At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 16 enrolled
Drug / intervention
harvonidrug
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.
A Phase IV, Single Arm, Open-Label Study to Determine the Efficacy and Safety of Ledipasvir/Sofosbuvir (LDV/SOF) in Treatment-Naive Alcoholic Subjects With Chronic Genotype 1 Hepatitis C Infection
In Brief
A Phase 4 clinical trial evaluating harvoni for Genotype 1 Hepatitis C Virus. Completed, enrolled 16 participants across 1 site.
Detailed Summary
To determine the efficacy and safety of Harvoni in treatment-naïve alcoholic subjects with Genotype 1 HCV infection
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGenotype 1 Hepatitis C Virus
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 2016
Enrollment StartAug 2016
Primary CompletionAug 2020
Study CompletionOct 2020
TodayJul 2026
First PostedMay 3, 2016
Enrollment StartAug 1, 2016
Primary CompletionAug 1, 2020
Study CompletionOct 1, 2020
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 10.2 years ago
Interventions
harvonidrug
8 or 12 weeks of harvoni therapy with monthly nursing visiting to monitor alcohol and adherence of harvoni therapy