Clinical Trial Results:
A Prospective 3-Year Follow-up Study in Subjects Treated in a Preceding Phase 2 or 3 Study With a Regimen Containing Odalasvir and AL-335 With or Without Simeprevir for the Treatment of Hepatitis C Virus (HCV) Infection
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Summary
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EudraCT number |
2016-002608-19 |
Trial protocol |
BE DE PL ES |
Global end of trial date |
13 Feb 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Mar 2019
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First version publication date |
01 Mar 2019
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
64294178HPC3001
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03099135 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Janssen-Cilag International NV
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Sponsor organisation address |
Turnhoutseweg, 30, Beerse, Belgium, 2340
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Public contact |
Clinical Registry Group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com
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Scientific contact |
Clinical Registry Group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
13 Feb 2018
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
13 Feb 2018
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
The main purpose of the study was to evaluate the durability of sustained virologic response (SVR) in subjects treated for hepatitis C virus (HCV) infection in a preceding Phase 2 or Phase 3 study who had achieved SVR at last post-therapy visit of the parent study (LPVPS).
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Protection of trial subjects |
The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements. The safety assessments included monitoring of adverse events, clinical laboratory assessments (serum chemistry, hematology, coagulation, and alpha-fetoprotein), and electrocardiograms (ECGs).
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
11 Apr 2017
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Canada: 6
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Country: Number of subjects enrolled |
New Zealand: 43
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Country: Number of subjects enrolled |
Poland: 3
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Country: Number of subjects enrolled |
Singapore: 2
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Worldwide total number of subjects |
54
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EEA total number of subjects |
3
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
52
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From 65 to 84 years |
2
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||||||||
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Pre-assignment
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Screening details |
A total of 54 subjects were enrolled from parent studies AL-335-604 (NCT02569710) and 64294178HPC2001 (NCT02765490) and analyzed in this follow-up study. | |||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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SVR at LPVPS | |||||||||||||||
Arm description |
Subjects who completed the last post-therapy visit of the parent study (LPVPS) (Phase 2 or Phase 3 study), in which they received a regimen containing odalasvir and AL-335 with or without simeprevir for the treatment of hepatitis C virus (HCV) infection, and who agreed to participate in this follow-up study was assessed for durability of sustained virologic response (SVR), incidence of late viral relapse, presence and long term-persistence of resistance associated substitutions (RAS) and liver disease status. SVR at the LPVPS is defined as subjects who achieved SVR 12 weeks after the end of treatment (SVR12) in the parent study, and maintained HCV ribonucleic acid (RNA) less than (<) the lower limit of quantification (LLOQ) until LPVPS. | |||||||||||||||
Arm type |
other | |||||||||||||||
Investigational medicinal product name |
Odalasvir
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received odalasvir as oral tablets in parent studies.
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Investigational medicinal product name |
AL-335
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received AL-335 as oral tablets in parent studies.
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Investigational medicinal product name |
Simeprevir
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received simeprevir as oral capsules in previous parent studies.
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Arm title
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No SVR at LPVPS | |||||||||||||||
Arm description |
Subjects who completed the LPVPS (Phase 2 or Phase 3 study), in which they received a regimen containing odalasvir and AL-335 with or without simeprevir for the treatment of HCV infection, and who agree to participate in this follow-up study was assessed for presence and long term-persistence of RAS and liver disease status. | |||||||||||||||
Arm type |
other | |||||||||||||||
Investigational medicinal product name |
Odalasvir
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received odalasvir as oral tablets in parent studies.
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Investigational medicinal product name |
AL-335
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received AL-335 as oral tablets in parent studies.
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Investigational medicinal product name |
Simeprevir
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received simeprevir as oral capsules in parent studies.
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Baseline characteristics reporting groups
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Reporting group title |
SVR at LPVPS
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Reporting group description |
Subjects who completed the last post-therapy visit of the parent study (LPVPS) (Phase 2 or Phase 3 study), in which they received a regimen containing odalasvir and AL-335 with or without simeprevir for the treatment of hepatitis C virus (HCV) infection, and who agreed to participate in this follow-up study was assessed for durability of sustained virologic response (SVR), incidence of late viral relapse, presence and long term-persistence of resistance associated substitutions (RAS) and liver disease status. SVR at the LPVPS is defined as subjects who achieved SVR 12 weeks after the end of treatment (SVR12) in the parent study, and maintained HCV ribonucleic acid (RNA) less than (<) the lower limit of quantification (LLOQ) until LPVPS. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
No SVR at LPVPS
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Reporting group description |
Subjects who completed the LPVPS (Phase 2 or Phase 3 study), in which they received a regimen containing odalasvir and AL-335 with or without simeprevir for the treatment of HCV infection, and who agree to participate in this follow-up study was assessed for presence and long term-persistence of RAS and liver disease status. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
SVR at LPVPS
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Reporting group description |
Subjects who completed the last post-therapy visit of the parent study (LPVPS) (Phase 2 or Phase 3 study), in which they received a regimen containing odalasvir and AL-335 with or without simeprevir for the treatment of hepatitis C virus (HCV) infection, and who agreed to participate in this follow-up study was assessed for durability of sustained virologic response (SVR), incidence of late viral relapse, presence and long term-persistence of resistance associated substitutions (RAS) and liver disease status. SVR at the LPVPS is defined as subjects who achieved SVR 12 weeks after the end of treatment (SVR12) in the parent study, and maintained HCV ribonucleic acid (RNA) less than (<) the lower limit of quantification (LLOQ) until LPVPS. | ||
Reporting group title |
No SVR at LPVPS
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Reporting group description |
Subjects who completed the LPVPS (Phase 2 or Phase 3 study), in which they received a regimen containing odalasvir and AL-335 with or without simeprevir for the treatment of HCV infection, and who agree to participate in this follow-up study was assessed for presence and long term-persistence of RAS and liver disease status. | ||
Subject analysis set title |
SVR at LPVPS + No SVR at LPVPS
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
All subjects (SVR at LPVPS + No SVR at LPVPS) who received odalasvir and AL-335 with or without simeprevir in parent studies were followed up in this study. SVR at LPVPS is defined as subjects who achieved SVR 12 weeks after the end of treatment (SVR12) in the parent study and maintained HCV RNA < LLOQ until LPVPS.
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End point title |
Percentage of Subjects who Maintained Sustained Virologic Response (SVR) Until the End of the Long-Term Follow-up [1] [2] | ||||||||||||||||||
End point description |
Percentage of subjects who maintained SVR (if hepatitis C virus [HCV] ribonucleic acid [RNA] was less than [<] lower limit of quantification (LLOQ) (Detected or Not Detected) at each time point in the present study) was reported. Here 'endpoint' refers to the last available measurement in this study. Population included all enrolled subjects with SVR at last post therapy visit of the parent study (LPVPS). Here 'n' refers to number of subjects who were evaluable at each specified time point. If a measurement at a time point was missing but a measurement was available at a later time point, the missing measurement was imputed with the measurement at the later time point.
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End point type |
Primary
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End point timeframe |
LPVPS, Months 6, 12, 18 and Endpoint (up to 3 years)
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive statistics (percentage and 95% confidence interval provided) were done, no inferential statistical analyses were performed. [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Endpoint was planned to be analyzed for specified arm only. |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Percentage of Subjects with Late Viral Relapse Among Subjects Who Achieved SVR at Last Post-therapy Visit of the Parent Study [3] | ||||||||||||||
End point description |
Late viral relapse is defined as subjects who had achieved SVR at LPVPS but who had confirmed HCV RNA greater than or equal to (>=) LLOQ during follow-up in the present study. SVR at LPVPS is defined as subject who achieved SVR 12 weeks after the end of treatment (SVR12) in the parent study and maintained HCV RNA < LLOQ until LPVPS. Population included all enrolled subjects with SVR at LPVPS. Here 'n' refers to number of subjects who were evaluable at each specified time point. If a measurement at a time point is missing but a measurement is available at a later time window, the missing measurement is imputed with the measurement at the later time point.
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End point type |
Secondary
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End point timeframe |
Months 6, 12 and 18 (up to 3 years)
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| Notes [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Endpoint was planned to be analyzed for specified arm only. |
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Change from Last Post-therapy Visit of the Parent Study in Albumin Levels at Month 6, 12, 18 and Endpoint | ||||||||||||||||||
End point description |
Change from LPVPS in albumin levels to the last available measurement (endpoint) was reported as measure of liver disease status. All enrolled analysis set included all subjects who signed an informed consent form (ICF) for the present study. Here 'n' refers to number of subjects who were evaluable at each time point.
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End point type |
Secondary
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End point timeframe |
LPVPS, Months 6, 12, 18 and Endpoint (up to 3 years)
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Change from Last Post-therapy Visit of the Parent Study in Alanine Aminotransferase Levels at Month 6, 12, 18 and Endpoint | ||||||||||||||||||
End point description |
Change from LPVPS in alanine aminotransferase levels to the last available measurement (endpoint) was reported as measure of liver disease status. All enrolled analysis set included all subjects who signed an ICF for the present study. Here 'n' refers to number of subjects who were evaluable at each time point.
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End point type |
Secondary
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End point timeframe |
LPVPS, Months 6, 12, 18 and Endpoint (up to 3 years)
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Change from Last Post-therapy Visit of the Parent Study in Alkaline Phosphatase Levels at Month 6, 12, 18 and Endpoint | ||||||||||||||||||
End point description |
Change from LPVPS in alkaline phosphatase levels to the last available measurement (endpoint) was reported as measure of liver disease status. All enrolled analysis set included all subjects who signed an ICF for the present study. Here 'n' refers to number of subjects who were evaluable at each time point.
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End point type |
Secondary
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End point timeframe |
LPVPS, Months 6, 12, 18 and Endpoint (up to 3 years)
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Change from Last Post-therapy Visit of the Parent Study in Aspartate Aminotransferase Levels at Month 6, 12, 18 and Endpoint | ||||||||||||||||||
End point description |
Change from LPVPS in aspartate aminotransferase levels to the last available measurement (endpoint) was reported as measure of liver disease status. All enrolled analysis set included all subjects who signed an ICF for the present study. Here 'n' refers to number of subjects who were evaluable at each time point.
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End point type |
Secondary
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End point timeframe |
LPVPS, Months 6, 12, 18 and Endpoint (up to 3 years)
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Change from Last Post-therapy Visit of the Parent Study in Bilirubin Levels at Month 6, 12, 18 and Endpoint | ||||||||||||||||||
End point description |
Change from LPVPS in bilirubin levels to the last available measurement (endpoint) was reported as measure of liver disease status. All enrolled analysis set included all subjects who signed an ICF for the present study. Here 'n' refers to number of subjects who were evaluable at each time point.
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End point type |
Secondary
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End point timeframe |
LPVPS, Months 6, 12, 18 and Endpoint (up to 3 years)
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Change from Last Post-therapy Visit of the Parent Study in Direct Bilirubin Levels at Month 6, 12, 18 and Endpoint | ||||||||||||||||||
End point description |
Change from LPVPS in direct bilirubin levels to the last available measurement (endpoint) was reported as measure of liver disease status. All enrolled analysis set included all subjects who signed an ICF for the present study. Here 'n' refers to number of subjects who were evaluable at each time point.
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End point type |
Secondary
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End point timeframe |
LPVPS, Months 6, 12, 18 and Endpoint (up to 3 years)
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Change from Last Post-therapy Visit of the Parent Study in Indirect Bilirubin Levels at Month 6 and Endpoint | ||||||||||||||
End point description |
Change from LPVPS in indirect bilirubin levels to the last available measurement (endpoint) was reported as measure of liver disease status. All enrolled analysis set included all subjects who signed an ICF for the present study. Here 'n' refers to number of subjects who were evaluable at each time point.
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End point type |
Secondary
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End point timeframe |
LPVPS, Month 6 and Endpoint (up to 3 years)
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Change from Last Post-therapy Visit of the Parent Study in Activated Partial Thromboplastin Time (aPTT) at Month 6, 12, 18 and Endpoint | ||||||||||||||||||
End point description |
Change from LPVPS in aPTT to the last available measurement (endpoint) was reported as measure of liver disease status. All enrolled analysis set included all subjects who signed an ICF for the present study. Here 'n' refers to number of subjects who were evaluable at each time point.
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End point type |
Secondary
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End point timeframe |
LPVPS, Months 6, 12, 18 and Endpoint (up to 3 years)
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Change from Last Post-therapy Visit of the Parent Study in Prothrombin International Normalized Ratio (INR) at Month 6, 12, 18 and Endpoint | ||||||||||||||||||
End point description |
Change from LPVPS in prothrombin INR to the last available measurement was reported as measure (endpoint) of liver disease status. All enrolled analysis set included all subjects who signed an ICF for the present study. Here 'n' refers to number of subjects who were evaluable at each time point.
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End point type |
Secondary
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End point timeframe |
LPVPS, Months 6, 12, 18 and Endpoint (up to 3 years)
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Change from Last Post-therapy Visit of the Parent Study in Prothrombin Time at Month 6, 12, 18 and Endpoint | ||||||||||||||||||
End point description |
Change from LPVPS in prothrombin time to the last available measurement (endpoint) was reported as measure of liver disease status. All enrolled analysis set included all subjects who signed an ICF for the present study. Here 'n' refers to number of subjects who were evaluable at each time point.
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End point type |
Secondary
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End point timeframe |
LPVPS, Months 6, 12, 18 and Endpoint (up to 3 years)
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Number of Subjects in Each Child-Pugh Grading Category at Endpoint | ||||||||||||||||||
End point description |
Number of subjects in each child-pugh grading category at endpoint was reported. The five clinical measures of liver disease, subsequently used to derive the Child-Pugh score are as followed :1- Encephalopathy grade, 2- Ascites, 3- Serum bilirubin milligram per deciliter (mg/dL), 4-Serum albumin gram per liter (g/L), 5- Prothrombin time, seconds prolonged. Each measure is scored from 1 to 3, with 3 indicating most severe derangement. In subjects with cirrhosis, the sum of the scores provides the child-pugh score as followed: child-pugh A (mild): 5-6 points, child-pugh B (moderate): 7-9 points, and child-pugh C (severe): 10-15 points. All enrolled analysis set included all subjects who signed an ICF for the present study with cirrhosis at baseline.
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End point type |
Secondary
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End point timeframe |
LPVPS to Endpoint (up to 3 years)
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| Notes [4] - No subjects with child-pugh liver disease grading + cirrhosis at baseline and without SVR at LPVPS. |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Number of Subjects in Each Liver Ultrasound Interpretation Result Category at Endpoint | |||||||||||||||
End point description |
The number of subjects in each liver ultrasound interpretation result category (normal or abnormal) at endpoint is reported. All enrolled analysis set included all subjects who signed an ICF for the present study with cirrhosis at baseline in 'SVR at LPVPS' group and subjects with metavir score F3 or F4 for 'No SVR at LPVPS' group. Here 'endpoint' refers to the last available measurement in this study.
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End point type |
Secondary
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End point timeframe |
LPVPS to Endpoint (up to 3 years)
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| No statistical analyses for this end point | ||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Up to 3 years
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Adverse event reporting additional description |
Safety analysis set included all subjects who received at least 1 dose of study treatment in a previous Phase 2 study and were enrolled into the present study.
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Assessment type |
Non-systematic | |||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||
Dictionary version |
19.0
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Reporting groups
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Reporting group title |
No SVR at LPVPS
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Reporting group description |
Subjects who completed the LPVPS (Phase 2 or Phase 3 study), in which they received a regimen containing odalasvir and AL-335 with or without simeprevir for the treatment of HCV infection, and who agree to participate in this follow-up study was assessed for presence and long term-persistence of RAS and liver disease status. SVR at LPVPS is defined as subjects who achieved SVR12 in the parent study and maintained HCV RNA < LLOQ until LPVPS. | |||||||||||||||||||||
Reporting group title |
SVR at LPVPS
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Reporting group description |
Subjects who completed the last post-therapy visit of the parent study (LPVPS) (Phase 2 or Phase 3 study), in which they received a regimen containing odalasvir and AL-335 with or without simeprevir for the treatment of hepatitis C virus (HCV) infection, and who agreed to participate in this follow-up study was assessed for durability of sustained virologic response (SVR), incidence of late viral relapse, presence and long term-persistence of resistance associated substitutions (RAS) and liver disease status. SVR at the LPVPS is defined as subjects who achieved SVR 12 weeks after the end of treatment (SVR12) in the parent study, and maintained HCV ribonucleic acid (RNA) less than (<) the lower limit of quantification (LLOQ) until LPVPS. | |||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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06 Nov 2017 |
The overall reason for the amendment was the decision to discontinue further development of JNJ-64294178 (a combination of three direct acting antivirals - AL-335, odalasvir , and simeprevir), and consequently, the stop of further enrollment in the current study. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| Due to the early termination of study, only 54 of planned 250 subjects were enrolled, and no subjects completed full 36-month follow-up period. Consequently, only limited long-term follow-up data was available and conclusions could not be drawn. | |||
