Clinical trial NCT00724464: Efficacy of PegIntron (Peginterferon Alfa-2b) and Rebetol (Ribavirin) in Treatment-naïve Subjects With Chronic Hepatitis C in Clinical Practice in Greece (Study P05209)
Official title: A Greek Observational Study on Relapse Rate and Sustained Virological Response in Naive CHC Patients, Treated With Pegylated Interferon Alpha-2b and Ribavirin in Daily Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Hepatitis C
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-07-29
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Treatment-naïve participants with chronic hepatitis C treated with PegIntron and Rebetol in accordance with approved labeling in clinical practice in Greece prior to enrollment in the current study. Data from patients treated at approximately 28 sites will be retrospectively analyzed.

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 will not be treated as part of the study. Data on participants treated in accordance with approved labeling will be collected retrospectively from approximately 30 sites in Greece.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up
timeFrame: 24 weeks following completion of 24 or 48 weeks of therapy
measure: Number of Participants Who Demonstrated Virological Relapse as Assessed at 24-week Post-treatment Follow-up
timeFrame: 24 weeks following completion of 24 or 48 weeks of therapy
Secondary outcomes:
measure: Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on HCV Genotype at Baseline
timeFrame: 24 weeks following completion of 24 or 48 weeks of therapy
measure: Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Liver Fibrosis Stage at Baseline
timeFrame: 24 weeks following completion of 24 or 48 weeks of therapy
measure: Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on HCV-RNA Viral Load at Baseline
timeFrame: 24 weeks following completion of 24 or 48 weeks of therapy
measure: Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Alanine Aminotransferase (ALT) Levels at Baseline
timeFrame: 24 weeks following completion of 24 or 48 weeks of therapy
measure: Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Study Treatment Dosage Modification
timeFrame: 24 weeks following completion of 24 or 48 weeks of therapy
measure: Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Achievement of Rapid Virological Response
timeFrame: 24 weeks following completion of 24 or 48 weeks of therapy
measure: Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Compliance With the 80/80/80 Rule
timeFrame: 24 weeks following completion of 24 or 48 weeks of therapy
Other outcomes:
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