Overview

This trial is active, not recruiting.

Condition hepatitis c virus infection
Treatments ldv/sof, rbv
Phase phase 3
Sponsor Gilead Sciences
Start date November 2015
End date February 2017
Trial size 300 participants
Trial identifier NCT02600351, GS-US-337-1746

Summary

This study will evaluate the efficacy, safety and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) for 12 weeks with or without ribavirin (RBV) in participants without cirrhosis, and LDV/SOF FDC for 12 weeks with RBV or LDV/SOF FDC for 24 weeks without RBV in participants with cirrhosis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
LDV/SOF for 12 weeks
ldv/sof Harvoni®
LDV/SOF (90/400 mg) FDC tablet administered orally once daily
(Experimental)
LDV/SOF + RBV for 12 weeks
ldv/sof Harvoni®
LDV/SOF (90/400 mg) FDC tablet administered orally once daily
rbv
RBV tablets administered orally in a divided daily dose according to weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
(Experimental)
LDV/SOF + RBV for 12 weeks
ldv/sof Harvoni®
LDV/SOF (90/400 mg) FDC tablet administered orally once daily
rbv
RBV tablets administered orally in a divided daily dose according to weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
(Experimental)
LDV/SOF for 24 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 cessation of therapy (SVR12)
time frame: Posttreatment Week 12
Proportion of participants who discontinued from study treatment for an adverse event
time frame: Up to 24 weeks

Secondary Outcomes

Measure
Proportion of participants with HCV RNA < the lower limit of quantitation (LLOQ) at 4 and 24 weeks posttreatment
time frame: Posttreatment Weeks 4 and 24
Proportion of participants with viral breakthrough
time frame: Up to 24 weeks
Proportion of participants with viral relapse
time frame: Up to Posttreatment Week 24
Proportion of participants with emerging resistance
time frame: Up to Posttreatment Week 24

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - HCV RNA > 15 IU/mL at screening - HCV genotype 1 or 4 - Chronic HCV infection (≥ 6 months) - Prior virologic failure after treatment with SOF in combination with simeprevir (SMV) ± RBV or with RBV ± PEG - Cirrhotic and non-cirrhotic as determined by standard methods - Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception Exclusion Criteria: - Prior exposure to approved or experimental non-structural protein (NS5A) inhibitors - Prior exposure to nucleos(t)ide polymerase inhibitors, other than SOF - Pregnant or nursing female or male with pregnant female partner - Coinfection with HIV or hepatitis B virus - Current or prior history of clinical hepatic decompensation - Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers) - Chronic use of systemic immunosuppressive agents - History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol

Additional Information

Official title A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without Ribavirin, in HCV Infected Subjects Who Have Failed Prior Treatment With Sofosbuvir-based Therapies
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Gilead Sciences.