Status:
COMPLETED
A Study of Combination Treatment With Peginterferon Alfa-2a (Pegasys) Plus Ribavirin (Copegus) in Participants With Chronic Hepatitis C
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This 3-arm study assessed the safety and efficacy of combination treatment with peginterferon alfa-2a + ribavirin in participants with chronic hepatitis C. Three groups of participants were studied; 1...
Eligibility Criteria
Inclusion
- Adult participants at least 18 years of age
- 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
- Chronic liver disease other than chronic hepatitis C
- 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)
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2009
Estimated Enrollment :
372 Patients enrolled
Trial Details
Trial ID
NCT00800748
Start Date
February 1 2006
End Date
January 9 2009
Last Update
May 22 2017
Active Locations (35)
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1
Beroun, Czechia
2
Brno, Czechia, 62500
3
Chomutov, Czechia
4
Česká Lípa, Czechia