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BMS-790052 (Daclatasvir) Plus Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Black/African-Americans, Latinos and White/Caucasians With Hepatitis C

NCT01389323 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 448

Last updated 2015-10-12

Study results available
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Summary

The purpose of this study is to compare the rates of sustained virologic response in each cohort (Black-African Americans, Latinos) in this study to historical rate.

Conditions

  • Hepatitis C

Interventions

DRUG

Daclatasvir

Tablet, Oral, 60 mg, once daily, 24 weeks

DRUG

Peg-Interferon Alfa-2a

Syringe, Subcutaneous Injection, 180 μg, Once weekly, 24 or 48 weeks depending on response

DRUG

Ribavirin

Tablet, Oral, 1000 or 1200 mg based on weight, Twice daily, 24 or 48 weeks depending on response

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-09-30
Completion
2014-01-31

Countries

  • United States
  • Puerto Rico

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 NCT01389323 on ClinicalTrials.gov