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Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without Ribavirin, in HCV Infected Participants Who Have Failed Prior Treatment With Sofosbuvir-based Therapies

NCT02600351 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2018-11-16

Study results available
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Summary

The primary objective of this study is to 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.

Conditions

  • Hepatitis C Virus Infection

Interventions

DRUG

LDV/SOF

90/400 mg FDC tablet administered orally once daily

DRUG

RBV

Tablets administered orally in a divided daily dose according to weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-11
Primary Completion
2017-03-21
Completion
2017-05-29
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Puerto Rico

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02600351 on ClinicalTrials.gov