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Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha-2b and Ribavirin) in Japanese Patients

NCT01016912 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2015-10-12

Study results available
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Summary

The purpose of this study is to identify at least 1 dose of daclatasvir that is safe, well tolerated, and efficacious when combined with peginterferon-alfa and ribavirin for the treatment of hepatitis C virus genotype 1 in chronically infected patients who are treatment-naïve and nonresponsive to the standard of care

Conditions

  • Hepatitis C Infection

Interventions

DRUG

BMS-790052

Tablets, Oral, 10 mg, daily, 24-48 weeks

DRUG

BMS-790052

Tablets, Oral, 60 mg, daily, 24-48 weeks

DRUG

Placebo

Tablets, Oral, 0 mg, daily, 48 weeks

DRUG

Peginterferon alfa-2b

Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks

DRUG

Ribavirin

Capsules, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • Japan

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 NCT01016912 on ClinicalTrials.gov