Phase III Hallmark DUAL: ASV+DCV (Nulls/Partials, Intolerants/Ineligibles. Naives)
NCT ID: NCT01581203
Last Updated: 2015-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
748 participants
INTERVENTIONAL
2012-05-31
2014-09-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
Asunaprevir (ASV)
Daclatasvir (DCV)
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
Asunaprevir (ASV)
Daclatasvir (DCV)
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
Asunaprevir (ASV)
Daclatasvir (DCV)
Pegylated-interferon alfa 2a (PegIFN)
Ribavirin (RBV)
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
Asunaprevir (ASV)
Daclatasvir (DCV)
Pegylated-interferon alfa 2a (PegIFN)
Ribavirin (RBV)
Interventions
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Asunaprevir (ASV)
Daclatasvir (DCV)
Pegylated-interferon alfa 2a (PegIFN)
Ribavirin (RBV)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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The Health Care Authority For Baptist Health
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
Uf Hepatology Research At Ctrb
Gainesville, Florida, United States
Johns Hopkins Medical Institutions
Lutherville, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Washington University School Of Medicine
St Louis, Missouri, United States
North Shore-Long Island Jewish Health System
Manhasset, New York, United States
Weill Cornell Medical College
New York, New York, United States
University Of North Carolina At Chapel Hill School Of Med
Chapel Hill, North Carolina, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Baylor College Of Medicine
Houston, Texas, United States
Vamc
Houston, Texas, United States
Alamo Medical Research
San Antonio, Texas, United States
Dean Clinic
Madison, Wisconsin, United States
Local Institution
Buenos Aires, Buenos Aires, Argentina
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Ciudad de Buenos Aires, Buenos Aires, Argentina
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Prov de Santa Fe, Santa Fe Province, Argentina
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Darlinghurst, New South Wales, Australia
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Kogarah, New South Wales, Australia
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Randwick, New South Wales, Australia
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Fitzroy, Queensland, Australia
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Adelaide, South Australia, Australia
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Bedford Park, Sa, South Australia, Australia
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Clayton, Victoria, Australia
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Heidelberg, Victoria, Australia
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Melbourne, Victoria, Australia
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Fremantle, Western Australia, Australia
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Nedlands, Western Australia, Australia
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Perth, Western Australia, Australia
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Graz, , Austria
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Linz, , Austria
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Salzburg, , Austria
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Vienna, , Austria
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Vienna, , Austria
Gastrointestinal Research Institute (G.I.R.I.)
Vancouver, British Columbia, Canada
Percuro Clinical Research Ltd
Victoria, British Columbia, Canada
Toronto General Hospital-University Health Network
Toronto, Ontario, Canada
Toronto Liver Centre
Toronto, Ontario, Canada
Toronto Digestive Disease Associates, Inc.
Vaughan, Ontario, Canada
Clinique Medicale Lactuel
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Alpha-Recherche Clinique
Québec, Quebec, Canada
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Clichy, , France
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Créteil, , France
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Lyon, , France
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Marseille, , France
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Paris, , France
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Paris, , France
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Toulouse, , France
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Vandœuvre-lès-Nancy, , France
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Berlin, , Germany
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Berlin, , Germany
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Bonn, , Germany
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Essen, , Germany
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Frankfurt, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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München, , Germany
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Dublin, Dublin, Ireland
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Dublin, Dublin, Ireland
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Haifa, , Israel
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Jerusalem, , Israel
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Jerusalem, , Israel
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Tel Aviv, , Israel
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Tel Litwinsky, , Israel
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Zafed, , Israel
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Messina, , Italy
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Milan, , Italy
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Roma, , Italy
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Torino, , Italy
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Amsterdam, , Netherlands
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Leiden, , Netherlands
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Rotterdam, , Netherlands
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Auckland, , New Zealand
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Hamilton, , New Zealand
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Wellington, , New Zealand
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Bialystok, , Poland
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Wroclaw, , Poland
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Chelyabinsk, , Russia
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Krasnoyarsk, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Samara, , Russia
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Smolensk, , Russia
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Tyumen, , Russia
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Busan, , South Korea
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Busan, , South Korea
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Busan, , South Korea
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Daegu, , South Korea
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Daegu, , South Korea
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Gyeonggi-do, , South Korea
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Gyeongsangnam-do, , South Korea
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Incheon, , South Korea
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Incheon, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Alicante, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Valencia, , Spain
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Taichung, , Taiwan
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Taichung, , Taiwan
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Tainan City, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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London, Greater London, United Kingdom
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London, Greater London, United Kingdom
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Manchester, Greater Manchester, United Kingdom
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Glasgow, Lanarkshire, United Kingdom
Countries
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References
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Kao JH, Lee YJ, Heo J, Ahn SH, Lim YS, Peng CY, Chang TT, Torbeyns A, Hughes E, Bhore R, Noviello S. All-oral daclatasvir plus asunaprevir for chronic hepatitis C virus (HCV) genotype 1b infection: a sub-analysis in Asian patients from the HALLMARK DUAL study. Liver Int. 2016 Oct;36(10):1433-41. doi: 10.1111/liv.13128. Epub 2016 Apr 28.
Kao JH, Jensen DM, Manns MP, Jacobson I, Kumada H, Toyota J, Heo J, Yoffe B, Sievert W, Bessone F, Peng CY, Roberts SK, Lee YJ, Bhore R, Mendez P, Hughes E, Noviello S. Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis. Liver Int. 2016 Jul;36(7):954-62. doi: 10.1111/liv.13049. Epub 2016 Jan 24.
Manns M, Pol S, Jacobson IM, Marcellin P, Gordon SC, Peng CY, Chang TT, Everson GT, Heo J, Gerken G, Yoffe B, Towner WJ, Bourliere M, Metivier S, Chu CJ, Sievert W, Bronowicki JP, Thabut D, Lee YJ, Kao JH, McPhee F, Kopit J, Mendez P, Linaberry M, Hughes E, Noviello S; HALLMARK-DUAL Study Team. All-oral daclatasvir plus asunaprevir for hepatitis C virus genotype 1b: a multinational, phase 3, multicohort study. Lancet. 2014 Nov 1;384(9954):1597-605. doi: 10.1016/S0140-6736(14)61059-X. Epub 2014 Jul 28.
Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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2011-005446-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AI447-028
Identifier Type: -
Identifier Source: org_study_id
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