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Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Phase 2b Study of Daclatasvir in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 1 and 4 Infection

NCT01125189•Bristol-Myers Squibb

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients chronically infected with hepatitis C virus (HCV) genotype 1 or 4
•HCV RNA viral load of ≥100,000 IU/mL
•No previous exposure to interferon, pegIFNα, or RBV
•Results of a liver biopsy demonstrating absence of cirrhosis obtained ≤24 months prior to randomization. Compensated cirrhotics with Hepatitis C virus genotype 1 infection are eligible, but will be capped at 10% of the randomized study population (biopsy can be from any time period prior to randomization)
•Findings on ultrasound, computed tomography scan, or magnetic resonance imaging 12 months prior to randomization that do not demonstrate evidence of hepatocellular carcinoma
•Body mass index of 18 to 35 kg/m\^2

Exclusion Criteria

•Positive for hepatitis B or HIV-1/HIV-2 antibody at screening
•Evidence of a medical condition associated with chronic liver disease other than HCV
•Evidence of decompensated cirrhosis based on radiologic criteria or biopsy

Locations (64)

Alabama Liver & Digestive Specialists (Alds)

Montgomery, Alabama, United States

Scripps Clinic

La Jolla, California, United States

Cli

Los Angeles, California, United States

Desta Digestive Disease Medical Center

San Diego, California, United States

University Of California, San Francisco/Sf General Hospital

San Francisco, California, United States

California Pacific Medical Center

San Francisco, California, United States

Kaiser Permanente Medical Center

San Francisco, California, United States

Transplant Center And Hepatology Clinic, B-154

Aurora, Colorado, United States

Yale University School Of Medicine

New Haven, Connecticut, United States

University Of Florida Hepatology

Gainesville, Florida, United States

Key Dates

Start Date

July 1, 2010

Primary Completion Date

April 1, 2012

Completion Date

August 1, 2012

Last Updated

October 23, 2015

Enrollment

558

ACTUAL participants

Conditions

Hepatitis C Virus

Interventions

Daclatasvir

DRUG

Daclatasvir

DRUG

Placebo

DRUG

peg-interferon alfa-2a

DRUG

ribavirin

DRUG

Acceptability of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users in Non-conventional Structures

NCT05361603

Hepatitis CTransmission, Intravenous Drug Abuser+3 more

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ACTIVE_NOT_RECRUITINGPHASE3

C-BEYOND: Efficacy and Safety of BEM/RZR vs. SOF/VEL in Subjects With Chronic HCV

NCT06868264

HEPATITIS C VIRUS CHRONIC INFECTION

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 23, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Acceptability of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users in Non-conventional Structures

C-BEYOND: Efficacy and Safety of BEM/RZR vs. SOF/VEL in Subjects With Chronic HCV

MAGIA H3S Point of Care Test Performance for HIV, HBV, HCV, and Syphilis Screening in Pregnant Women in DR Congo

Relinking Diagnosed But Untreated HCV Patients Back Into Care.

Screening, Treatment, and Eradication of Hep C

Trends in Risk Factors for Mother-to-Child Transmission of Hepatitis C Among a Southern European Population