Overview

This trial is active, not recruiting.

Condition hepatitis c virus infection
Treatment ldv/sof
Phase phase 3
Sponsor Gilead Sciences
Start date December 2015
End date January 2017
Trial size 111 participants
Trial identifier NCT02613871, GS-US-337-1655

Summary

This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 weeks in chronic genotype 1 or 2 HCV infected adults who are co-infected with HBV in Taiwan.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
LDV/SOF FDC for 12 weeks
ldv/sof Harvoni®
LDV/SOF (90/400 mg) FDC tablet administered orally once daily

Primary Outcomes

Measure
Proportion of participants with sustained virologic response (SVR) 12 Weeks after discontinuation of therapy (SVR12)
time frame: Posttreatment Week 12
Incidence of any adverse event leading to permanent discontinuation of study drug
time frame: Up to 12 weeks

Secondary Outcomes

Measure
Proportion of participants with SVR at 4 Weeks after discontinuation of therapy (SVR4)
time frame: Posttreatment Week 4
Proportion of participants with HCV RNA < LLOQ while on treatment and during posttreatment follow-up
time frame: Up to Posttreatment Week 108
HCV RNA change from baseline while on treatment
time frame: Baseline and up to 12 weeks
Proportion of participants with virologic failure
time frame: Up to Posttreatment Week 12
Plasma HBV DNA change from baseline while on treatment and during posttreatment follow-up
time frame: Baseline and up to Posttreatment Week 108
HBsAg level change from baseline while on treatment and during posttreatment follow-up
time frame: Baseline and up to Posttreatment Week 108
Serum Lysyl oxidase-like 2 (LOXL-2) change from baseline while on treatment and during posttreatment follow-up
time frame: Baseline and up to Posttreatment Week 108
Proportion of participants that require HBV therapy
time frame: Up to Posttreatment Week 108
Fibrosis status as assessed by Fibroscan® at posttreatment Weeks 12, 60, and 108
time frame: Posttreatment Weeks 12, 60, and 108
Proportion of participants that develop hepatocellular carcinoma (HCC)
time frame: Up to Posttreatment Week 108

Eligibility Criteria

Male or female participants at least 20 years old.

Inclusion Criteria: - Individuals with chronic genotype 1 or 2 HCV and HBV coinfection - Individuals must not be taking or require treatment with HBV antiviral therapy at screening. For participants that are HBV treatment experienced, the most recent treatment must have been completed at least 6 months prior to Day 1. - Cirrhosis determination by Fibroscan - Screening laboratory values within defined thresholds - Use of two effective contraception methods if female or male is of childbearing potential Exclusion Criteria: - Current or prior history of clinically-significant illness or any other major medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol - Pregnant or nursing female - Infection with human immunodeficiency virus (HIV) or Hepatitis Delta virus (HDV) - Hepatocellular carcinoma (HCC) or other malignancy - Current or prior history of clinical hepatic decompensation

Additional Information

Official title A Phase 3b Open-Label Study of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 2 Hepatitis C Virus (HCV) and Hepatitis B Virus (HBV) Coinfection
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Gilead Sciences.