Status:
COMPLETED
Efficacy of PegIntron (Peginterferon Alfa-2b) and Rebetol (Ribavirin) in Treatment-naïve Subjects With Chronic Hepatitis C in Clinical Practice in Greece (Study P05209)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis C, Chronic
Hepatitis C
Eligibility:
All Genders
18+ years
Brief Summary
The objective of the study is to evaluate the rates of Hepatitis C virus (HCV) eradication and relapse in participants treated with PegIntron and Rebetol in clinical practice in Greece. Participants w...
Eligibility Criteria
Inclusion
- Participants who have already begun Summary of Product Characteristics (SmPC)-based combination treatment with pegylated interferon alpha-2b and ribavirin, prior to the site initiation date.
- Participants who have been receiving combination treatment with pegylated interferon alpha-2b and ribavirin for at least 6 months before enrollment.
- Participants who have achieved negative HCV RNA at the end of treatment, defined according to genotype (24 weeks for HCV genotypes 2/3 and 48 weeks for genotypes 1/4).
- Participants with diagnosed chronic hepatitis C (CHC) and HCV genotype 1, 2, 3 or 4.
- Participants older than 18 years, regardless of gender or race.
Exclusion
- The participant has received treatment for CHC in the past (not treatment-naive).
- The participant has received treatment in the context of a clinical trial in the participating site.
- The participant has been diagnosed with a concomitant infection e.g. with hepatitis B or HIV
- The participant has de-compensated liver disease or belongs to a special population, such as liver transplant, hemophilia, severe pre-existing psychiatric disorder, auto-immune disease, thalassaemia.
- The participant has positive HCV RNA at the end of treatment.
- Pregnant women or women intending to bear children or sexual partners of women wishing to bear children and for a 7-month period after the end of treatment, as indicated in the SmPC of Rebetol.
- The participant is not eligible on grounds of contra-indications, special warnings, particular population and/or the section on pregnancy and lactation of the SmPC.
- The participant has interrupted treatment for any reason.
Key Trial Info
Start Date :
December 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
332 Patients enrolled
Trial Details
Trial ID
NCT00724464
Start Date
December 1 2007
End Date
October 1 2010
Last Update
October 19 2015
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