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Trial record 22 of 396 for:    IFNA2 AND RBV AND sustained

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

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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.

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Retrospective
Conditions Hepatitis C, Chronic
Hepatitis C
Interventions Biological: PegIntron (peginterferon alfa-2b, pegylated interferon alfa-2b)
Drug: Rebetol (ribavirin)
Enrollment 332
Recruitment Details  
Pre-assignment Details 401 participants were screened for eligibility. 332 participants were enrolled in the study.
Arm/Group Title Pegylated Interferon Alpha-2b and Ribavirin
Hide Arm/Group Description Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
Period Title: Overall Study
Started 332
Completed 309
Not Completed 23
Arm/Group Title Pegylated Interferon Alpha-2b and Ribavirin
Hide Arm/Group Description Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
Overall Number of Baseline Participants 332
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 332 participants
39.9  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 332 participants
Female
102
  30.7%
Male
230
  69.3%
1.Primary Outcome
Title Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up
Hide Description 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).
Time Frame 24 weeks following completion of 24 or 48 weeks of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Analysis Set (EAS) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up.
Arm/Group Title Pegylated Interferon Alpha-2b and Ribavirin
Hide Arm/Group Description:
Participants with Chronic Hepatitis C (CHC) of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on Hepatitis C virus (HCV) genotype and viral load followed by a 24-week post-treatment follow-up.
Overall Number of Participants Analyzed 309
Measure Type: Number
Unit of Measure: Participants
286
2.Primary Outcome
Title Number of Participants Who Demonstrated Virological Relapse as Assessed at 24-week Post-treatment Follow-up
Hide Description 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.
Time Frame 24 weeks following completion of 24 or 48 weeks of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Analysis Set (EAS) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up.
Arm/Group Title Pegylated Interferon Alpha-2b and Ribavirin
Hide Arm/Group Description:
Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
Overall Number of Participants Analyzed 309
Measure Type: Number
Unit of Measure: Participants
23
3.Secondary Outcome
Title 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
Hide Description 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).
Time Frame 24 weeks following completion of 24 or 48 weeks of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis. 23 participants were relapsers.
Arm/Group Title Pegylated Interferon Alpha-2b and Ribavirin
Hide Arm/Group Description:
Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
Overall Number of Participants Analyzed 286
Measure Type: Number
Unit of Measure: Participants
Genotype 1 81
Genotype 2 28
Genotype 3 146
Genotype 4 30
Genotype 2 & 3 1
4.Secondary Outcome
Title 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
Hide Description 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).
Time Frame 24 weeks following completion of 24 or 48 weeks of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis. There was missing data for 157 participants.
Arm/Group Title Pegylated Interferon Alpha-2b and Ribavirin
Hide Arm/Group Description:
Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
Overall Number of Participants Analyzed 286
Measure Type: Number
Unit of Measure: Participants
Absence 83
Minimal 27
Moderate 15
Significant 4
Missing 157
5.Secondary Outcome
Title 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
Hide Description 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).
Time Frame 24 weeks following completion of 24 or 48 weeks of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis. There was missing data for 32 participants.
Arm/Group Title Pegylated Interferon Alpha-2b and Ribavirin
Hide Arm/Group Description:
Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
Overall Number of Participants Analyzed 286
Measure Type: Number
Unit of Measure: Participants
Low Viral Load 99
High Viral Load 155
Missing 32
6.Secondary Outcome
Title 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
Hide Description 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).
Time Frame 24 weeks following completion of 24 or 48 weeks of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis. There was missing data for 6 participants.
Arm/Group Title Pegylated Interferon Alpha-2b and Ribavirin
Hide Arm/Group Description:
Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
Overall Number of Participants Analyzed 286
Measure Type: Number
Unit of Measure: Participants
Normal Baseline ALT levels 28
Elevated Baseline ALT levels 252
Missing 6
7.Secondary Outcome
Title 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
Hide Description 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).
Time Frame 24 weeks following completion of 24 or 48 weeks of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis.
Arm/Group Title Pegylated Interferon Alpha-2b and Ribavirin
Hide Arm/Group Description:
Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
Overall Number of Participants Analyzed 286
Measure Type: Number
Unit of Measure: Participants
No Dosage Modification of Study Treatment 234
Any Dosage Modification of Study Treatment 52
8.Secondary Outcome
Title 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
Hide Description 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).
Time Frame 24 weeks following completion of 24 or 48 weeks of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis. There was missing data for 250 participants.
Arm/Group Title Pegylated Interferon Alpha-2b and Ribavirin
Hide Arm/Group Description:
Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
Overall Number of Participants Analyzed 286
Measure Type: Number
Unit of Measure: Participants
RVR at Week 4 (+/- 1) 20
Non-RVR at Week 4 (+/- 1) 16
Missing 250
9.Secondary Outcome
Title 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
Hide Description 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.
Time Frame 24 weeks following completion of 24 or 48 weeks of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
No data had been captured in the Case Report Forms, and therefore no relevant analysis had been performed.
Arm/Group Title Pegylated Interferon Alpha-2b and Ribavirin
Hide Arm/Group Description:
Participants with Chronic Hepatitis C (CHC) of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on Hepatitis C virus (HCV) genotype and viral load followed by a 24-week post-treatment follow-up.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description The safety population included the total number of participants screened for eligibility (N=401). This population includes the total number of eligible participants enrolled in the study or the Full Analysis Set (N=332) and the non-eligible participants or the screening failure set (N=69).
 
Arm/Group Title Pegylated Interferon Alpha-2b and Ribavirin
Hide Arm/Group Description Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
All-Cause Mortality
Pegylated Interferon Alpha-2b and Ribavirin
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pegylated Interferon Alpha-2b and Ribavirin
Affected / at Risk (%) # Events
Total   5/401 (1.25%)    
Blood and lymphatic system disorders   
Anaemia  1/401 (0.25%)  1
General disorders   
Oedema  1/401 (0.25%)  1
Pain  1/401 (0.25%)  1
Pyrexia  2/401 (0.50%)  2
Infections and infestations   
Lung Infection  1/401 (0.25%)  1
Pneumonia  1/401 (0.25%)  1
Tooth Abscess  1/401 (0.25%)  1
Nervous system disorders   
Epilepsy  1/401 (0.25%)  1
Psychiatric disorders   
Emotional Disorder  1/401 (0.25%)  1
Skin and subcutaneous tissue disorders   
Erythema  1/401 (0.25%)  1
Vascular disorders   
Thrombophlebitis  1/401 (0.25%)  1
1
Term from vocabulary, MedDRA (13.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pegylated Interferon Alpha-2b and Ribavirin
Affected / at Risk (%) # Events
Total   123/401 (30.67%)    
Blood and lymphatic system disorders   
Anaemia  61/401 (15.21%)  61
Leukopenia  31/401 (7.73%)  32
General disorders   
Fatigue 1 [1]  38/401 (9.48%)  41
Investigations   
Weight Decreased  27/401 (6.73%)  27
Skin and subcutaneous tissue disorders   
Alopecia 1 [2]  21/401 (5.24%)  21
1
Term from vocabulary, MedDRA (13.1)
[1]
Includes Fatigue, Lassitude, and Fatigability
[2]
Includes Alopecia, Hair Loss, and Accelerated Hair Loss
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The principal investigator agrees not to publish or publicly present any interim results of the Study without prior written consent of the SPONSOR. The principal investigator further agrees to provide forty-five (45) days written notice to the SPONSOR prior to submission for publication or presentation

to permit the SPONSOR to review copies of abstracts or manuscripts for publication which report any results of the Study. The SPONSOR shall have the right to review & comment on any presentation.

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
EMail: ClinicalTrialsDisclosure@Merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00724464     History of Changes
Other Study ID Numbers: P05209
First Submitted: July 25, 2008
First Posted: July 29, 2008
Results First Submitted: October 4, 2011
Results First Posted: November 8, 2011
Last Update Posted: October 19, 2015