protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT04870606 | 11.3 | Informed Consent Procedures | 11.3 Informed Consent Procedures For each study subject, written informed consent will be obtained prior to any protocol-related activities. As part of this procedure, the Principal Investigator or one of his/her associates must explain orally and in writing the nature, duration, and purpose of the study, and the actio... | [] |
NCT04870606 | 11.4 | Discontinuation of the Study | 11.4 Discontinuation of the Study Discontinuation of specific sites or of the study as a whole are handled as part of regulatory, ethical, and study oversight considerations. In rare instances, it may be necessary for a subject to permanently discontinue (definitive discontinuation) study intervention. | [] |
NCT04870606 | 11.5 | Publication of Study Protocol and Results | 11.5 Publication of Study Protocol and Results Both the use of data and the publication policy are detailed within the clinical study agreement. Intellectual property rights (and related matters) generated by the Investigator and others performing the clinical study will be subject to the terms of a clinical study agre... | [] |
NCT04870606 | 11.6 | Study Documentation, Record Keeping and Retention of Documents | 11.6 Study Documentation, Record Keeping and Retention of Documents The Investigator must maintain all study documentation as confidential and take measures to prevent accidental or premature destruction of these documents. The Investigator must retain the study documents at least 2 years after the last approval of a m... | [] |
NCT04870606 | 11.7 | Source Documents | 11.7 Source Documents Source documents provide evidence for the existence of the subject and substantiate the integrity of the data collected. Source documents are filed at the Investigator's site. Data reported in the eCRF that are transcribed from source documents must be consistent with the source documents or the d... | [] |
NCT04870606 | 11.8 | Confidentiality of Study Documents and Subject Records | 11.8 Confidentiality of Study Documents and Subject Records All communications, reports, and subject samples will be identified by site number, and a code number and/or initials to maintain subject confidentiality. All records will be kept confidential to the extent permitted by law. If a waiver or authorization separa... | [] |
NCT04870606 | 11.9 | Audits and Inspections | 11.9 Audits and Inspections Suzhou Kintor Pharmaceuticals, Inc.'s Quality Assurance Unit (or representative) may conduct audits at the study site(s). Audits will include, but are not limited to: drug supply, presence of required documents, the informed consent process, laboratory specimen processing, and comparison of ... | [] |
NCT04870606 | 11.10 | Financial Disclosures | 11.10 Financial Disclosures Prior to the study commencing, the Sponsor (or its designee) and the Investigator (or the institution, as applicable) will agree on costs necessary to perform the study. This agreement will be documented in a financial agreement that will be signed by the Investigator (or the institution sig... | [] |
NCT04870606 | 12 | PROTOCOL ADHERENCE | 12. PROTOCOL ADHERENCE The Investigator will not make any changes to this protocol without prior written consent from the Sponsor Suzhou Kintor Pharmaceuticals, Inc. and subsequent approval by the IRB/IEC. Any permanent change to the protocol, whether it is an overall change or a change for specific study center(s), mu... | [] |
NCT04870606 | 13 | REFERENCES | 13. REFERENCES - Hoffmann M, Kleine-Weber H, Schroeder S, Krüger N, Herrier T, Erichsen S, Schiergens TS, Herrler G, Wu NH, Nitsche A, Müller M, Drosten C, Pöhlmann, S. n.d. - C., Jennison, and B. W. Turnbull. 2000. Group Sequential Methods with Applications to Clinical Trials. - Damien A. Leach, Ana-Maria Isac, Charlo... | [] |
NCT04870606 | 14 | APPENDICES | 14.APPENDICES
Appendix 1. Drugs that Should Be Used Cautiously with GT0918 | | Strong Inhibitors | Moderate Inhibitors | Weak Inhibitors | |--------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [
"Appendix 1. Drugs that Should Be Used Cautiously with GT0918",
"Appendix 2. Common COVID-19-Related Symptoms",
"Appendix 3 COVID-19: BASELINE SEVERITY CATEGORIZATION (Developing Drugs and Biological Products for Treatment or Prevention Guidance for Industry )",
"SARS-CoV-2 infection without symptoms",
"Mil... |
NCT04922554 | 1 | DISCLOSURE STATEMENT | 1 DISCLOSURE STATEMENT
Restricted Distribution of Documents This document contains information that is confidential and proprietary to the sponsor. This information is being provided to you solely for the purpose of evaluating and/or conducting a clinical study for the sponsor. You may disclose the contents of this do... | [
"Restricted Distribution of Documents"
] |
NCT04922554 | 2 | CONTACTS | 2 CONTACTS | [] |
NCT04922554 | 2.1 | Emergency Contacts | 2.1 Emergency Contacts Phone (during business hours): Phone (after business hours): E-mail (not for emergencies):  | [] |
NCT04922554 | 2.2 | Additional Contacts | 2.2 Additional Contacts SAE contact information: E-Mail: clinicalsafety@propharmagroup.com | [] |
NCT04922554 | 3 | INTRODUCTION | 3 INTRODUCTION | [] |
NCT04922554 | 3.1 | Nontuberculous Mycobacterial Pulmonary Disease | 3.1 Nontuberculous Mycobacterial Pulmonary Disease More than 140 nontuberculous mycobacterial (NTM) species have been identified, with more than half of the NTM pulmonary infections in the United States (US) associated with Mycobacterium avium complex (MAC) (Prevots 2010; Spaulding 2017). Mycobacterium abscessus comple... | [] |
NCT04922554 | 3.2 | Omadacycline | 3.2 Omadacycline The investigational product, omadacycline (formerly named PTK 0796), is the first member of the aminomethylcycline class of antibiotics, which are semisynthetic derivatives of the tetracycline class. As a class, tetracyclines have been in use for approximately 70 years. They are well-tolerated and have... | [] |
NCT04922554 | 3.3 | Properties of Omadacycline that Address the Unmet Treatment Need for M. abscessus Complex Pulmonary Infection | 3.3 Properties of Omadacycline that Address the Unmet Treatment Need for M. abscessus Complex Pulmonary Infection Omadacycline has several key characteristics that may prove beneficial to patients with MABc pulmonary infection: - Potent in vitro activity versus M. abscessus complex subspecies - No antagonism in vitro w... | [] |
NCT04922554 | 4 | STUDY OBJECTIVES AND ENDPOINTS | 4 STUDY OBJECTIVES AND ENDPOINTS | | Endpoint | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------... | [] |
NCT04922554 | 5 | INVESTIGATIONAL PLAN | 5 INVESTIGATIONAL PLAN | [] |
NCT04922554 | 5.1 | Overall Study Description | 5.1 Overall Study Description This is a Phase 2, double-blind, randomized, placebo-controlled, parallel-group, multi-center study in adults with NTM pulmonary disease caused by MABc. The study design is shown in Figure 1. Figure 1. Study Design Schema  Following a Screening period of up to 56 day... | [] |
NCT04922554 | 5.2 | Rationale for Study Design | 5.2 Rationale for Study Design This study is intended to assess the safety and efficacy of omadacycline in addition to nonpharmacologic standard of care in NTM subjects caused by MABc. Non-pharmacologic measures, including patient education, airway clearance technique, inspiratory muscle training, and exercise training... | [] |
NCT04922554 | 5.3 | Approximate Duration of Study | 5.3 Approximate Duration of Study The study is expected to be clinically complete in approximately 28 months. | [] |
NCT04922554 | 5.4 | Approximate Number of Subjects | 5.4 Approximate Number of Subjects Approximately 75 subjects (45 omadacycline and 30 placebo) will be enrolled at approximately 20 sites within the US. | [] |
NCT04922554 | 6 | STUDY POPULATION SELECTION | 6 STUDY POPULATION SELECTION Each subject must participate in the informed consent process and sign and date an IRB/IEC/REB-approved informed consent form (ICF) before any procedures specified in this protocol are performed. | [] |
NCT04922554 | 6.1 | Study Population | 6.1 Study Population This study will evaluate adult subjects with NTM pulmonary disease caused by MABc. | [] |
NCT04922554 | 6.2 | Inclusion Criteria | 6.2 Inclusion Criteria Subjects must meet all of the following criteria at Screening and/or Baseline to be eligible to participate in the study: - 1. Written and signed informed consent must be obtained before any protocol-specific assessment is performed. - 2. Male and female subjects age 18 years or older. - 3. Diagn... | [] |
NCT04922554 | 6.3 | Exclusion Criteria | 6.3 Exclusion Criteria Subjects meeting any of the following criteria at Screening and/or Baseline will be excluded from participation in the study: - 1. Pregnant or nursing (breastfeeding) women. - 2. Has received antibiotic treatment within 6 months prior to Screening for MABc or MAC. - 3. Has received systemic or in... | [] |
NCT04922554 | 6.4 | Screen Failures | 6.4 Screen Failures Subjects who sign the ICF but withdraw or are withdrawn from the study before random assignment to double-blind treatment are defined as screen failures. All screen failures should be recorded on the subject master list. Limited information including reason for screen failure will be recorded on the... | [] |
NCT04922554 | 7 | STUDY TREATMENT(S) | 7 STUDY TREATMENT(S) | [] |
NCT04922554 | 7.1 | Treatments Administered | 7.1 Treatments Administered Test articles will be supplied by Paratek Pharmaceuticals, Inc. (the sponsor). Test articles will be labeled according to regulations. The test articles should be administered only to subjects who have provided informed consent and who meet all of the inclusion criteria and none of the exclu... | [] |
NCT04922554 | 7.2 | Identity of the Investigational Product: Omadacycline | 7.2 Identity of the Investigational Product: Omadacycline
Oral Formulation (Omadacycline) 
Placebo | Name | Placebo tablets | |-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------... | [
"Oral Formulation (Omadacycline)",
"Placebo"
] |
NCT04922554 | 7.3 | Dose Selection Rationale | 7.3 Dose Selection Rationale The dosing regimen of omadacycline selected for this study is based on the demonstration of efficacy in a mouse model of M. abscessus pulmonary infection, as well as the totality of nonclinical and clinical experience to date, including in vitro antibacterial activity, PK characteristics, a... | [] |
NCT04922554 | 7.4 | Description of Treatments | 7.4 Description of Treatments Subjects will be randomized (1.5:1) to 1 of the following treatment groups: - Group 1: 300 mg oral omadacycline (2 × 150 mg tablets administered once daily, q24h) - Group 2: Placebo tablets resembling omadacycline (2 tablets administered once daily, q24h) | [] |
NCT04922554 | 7.5 | Test Article Administration | 7.5 Test Article Administration | [] |
NCT04922554 | 7.5.1 | Oral Administration of Test Article | 7.5.1 Oral Administration of Test Article All doses of oral test article should be taken with water once daily, at approximately the same time of day. All doses should be taken in a fasted state. Fasting is defined as no food, antacids or multivitamins containing multivalent cations (eg, aluminum, magnesium, calcium, b... | [] |
NCT04922554 | 7.6 | Dose Adjustments and Interruptions of Test Article | 7.6 Dose Adjustments and Interruptions of Test Article No dose adjustments or planned interruptions of test article will be permitted during this study. | [] |
NCT04922554 | 7.7 | Method of Assigning Patients to Treatment Groups | 7.7 Method of Assigning Patients to Treatment Groups All eligible subjects will be randomized via an IxRS that assigns them to the treatment group in a 1.5 to 1 ratio (omadacycline: placebo). The site delegate will contact the IxRS after confirming that the subject fulfills all the inclusion criteria and has none of th... | [] |
NCT04922554 | 7.7.1 | Subject Numbering | 7.7.1 Subject Numbering Upon the subject signing the informed consent, site personnel should enter the subject in the IxRS, and the subject will be assigned a unique subject number. Subjects who have been pre-screened but who do not sign an ICF will not be assigned a subject number. A subject who discontinues participa... | [] |
NCT04922554 | 7.8 | Dispensing Test Article | 7.8 Dispensing Test Article Each study site will be supplied by the sponsor with the test article. Oral test article supplies are completely blinded, and blinded study personnel can conduct storage, dispensation, and reconciliation. The IxRS will assign the test article kit to be given to the subject. Oral test article... | [] |
NCT04922554 | 7.9 | Blinding | 7.9 Blinding The investigator and sponsor will be blinded to treatment group assignments throughout the study. The sponsor designee (eg, clinical supply manager, IxRS vendor, etc.) will have a designated randomization administrator who will maintain the randomization codes in accordance with standard operating procedur... | [] |
NCT04922554 | 7.10 | Emergency Unblinding of Treatment Assignment | 7.10 Emergency Unblinding of Treatment Assignment Emergency unblinding should only be undertaken when it is essential to treat the subject safely and efficaciously. Most often, test article discontinuation and knowledge of the possible treatment assignments are sufficient to treat a study subject who presents with an e... | [] |
NCT04922554 | 7.11 | Prior and Concomitant Therapy | 7.11 Prior and Concomitant Therapy - All antibiotics administered for the subject's MABc or MAC infection within 2 years prior to the date of informed consent will be recorded in the eCRF. - All significant non-pharmacological therapies related to MABc infection including patient education, airway clearance technique, ... | [] |
NCT04922554 | 7.12 | Prohibited Therapy | 7.12 Prohibited Therapy The following therapies (including timeframe for exclusion) are prohibited: - Antibiotic treatment for MABc or MAC infection (including systemic or inhaled antibiotics) within 6 months prior to Screening and through Day 84/end of treatment (EOT) visit - Systemic or inhaled antibiotic therapy (ot... | [] |
NCT04922554 | 7.13 | Permitted Treatments | 7.13 Permitted Treatments All other treatments not specified as prohibited are permitted during the study. Subjects requiring additional or alternative therapy for their MABc NTM pulmonary disease will be discontinued from test article. Further treatment for their infection is at the discretion of the investigator or t... | [] |
NCT04922554 | 7.14 | Treatment Compliance | 7.14 Treatment Compliance Subjects will record daily test article dosing information in a paper diary. Study personnel at the site should monitor oral test article compliance at each study visit by comparing the returned test article with the dosing information reported by the subject. Compliance and any unresolved dis... | [] |
NCT04922554 | 7.15 | Packaging and Labeling | 7.15 Packaging and Labeling The investigational test article, omadacycline, and the placebo will be packaged by the sponsor and supplied to the investigator. | [] |
NCT04922554 | 7.16 | Storage and Accountability | 7.16 Storage and Accountability Test article must be received at the study site by a designated person, acknowledged in the IxRS, handled and stored safely and properly, and kept in a secured location to which only the investigator and designated staff have access. Upon receipt, the test article should be stored accord... | [] |
NCT04922554 | 7.17 | Investigational Product Retention at Study Site | 7.17 Investigational Product Retention at Study Site At the conclusion of the study, and as appropriate during the course of the study, with instruction and approval from the sponsor, the designated study personnel will destroy on site as permitted by local site operating procedures, or return all unused test articles,... | [] |
NCT04922554 | 8 | STUDY PROCEDURES | 8 STUDY PROCEDURES Written, signed, and dated informed consent will be obtained before any study-related procedures have been performed. Upon signing the informed consent, the subject will be assigned a study subject number. Subjects who have been pre-screened but who do not sign an ICF will not be assigned a subject n... | [] |
NCT04922554 | 8.1 | Informed Consent | 8.1 Informed Consent The investigator will provide for the protection of the subjects by following all applicable regulations. These regulations are available upon request from the sponsor. The ICF must be reviewed by the sponsor and approved by the IRB/IEC/REB. Before any procedures specified in the protocol are perfo... | [] |
NCT04922554 | 8.2 | Subject Demographics/Other Baseline Characteristics | 8.2 Subject Demographics/Other Baseline Characteristics Subject demographic and baseline characteristic data to be collected on all subjects include date of birth (per local regulations), gender, and race/ethnicity. | [] |
NCT04922554 | 8.3 | Medical History | 8.3 Medical History The investigator will perform a comprehensive history at the Screening visit. Significant medical history (at any time) and any medical history within the past 6 months including ongoing medical conditions at the time of signing of the ICF will be recorded. Where possible, diagnoses are to be record... | [] |
NCT04922554 | 8.4 | Physical Examination | 8.4 Physical Examination At Screening and Day 84/EOT, a full physical examination will include the examination of general appearance, skin, neck (including thyroid), eyes, ears, nose, throat, lungs, heart, abdomen, back, lymph nodes, extremities, and vascular and neurological systems. Information for all physical exami... | [] |
NCT04922554 | 8.5 | Vital Signs | 8.5 Vital Signs Vital signs including blood pressure, heart rate, body temperature, and pulse oximetry will be measured at the timepoints as specified in Appendix 1. The subject's vital signs should be captured after at least 5 minutes (+ 5 minutes) of rest while in a non-standing position (supine or sitting). Subseque... | [] |
NCT04922554 | 8.6 | Height, Weight and Body Mass Index | 8.6 Height, Weight and Body Mass Index Height and body weight should be obtained with the subject's shoes off and recorded in the eCRF at the timepoints as specified in Appendix 1. Body mass index will be automatically calculated upon entry of height and weight in the eCRF. | [] |
NCT04922554 | 8.7 | Electrocardiogram | 8.7 Electrocardiogram A standard 12-lead ECG should be obtained using site equipment. The ECG will be obtained after the subject has been in a semi-recumbent position for approximately 10 minutes at the Screening and Day 84/EOT Visit. Reading and interpretation of the ECG will be performed locally by the investigator, ... | [] |
NCT04922554 | 8.8 | Computed Tomography Scan – Chest | 8.8 Computed Tomography Scan – Chest Computed tomography scans of the chest will be performed using site equipment or local radiology facility. High resolution CT scan is preferred, if available. The CT scan will be interpreted by appropriately qualified personnel who are certified or licensed to interpret chest radiog... | [] |
NCT04922554 | 8.9 | Clinical Laboratory Tests | 8.9 Clinical Laboratory Tests | [] |
NCT04922554 | 8.9.1 | Central Safety Laboratory Parameters | 8.9.1 Central Safety Laboratory Parameters A Central Laboratory will be used for safety analysis of all specimens collected. Details on the collection tubes and containers, shipment of samples and reporting of results by the Central Laboratory are provided to investigators in the Central Laboratory Manual. The total vo... | [] |
NCT04922554 | 8.9.2 | Local Safety Laboratory Parameters | 8.9.2 Local Safety Laboratory Parameters All female subjects will have a local urine or serum pregnancy test at the site during Screening and at the Baseline Visit (just prior to randomization). Urine pregnancy test kits will be provided by the sponsor through the Central Laboratory. If a positive urine or serum pregna... | [] |
NCT04922554 | 8.10 | Sputum Collection For Microbiology | 8.10 Sputum Collection For Microbiology A Central Specialty Microbiology Laboratory will be used for analysis of all sputum specimens. Details on the collection supplies, shipment of samples and reporting of results are provided to investigators in the Central Laboratory Manual. Pre-dose expectorated or induced sputum ... | [] |
NCT04922554 | 8.11 | Serum and Plasma Collection for Biomarkers (optional) | 8.11 Serum and Plasma Collection for Biomarkers (optional) Serum and plasma for biomarkers will be collected and stored at a central laboratory for future use for all subjects who provide consent for this optional portion of the study. Samples may be stored for a period of up to 2 years after the completion (terminatio... | [] |
NCT04922554 | 8.12 | NTM Symptom Assessment Questionnaire | 8.12 NTM Symptom Assessment Questionnaire The NTM Symptom Assessment Questionnaire is a tool created by Paratek to evaluate efficacy based on individual subject assessment of symptoms. It is a self-administered questionnaire that evaluates a list of 12 common NTM symptoms, asking subjects if they have experienced each ... | [] |
NCT04922554 | 8.13 | Other Patient-Reported Outcomes and Clinician-Assessed Outcomes | 8.13 Other Patient-Reported Outcomes and Clinician-Assessed Outcomes Patient-reported outcomes are being utilized in this study to help understand and assess the subject's health, quality of life or functional status associated with the disease under study and treatment received. The PROs are completed by the subject w... | [] |
NCT04922554 | 8.13.1 | Quality of Life – Bronchiectasis | 8.13.1 Quality of Life – Bronchiectasis The QOL-B is a self-administered, patient-reported outcome measure assessing symptoms, functioning and health-related quality of life for patients with non-cystic fibrosis bronchiectasis using a series of 37 questions. | [] |
NCT04922554 | 8.13.2 | St. Georges Respiratory Questionnaire | 8.13.2 St. Georges Respiratory Questionnaire The SGRQ is a self-administered questionnaire that assesses health-related quality of life in subjects with chronic pulmonary disease by evaluating 3 health domains: - symptoms (distress caused by respiratory symptoms) - activity (effects of disturbances to mobility and phys... | [] |
NCT04922554 | 8.13.3 | Patient-Reported Outcomes Measurement Information System Short Form v1.0 – Fatigue 7a Daily | 8.13.3 Patient-Reported Outcomes Measurement Information System Short Form v1.0 – Fatigue 7a Daily The PROMIS Fatigue is a self-administered questionnaire that assesses fatigue and its impact on physical, mental, and social activities. The fatigue short form is universal rather than disease-specific and assesses fatigu... | [] |
NCT04922554 | 8.13.4 | Patient Clinical Impression of Severity | 8.13.4 Patient Clinical Impression of Severity The PGI-S is a self-administered, single question assessed using a 7-point scale that measures a subject's perception of disease severity. | [] |
NCT04922554 | 8.13.5 | Patient Clinical Impression of Change | 8.13.5 Patient Clinical Impression of Change The PGI-C is a self-administered, single question assessed using a 7-point scale that measures a subject's perceived change in clinical status and overall improvement. | [] |
NCT04922554 | 8.13.6 | Clinical Global Impression – Severity of Illness | 8.13.6 Clinical Global Impression – Severity of Illness The CGI-S is administered by an experienced clinician who is familiar with the disease under study. The CGI-S is a 1-item observer-rated scale that rates illness severity based upon observed and reported symptoms, behavior, and function over the past seven days. | [] |
NCT04922554 | 8.13.7 | Clinical Global Impression – Improvement | 8.13.7 Clinical Global Impression – Improvement The CGI-I is administered by an experienced clinician who is familiar with the disease under study and who can make an expert judgment about the total picture of the subject at each visit. The CGI-I is a 1-item observer-rated scale that rates total subject improvement com... | [] |
NCT04922554 | 8.14 | Adverse Events | 8.14 Adverse Events An AE is any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given a test article or in a clinical study. The event does not need to be causally related to the test article or clinical study. An AE inclu... | [] |
NCT04922554 | 8.15 | Serious Adverse Events | 8.15 Serious Adverse Events An SAE is an AE that: - Results in death. - Is life-threatening (see below). - Requires hospitalization or prolongation of an existing hospitalization (see below). - Results in a persistent or significant disability or incapacity (see below). - Results in a congenital anomaly or birth defect... | [] |
NCT04922554 | 8.16 | Other Reportable Information | 8.16 Other Reportable Information Certain information, although not considered an SAE, must be recorded, reported, and followed up as indicated for an SAE. This includes: - Pregnancy exposure to a test article: If a pregnancy is confirmed, use of the test article must be discontinued immediately. Information about preg... | [] |
NCT04922554 | 8.17 | Overdose | 8.17 Overdose Any administration of omadacycline of greater than 600 mg within a 24-hour period will be an overdose, regardless of whether the overdose is intentional or accidental. It is a reportable event and the sponsor must be notified within 1 business day. The physician managing the overdose may order any test he... | [] |
NCT04922554 | 8.18 | Medication Errors | 8.18 Medication Errors Medication errors are the result of administration or consumption of the wrong product, by the wrong subject, at the wrong time, and/or by the wrong administration route, due to human error. Medication errors include, but are not limited to, the following: - The administration and/or consumption ... | [] |
NCT04922554 | 8.19 | Recording and Reporting | 8.19 Recording and Reporting A subject's AEs and SAEs will be recorded and reported from the signing of the ICF to the time of the Follow-up assessment. The investigator must instruct the subject to report AEs and SAEs during this time period. Reports of death after the last study contact with the subject will be repor... | [] |
NCT04922554 | 8.19.1 | Serious Adverse Event Reporting | 8.19.1 Serious Adverse Event Reporting All SAEs and follow-up information must be reported within 1 business day or 24 hours as required by local regulations by emailing a completed SAE Report to the email address below.  | [] |
NCT04922554 | 8.19.2 | Assessment of Relatedness | 8.19.2 Assessment of Relatedness The investigator will assess causality (ie, whether there is a reasonable possibility that test article caused the event) for all AEs and SAEs. The relationship will be characterized using the following classification: - Not Related: This relationship suggests that there is no associati... | [] |
NCT04922554 | 8.19.3 | Assessment of Severity | 8.19.3 Assessment of Severity The severity (or intensity) of an AE will be classified using the following criteria: - Mild: These events are usually transient, require minimal or no treatment, and do not interfere with the subject's daily activities. - Moderate: These events result in a low level of inconvenience or co... | [] |
NCT04922554 | 8.19.4 | Laboratory Findings | 8.19.4 Laboratory Findings Protocol-defined safety laboratory test results will be analyzed as part of specific laboratory safety analyses. Additional laboratory test results at other timepoints may be available to the investigator as part of standard clinical practice. Throughout the study, laboratory-related abnormal... | [] |
NCT04922554 | 8.19.5 | Worsening or Progression of Disease Under Study | 8.19.5 Worsening or Progression of Disease Under Study Worsening or progression of NTM pulmonary disease caused by Mycobacterium abscessus including worsening of baseline symptoms, should not be recorded as an AE unless the worsening/progression also meets the criteria for a serious AE (in which case the event also sho... | [] |
NCT04922554 | 8.19.6 | Pregnancies | 8.19.6 Pregnancies To ensure subject safety, each pregnancy in a subject on test article must be reported to the sponsor within 1 business day of learning of its occurrence. Test article should be discontinued immediately, and the pregnancy should be followed up to determine outcome, including spontaneous or voluntary ... | [] |
NCT04922554 | 8.20 | Concomitant Medication Assessments | 8.20 Concomitant Medication Assessments The investigator should instruct the subject to notify the study site about any new medications they take after the start of the test article. All prescription medications, over-the-counter drugs, and recreational drugs taken within the timeframe defined in the entry criteria pri... | [] |
NCT04922554 | 8.21 | Subject Discontinuation or Withdrawal | 8.21 Subject Discontinuation or Withdrawal Reasons why a subject may discontinue or be withdrawn from the study include, but are not limited to, AE, worsening of disease under study, lost to follow up, withdrawal by subject, physician decision, death, and other (specify reason eg, subject non-compliance or study termin... | [] |
NCT04922554 | 9 | STUDY ACTIVITIES | 9 STUDY ACTIVITIES | [] |
NCT04922554 | 9.1 | Screening Period | 9.1 Screening Period Screening procedures (as detailed in Appendix 1) may begin once informed consent is obtained and will be used to establish subject eligibility and baseline characteristics for each subject. The Screening period for this study is up to 8 weeks to allow sufficient time for collection and analysis of ... | [] |
NCT04922554 | 9.2 | Double-blind Treatment Period | 9.2 Double-blind Treatment Period The double-blind treatment period is approximately 3 months (84 days) in duration. Subjects who meet all of the inclusion criteria and none of the exclusion criteria may be randomized. In-clinic visits will occur at Baseline/Day 1, Day 28 (± 3 days), Day 56 (± 3 days), and Day 84/EOT (... | [] |
NCT04922554 | 9.3 | Follow-up Period | 9.3 Follow-up Period | [] |
NCT04922554 | 9.3.1 | 30-Day Safety Follow-up Call | 9.3.1 30-Day Safety Follow-up Call The Follow-up assessment should be conducted 30 to 37 days following the subject's last dose of test article to assess safety via review of AEs and concomitant medications. This evaluation should also be conducted for any prematurely withdrawn subject except for subjects who withdraw ... | [] |
NCT04922554 | 10 | STUDY SUSPENSION, TERMINATION, AND COMPLETION | 10 STUDY SUSPENSION, TERMINATION, AND COMPLETION | [] |
NCT04922554 | 10.1 | Study Completion and Post-study Test Article | 10.1 Study Completion and Post-study Test Article A subject will have successfully completed the study after the planned test article regimen has been administered, and all assessments and visits have been performed up through the final Follow-up assessment. The study will be completed when the last subject has either ... | [] |
NCT04922554 | 10.2 | Study Suspension or Termination | 10.2 Study Suspension or Termination The sponsor may suspend or terminate the study or part of the study at any time for any reason. Should termination be necessary, subjects should be seen as soon as possible and treated as described in Section 8.21 for prematurely withdrawn subjects. The investigator may be informed ... | [] |
NCT04922554 | 11 | QUALITY CONTROL AND ASSURANCE | 11 QUALITY CONTROL AND ASSURANCE The sponsor performs quality control and assurance checks on all clinical studies that it sponsors. Before enrolling any subjects in this study, sponsor personnel and the investigator review the protocol, the Investigator's Brochure, the case report forms and instructions for their comp... | [] |
NCT04922554 | 12 | PLANNED STATISTICAL METHODS | 12 PLANNED STATISTICAL METHODS | [] |
NCT04922554 | 12.1 | General Considerations | 12.1 General Considerations All analyses of data for this study will comply with International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH-E9) and the sponsor's guidance documents and standards. Statistical analyses will be performed using Statistical ... | [] |
NCT04922554 | 12.2 | Determination of Sample Size | 12.2 Determination of Sample Size As the study is exploratory with respect to determination of efficacy, the sample size determination is provided to better ensure sufficient subjects are enrolled to provide an initial assessment of efficacy rather than test a specific hypothesis. A sample size of 75 subjects will prov... | [] |
NCT04922554 | 12.3 | Analysis Populations | 12.3 Analysis Populations The following subject analysis sets have been defined: - Intent-to-treat (ITT) Analysis Set includes all randomized subjects. - Per-Protocol Analysis Set includes all randomized subjects who received at least 1 dose of test article and completed the study without major protocol deviations that... | [] |
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