A Study of Combination Treatment With Peginterferon Alfa-2a (Pegasys) Plus Ribavirin (Copegus) in Participants With Chronic Hepatitis C
NCT ID: NCT00800748
Last Updated: 2017-05-22
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
PHASE4
372 participants
INTERVENTIONAL
2006-02-01
2009-01-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
Participants with genotype 1, 4, 5 or 6 received peginterferon alfa-2a 180 mcg SC qw + ribavirin 1000-1200 mg PO daily (dependent on body weight) for 48 weeks.
Peginterferon alfa-2a
Peginterferon alfa-2a was administered at a dose of 180 mcg SC weekly for 48 weeks to participants with genotype 1, 4, 5, 6 and to participants with HIV co-infection, or for 24 weeks to participants with genotype 2 and 3.
Ribavirin
Ribavirin was administered at a dose of 1000-1200 mg PO daily for 48 weeks to participants with genotype 1, 4, 5, 6 or 800 mg PO daily for 24 weeks to participants with genotype 2 and 3.
Group B
Participants with genotype 2 or 3 received peginterferon alfa-2a 180 mcg SC qw + ribavirin 800 mg PO daily for 24 weeks.
Peginterferon alfa-2a
Peginterferon alfa-2a was administered at a dose of 180 mcg SC weekly for 48 weeks to participants with genotype 1, 4, 5, 6 and to participants with HIV co-infection, or for 24 weeks to participants with genotype 2 and 3.
Ribavirin
Ribavirin was administered at a dose of 1000-1200 mg PO daily for 48 weeks to participants with genotype 1, 4, 5, 6 or 800 mg PO daily for 24 weeks to participants with genotype 2 and 3.
Group C
Participants with HIV co-infection received peginterferon alfa-2a 180 mcg SC qw + ribavirin 800 mg PO daily for 48 weeks.
Peginterferon alfa-2a
Peginterferon alfa-2a was administered at a dose of 180 mcg SC weekly for 48 weeks to participants with genotype 1, 4, 5, 6 and to participants with HIV co-infection, or for 24 weeks to participants with genotype 2 and 3.
Ribavirin
Ribavirin was administered at a dose of 1000-1200 mg PO daily for 48 weeks to participants with genotype 1, 4, 5, 6 or 800 mg PO daily for 24 weeks to participants with genotype 2 and 3.
Interventions
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Peginterferon alfa-2a
Peginterferon alfa-2a was administered at a dose of 180 mcg SC weekly for 48 weeks to participants with genotype 1, 4, 5, 6 and to participants with HIV co-infection, or for 24 weeks to participants with genotype 2 and 3.
Ribavirin
Ribavirin was administered at a dose of 1000-1200 mg PO daily for 48 weeks to participants with genotype 1, 4, 5, 6 or 800 mg PO daily for 24 weeks to participants with genotype 2 and 3.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Chronic hepatitis C, with detectable serum hepatitis C virus (HCV) ribonucleic acid (RNA)
* Scheduled for treatment with peginterferon alfa-2a
* Compensated liver disease
* Women in fertile age must be informed about obligation of using adequate contraception during and 6 months post treatment with ribavirin (Copegus®)
* Men with a sexual partner in fertile age must be informed about obligatory contraception preventing pregnancy during the course of treatment with ribavirin (Copegus®) as well as 6 months after treatment cessation
* Female participants in the study must have a negative pregnancy test performed not sooner than within 2 weeks preceding the planned inclusion to the study
* Men with a sexual partner in fertile age must produce a negative result of the partner's pregnancy test performed not sooner than within 2 weeks preceding the planned partner's inclusion to the study
Exclusion Criteria
* Active hepatitis A virus or hepatitis B virus infection
* Therapy with any systemic antiviral, antineoplastic or immunomodulatory treatment less than or equal to (\<=) 6 months prior to first dose of study drug
* Hemoglobin \<120 grams per liter (g/L) in female participants or \<130 g/L in male participants (the result must not be older than 2 weeks prior to inclusion to the study)
* Platelet count \<90 x 10\^9/liter (the result must not be older than 2 weeks prior to inclusion to the study
* Neutrofil count \<1.5 x 10\^9/liter (the result must not be older than 2 weeks prior to inclusion to the study)
* Participants with increased risk of anaemia, or participants at risk of serious health problems resulting from anaemia or decrease of hemoglobin (e.g., participants with serious cardiovascular or cerebrovascular disease)
* History or presence of a serious mental disease, especially depression, which, in the investigator's opinion, does not allow administration of peginterferon alfa-2a (Pegasys®)
* History or presence of a disease consequent to immunodeficiency (e.g., inflammatory diseases of intestine, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, rheumatoid arthritis)
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Beroun, , Czechia
Brno, , Czechia
Chomutov, , Czechia
Česká Lípa, , Czechia
České Budějovice, , Czechia
Děčín, , Czechia
Havířov, , Czechia
Havlíčkův Brod, , Czechia
Hradec Králové, , Czechia
Hradec Králové, , Czechia
Jablonec/nisou, , Czechia
Jihlava, , Czechia
Karlovy Vary, , Czechia
Kolín, , Czechia
Liberec, , Czechia
Mělník, , Czechia
Most, , Czechia
Olomouc, , Czechia
Opava, , Czechia
Ostrava, , Czechia
Pardubice, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Prostějov, , Czechia
Ústí nad Labem, , Czechia
Banská Bystrica, , Slovakia
Bratislava, , Slovakia
Bratislava, , Slovakia
Košice, , Slovakia
Košice, , Slovakia
Martin, , Slovakia
Trenčín, , Slovakia
Countries
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Other Identifiers
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2005-003932-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ML19387
Identifier Type: -
Identifier Source: org_study_id
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