Phase III Hallmark DUAL: ASV+DCV (Nulls/Partials, Intolerants/Ineligibles. Naives) (Hallmark DUAL)

September 23, 2015 updated by: Bristol-Myers Squibb

A Phase 3 Study With Asunaprevir and Daclatasvir (DUAL) for Null or Partial Responders to Peginterferon Alfa and Ribavirin (P/R), Intolerant or Ineligible to P/R Subjects and Treatment-Naive Subjects With Chronic Hepatitis C Genotype 1b Infection

The purpose of this study is to estimate 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, for subjects who are prior null or partial responders to P/R or who are treatment-naive.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Allocation: Treatment naive cohort: Randomized Controlled Trial, Null/partial responder and intolerant/ineligible cohorts: N/A (Single arm study)

Masking: Treatment naive cohort: Double Blind, Null/partial responder and intolerant/ineligible cohorts: Open

Intervention Model: Treatment naive cohort: Parallel, Null/partial responder and intolerant/ineligible cohorts: Single group

Study Type

Interventional

Enrollment (Actual)

748

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, Argentina, 1119
        • Local Institution
    • Buenos Aires
      • Ciudad De Buenos Aires, Buenos Aires, Argentina, C1181ACH
        • Local Institution
    • Santa Fe
      • Prov De Santa Fe, Santa Fe, Argentina, 2000
        • Local Institution
  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Local Institution
      • Kogarah, New South Wales, Australia, 2217
        • Local Institution
      • Randwick, New South Wales, Australia, 2070
        • Local Institution
    • Queensland
      • Fitzroy, Queensland, Australia, 3065 VIC
        • Local Institution
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Local Institution
      • Bedford Park, Sa, South Australia, Australia, 5042
        • Local Institution
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Local Institution
      • Heidelberg, Victoria, Australia, 3084
        • Local Institution
      • Melbourne, Victoria, Australia, 3004
        • Local Institution
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • Local Institution
      • Nedlands, Western Australia, Australia, 6009
        • Local Institution
      • Perth, Western Australia, Australia, 6001
        • Local Institution
  • Austria
      • Graz, Austria, 8036
        • Local Institution
      • Linz, Austria, 4010
        • Local Institution
      • Salzburg, Austria, 5020
        • Local Institution
      • Wien, Austria, 1090
        • Local Institution
      • Wien, Austria, 1160
        • Local Institution
  • Canada
      • Quebec, Canada, G3K 2P8
        • Alpha-Recherche Clinique
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • Gastrointestinal Research Institute (G.I.R.I.)
      • Victoria, British Columbia, Canada, V8V 3P9
        • Percuro Clinical Research Ltd
    • Ontario
      • Toronto, Ontario, Canada, M6H 3M1
        • Toronto Liver Centre
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital-University Health Network
      • Vaughan, Ontario, Canada, L4L 4Y7
        • Toronto Digestive Disease Associates, Inc.
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital
      • Montreal, Quebec, Canada, H2L 4P9
        • Clinique Medicale lActuel
  • France
      • Clichy Cedex, France, 92118
        • Local Institution
      • Creteil, France, 94000
        • Local Institution
      • Lyon Cedex 04, France, 69317
        • Local Institution
      • Marseille Cedex 08, France, 13285
        • Local Institution
      • Paris, France, 75014
        • Local Institution
      • Paris Cedex 13, France, 75651
        • Local Institution
      • Toulouse, France, 31059
        • Local Institution
      • Vandoeuvre Les Nancy, France, 54511
        • Local Institution
  • Germany
      • Berlin, Germany, 13353
        • Local Institution
      • Berlin, Germany, 12157
        • Local Institution
      • Bonn, Germany, 53105
        • Local Institution
      • Essen, Germany, 45147
        • Local Institution
      • Frankfurt, Germany, 60590
        • Local Institution
      • Hamburg, Germany, 20246
        • Local Institution
      • Hannover, Germany, 30623
        • Local Institution
      • Muenchen, Germany, 81377
        • Local Institution
  • Ireland
      • Dublin, Ireland, DUBLIN 7
        • Local Institution
      • Dublin, Ireland, DUBLIN 8
        • Local Institution
  • Israel
      • Haifa, Israel, 31096
        • Local Institution
      • Jerusalem, Israel, 91120
        • Local Institution
      • Jerusalem, Israel, 91031
        • Local Institution
      • Tel Aviv, Israel, 64239
        • Local Institution
      • Tel Hashomer, Israel, 52621
        • Local Institution
      • Zafed, Israel, 13110
        • Local Institution
  • Italy
      • Messina, Italy, 98124
        • Local Institution
      • Milano, Italy, 20121
        • Local Institution
      • Roma, Italy, 00161
        • Local Institution
      • Torino, Italy, 10126
        • Local Institution
  • Korea, Republic of
      • 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
      • Daegu, Korea, Republic of, 705-703
        • Local Institution
      • Gyeonggi-do, Korea, Republic of, 420-767
        • 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
      • Seoul, Korea, Republic of, 138-736
        • Local Institution
      • Seoul, Korea, Republic of, 110-774
        • Local Institution
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Local Institution
      • Leiden, Netherlands, 2300 RC
        • Local Institution
      • Rotterdam, Netherlands, 3015 CE
        • Local Institution
  • New Zealand
      • Auckland, New Zealand, 92024
        • Local Institution
      • Hamilton, New Zealand, 3240
        • Local Institution
      • Wellington, New Zealand, 6021
        • Local Institution
  • Poland
      • Bialystok, Poland, 15-540
        • Local Institution
      • Wroclaw, Poland, 50-349
        • Local Institution
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454052
        • Local Institution
      • Krasnoyarsk, Russian Federation, 660049
        • Local Institution
      • Moscow, Russian Federation, 111123
        • Local Institution
      • Moscow, Russian Federation, 115446
        • Local Institution
      • Saint-Petersburg, Russian Federation, 190103
        • Local Institution
      • Samara, Russian Federation, 443077
        • Local Institution
      • Smolensk, Russian Federation, 214018
        • Local Institution
      • Tyumen, Russian Federation, 625026
        • Local Institution
  • Spain
      • Alicante, Spain, 03010
        • Local Institution
      • Barcelona, Spain, 08028
        • Local Institution
      • Madrid, Spain, 28222
        • Local Institution
      • Valencia, Spain, 46009
        • Local Institution
  • Taiwan
      • Taichung, Taiwan, 40447
        • Local Institution
      • Taichung, Taiwan, 402
        • Local Institution
      • Tainan, Taiwan, 704
        • Local Institution
      • Taipei, Taiwan, 100
        • Local Institution
      • Taipei, Taiwan, 112
        • Local Institution
  • United Kingdom
    • Greater London
      • London, Greater London, United Kingdom, SW17 0QT
        • Local Institution
      • London, Greater London, United Kingdom, NW3 2QG,
        • Local Institution
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M8 6RL
        • Local Institution
    • Lanarkshire
      • Glasgow, Lanarkshire, United Kingdom, G12 0YN
        • Local Institution
  • United States
    • Alabama
      • Montgomery, Alabama, United States, 36116
        • The Health Care Authority For Baptist Health
    • 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
    • Florida
      • Gainesville, Florida, United States, 32610
        • UF Hepatology Research at CTRB
    • Maryland
      • Lutherville, Maryland, United States, 21093
        • Johns Hopkins Medical Institutions
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New York
      • Manhasset, New York, United States, 11030
        • North Shore-Long Island Jewish Health System
      • New York, New York, United States, 10021
        • Weill Cornell Medical College
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University Of North Carolina At Chapel Hill School Of Med
      • Charlotte, North Carolina, United States, 28204
        • Carolinas Medical Center
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030
        • VAMC
      • San Antonio, Texas, United States, 78215
        • Alamo Medical Research
    • 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

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Males and females, ≥ 18 years of age
  • HCV Genotype 1b who previously failed treatment with peginterferon alfa and ribavirin, classified as previous null or partial responders based on previous therapy, OR intolerant or ineligible to P/R due to neutropenia, anemia, depression or thrombocytopenia with fibrosis/cirrhosis, OR treatment naive
  • 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

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm 1: Null or Partial Responder to P/R (ASV + DCV)

Asunaprevir 100 mg Capsules by mouth, Twice daily for 24 Weeks

Daclatasvir 60 mg Tablet by mouth, Once daily for 24 Weeks
Drug: Asunaprevir (ASV)
Other Names:
  • BMS-650032
Drug: Daclatasvir (DCV)
Other Names:
  • BMS-790052
EXPERIMENTAL: Arm 2: Intolerant to or Ineligible for P/R (ASV + DCV)

Asunaprevir 100 mg Capsules by mouth, Twice daily for 24 Weeks

Daclatasvir 60 mg Tablet by mouth, Once daily for 24 Weeks
Drug: Asunaprevir (ASV)
Other Names:
  • BMS-650032
Drug: Daclatasvir (DCV)
Other Names:
  • BMS-790052
EXPERIMENTAL: Arm 3: Treatment naive (ASV + DCV)

[Subjects will receive ASV + DCV for 24 weeks] followed by ASV + DCV for 24 weeks in protocol AI444026]

Subjects meeting prespecified rescue criteria in the treatment naive cohort may have therapeutic rescue instituted with QUAD regimen (QUAD= ASV + DCV + P/R)

Asunaprevir 100 mg Capsules by mouth, Twice daily for 24 or 48 Weeks

Daclatasvir 60 mg Tablet by mouth, Once daily for 24 or 48 Weeks

Pegylated-interferon alfa 2a (PegIFN) 180 mcg/0.5 mL injection subcutaneously (SC), once weekly for 24 or 48 weeks

Ribavirin 1000 mg/1200 mg (total daily dose) tablet by mouth for 24 or 48 weeks
Drug: Asunaprevir (ASV)
Other Names:
  • BMS-650032
Drug: Daclatasvir (DCV)
Other Names:
  • BMS-790052
Drug: Pegylated-interferon alfa 2a (PegIFN)
Other Names:
  • Pegasys
Drug: Ribavirin (RBV)
Other Names:
  • Copegus
EXPERIMENTAL: Arm 4: Null or Partial Responder to P/R (ASV + DCV) 24/48 week

Subjects meeting prespecified rescue criteria in the null or partial responder cohort or active arm of the treatment naive cohort may have therapeutic rescue instituted with QUAD regimen (QUAD= ASV + DCV + P/R)

Asunaprevir 100 mg Capsules by mouth, Twice daily for 24 or 48 Weeks

Daclatasvir 60 mg Tablet by mouth, Once daily for 24 or 48 Weeks

Pegylated-interferon alfa 2a (PegIFN) 180 mcg/0.5 mL injection subcutaneously (SC), once weekly for 24 or 48 weeks

Ribavirin 1000 mg / 1200 mg (total daily dose) Tablet by mouth, for 24 or 48 weeks
Drug: Asunaprevir (ASV)
Other Names:
  • BMS-650032
Drug: Daclatasvir (DCV)
Other Names:
  • BMS-790052
Drug: Pegylated-interferon alfa 2a (PegIFN)
Other Names:
  • Pegasys
Drug: Ribavirin (RBV)
Other Names:
  • Copegus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of treated subjects with SVR12, defined as HCV RNA < LOQ at post treatment Week 12, for subjects who are prior null or partial responders to P/R or are treatment-naive
Time Frame: At 12 weeks post-treatment
At 12 weeks post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of treated subjects with SVR12, defined as HCV RNA < LOQ at post-treatment Week 12, for subjects who are intolerant or ineligible to P/R
Time Frame: Post-treatment Week 12
Post-treatment Week 12
On treatment safety, as measured by frequency of Serious Adverse Events (SAEs) and discontinuations due to Adverse Events (AEs)
Time Frame: End of Treatment (up to 48 weeks) plus 7 days
End of Treatment (up to 48 weeks) plus 7 days
Differences in rates of selected grade 3-4 laboratory abnormalities during the first 12 weeks between treatments (ASV + DCV vs PBO) for naive subjects
Time Frame: Up to first 12 weeks
Up to first 12 weeks
Proportion of genotype 1b subjects with SVR12 (HCV RNA < LOQ at post treatment Week 12) by the rs12979860 single nucleotide polymorphisms (SNP) in the IL28B gene for each cohort
Time Frame: Post-treatment Week 12
Post-treatment Week 12
Proportion of genotype 1b subjects with HCV RNA undetectable
Time Frame: At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [eRVR]; EOT (up to 24 weeks), post-treatment Week 12, or post-treatment Week 24 for each cohort
eRVR = Extended rapid virologic response, EOT = End of treatment
At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [eRVR]; EOT (up to 24 weeks), post-treatment Week 12, or post-treatment Week 24 for each cohort
Proportion of genotypes 1b subjects with HCV RNA < LOQ
Time Frame: At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [VR(4&12)]; EOT (up to 24 weeks), post-treatment Week 24 (SVR24) for each cohort
At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [VR(4&12)]; EOT (up to 24 weeks), post-treatment Week 24 (SVR24) for each cohort
Proportion of subjects with anemia
Time Frame: At 12 weeks post-treatment
At 12 weeks post-treatment
Proportion of subjects with rash
Time Frame: At 12 weeks post-treatment
At 12 weeks post-treatment

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)

October 1, 2013

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

April 18, 2012

First Submitted That Met QC Criteria

April 19, 2012

First Posted (ESTIMATE)

April 20, 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

  • AI447-028
  • 2011-005446-35 (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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