CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 161 enrolled
Drug / intervention
AL-335 +2 moredrug
Likely dose
AL-335 1200 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.

Search/NCT02569710
NCT02569710Phase 2Completed
CompareCT.gov

A Phase 2a, Open-Label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335 and Odalasvir, With or Without Simeprevir, in Treatment-Naïve Subjects With Genotype 1, 2 or 3 Chronic Hepatitis C Infection With or Without Compensated Child Pugh A Cirrhosis

Alios Biopharma Inc.·interventional·Posted Oct 7, 2015·Updated Jul 16, 2019

In Brief

A Phase 2 clinical trial evaluating AL-335, Odalasvir (ODV), and 1 other intervention for Chronic Hepatitis C. Completed, enrolled 161 participants across 11 sites in 4 countries.

Detailed Summary

The purpose of this study is to evaluate the safety and tolerability of AL-335 in combination with odalasvir (ODV) with or without simeprevir (SMV) in participants with genotype (GT)1 or GT2 or GT3 chronic hepatitis C (CHC) infection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C
CountriesMauritius, Moldova, New Zealand, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 7, 2015
Enrollment StartOct 31, 2015
Primary CompletionMay 11, 2018
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 10.7 years ago

Interventions

AL-335drug

AL-335 tablets will be administered in a dose range of 400 to 1200 mg once daily (QD).

Odalasvir (ODV)drug

ODV capsules will be administered in a dose range of 25 to 50 mg.

Simeprevir (SMV)drug

SMV tablets will be administered in a dose range of 75 to 150 mg QD or every other day (QOD).