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Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination (FDC) With and Without Ribavirin for the Treatment of HCV

NCT01701401 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 870

Last updated 2018-11-16

Study results available
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Summary

The purpose of this study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir (LDV)/sofosbuvir (SOF) fixed-dose combination (FDC) tablets with or without ribavirin (RBV) administered for 12 and 24 weeks in treatment-naive subjects with chronic genotype 1 HCV infection.

Conditions

  • Chronic Hepatitis C Virus

Interventions

DRUG

LDV/SOF

LDV/SOF 90/400 mg FDC tablet administered orally once daily

DRUG

RBV

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

Sponsors & Collaborators

Principal Investigators

  • Jenny Yang, Pharm D · 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
2012-09-30
Primary Completion
2014-03-31
Completion
2014-04-30

Countries

  • United States
  • France
  • Germany
  • Italy
  • Puerto Rico
  • Spain
  • United Kingdom

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 NCT01701401 on ClinicalTrials.gov