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Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection in Participants With Chronic Genotype 1, 2, 3, or 6 HCV Infection

NCT01826981 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 359

Last updated 2018-11-16

Study results available
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Summary

The purpose of this study is to evaluate the antiviral efficacy, safety, tolerability of combination therapy with sofosbuvir (SOF) containing regimens for the treatment of chronic hepatitis C virus (HCV) infection.

Conditions

  • Chronic Hepatitis C

Interventions

DRUG

LDV/SOF

Ledipasvir/sofosbuvir (LDV/SOF) (90 /400 mg) fixed-dose combination (FDC) tablet administered orally once daily

DRUG

SOF

SOF 400 mg tablet administered orally once daily

DRUG

RBV

Ribavirin (RBV) 200 mg 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)

DRUG

Peg-IFN

pegylated interferon (Peg-IFN) 180 µg administered subcutaneously once weekly

DRUG

GS-9669

GS-9669 500 mg (2 × 250 mg tablet) administered orally once daily

DRUG

VEL

Velpatasvir (VEL) tablet(s) administered orally once daily

Sponsors & Collaborators

Principal Investigators

  • Robert H Hyland, DPhil · 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
2013-04-30
Primary Completion
2015-03-31
Completion
2015-05-31

Countries

  • New Zealand

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 NCT01826981 on ClinicalTrials.gov