CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 52 enrolled
Drug / intervention
Alisporivir +1 moredrug
Likely dose
Alisporivir 200 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/NCT02094443
NCT02094443Phase 2Completed
CompareCT.gov

A Multicenter, Open-label, Randomized, 2-arm, Phase II Trial of Pharmacodynamics, Pharmacokinetics and Safety of Two Dose Regimens of DEB025/Alisporivir in Combination With Ribavirin Therapy in Chronic Hepatitis C Genotype 2 and 3 Patients Who Have Previously Failed Interferon Therapy or Are Intolerant or Unable to Take Interferon.

Debiopharm International SA·interventional·Posted Mar 21, 2014·Updated Oct 13, 2016

In Brief

A Phase 2 clinical trial evaluating Alisporivir and Ribavirin for Hepatitis C and Liver Disease. Completed, enrolled 52 participants across 16 sites in 2 countries.

Detailed Summary

The primary purpose of this study is to evaluate the pharmacodynamic (i.e. hepatitis C virus (HCV) viral load), pharmacokinetic and safety profiles between two treatment groups receiving different doses of DEB025 in combination with ribavirin (RBV) during the first 12 weeks treatment in chronic hepatitis C genotype (GT)-2 and GT-3 patients who had previously failed interferon therapy or were intolerant or unable to take interferon.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Liver Disease
CountriesFrance, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 21, 2014
Enrollment StartMar 1, 2014
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 12.3 years ago

Interventions

Alisporivirdrug

ALV 100 and 200 mg soft gel capsules administered orally

Ribavirindrug

RBV 200 mg tablets (weight-based dose: \< 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose