- ICH GCP
- US Clinical Trials Registry
- 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)
October 16, 2015 updated by: Merck Sharp & Dohme LLC
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
332
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Participants with Chronic Hepatitis C
Treatment-naïve participants with chronic hepatitis C, undergoing treatment with a standard treatment regimen of PegIntron and Rebetol in clinical practice at approximately 28 sites in Greece
|
Prior to enrollment in the study, PegIntron was to be administered at a dose of 1.5 μg/kg/week subcutaneously in accordance with approved labeling.
Therapy duration varied from 24 to 48 weeks depending on HCV viral load and genotype followed by a 24-week post-treatment follow-up.
Other Names:
Prior to enrollment in the study, Rebetol was to be administered at a dose of 800-1200 mg/day orally in accordance with approved labeling.
Therapy duration varied from 24 to 48 weeks depending on HCV viral load and genotype followed by a 24-week post-treatment follow-up.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up
Time Frame: 24 weeks following completion of 24 or 48 weeks of therapy
|
Sustained virological response (SVR) was assessed at the 24-week post-treatment follow-up (Visit 2).
SVR was defined as undetectable plasma Hepatitis C virus Ribonucleic acid (HCV-RNA) at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).
|
24 weeks following completion of 24 or 48 weeks of therapy
|
Number of Participants Who Demonstrated Virological Relapse as Assessed at 24-week Post-treatment Follow-up
Time Frame: 24 weeks following completion of 24 or 48 weeks of therapy
|
Virological relapse was assessed at the 24-week post-treatment follow-up (Visit 2).
Virological relapse was defined as undetectable plasma HCV-RNA at end of combination treatment (Visit 1- considered Week 24 or Week 48 after treatment start depending on treatment duration), but with positive HCV-RNA at the 24-week post treatment follow-up.
|
24 weeks following completion of 24 or 48 weeks of therapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 24 weeks following completion of 24 or 48 weeks of therapy
|
SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on HCV genotype (1, 2, 3, 4, or 2 & 3) at baseline.
SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).
|
24 weeks following completion of 24 or 48 weeks of therapy
|
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
Time Frame: 24 weeks following completion of 24 or 48 weeks of therapy
|
SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on liver fibrosis stage, where biopsy was available, at baseline: absence, minimal, moderate, or significant as assessed by investigator.
SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).
|
24 weeks following completion of 24 or 48 weeks of therapy
|
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
Time Frame: 24 weeks following completion of 24 or 48 weeks of therapy
|
SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on HCV-RNA viral load at baseline as assessed by investigator.
Low viral load was defined as <400,000 International Units/milliliter (IU/mL) and high viral load was defined as >=400,000 IU/mL.
SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).
|
24 weeks following completion of 24 or 48 weeks of therapy
|
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
Time Frame: 24 weeks following completion of 24 or 48 weeks of therapy
|
SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on ALT levels at baseline as assessed by investigator.
Normal baseline ALT level was defined as <40 IU/mL and elevated baseline ALT level was defined as >= 40 IU/mL.
SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).
|
24 weeks following completion of 24 or 48 weeks of therapy
|
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
Time Frame: 24 weeks following completion of 24 or 48 weeks of therapy
|
SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on study treatment dosage modification: no dosage modification or any dosage modification of study treatment.
SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).
|
24 weeks following completion of 24 or 48 weeks of therapy
|
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
Time Frame: 24 weeks following completion of 24 or 48 weeks of therapy
|
SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on achievement of rapid virological response (RVR) where data was available.
RVR was defined as negative HCV-RNA after 4 (+/- 1) weeks of treatment.
SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).
|
24 weeks following completion of 24 or 48 weeks of therapy
|
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
Time Frame: 24 weeks following completion of 24 or 48 weeks of therapy
|
SVR was assessed by subgroups based on compliance with the 80/80/80 rule where data was available.
80/80/80 compliant participants were those that received >= 80% of the planned total doses of both pegylated interferon alfa-2b & ribavirin for >=80% of the duration of therapy.
3 rates were to be computed: Compliance with study duration, compliance with pegylated interferon dose, & compliance with ribavirin dose.
A participant was defined as compliant, if none of the 3 rates were < than 80%.
SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment.
|
24 weeks following completion of 24 or 48 weeks of therapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Primary Completion (Actual)
October 1, 2010
Study Completion (Actual)
October 1, 2010
Study Registration Dates
First Submitted
July 25, 2008
First Submitted That Met QC Criteria
July 25, 2008
First Posted (Estimate)
July 29, 2008
Study Record Updates
Last Update Posted (Estimate)
October 19, 2015
Last Update Submitted That Met QC Criteria
October 16, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis C, Chronic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites
- Antineoplastic Agents
- Immunologic Factors
- Interferons
- Interferon-alpha
- Ribavirin
- Interferon alpha-2
- Peginterferon alfa-2b
Other Study ID Numbers
- P05209
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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