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Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha and Ribavirin)

NCT00874770 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2015-10-23

Study results available
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Summary

The purpose of this study is to identify 1 or more doses of daclatasvir, which when used in combination with pegylated interferon alpha and ribavirin, are safe and demonstrate sufficient anti-hepatitis C virus activity.

Conditions

  • Hepatitis C Infection

Interventions

DRUG

Daclatasvir

Tablets, oral, 3 mg, Daily, 48 weeks

DRUG

Daclatasvir

Tablets, oral, 10 mg, Daily, 48 weeks

DRUG

Daclatasvir

Tablets, oral, 60 mg, Daily, 48 weeks

DRUG

Placebo

Tablet, oral, 0 mg, Daily 48 weeks

DRUG

Peginterferon alpha-2a

Syringe, subcutaneous, 180 µg, Weekly, 48 weeks

DRUG

ribavirin

Tablet, oral, 1000 or 1200 mg, based on weight, Daily, 48 weeks

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2009-11-30
Completion
2011-01-31

Countries

  • United States
  • France

Study Locations

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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 NCT00874770 on ClinicalTrials.gov