Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of PegIntron (Peginterferon Alfa-2b) and Rebetol (Ribavirin) in Treatment-naïve Subjects With Chronic Hepatitis C in Clinical Practice in Greece (Study P05209)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00724464
Recruitment Status : Completed
First Posted : July 29, 2008
Results First Posted : November 8, 2011
Last Update Posted : October 19, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date July 25, 2008
First Posted Date July 29, 2008
Results First Submitted Date October 4, 2011
Results First Posted Date November 8, 2011
Last Update Posted Date October 19, 2015
Study Start Date December 2007
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 4, 2011)
  • 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).
  • 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.
Original Primary Outcome Measures
 (submitted: July 25, 2008)
Sustained virologic response and relapse rates [ Time Frame: Assessed at the end of treatment and 24 weeks post-treatment. Treatment duration is in accordance with approved labeling. ]
Change History Complete list of historical versions of study NCT00724464 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 4, 2011)
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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.
Original Secondary Outcome Measures
 (submitted: July 25, 2008)
Sustained virologic response by subgroups based on HCV genotype, histology, baseline viral load, baseline ALT levels, dose modification, adherence, and virologic response at Treatment Week 4 [ Time Frame: Assessed at Treatment Week 4 and end of treatment, ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Hepatitis C, Chronic
  • Hepatitis C
Intervention
  • Biological: PegIntron (peginterferon alfa-2b, pegylated interferon alfa-2b)
    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 Name: SCH 54031
  • Drug: Rebetol (ribavirin)
    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 Name: SCH 18908
Study Groups/Cohorts 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
Interventions:
  • Biological: PegIntron (peginterferon alfa-2b, pegylated interferon alfa-2b)
  • Drug: Rebetol (ribavirin)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 4, 2011)
332
Original Estimated Enrollment
 (submitted: July 25, 2008)
417
Actual Study Completion Date October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries Greece
 
Administrative Information
NCT Number NCT00724464
Other Study ID Numbers P05209
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor Merck Sharp & Dohme Corp.
Collaborators Not Provided
Investigators Not Provided
PRS Account Merck Sharp & Dohme Corp.
Verification Date October 2015