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A Study of Combination Therapy With PEGASYS (Pegylated Interferon Alfa-2a (40KD)) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 2 or 3 Who Do Not Achieve a Rapid Viral Response

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C, Chronic

Intervention: peginterferon alfa-2a (Drug); Ribavirin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

Summary

This study will evaluate the efficacy and safety of peginterferon alfa-2a 40KD + ribavirin combination therapy given for 24 weeks versus 48 weeks in patients with chronic hepatitis C, genotype 2/3.

Clinical Details

Official title: A Randomized, Open-label Study of the Effects of 24 vs 48 Weeks of Combination Therapy With PEGASYS (Peginterferon Alfa-2a 40KD) Plus COPEGUS (Ribavirin) on Sustained Virological Response in Patients With Chronic Hepatitis C, Genotype 2 or 3 Who do Not Achieve a Rapid Viral Response

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

Primary outcome:

Percentage of Participants With a Sustained Virologic Response 24 Weeks After Scheduled Completion of Treatment

Percentage of Participants With a Sustained Virologic Response 24 Weeks After Actual End of Treatment

Secondary outcome:

Percentage of Participants With Virological Response 72 Weeks After Treatment Initiation

Percentage of Participants With Virological Response at End of Treatment

Percentage of Participants With Virological Relapse

Percentage of Participants With a Sustained Virologic Response 12 Weeks After Actual End of Treatment

Number of Participants With Adverse Events (AEs)

Detailed description: During a pre-study run-in phase patients with chronic hepatitis C genotype 2/3, who had started therapy with PEG-IFN alfa-2a plus ribavirin according to local standard of care and did not achieve a rapid viral response (RVR) (defined as Hepatitis C virus (HCV) RNA <15 IU/mL at Week 4 of treatment measured with the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test) were eligible for the study and entered the screening phase between treatment Week 4 and 8 as soon as the result of the Week 4 HCV RNA test was available. Eligible patients entered the study and continued with the dose regimens of PEG-IFN alfa-2a and ribavirin they were taking prior to enrolment into the trial up to Week 24 of treatment. Patients who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24, were randomized at treatment Week 24 to one of the two study groups. Upon randomization, participants either stopped treatment (equaling 24 weeks of treatment) or continued treatment for another 24 weeks (equaling 48 weeks of treatment). A treatment free follow-up period of 24 weeks (for participants in the 48-week treatment group) or 48 weeks (participants in the 24-week treatment group) completed the study.

Eligibility

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

Criteria:

Inclusion Criteria:

- adult patients, >=18 years of age;

- serological evidence of chronic hepatitis C (CHC);

- CHC genotype 2 or 3;

- receiving PEGASYS + Copegus according to local standard of care and no rapid viral

response (RVR);

- compensated liver disease.

Exclusion Criteria:

- pegylated interferon, standard interferon or ribavirin therapy at any time prior to

initiation of current therapy with PEGASYS + Copegus;

- coinfection with hepatitis A or B, or human immunodeficiency virus (HIV);

- history or other evidence of decompensated liver disease.

Locations and Contacts

Darlinghurst 2010, Australia

Fremantle 6160, Australia

Melbourne 3186, Australia

Nedlands 6009, Australia

Sydney 2139, Australia

Graz 8036, Austria

Innsbruck 6020, Austria

Linz 4010, Austria

Oberndorf 5110, Austria

Wien 1090, Austria

Wien 1160, Austria

Antwerpen 2650, Belgium

Bruxelles 1070, Belgium

Bruxelles 1000, Belgium

Bruxelles 1020, Belgium

Gent 9000, Belgium

Kortrijk 8500, Belgium

Liege 4000, Belgium

Brasilia 70335-000, Brazil

Campinas 13012-970, Brazil

Campinas 13081-970, Brazil

Porto Alegre 90035-003, Brazil

Porto Alegre 90020-090, Brazil

Ribeirao Preto 14049-900, Brazil

Rio de Janeiro 20020-022, Brazil

Santo Andre 09060-650, Brazil

Sao Luis 78048-790, Brazil

Sao Paulo 04040-003, Brazil

Sorocaba 18047-600, Brazil

Vitoria 29043-260, Brazil

Berlin 10969, Germany

Berlin 13353, Germany

Bonn 53127, Germany

Düsseldorf 40225, Germany

Düsseldorf 40237, Germany

Frankfurt Am Main 60590, Germany

Freiburg 79106, Germany

Giessen 35392, Germany

Hamburg 20099, Germany

Heidelberg 69120, Germany

Jena 07747, Germany

Kiel 24105, Germany

Köln 50937, Germany

Mainz 55101, Germany

München 81675, Germany

Offenburg 77654, Germany

Tübingen 72076, Germany

ULM 89081, Germany

Guadalajara 44160, Mexico

Guadalajara 44670, Mexico

Mexicali 21000, Mexico

Mexico City 14050, Mexico

Mexico Df 11649, Mexico

Puebla 72560, Mexico

Santurce 00909, Puerto Rico

Lausanne 1005, Switzerland

Lugano 6903, Switzerland

St. Gallen 9007, Switzerland

Zürich 8091, Switzerland

Birmingham, Alabama 35294, United States

Edmonton, Alberta T6G 2B7, Canada

Vancouver, British Columbia V6Z 2K5, Canada

La Jolla, California 92037-1030, United States

Lancaster, California 93534, United States

Long Beach, California 90822, United States

Los Angeles, California 90057, United States

Los Angeles, California 90048, United States

Sacramento, California 95816, United States

Sacramento, California 95817, United States

San Diego, California 92103-8465, United States

Torrance, California 90505, United States

Aurora, Colorado 80045, United States

Jacksonville, Florida 32256, United States

Orlando, Florida 32803, United States

Atlanta, Georgia 30308, United States

Marietta, Georgia 30060, United States

Honolulu, Hawaii 96813, United States

Baton Rouge, Louisiana 70890, United States

Opelousas, Louisiana 70520, United States

Boston, Massachusetts 02114, United States

Tupelo, Mississippi 38801, United States

St Louis, Missouri 63104, United States

St Louis, Missouri 63110, United States

Egg Harbour Township, New Jersey 08234, United States

Hackensack, New Jersey 07601, United States

Albuquerque, New Mexico 87131, United States

New York, New York 10016, United States

Syracuse, New York 13210, United States

Asheville, North Carolina 28801, United States

Chapel Hill, North Carolina 27599-7080, United States

Winston-salem, North Carolina 27103, United States

Oklahoma City, Oklahoma 73112-4481, United States

Hamilton, Ontario L8N 4A6, Canada

Mississauga, Ontario L5M 4N4, Canada

Portland, Oregon 97239, United States

Kingsport, Tennessee 37660, United States

Fort Sam Houston, Texas 78234-3879, United States

Salt Lake City, Utah 84132, United States

Charlottesville, Virginia 22908, United States

Fairfax, Virginia 22031, United States

Richmond, Virginia 23249, United States

Additional Information

Starting date: June 2008
Last updated: July 15, 2013

Page last updated: August 23, 2015

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