protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT02996682 | 6.7 | Unscheduled Visit | A subject should attend an unscheduled visit if requested by the sponsor or the investigator. The assessments are at the investigator's discretion as clinically indicated, but the investigator should, at a minimum, collect AE and concomitant medication information. At all unscheduled visits initiated for the purpose of... | [] |
NCT02996682 | 6.8 | Procedures and Specifications | [] | |
NCT02996682 | 6.8.1 | Clinical Laboratory Analytes | Hematology: Hematocrit, Hemoglobin (Hb), Platelet count, Red blood cell count (RBC), White blood cell count (WBC) with differential (absolute and percentage) including Lymphocytes, Monocytes, Neutrophils, Eosinophils, and Basophils, Reticulocyte count and mean corpuscular volume (MCV).
Coagulation: INR, Prothrombin Ac... | [] |
NCT02996682 | 6.8.2 | Medical History | Medical history, including details regarding illnesses and allergies, date(s) of onset, and whether condition(s) is currently ongoing, and medication history will be collected on all subjects during screening. | [] |
NCT02996682 | 6.8.3 | Complete Physical Examination | A physical examination must include source documentation of general appearance, and the following body systems: Head, neck, and thyroid; eyes, ears, nose, throat, mouth, and tongue; chest (excluding breasts); respiratory; cardiovascular; lymph nodes; abdomen; skin, hair, nails; musculoskeletal; neurological. | [] |
NCT02996682 | 6.8.4 | Vital Signs | Assessment of vital signs will include measurement of resting blood pressure, pulse, respiratory rate, and temperature.
Blood pressure will be measured using the following standardized process:
- Subject should sit for ≥ 5 minutes with feet flat on the floor and measurement arm supported so that the midpoint of the m... | [] |
NCT02996682 | 6.8.5 | 12-Lead ECG | Subjects will be required to rest in a supine position for 5 minutes prior to making a recording. The investigator (or qualified designee) should review the ECG traces recorded in real time for clinically significant abnormalities. | [] |
NCT02996682 | 6.8.6 | Health Related Quality of Life (HRQoL) | Health Related Quality of Life surveys (HRQoL) included in this study are the SF-36, Chronic Liver Disease Questionnaire (CLDQ-HCV), Fatigue Index (FACIT-F), and Work Productivity and Activity Impairment Questionnaire: Hepatitis C, v2.0 (WPAI: Hepatitis C).
The Health Related Quality of Life surveys (HRQoL) will only ... | [] |
NCT02996682 | 6.8.7 | MELD and CPT Score Calculations | MELD score and CPT score will be calculated from the central laboratory values attained at each visit. Assessment of ascites and hepatic encephalopathy will be determined by the site as in below table and will be entered into the eCRF. Besides calculating the CPT score at screening (using central laboratory values) and... | [] |
NCT02996682 | 6.8.7.1 | MELD Score | The MELD score is calculated using the following formula {MELD/PELD 2009}:
MELD = 3.8[serum bilirubin (mg/dL)] + 11.2[INR] + 9.57[serum creatinine\* (mg/dL)] + 6.43
Round to the nearest whole number. Laboratory values less than 1.0 are set to 1.0 for the purposes of the MELD score calculation. | [] |
NCT02996682 | 6.8.7.2 | CPT Score | Child-Pugh-Turcotte score should be assessed at all visits per Table 6-1.
Table 6-1. Child-Pugh-Turcotte Classification of the severity of cirrhosis
| Measure | | 1 point ... | [] |
NCT02996682 | 6.8.8 | Creatinine Clearance | Creatinine clearance is calculated by the Cockcroft-Gault equation {Cockcroft et al 1976} using actual body weight (ABW).
Male:
$$CL_{cr} (mL/min) = [\underline{140 - age (years)}] \times ABW(kg)$$
$72 \times S_{cr}$
Female:
$$CL_{cr} (mL/min) = [140 - age (years)] \times ABW(kg) \times 0.85$$
$72 \times S... | [] |
NCT02996682 | 6.8.9 | Viral RNA Sequencing / Phenotyping Sample | Plasma samples will be collected at Day 1 and at on-treatment visits at Weeks 2, 4, 8, and 12 or early termination and all posttreatment visits and may be archived for viral sequence analysis. At any unscheduled visit initiated for the purpose of confirming virologic breakthrough, a viral sequence analysis plasma sampl... | [] |
NCT02996682 | 6.8.10 | HBV DNA Sample | A sample for HBV DNA testing will be collected at on-treatment visits at Weeks 2, 4, 8, and 12 or early termination and all posttreatment visits. HBV DNA will only be tested when ALT > 2x Day 1 value in subjects who are HBsAb or HBcAb positive at Screening. | [] |
NCT02996682 | 6.8.11 | Single Pharmacokinetic (PK) Sample | Single PK blood samples will be collected for all subjects at on-treatment visits at Weeks 2, 4, 8, and 12 or early termination and archived for PK analysis of SOF, its metabolites, VEL, and RBV (if appropriate). Approximately 6 mL of whole blood will be collected for each sample (which is included in the total blood v... | [] |
NCT02996682 | 6.8.12 | Pregnancy Testing | All females of childbearing potential will have a semm pregnancy test at Screening. Urine pregnancy testing will occur at Day 1 and eve1y 4 weeks through posttreatment 4.
Females of childbearing potential in the treatment group receiving RBV will have additional urine pregnancy testing eve1y 4 weeks for a minimum of 6... | [] |
NCT02996682 | 6.8.13 | IL28B Testing | A blood sample will be obtained at Day 1 for specific genetic analysis of the rs12979860 (IL28B) genetic variant. | [] |
NCT02996682 | 6.8.14 | Archive Plasma Sample | For subjects who provide consent, an archive plasma san1ple (non-genetic) will be collected at Day 1 and Week 12 or ET (if applicable) visits. Approximately 12 mL of whole blood will be collected for each sample. The specimens collected will be used to increase our knowledge and understanding of the biology pathogenesi... | [] |
NCT02996682 | 6.8.15 | Genomic Testing | 
CONFIDENTIAL Page 50 17 November 2016
 | [] |
NCT02996682 | 6.9 | End of Study | Subjects al'e considered to have completed the study after the posttreatment Week 24 visit, regardless of treatment dmation or early temlination of study dmgs. | [] |
NCT02996682 | 6.10 | Post Study Care | No poststudy ongoing care will be provided. | [] |
NCT02996682 | 7 | ADVERSE EVENTS AND TOXICITY MANAGEMENT | [] | |
NCT02996682 | 7.1 | Definitions of Adverse Events, Adverse Reactions, and Serious Adverse Events | [] | |
NCT02996682 | 7.1.1 | Adverse Events | An adverse event (AE) is any untoward medical occurrence in a clinical study subject administered a medicinal product, which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medi... | [] |
NCT02996682 | 7.1.2 | Serious Adverse Events | A serious adverse event (SAE) is defined as an event that, at any dose, results in the following:
- Death
- Life-threatening (Note: The term "life-threatening" in the definition of "serious" refers to an event in which the subject was at risk of death at the time of the event; it does not refer to an event that hypoth... | [] |
NCT02996682 | 7.1.3 | Clinical Laboratory Abnormalities and Other Abnormal Assessments as Adverse Events or Serious Adverse Events | Laboratory abnormalities without clinical significance are not recorded as AEs or SAEs. However, laboratory abnormalities (eg, clinical chemistry, hematology, and urinalysis) that require medical or surgical intervention or lead to IMP interruption, modification, or discontinuation must be recorded as an AE, as well as... | [] |
NCT02996682 | 7.2 | Assessment of Adverse Events and Serious Adverse Events | The investigator or qualified subinvestigator is responsible for assessing AEs and SAEs for causality and severity, and for final review and confirmation of accuracy of event information and assessments. | [] |
NCT02996682 | 7.2.1 | Assessment of Causality for Study Drugs and Procedures | The investigator or qualified subinvestigator is responsible for assessing the relationship to study drug(s) therapy using clinical judgment and the following considerations:
- No: Evidence exists that the adverse event has an etiology other than the IMP. For SAEs, an alternative causality must be provided (eg, pre-ex... | [] |
NCT02996682 | 7.2.2 | Assessment of Severity | The severity grading of AEs will be assessed as Grade 1, 2, 3, or 4 using the GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities (Appendix 3). For AEs associated with laboratory abnormalities, the event should be graded on the basis of the clinical severity in the context of the underlying co... | [] |
NCT02996682 | 7.3 | Investigator Requirements and Instructions for Reporting Adverse Events and Serious Adverse Events to Gilead or CRO | Requirements for collection prior to study drug(s) initiation:
After informed consent, but prior to initiation of study drug(s), the following types of events should be reported on the case report form (eCRF): all SAEs, and adverse events related to protocol-mandated procedures.
Following initiation of study drug(s),... | [
"Adverse Events",
"Serious Adverse Events",
"Electronic Serious Adverse Event (eSAE) Reporting Process"
] |
NCT02996682 | 7.4 | Gilead Reporting Requirements | Depending on relevant local legislation or regulations, including the applicable US FDA Code of Federal Regulations, the EU Clinical Trials Directive (2001/20/EC) and relevant updates, and other country-specific legislation or regulations, Gilead may be required to expedite to worldwide regulatory agencies reports of S... | [] |
NCT02996682 | 7.5 | Toxicity Management | [] | |
NCT02996682 | 7.5.1 | RBV Dose Adjustments | Dose reduction or discontinuation of RBV due to toxicity is allowed at the discretion of the investigator. Once discontinued or reduced, the RBV dosing may be restarted or increased to the starting dose at the discretion of the investigator. RBV may be permanently discontinued due to toxicity without stopping SOF/VEL. ... | [] |
NCT02996682 | 7.6 | Special Situations Reports | [] | |
NCT02996682 | 7.6.1 | Definitions of Special Situations | Special situation reports include all reports of medication error, abuse, misuse, overdose, reports of adverse events associated with product complaints, and pregnancy reports regardless of an associated AE.
Medication error is any unintentional error in the prescribing, dispensing, or administration of a medicinal pr... | [] |
NCT02996682 | 7.6.2 | Instructions for Reporting Special Situations | [] | |
NCT02996682 | 7.6.2.1 | Instructions for Reporting Pregnancies | The investigator should report pregnancies in female study subjects that are identified after initiation of study drug(s) and throughout the study, including the post study drug(s) follow-up period, to Gilead DSPH by transmitting electronically and also by sending paper pregnancy report form within 24 hours of becoming... | [] |
NCT02996682 | 7.6.2.2 | Reporting Other Special Situations | All other special situation reports must be reported on electronic special situations report form and transmitted to Gilead DSPH within 24 hours of the investigator becoming aware of the situation. If for any reason it is not possible to record the special situation report (SSR) information electronically, ie, the eCRF... | [] |
NCT02996682 | 8 | STATISTICAL CONSIDERATIONS | [] | |
NCT02996682 | 8.1 | Analysis Objectives and Endpoints | [] | |
NCT02996682 | 8.1.1 | Analysis Objectives | The prima1y objectives of this study are:
- To evaluate the antiviral efficacy of therapy with sofosbuvir/velpatasvir (SOFNEL) fixed-dose combination (FDC) with or without ribavirin for 12 weeks as measured by the propmtion of subjects with sustained virologic response 12 weeks after cessation of treatment (SVR12)
- T... | [] |
NCT02996682 | 8.1.2 | Primary Endpoint | The prima1y efficacy endpoint is SVR12 (HCV RNA < LLOQ 12 weeks after cessation of treatment) in the Full Analysis Set (F AS) population.
The prima1y safety endpoint is any AE leading to pe1manent discontinuation of study mugs. | [] |
NCT02996682 | 8.1.3 | Secondary Endpoint | The secondary efficacy endpoints include the following:
- The proportion of subjects with HCV RNA < LLOQ at 4 and 24 weeks after cessation of treatment (SVR4 and SVR24)
- Proportion of subjects who have HCV RNA < LLOQ by visit while on treatment
- MELD and CPT score changes from Baseline
- HCV RNA change from Baseline... | [] |
NCT02996682 | 8.1.4 | Other Endpoints of Interest | Additional efficacy evaluations may include the health related quality of life endpoints. | [] |
NCT02996682 | 8.2 | Analysis Conventions | All individual subject data will be listed as measured. All statistical summaries and analyses will be performed using SAS® software (SAS Institute, Cary, North Carolina, USA).
The study drugs in this study include SOF/VEL FDC and RBV. Last dose of study drugs refers to the last dose of the study drugs in a treatment ... | [] |
NCT02996682 | 8.2.1 | Analysis Sets | [] | |
NCT02996682 | 8.2.1.1 | Efficacy | The primary analysis set for efficacy analysis is defined as the Full Analysis Set (FAS) which includes all randomized subjects who took at least 1 dose of study drug(s). | [] |
NCT02996682 | 8.2.1.2 | Safety | The primary analysis set for safety analyses will include all subjects who took at least 1 dose of study drug(s). Treatment-emergent data will be analyzed and defined as data collected from the first dose of study drugs through the date of last dose of study drugs plus 30 days. | [] |
NCT02996682 | 8.2.1.3 | Pharmacokinetics | The Pharmacokinetic (PK) Analysis Set includes all subjects who took at least 1 dose of the study drugs and have at least 1 nonmissing concentration value for the corresponding analyte in plasma. The analyte of interest may include SOF, GS-566500, GS-331007, VEL, and RBV (if appropriate). The PK analysis set will be us... | [] |
NCT02996682 | 8.3 | Data Handling Conventions | Missing data can have an impact upon the interpretation of the trial data. Other than the endpoints discussed below, values for missing data will not be imputed.
For the analyses of categorical HCV RNA data, missing posttreatment HCV RNA data will have the missing data imputed. Missing on-treatment HCV RNA will have t... | [] |
NCT02996682 | 8.4 | Demographic Data and Baseline Characteristics | Demographic and baseline measurements will be summarized using standard descriptive methods.
Demographic data will include age, sex, self-identified race and ethnicity. Baseline characteristic data will include body mass index, HCV RNA level (log10 IU/mL), genotype of HCV infection, IL28B genotype, CPT, MELD scores an... | [] |
NCT02996682 | 8.5 | Efficacy Analysis | [] | |
NCT02996682 | 8.5.1 | Primary Analysis | The primary efficacy endpoint for this study will be the proportion of subjects with SVR12, defined as HCV RNA < LLOQ 12 weeks after cessation of treatment. The primary analysis will be performed after all randomized and treated subjects have been followed through 12 weeks posttreatment or discontinued from study.
A p... | [] |
NCT02996682 | 8.5.2 | Secondary Analyses | The proportion of subjects with HCV RNA below LLOQ over time (including SVR endpoints) will be presented in tabular and graphical form.
Descriptive summaries and listings will be provided for additional efficacy evaluations including HCV RNA values and change from baseline through end of treatment, MELD and CPT scores... | [] |
NCT02996682 | 8.6 | Safety Analysis | Safety will be evaluated by assessment of clinicallaborat01y tests, physical examinations, and vital signs measurements and AEs will be docmnented at various time points during the study.
All safety data collected, on or after the first dose of study dtugs adtninistration up to 30 days after the last dose of study dt1... | [] |
NCT02996682 | 8.6.1 | Extent of Exposure | A subject's extent of exposure to the study dmg will be generated from the study dt11g adtninistration page of eCRF. Exposure data will be smnmarized by treatment group. | [] |
NCT02996682 | 8.6.2 | Adverse Events | Clinical and laboratory adverse events will be coded using the Medical Dictionary for Regulat01y Activities (MedDRA). System Organ Class (SOC), High-Level Group Tetm (HLGT), High-Level Tenn (HLT), Prefened Te1m (PT), and Lower-Level Te1m (LLT) will be attached to the clinical database.
Events will be summarized on the... | [] |
NCT02996682 | 8.6.3 | Laboratory Evaluations | Selected laboratory data will be summarized (n, mean, SD, median, Q1, Q3, minimum, and maximum) by treatment group and study visit along with corresponding change from baseline.
Graded laboratory abnormalities will be defined using the laboratory toxicity grading scheme defined in Appendix 3 of this protocol. The inci... | [] |
NCT02996682 | 8.6.4 | Other Safety Evaluations | Individual data for vital signs measurements will be listed by subject and summarized by treatment group by descriptive statistical summaries (n, mean, SD, median, Q1, Q3, minimum, and maximum), as appropriate. | [] |
NCT02996682 | 8.7 | Pharmacokinetic Analysis | In the PK analysis set, concentrations of SOF, its metabolites GS-566500 and GS-331007, VEL, and RBV (if appropriate) in plasma may be determined using validated bioanalytical assays and listed. Details of the analyses will be provided in the pharmacokinetic reporting and analysis plan. | [] |
NCT02996682 | 8.8 | Sample Size | A sample size of 50 subjects in each treatment group will provide over 99% power to detect at least 40% improvement in SVR12 rate from the assumed spontaneous rate of 1% or less using a two-sided exact one-sample binomial test at significance level of 0.025. | [] |
NCT02996682 | 8.9 | Data Monitoring Committee | An external multidisciplinary data monitoring committee (DMC) will perform a review of accumulated safety data from the first 20 subjects with CPT B cirrhosis at Screening enrolled through 4 weeks of treatment (or treatment discontinuation) and provide a recommendation to Gilead on whether these data support enrollment... | [] |
NCT02996682 | 9 | RESPONSIBILITIES | [] | |
NCT02996682 | 9.1 | Investigator Responsibilities | [] | |
NCT02996682 | 9.1.1 | Good Clinical Practice | The investigator will ensure that this study is conducted in accordance with the principles of the Declaration of Helsinki (as amended in Edinburgh, Tokyo, Venice, Hong Kong, and South Africa), International Conference on Harmonisation (ICH) guidelines, or with the laws and regulations of the country in which the resea... | [] |
NCT02996682 | 9.1.2 | Institutional Review Board (IRB)/Independent Ethics Committee (IEC) Review and Approval | The investigator (or sponsor as appropriate according to local regulations) will submit this protocol, informed consent form, and any accompanying material to be provided to the subject (such as advertisements, subject information sheets, or descriptions of the study used to obtain informed consent) to an IRB or IEC. T... | [] |
NCT02996682 | 9.1.3 | Informed Consent | The investigator is responsible for obtaining written informed consent from each individual participating in this study after adequate explanation of the aims, methods, objectives, and potential hazards of the study and before undertaking any study-related procedures. The
investigator must use the most current approve... | [] |
NCT02996682 | 9.1.4 | Confidentiality | The investigator must assure that subjects' anonymity will be strictly maintained and that their identities are protected from unauthorized parties. Only subject initials, date of birth, another unique identifier (as allowed by local law), and an identification code will be recorded on any form or biological sample sub... | [] |
NCT02996682 | 9.1.5 | Study Files and Retention of Records | The investigator must maintain adequate and accurate records to enable the conduct of the study to be fully documented and the study data to be subsequently verified. These documents should be classified into at least the following two categories: (1) investigator's study file, and (2) subject clinical source documents... | [] |
NCT02996682 | 9.1.6 | Case Report Forms | For each subject consented, an eCRF will be completed by an authorized study staff member whose training for this function is documented according to study procedures. eCRF should be completed on the day of the subject visit to enable the sponsor to perform central monitoring of safety data. The Eligibility Criteria eC... | [] |
NCT02996682 | 9.1.7 | Study Drug Accountability and Return | Gilead recommends that used and unused study drugs supplies be returned to the shipping facility from which it came for eventual destruction. The study monitor will provide instructions for return. If return is not possible, the study monitor will evaluate each study center's study drugs disposal procedures and provide... | [] |
NCT02996682 | 9.1.8 | Inspections | The investigator will make available all source documents and other records for this trial to Gilead's appointed study monitors, to IRB/IECs, or to regulatory authority or health authority inspectors. | [] |
NCT02996682 | 9.1.9 | Protocol Compliance | The investigator is responsible for ensuring the study is conducted in accordance with the procedures and evaluations described in this protocol. | [] |
NCT02996682 | 9.2 | Sponsor Responsibilities | [] | |
NCT02996682 | 9.2.1 | Protocol Modifications | Protocol modifications, except those intended to reduce immediate risk to study subjects, may be made only by Gilead. The investigator must submit all protocol modifications to the IRB or IEC in accordance with local requirements and receive documented approval before modifications can be implemented. | [] |
NCT02996682 | 9.2.2 | Study Report and Publications | A clinical study report (CSR) will be prepared and provided to the regulatory agency. Gilead will ensure that the report meets the standards set out in the ICH Guideline for Structure and Content of Clinical Study Reports (ICH E3). Note that an abbreviated report may be prepared in certain cases.
Investigators in this... | [] |
NCT02996682 | 9.3 | Joint Investigator/Sponsor Responsibilities | [] | |
NCT02996682 | 9.3.1 | Access to Information for Monitoring | In accordance with ICH Good Clinical Practice (ICH GCP) guidelines, the study monitor must have direct access to the investigator's source documentation in order to verify the accuracy of the data recorded in the eCRF.
The monitor is responsible for routine review of the eCRF at regular intervals throughout the study ... | [] |
NCT02996682 | 9.3.2 | Access to Information for Auditing or Inspections | Representatives of regulatory authorities or of Gilead may conduct inspections or audits of the clinical study. If the investigator is notified of an inspection by a regulatory authority the investigator agrees to notify Gilead or the CRO immediately. The investigator agrees to provide to representatives of a regulator... | [] |
NCT02996682 | 9.3.3 | Study Discontinuation | Both the sponsor and the investigator reserve the right to terminate the study at any time. Should this be necessary, both parties will arrange discontinuation procedures and notify the appropriate regulatory authority(ies), IRBs, and IECs. In terminating the study, Gilead and the investigator will assure that adequate... | [] |
NCT02996682 | 10 | REFERENCES | - Allison RD, Tong X, Moorman AC, Ly KN, Rupp L, Xu F, et al. Increased Incidence of Cancer and Cancer-related Mortality Among Persons with Chronic Hepatitis C Infection, 2006-2010. J Hepatol 2015.
- Arias A, Aguilera A, Soriano V, Benitez-Gutierrez L, Lledo G, Navarro D, et al. Rate and predictors of treatment failure... | [] |
NCT02996682 | 11 | APPENDICES | | Appendix 1. | Investigator Signature Page |
|-------------|-----------------------------|
| Appendix 2. | Study Procedures Table |
Appendix 3. GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities Appendix 4. Pregnancy Precautions, Definition for Female of Childbearing Potential, and
Co... | [
"Appendix 1. Investigator Signature Page",
"STUDY ACKNOWLEDGEl\\tiENT",
"Notes:",
"Appendix 4. Pregnancy Precautions, Definition for Female of Childbearing Potential, and Contraceptive Requirements",
"1) Background",
"a) Ribavirin Warnings for Pregnancy",
"2) Definitions",
"a) Definition of Childbeari... |
NCT03329092 | 1 | INTRODUCTION | [] | |
NCT03329092 | 1.1 | Background | The prevalence of multidrug resistant (MDR) bacteria is increasing worldwide. This has become a significant public health threat as there are fewer, or even sometimes no, effective antimicrobial agents available for infections caused by MDR bacteria (Lucasti et al. 2013; Magiorakos et al. 2012). In particular, ongoing ... | [] |
NCT03329092 | 1.2 | Mechanism of Action/Indication | With more than 30 years of use worldwide, aztreonam (ATM) is an established injectable antibiotic indicated for the treatment of various infections caused by Gram-negative bacteria including but not limited to pneumonia and complicated intra abdominal infections (cIAIs) (see Summary of Product Characteristics [SmPC] of... | [] |
NCT03329092 | 1.3 | Rationale for Conducting This Study | The combination product referred to as ATM-AVI in this Clinical Study Protocol (CSP) is being developed for the treatment of serious infections caused by Gram-negative bacteria for which there are limited or no treatment options. These include infections caused by MBL-producing pathogens that can also co-produce ESBLs,... | [] |
NCT03329092 | 1.4 | Rationale for Study Design, Doses and Control Groups | In patients with hospital-acquired pneumonia/ventilator-associated pneumonia (HAP/VAP) and cIAIs, Gram-negative pathogens, including those producing ESBLs and AmpC β-lactamases, are important causative pathogens.
Most intra-abdominal infections are polymicrobial and caused by organisms residing in the gastrointestinal... | [] |
NCT03329092 | 1.4.1 | Study Design and Control Group | This is a Phase 3 prospective, randomized, open-label, central assessor-blinded, parallel group, multicenter comparative study to determine the efficacy, safety and tolerability of aztreonam-avibactam ±metronidazole (ATM-AVI ±MTZ) versus meropenem ±colistin (MER ±COL) in the treatment of serious infections due to Gram-... | [] |
NCT03329092 | 1.4.2 | Dose Selection for ATM-AVI | The intention for ATM-AVI is that it will be active against clinically isolated Gram-negative bacteria for which there are limited or no treatment options. The ATM-AVI doses for this Phase 3 study have been selected based on pre-clinical and clinical data on ATM-AVI, using PK data for ATM, AVI and ATM-AVI and including... | [
"Dose selection (ATM-AVI) for patients with normal renal function or mild renal impairment (CrCL >50 mL/min)"
] |
NCT03329092 | 1.4.3 | Dose Selection for Metronidazole | MTZ will be co-administered with ATM-AVI in patients with cIAI for the entire duration of study drug treatment (5 to 14 days) to provide coverage for anaerobic pathogens. The dose to be administered (500 mg MTZ IV over 1 hour q8h starting after the extended loading dose [second dose] of ATM-AVI) was chosen based on the... | [] |
NCT03329092 | 1.4.4 | Dose Selection for Meropenem | The dose of MER selected for this study (1 g IV q8h over 30 minutes) is consistent with the currently labeled recommendations for adult patients with cIAI (MERONEM SmPC 2017, MERREM 2016) and HAP/VAP (MERONEM SmPC 2017). The protocol allows for the option to use an increased dose of MER (2 g IV q8h) in the case of prov... | [] |
NCT03329092 | 1.4.5 | Dose Selection for Colistin | The COL dosing regimen specified by the study protocol is consistent with recent guidance issued by EMA (EMA 2014a and EMA 2014b), which indicates that COL should be dosed and monitored as follows: a loading dose of 9 million international units (IU) over 30 to 60 minutes, followed by 9 million IU daily in 2 or 3 divid... | [] |
NCT03329092 | 1.5 | Single Reference Safety Document | Additional information for ATM-AVI may be found in the single reference safety document (SRSD), which for this study is the ATM-AVI Investigator Brochure (IB).
The SRSD for co- administered drug MTZ is MTZ United Kingdom (UK) SmPCs (Baxter Healthcare Ltd.) and Metronidazole, CHINA; Metronidazole, USA. The SRSD for com... | [] |
NCT03329092 | 1.6 | Benefits/Risk and Ethical Assessment | Patients enrolled into this clinical study will have cIAIs requiring surgical intervention (including open laparotomy, percutaneous drainage of an abscess and laparoscopic surgery) or nosocomial pneumonia (NP) including HAP and VAP that are of sufficient severity to require hospitalization and treatment with IV antibio... | [] |
NCT03329092 | 2 | STUDY OBJECTIVES AND ENDPOINTS | [] | |
NCT03329092 | 2.1 | Primary Objective | Based on differing regulatory requirements for EMA and FDA, the following objectives and outcome measures may differ for the US and non-US countries analyses as noted below.
| PrimaryObjective: | Primary Endpoint: |
|----------------------------------... | [] |
NCT03329092 | 2.2 | Secondary Objectives | | SecondaryObjectives: ... | [] |
NCT03329092 | 2.3 | Safety Objectives | | SafetyObjective: | Safety Endpoint: |
|----------------... | [] |
NCT03329092 | 2.4 | Tertiary Objectives | | TertiaryObjective: | Tertiary Endpoint(s): ... | [] |
NCT03329092 | 2.5 | Exploratory Objectives | | Exploratory Objectives: | ExploratoryEndpoint(s): ... | [] |
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