Clinical Trials Directory

Trials / Completed

CompletedNCT02759861

Determine the Efficacy and Safety of Harvoni in Genotype 1 Chronic Hepatitis c Infected People Who Are Alcoholics

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
16 (actual)
Sponsor
University of Nebraska · Academic / Other
Sex
All
Age
19 Years
Healthy volunteers
Not accepted

Summary

To determine the efficacy and safety of Harvoni in treatment-naïve alcoholic subjects with Genotype 1 HCV infection

Detailed description

determine the cure rate of Harvoni in treatment naïve alcoholic subjects with Genotype 1 HCV infection

Conditions

Interventions

TypeNameDescription
DRUGharvoni8 or 12 weeks of harvoni therapy with monthly nursing visiting to monitor alcohol and adherence of harvoni therapy

Timeline

Start date
2016-08-01
Primary completion
2020-08-01
Completion
2020-10-01
First posted
2016-05-03
Last updated
2023-12-29
Results posted
2023-02-23

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT02759861. Inclusion in this directory is not an endorsement.