Clinical trial NCT00623428: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-02-26
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Percentage of Participants With a Sustained Virologic Response 24 Weeks After Scheduled Completion of Treatment
timeFrame: 24 weeks after scheduled treatment completion (approximately Week 48 for participants in the 24-week treatment group and Week 72 for participants in the 48-week treatment group.
measure: Percentage of Participants With a Sustained Virologic Response 24 Weeks After Actual End of Treatment
timeFrame: 24 weeks after actual end of treatment (range from Week 48 to Week 72).
Secondary outcomes:
measure: Percentage of Participants With Virological Response 72 Weeks After Treatment Initiation
timeFrame: Week 72
measure: Percentage of Participants With Virological Response at End of Treatment
timeFrame: End of Treatment (Week 24 and Week 48 for each treatment group respectively).
measure: Percentage of Participants With Virological Relapse
timeFrame: End of treatment (Weeks 24 or 48) and 24 weeks after the end of treatment (weeks 48 and 72 in each treatment group respectively).
measure: Percentage of Participants With a Sustained Virologic Response 12 Weeks After Actual End of Treatment
timeFrame: 12 weeks after actual end of treatment (range from Week 36 to Week 60)
measure: Number of Participants With Adverse Events (AEs)
timeFrame: From Week 1 through Week 72.
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: La Jolla
country: United States
state: California
city: Lancaster
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: Torrance
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Jacksonville
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Baton Rouge
country: United States
state: Louisiana
city: Opelousas
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Tupelo
country: United States
state: Mississippi
city: St Louis
country: United States
state: Missouri
city: St Louis
country: United States
state: Missouri
city: Egg Harbour Township
country: United States
state: New Jersey
city: Hackensack
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: New York
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Chapel Hill
country: United States
state: North Carolina
city: Winston-salem
country: United States
state: North Carolina
city: Oklahoma City
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Kingsport
country: United States
state: Tennessee
city: Fort Sam Houston
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Charlottesville
country: United States
state: Virginia
city: Fairfax
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Darlinghurst
country: Australia
city: Fremantle
country: Australia
city: Melbourne
country: Australia
city: Nedlands
country: Australia
city: Sydney
country: Australia
city: Graz
country: Austria
city: Innsbruck
country: Austria
city: Linz
country: Austria
city: Oberndorf
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Antwerpen
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Gent
country: Belgium
city: Kortrijk
country: Belgium
city: Liege
country: Belgium
city: Brasilia
country: Brazil
city: Campinas
country: Brazil
city: Campinas
country: Brazil
city: Porto Alegre
country: Brazil
city: Porto Alegre
country: Brazil
city: Ribeirao Preto
country: Brazil
city: Rio de Janeiro
country: Brazil
city: Santo Andre
country: Brazil
city: Sao Luis
country: Brazil
city: Sao Paulo
country: Brazil
city: Sorocaba
country: Brazil
city: Vitoria
country: Brazil
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Hamilton
country: Canada
state: Ontario
city: Mississauga
country: Canada
state: Ontario
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Bonn
country: Germany
city: Düsseldorf
country: Germany
city: Düsseldorf
country: Germany
city: Frankfurt Am Main
country: Germany
city: Freiburg
country: Germany
city: Giessen
country: Germany
city: Hamburg
country: Germany
city: Heidelberg
country: Germany
city: Jena
country: Germany
city: Kiel
country: Germany
city: Köln
country: Germany
city: Mainz
country: Germany
city: München
country: Germany
city: Offenburg
country: Germany
city: Tübingen
country: Germany
city: ULM
country: Germany
city: Guadalajara
country: Mexico
city: Guadalajara
country: Mexico
city: Mexicali
country: Mexico
city: Mexico City
country: Mexico
city: Mexico Df
country: Mexico
city: Puebla
country: Mexico
city: Santurce
country: Puerto Rico
city: Lausanne
country: Switzerland
city: Lugano
country: Switzerland
city: St. Gallen
country: Switzerland
city: Zürich
country: Switzerland
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: