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Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients

NCT01125189 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 558

Last updated 2015-10-23

Study results available
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Summary

To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid virologic response rates at least 35% greater than those with placebo.

Conditions

  • Hepatitis C Virus

Interventions

DRUG

Daclatasvir

Tablets, oral, 20 mg, once daily, 12-24 weeks, depending on response

DRUG

Daclatasvir

Tablets, oral, 60 mg, once daily, 12-24 weeks, depending on response

DRUG

Placebo

Tablets, oral, 0 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

Tablets, oral, 1000 or 1200 mg based on weight, once daily, 24 or 48 weeks depending on response

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
2010-07-31
Primary Completion
2012-04-30
Completion
2012-08-31

Countries

  • United States
  • Australia
  • Canada
  • Denmark
  • Egypt
  • France
  • Germany
  • Italy
  • Mexico
  • Puerto Rico
  • Sweden

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 NCT01125189 on ClinicalTrials.gov