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Phase III Hallmark QUAD: ASV+DCV+Peg+Rib (Nulls/Partials) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Phase III Hallmark QUAD: ASV+DCV+Peg+Rib (Nulls/Partials)

A Phase 3, Open-Label Study With Asunaprevir and Daclatasvir Plus Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) (P/R) (QUAD) for Subjects Who Are Null or Partial Responders to Peginterferon Alfa 2a or 2b Plus Ribavirin With Chronic Hepatitis C Genotypes 1 or 4 Infection

NCT01573351•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess efficacy, as determined by the proportion of subjects with Sustained Virologic Response at Post-Treatment Week 12 (SVR12), defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) \< Limit of quantitation (LOQ) at post-treatment Week 12.

Detailed Description

* ASV = Asunaprevir (BMS-650032) * DCV = Daclatasvir (BMS-790052) * Peg = Peg-interferon Alfa-2a (PegIFN) * Rib = Ribavirin (RBV)

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Males and females, ≥ 18 years of age
•HCV Genotype 1 or 4 who previously failed treatment with Peginterferon alfa-2a or peginterferon alfa-2b and Ribavirin (P/R), classified as previous null and partial responders based on previous therapy
•HCV RNA ≥ 10,000 IU/mL
•Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg)
•Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population)

Exclusion Criteria

•Prior treatment of HCV with HCV direct acting antiviral (DAA)
•Evidence of a medical condition contributing to chronic liver disease other than HCV
•Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
•Diagnosed or suspected hepatocellular carcinoma or other malignancies
•Uncontrolled diabetes or hypertension
•Total bilirubin ≥ 34 μmol/L (or ≥ 2 mg/dL) unless subject has a documented history of Gilbert's disease
•Alanine aminotransferase (ALT) ≥ 5x Upper limit of normal (ULN)
•Albumin \< 3.5 g/dL (35 g/L)
•Alpha Fetoprotein (AFP) \> 100 ng/mL (\>82.6 IU/mL) or ≥ 50 and ≤ 100 ng/mL requires a liver ultrasound and subjects with findings suspicious of Hepatocellular carcinoma (HCC) are excluded
•Absolute neutrophil count (ANC) \< 1.5 x 1000,000,000 cells/L (\< 1.2 x 1000,000,000 cells/L for Black/African-Americans)
+3 more criteria

Locations (79)

Alabama Liver & Digestive Specialists (Alds)

Montgomery, Alabama, United States

Scripps Clinic

La Jolla, California, United States

Scpmg/ Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

University Of Colorado Denver And Hospital

Aurora, Colorado, United States

South Denver Gastroenterology, Pc

Englewood, Colorado, United States

Mayo Clinic

Jacksonville, Florida, United States

University Of Miami Schiff Center For Liver Diseases

Miami, Florida, United States

University Of Chicago Medical Center

Chicago, Illinois, United States

North Shore University Hospital

Manhasset, New York, United States

University Of North Carolina At Chapel Hill School Of Med

Chapel Hill, North Carolina, United States

Key Dates

Start Date

May 1, 2012

Primary Completion Date

September 1, 2013

Completion Date

December 1, 2013

Last Updated

October 9, 2015

Enrollment

398

ACTUAL participants

Conditions

Hepatitis C Virus

Interventions

Asunaprevir

DRUG

Daclatasvir

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 9, 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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Phase III Hallmark QUAD: ASV+DCV+Peg+Rib (Nulls/Partials)

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