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Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3

NCT01260350 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 292

Last updated 2014-11-17

Study results available
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Summary

This study is to assess the safety and tolerability of sofosbuvir (SOF) 400 mg with and without ribavirin (RBV) and/or with and without pegylated interferon alfa-2a (PEG) in subjects with genotype 1, 2 or 3 hepatitis C (HCV) infection.

Conditions

  • Chronic Hepatitis C Infection

Interventions

DRUG

SOF

Sofosbuvir (SOF) tablets administered orally once daily

DRUG

RBV

Ribavirin (RBV) capsules administered orally in a divided daily dose

DRUG

PEG

Peginterferon alfa-2a (PEG) administered via subcutaneous injection once weekly

DRUG

LDV

Ledipasvir (LDV) tablets administered orally once daily

DRUG

GS-9669

GS-9669 tablets administered orally once daily

DRUG

LDV/SOF

LDV/SOF fixed-dose combination (FDC) tablet administered 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
2010-12-31
Primary Completion
2013-10-31
Completion
2013-12-31

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 NCT01260350 on ClinicalTrials.gov