MedTrace Logo

Study in Genotype 2 or 3 Patients With Chronic Hepatitis Virus Infection

NCT01257204 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2015-12-14

Study results available
· View outcomes & findings →

Summary

To identify a shorter duration of antiviral therapy (12 or 16 weeks) for the combination of daclatasvir with pegylated interferon alfa-2a and ribavirin.

Conditions

  • Hepatitis C Virus

Interventions

DRUG

Placebo

Tablets, oral, 0 mg, once daily, for 24 weeks

DRUG

Daclatasvir

Tablets, oral, 60 mg, once daily, for 12, 16, or 24 weeks

DRUG

Pegylated interferon alfa-2a

Solution for injection, subcutaneous injection, 180 µg/0.5 mL, once weekly, for 12, 16, or 24 weeks

DRUG

Ribavirin

Tablets, oral, 800 mg, twice daily, for 12, 16, or 24 weeks

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2012-05-31
Completion
2012-09-30

Countries

  • United States
  • Australia
  • Canada
  • Denmark
  • France
  • Italy

Study Locations

More Related Trials

Entities

Drugs
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 NCT01257204 on ClinicalTrials.gov