At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 53 enrolled
Drug / intervention
Daclatasvir +2 moredrug
Likely dose
Not stated in 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.
Open-Label, Randomized Study of Daclatasvir, Sofosbuvir, and Ribavirin for 12 vs. 16 Weeks in Treatment Naive and Treatment Experienced Patients With Genotype 3 Chronic Hepatitis C Infection Subjects With Compensated Advanced Fibrosis/Cirrhosis (F3/F4)
In Brief
A Phase 3 clinical trial evaluating Daclatasvir, Sofosbuvir, and 1 other intervention for Hepatitis C. Completed, enrolled 53 participants across 10 sites in 2 countries.
Detailed Summary
The purpose of the study is to determine if the combination of Daclatasvir, Sofosbuvir and Ribavirin for 12 or 16 weeks is safe and effective in the treatment of Genotype 3 Chronic Hepatitis C (HCV) in patients with advanced fibrosis or compensated cirrhosis. Patients in this study may have already been treated prior for HCV or may have never received treatment for their HCV.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesAustralia, France
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 2014
Enrollment StartFeb 2015
Primary CompletionOct 2015
Study CompletionDec 2015
TodayJul 2026
First PostedDec 18, 2014
Enrollment StartFeb 1, 2015
Primary CompletionOct 1, 2015
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 11.5 years ago
Interventions
Daclatasvirdrug
Sofosbuvirdrug
Ribavirindrug