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Study Comparing BMS-790052 (Daclatasvir) to Telaprevir Combined With Peginterferon Alfa-2a and Ribavirin in Untreated Hepatitis C Patients

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C

Intervention: BMS-790052 (Daclatasvir) (Drug); Telaprevir (Drug); Peginterferon alfa-2a (Drug); Ribavirin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Summary

The purpose of this study is to compare the effectiveness of BMS-790052 (Daclatasvir) and Telaprevir when given in combination with Peginterferon alfa-2a and Ribavirin in genotype 1b patients

Clinical Details

Official title: A Phase 3 Evaluation of BMS-790052 (Daclatasvir) Compared With Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Proportion of genotype 1b patients with SVR12, defined as HCV RNA less than limit of quantitation at follow-up Week 12 in each group

Secondary outcome:

Proportion of genotype 1b patients with hemoglobin value less than 10 g/dL

Proportion of genotype 1b patients with rash events

Proportion of genotype1b patients with HCV RNA undetectable Week 12

Proportion of genotype 1b patients with HCV RNA undetectable Week 4

Proportion of genotype 1b patients with HCV RNA undetectable Weeks 4 and 12

Proportion of genotype 1b patients with SVR24, defined as HCV RNA < Limit of Quantification (LOQ) at follow-up Week 24 for each cohort

Proportion of genotype 1b patients with SVR12 based on IL28B rs12979860 Single nucleotide polymorphism (SNP) genotype (CC or non-CC)

Proportion of genotype 1a patients with SVR12 defined as HCV RNA < LOQ at follow-up Week 12 for each cohort

Detailed description: Allocation: Randomized Stratified

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects chronically infected with HCV genotype 1a or 1b

- HCV RNA viral load ≥ 10,000 IU/mL

- No prior treatment including but not limited to interferon, ribavirin and

direct-acting antivirals

- if no prior history of cirrhosis liver biopsy within 3 years or Fibroscan® within 1

year

- Body Mass Index (BMI) of 18 to 35 kg/m2

- Negative for Human immunodeficiency virus (HIV) and Hepatitis B

Exclusion Criteria:

- Evidence of decompensated liver disease

- Evidence of medical condition contributing to chronic liver disease other than HCV

Locations and Contacts

Local Institution, Linz 4010, Austria

Local Institution, Wien 1090, Austria

Local Institution, Wien 1160, Austria

Local Institution, Sao Paulo 04023-062, Brazil

Local Institution, Hvidovre 2650, Denmark

Local Institution, Odense 5000, Denmark

Local Institution, Besancon 25000, France

Local Institution, Bondy Cedex 93143, France

Local Institution, Grenoble Cedex 09 38043, France

Local Institution, Lille Cedex 59037, France

Local Institution, Paris Cedex 12 75571, France

Local Institution, Paris Cedex 13 75651, France

Local Institution, Pessac 33600, France

Local Institution, Strasbourg 67090, France

Local Institution, Berlin 10969, Germany

Local Institution, Berlin 13353, Germany

Local Institution, Essen 45122, Germany

Local Institution, Frankfurt 60590, Germany

Local Institution, Freiburg 79106, Germany

Local Institution, Hamburg 20246, Germany

Local Institution, Hannover 30625, Germany

Local Institution, Koeln 50937, Germany

Local Institution, Haifa 31096, Israel

Local Institution, Nazareth 16100, Israel

Local Institution, Tel Aviv 64239, Israel

Local Institution, Zefat 13110, Israel

Local Institution, Bergamo 24127, Italy

Local Institution, Cisanello (pisa) 56124, Italy

Local Institution, Firenze 50134, Italy

Local Institution, Napoli 80131, Italy

Local Institution, Torino 10100, Italy

Local Institution, Bialystok 15-540, Poland

Local Institution, Chorzow 41-500, Poland

Local Institution, Kielce 25-317, Poland

Local Institution, Myslowice 41-400, Poland

Local Institution, Raciborz 47-400, Poland

Local Institution, Wroclaw 50-220, Poland

Local Institution, Moscow 109240, Russian Federation

Local Institution, Moscow 119991, Russian Federation

Local Institution, Moscow 121170, Russian Federation

Local Institution, Alcorcon 28922, Spain

Local Institution, Barcelona 08003, Spain

Local Institution, Barcelona 08036, Spain

Local Institution, Valencia 46010, Spain

Local Institution, Zurich 8091, Switzerland

The Kirklin Clinic, Birmingham, Alabama 35294, United States

Local Institution, Calgary, Alberta T2N 4Z6, Canada

Local Institution, Edmonton, Alberta T6G 2B7, Canada

Mayo Clinic Arizona, Phoenix, Arizona 85054, United States

Local Institution, Vancouver, British Columbia V6Z 2K5, Canada

Local Institution, Ciudad De Buenos Aires, Buenos Aires C1121ABE, Argentina

Local Institution, Ciudad De Buenos Aires, Buenos Aires C1181ACH, Argentina

Local Institution, Prov. Buenos Aires, Buenos Aires 1629, Argentina

Va Long Beach Healthcare System, Long Beach, California 90822, United States

Medical Associates Research Group, San Diego, California 92123, United States

Yale University School Of Medicine, New Haven, Connecticut 06520-8019, United States

Orlando Immunology Center, Orlando, Florida 32803, United States

Atlanta Medical Center, Atlanta, Georgia 30312, United States

Gastrointestinal Specialists Of Georgia, Marietta, Georgia 30060, United States

Local Institution, London, Greater London SE5 9RS, United Kingdom

Northwestern University, Chicago, Illinois 60611, United States

Rush University Medical Center, Chicago, Illinois 60612, United States

Local Institution, Winnipeg, Manitoba R3E 3P4, Canada

University Of Maryland, Baltimore, Maryland 21201-1595, United States

Johns Hopkins University, Lutherville, Maryland 21093, United States

Minnesota Gastroenterology, P.A., Saint Paul, Minnesota 55114, United States

Saint Louis University Gastroenterology & Hepatology, St. Louis, Missouri 63104, United States

Local Institution, Camperdown, New South Wales 2050, Australia

Local Institution, Penrith, New South Wales 2750, Australia

Local Institution, Westmead Nsw, New South Wales 2145, Australia

Weill Cornell Medical College, New York, New York 10021, United States

University Of North Carolina At Chapel Hill School Of Med, Chapel Hill, North Carolina 27599-7584, United States

Carolinas Medical Center, Charlotte, North Carolina 28203, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

Local Institution, Ottawa, Ontario K1H 8L6, Canada

Local Institution, Toronto, Ontario M5G 2N2, Canada

Albert Einstein Medical Center, Philadelphia, Pennsylvania 19141, United States

Local Institution, Greenslopes Qld, Queensland 4120, Australia

The Miriam Hospital, Providence, Rhode Island 02906, United States

University Gastroenterology, Providence, Rhode Island 02905, United States

Local Institution, Prov De Santa Fe, Santa Fe 2000, Argentina

Local Institution, Edinburgh, Scotland EH4 2XU, United Kingdom

Local Institution, Glasgow, Scotland G12 0YN, United Kingdom

Local Institution, Adelaide, South Australia 5000, Australia

Brooke Army Medical Center, Ft. Sam Houston, Texas 78234, United States

Baylor College Of Medicine, Houston, Texas 77030, United States

Research Specialists Of Texas, Houston, Texas 77030, United States

Alamo Medical Research, San Antonio, Texas 78215, United States

Local Institution, Fitzroy, Victoria 3065 VIC, Australia

Local Institution, Prahran, Victoria 3181, Australia

Local Institution, Birmingham, West Midlands B15 2TH, United Kingdom

Additional Information

BMS Clinical Trial Information

BMS clinical trial educational resource

Investigator Inquiry form

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Starting date: January 2012
Last updated: May 5, 2014

Page last updated: August 23, 2015

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