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

NCT01017575 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2015-09-11

Study results available
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Summary

The purpose of this study is to identify at least 1 dose of Daclatasvir, that when combined with peginterferon-alfa (PegIFNα) and ribavirin (RBV) for the treatment of chronically infected HCV genotype 1 treatment-naïve and non-responder to standard of care subjects is safe, well tolerated, and efficacious

Conditions

  • Hepatitis C Infection

Interventions

DRUG

Daclatasvir

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

DRUG

Daclatasvir

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

DRUG

Placebo

Tablets, Oral, 0 mg, daily, 48 weeks

DRUG

Peginterferon alfa-2a

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

DRUG

Ribavirin

Tablets, 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
2011-10-31
Completion
2011-10-31

Countries

  • Japan

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 NCT01017575 on ClinicalTrials.gov