Phase III Hallmark QUAD: ASV+DCV+Peg+Rib (Nulls/Partials)
NCT ID: NCT01573351
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
398 participants
INTERVENTIONAL
2012-05-31
2013-12-31
Brief Summary
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Detailed Description
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* DCV = Daclatasvir (BMS-790052)
* Peg = Peg-interferon Alfa-2a (PegIFN)
* Rib = Ribavirin (RBV)
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
Asunaprevir
Daclatasvir
Peg-interferon Alfa-2a
Ribavirin
Interventions
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Asunaprevir
Daclatasvir
Peg-interferon Alfa-2a
Ribavirin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
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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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
University Of Cincinnati
Cincinnati, Ohio, United States
Options Health Research, Llc
Tulsa, Oklahoma, United States
Oregon Health & Science University
Portland, Oregon, United States
University Of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Gastro One
Germantown, Tennessee, United States
Baylor College Of Medicine
Houston, Texas, United States
Texas Liver Institute
San Antonio, Texas, United States
Mcguire Dvamc
Richmond, Virginia, United States
Dean Clinic
Madison, Wisconsin, United States
Local Institution
Ciudad de Buenos Aires, Buenos Aires, Argentina
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Mar del Plata, Buenos Aires, Argentina
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Prov. Buenos Aires, Buenos Aires, Argentina
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Aalborg, , Denmark
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Hvidovre, , Denmark
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Odense, , Denmark
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Créteil, , France
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Montpellier, , France
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Nice, , France
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Paris, , France
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Paris, , France
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Pessac, , France
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Berlin, , Germany
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Düsseldorf, , Germany
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Frankfurt, , Germany
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Freiburg im Breisgau, , Germany
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Hamburg, , Germany
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Heidelberg, , Germany
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Tübingen, , Germany
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Brescia, , Italy
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Cisanello (pisa), , Italy
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Milan, , Italy
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Palermo, , Italy
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Mexico City, Mexico City, Mexico
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México, State of Mexico, Mexico
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Amsterdam, , Netherlands
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Rotterdam, , Netherlands
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Moscow, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Stavropol, , Russia
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Tyumen, , Russia
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Bucheon-si, , South Korea
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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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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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Alcorcón, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Seville, , Spain
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Gvteborg, , Sweden
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Stockholm, , Sweden
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Bern, , Switzerland
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Lausanne, , Switzerland
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Chiayi City, , Taiwan
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
Countries
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References
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Jensen D, Sherman KE, Hezode C, Pol S, Zeuzem S, de Ledinghen V, Tran A, Elkhashab M, Younes ZH, Kugelmas M, Mauss S, Everson G, Luketic V, Vierling J, Serfaty L, Brunetto M, Heo J, Bernstein D, McPhee F, Hennicken D, Mendez P, Hughes E, Noviello S; HALLMARK-QUAD Study Team. Daclatasvir and asunaprevir plus peginterferon alfa and ribavirin in HCV genotype 1 or 4 non-responders. J Hepatol. 2015 Jul;63(1):30-7. doi: 10.1016/j.jhep.2015.02.018. Epub 2015 Feb 19.
Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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2011-005422-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AI447-029
Identifier Type: -
Identifier Source: org_study_id
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