detailed instructions on the receipt, storage, dispensing, preparation, and administration of the investigational product, as outlined below. If there is any conflict between this protocol and the IP ... | [] |
NCT04126031 | 5.4.1 | Dosage Form(s) and Packaging | 5.4.1. Dosage Form(s) and Packaging The investigational product, Zavicefta (ceftazidime 2 g/avibactam 0.5 g), will be supplied by Pfizer as a white to yellow powder for concentrate for solution for infusion in a 20 mL glass vial. Each vial contains a fixed dose combination of ceftazidime pentahydrate equivalent to 2 g ... | [] |
NCT04126031 | 5.4.2 | Preparation and Dispensing | 5.4.2. Preparation and Dispensing Detailed instructions for the preparation of CAZ-AVI powder for concentrate for solution for infusion will be provided in the separate IP Manual. The investigational product should be prepared and dispensed by an appropriately qualified and experienced member of the study staff (eg, ph... | [] |
NCT04126031 | 5.5 | Administration (Dose and Treatment Regimen) | 5.5. Administration (Dose and Treatment Regimen) The prepared doses of CAZ-AVI are intended for intravenous infusion based on age and weight as detailed in Table 2. The dose should generally be calculated based on the subject's first weight of the day on the starting day, although other options such as the birth weight... | [] |
NCT04126031 | 5.5.1 | Part A | 5.5.1. Part A On Day 1 subjects in Part A will receive a single IV infusion of CAZ-AVI over a 2-hour (10 min) period according to their cohort as indicated in Table 2. The infusion can be administered any time during the subject's course of treatment with the other intravenous antibiotic, with the exception that no dos... | [] |
NCT04126031 | 5.5.2 | Part B | 5.5.2. Part B On Day 1 subjects in Part B will begin receiving IV CAZ-AVI over a 2-hour (10 min) period every 8 hours (1 hour) according to their cohort as indicated in Table 2. The CAZ-AVI dose in Part B should not be adjusted based on fluctuations in daily weight, and it should remain the same throughout the dosing p... | [] |
NCT04126031 | 5.6 | Investigational Product Storage | 5.6. Investigational Product Storage The Investigator or an approved representative, eg, pharmacist, will ensure that all investigational products are stored in a secured area with controlled access under required storage conditions and in accordance with applicable regulatory requirements. Investigational products sho... | [] |
NCT04126031 | 5.7 | Investigational Product Accountability | 5.7. Investigational Product Accountability The Investigator site must maintain adequate records documenting the receipt, use, loss, or other disposition of the investigational product supplies. All investigational products will be accounted for using a drug accountability form/record. | [] |
NCT04126031 | 5.7.1 | Destruction of Investigational Product Supplies | 5.7.1. Destruction of Investigational Product Supplies The Sponsor or designee will provide guidance on the destruction of unused investigational product (eg, at the site). If destruction is authorized to take place at the Investigator site, the Investigator must ensure that the materials are destroyed in compliance wi... | [] |
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