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

September 23, 2015 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

398

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • Ciudad De Buenos Aires, Buenos Aires, Argentina, C1121ABE
        • Local Institution
      • Mar Del Plata, Buenos Aires, Argentina, 7600
        • Local Institution
      • Prov. Buenos Aires, Buenos Aires, Argentina, 1629
        • Local Institution
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Local Institution
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • Local Institution
      • Victoria, British Columbia, Canada, V8V 3P9
        • Local Institution
    • Ontario
      • Toronto, Ontario, Canada, M6H 3M1
        • Local Institution
    • Quebec
      • Montreal, Quebec, Canada, H2L 4P9
        • Local Institution
  • Denmark
      • Aalborg, Denmark, 9100
        • Local Institution
      • Hvidovre, Denmark, 2650
        • Local Institution
      • Odense, Denmark, 5000
        • Local Institution
  • France
      • Creteil, France, 94000
        • Local Institution
      • Montpellier Cedex 5, France, 34295
        • Local Institution
      • Nice Cedex 03, France, 06202
        • Local Institution
      • Paris Cedex 12, France, 75571
        • Local Institution
      • Paris Cedex 14, France, 75679
        • Local Institution
      • Pessac, France, 33604
        • Local Institution
  • Germany
      • Berlin, Germany, 13353
        • Local Institution
      • Duesseldorf, Germany, 40237
        • Local Institution
      • Frankfurt, Germany, 60590
        • Local Institution
      • Freiburg, Germany, 79106
        • Local Institution
      • Hamburg, Germany, 20246
        • Local Institution
      • Heidelberg, Germany, 69120
        • Local Institution
      • Tuebingen, Germany, 72076
        • Local Institution
  • Italy
      • Brescia, Italy, 25123
        • Local Institution
      • Cisanello (pisa), Italy, 56124
        • Local Institution
      • Milano, Italy, 20122
        • Local Institution
      • Palermo, Italy, 90127
        • Local Institution
  • Korea, Republic of
      • Bucheon-si, Korea, Republic of, 420-767
        • Local Institution
      • Busan, Korea, Republic of, 602-739
        • Local Institution
      • Busan, Korea, Republic of, 614-735
        • Local Institution
      • Busan, Korea, Republic of, 602-715
        • Local Institution
      • Daegu, Korea, Republic of, 700-721
        • Local Institution
      • Gyeongsangnam-do, Korea, Republic of, 626-770
        • Local Institution
      • Incheon, Korea, Republic of, 400-711
        • Local Institution
      • Incheon, Korea, Republic of, 403-720
        • Local Institution
      • Seoul, Korea, Republic of, 120-752
        • Local Institution
      • Seoul, Korea, Republic of, 135-710
        • Local Institution
  • Mexico
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 03720
        • Local Institution
    • Estado De Mexico
      • Mexico City, Estado De Mexico, Mexico, 06700
        • Local Institution
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Local Institution
      • Rotterdam, Netherlands, 3015 CE
        • Local Institution
  • Russian Federation
      • Moscow, Russian Federation, 117593
        • Local Institution
      • Moscow, Russian Federation, 127015
        • Local Institution
      • Saint-Petersburg, Russian Federation, 194044
        • Local Institution
      • Stavropol, Russian Federation, 355000
        • Local Institution
      • Tyumen, Russian Federation, 625026
        • Local Institution
  • Spain
      • Alcorcon, Spain, 28922
        • Local Institution
      • Barcelona, Spain, 08916
        • Local Institution
      • Madrid, Spain, 28029
        • Local Institution
      • Sevilla, Spain, 41014
        • Local Institution
  • Sweden
      • Gvteborg, Sweden, SE-41685
        • Local Institution
      • Stockholm, Sweden, 141 86
        • Local Institution
  • Switzerland
      • Bern, Switzerland, 3010
        • Local Institution
      • Lausanne, Switzerland, 1011
        • Local Institution
  • Taiwan
      • Chia-Yi, Taiwan, 600
        • Local Institution
      • Kaohsiung, Taiwan, 807
        • Local Institution
      • Taichung, Taiwan, 40705
        • Local Institution
      • Taipei, Taiwan, 11217
        • Local Institution
  • United States
    • Alabama
      • Montgomery, Alabama, United States, 36116
        • Alabama Liver & Digestive Specialists (Alds)
    • California
      • La Jolla, California, United States, 92037
        • Scripps Clinic
      • Los Angeles, California, United States, 90027
        • Scpmg/ Kaiser Permanente Los Angeles Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver and Hospital
      • Englewood, Colorado, United States, 80113
        • South Denver Gastroenterology, PC
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
      • Miami, Florida, United States, 33136
        • University of Miami Schiff Center for Liver Diseases
    • Illinois
      • Chicago, Illinois, United States, 60637-1432
        • University of Chicago Medical Center
    • New York
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7584
        • University Of North Carolina At Chapel Hill School Of Med
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Options Health Research, LLC
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Gastro One
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • San Antonio, Texas, United States, 78215
        • Texas Liver Institute
    • Virginia
      • Richmond, Virginia, United States, 23249
        • McGuire DVAMC
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • Dean Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)
  • Platelets < 90 x 1000,000,000 cells/L
  • Hemoglobin < 12 g/dL for females or < 13 g/dL for males
  • Any criteria that would exclude the subject from receiving P/R

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: QUAD: Asunaprevir+Daclatasvir+Peg-interferon Alfa-2a+Ribavirin

Asunaprevir: Capsule, Oral, 100 mg, Twice daily, 24 weeks

Daclatasvir: Tablet, Oral, 60 mg, Once daily, 24 weeks

Peg-interferon Alfa-2a: Injection, subcutaneous (SC), 180 mcg/0.5 mL, Once weekly, 24 weeks

Ribavirin: Tablet, Oral, 1000 mg/1200 mg (total daily dose), 24 weeks
Drug: Ribavirin
Other Names:
  • Copegus®
Drug: Daclatasvir
Other Names:
  • BMS-790052
Drug: Asunaprevir
Other Names:
  • BMS-650032
Drug: Peg-interferon Alfa-2a
Other Names:
  • Pegasys®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of genotype 1 subjects with SVR12, defined as HCV RNA < LOQ at post-treatment Week 12, for all subjects infected with HCV genotype 1
Time Frame: At 12 weeks post-treatment
At 12 weeks post-treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
On-treatment safety, as measured by frequency of Serious Adverse Events (SAEs) and discontinuations due to Adverse Events (AEs) through the end of treatment
Time Frame: Through the end of treatment (maximum up to 24 weeks) plus 7 days
Through the end of treatment (maximum up to 24 weeks) plus 7 days
Proportion of subjects with SVR12 (HCV RNA < LOQ at post-treatment Week 12) by the rs12979860 single nucleotide polymorphisms (SNP) in the IL28 gene
Time Frame: At post-treatment Week 12
At post-treatment Week 12
Proportion of subjects with HCV RNA undetectable
Time Frame: Weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [Extended rapid virologic response (eRVR)], end of treatment (up to 24 weeks), post-treatment Week 12 or post-treatment Week 24
Weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [Extended rapid virologic response (eRVR)], end of treatment (up to 24 weeks), post-treatment Week 12 or post-treatment Week 24
Proportion of subjects with HCV RNA < LOQ
Time Frame: Weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12, end of treatment (up to 24 weeks), post-treatment Week 24 (SVR24)
Weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12, end of treatment (up to 24 weeks), post-treatment Week 24 (SVR24)
Proportion of patients with SVR12 (HCV RNA < LOQ at post-treatment Week 12) for HCV genotype 4 subjects
Time Frame: Post-treatment Week 12
Post-treatment Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

April 5, 2012

First Submitted That Met QC Criteria

April 6, 2012

First Posted (Estimate)

April 9, 2012

Study Record Updates

Last Update Posted (Estimate)

October 9, 2015

Last Update Submitted That Met QC Criteria

September 23, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI447-029
  • 2011-005422-21 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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