At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 365 enrolled
Drug / intervention
AL-335 +2 moredrug
Likely dose
AL-335 800 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2b, Multicenter, Randomized, Open-label Study to Investigate the Efficacy, Safety and Pharmacokinetics of Different Treatment Regimens of AL-335, Odalasvir, and Simeprevir in Treatment-naive and Treatment-experienced Subjects With Chronic Hepatitis C Virus Genotype 1, 2, 4, 5, and 6 Infection Without Cirrhosis
In Brief
A Phase 2 clinical trial evaluating AL-335, Odalasvir, and 1 other intervention for Hepatitis C, Chronic. Completed, enrolled 365 participants across 28 sites in 6 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy (proportion of subjects with SVR12), safety, tolerability and pharmacokinetics of an 8- and 6-week treatment regimen of AL-335, odalasvir (ODV) and simeprevir (SMV) in chronic HCV genotype 1, 2, 4, 5 or 6 infected subjects without cirrhosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic
CountriesBelgium, Canada, Germany, Poland, Singapore, Spain
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 2016
Enrollment StartNov 2016
Primary CompletionAug 2017
Study CompletionNov 2017
TodayJul 2026
First PostedMay 6, 2016
Enrollment StartNov 9, 2016
Primary CompletionAug 9, 2017
Study CompletionNov 16, 2017
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 10.2 years ago
Interventions
AL-335drug
AL-335 800 mg (2\*400) tablet will be administered once daily.
Odalasvirdrug
Odalasvir 25 mg tablet will be administered once daily.
Simeprevirdrug
Simeprevir 75 mg capsule will be administered once daily.