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Study to Determine the Safety and Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) in Patients Who Have Previously Not Received the Standard of Care

NCT01359644 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2015-10-23

Study results available
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Summary

The purpose of the study is to determine whether therapy with the combination of PSI-7977 and daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C virus (HCV) infection when given for 12 or 24 weeks as measured by sustained virologic response with undetectable HCV RNA 12 weeks post treatment

Conditions

  • Chronic Hepatitis C

Interventions

DRUG

PSI-7977

Tablets, oral, 400 mg, once daily

DRUG

Daclatasvir

Tablets, oral, 60 mg, once daily

DRUG

Ribavirin

Tablets, oral, 200 mg

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2013-01-31
Completion
2013-10-31

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 NCT01359644 on ClinicalTrials.gov