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Trial record 45 of 1270 for:    IFNA2

Relapse Rate in Hepatitis C Patients Treated With Peginterferon Alfa-2b Plus Ribavirin in Common Clinical Practice in France (P05484)(Completed) (RE-CHUT)

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ClinicalTrials.gov Identifier: NCT00725842
Recruitment Status : Terminated (Low enrollment)
First Posted : July 31, 2008
Results First Posted : August 7, 2012
Last Update Posted : September 21, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Hepatitis C
Hepatitis C, Chronic
Interventions Biological: Peg-IFN alfa-2b
Drug: Ribavirin
Enrollment 97
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Peg-IFN Alfa-2b + Ribavirin
Hide Arm/Group Description Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
Period Title: Overall Study
Started 97
Participants Eligible for Analysis 90
Completed 57
Not Completed 40
Reason Not Completed
Lost to Follow-up             19
Death             1
Positive HCV-RNA at Visit 2             13
Consent date prior to study start date             5
Inclusion criterion not met             1
No Visit 1 data             1
Arm/Group Title Peg-IFN Alfa-2b + Ribavirin
Hide Arm/Group Description Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
Overall Number of Baseline Participants 90
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 90 participants
46.0  (12.5)
[1]
Measure Description: Age data unavailable for the 7 participants excluded from analysis.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants
Female
25
  27.8%
Male
65
  72.2%
[1]
Measure Description: Gender data unavailable for the 7 participants excluded from analysis.
1.Primary Outcome
Title Number of Participants With Positive Hepatitis C Virus (HCV)-Ribonucleic Acid (RNA) at 24 Weeks Off-treatment
Hide Description HCV-RNA virus levels were measured by polymerase chain reaction (PCR) assay 24 weeks post end of treatment (EOT) with Peg-IFN alfa-2b + ribavirin. Participants with positive HCV-RNA were considered relapsers.
Time Frame 24 weeks post end of treatment (EOT)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 97 participants who started the study, 7 were excluded from analysis because of protocol violations. 90 participants underwent HCV-RNA testing at Week 24 post EOT.
Arm/Group Title Peg-IFN Alfa-2b + Ribavirin
Hide Arm/Group Description:
Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
Overall Number of Participants Analyzed 90
Measure Type: Number
Unit of Measure: participants
13
2.Secondary Outcome
Title Number of Participants With Rapid Virologic Response (RVR), Early Virologic Response (EVR), or Slow Response Who Relapsed After Treatment
Hide Description Negative HCV-RNA at Week 4 of treatment with Peg-IFN alfa-2b + ribavirin was considered RVR; negative HCV-RNA at Week 12 of treatment with Peg-IFN alfa-2b + ribavirin was considered EVR; negative HCV-RNA between Week 12 and the end of treatment with Peg-IFN alfa-2b + ribavirin was considered a slow response. For participants who achieved RVR, EVR, or slow response, the relapse rate at 24 Weeks post EOT was to be determined on this observational study; relapse was defined as positive HCV-RNA.
Time Frame 24 weeks post EOT
Hide Outcome Measure Data
Hide Analysis Population Description
The planned analysis for this outcome measure was not performed due to insufficient enrollment.
Arm/Group Title Peg-IFN Alfa-2b + Ribavirin
Hide Arm/Group Description:
Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Assessment of Pre-treatment Risk Factors of Relapse in Participants With Sustained Virologic Response
Hide Description Baseline risk factors included but were not limited to viral load, genotype 1a versus 1b, histology, treatment compliance, gender, age, and substance abuse. Sustained virologic response was defined as having negative HCV-RNA at 24 weeks post EOT. Relapse was defined as positive HCV-RNA.
Time Frame Baseline and 24 weeks post EOT
Hide Outcome Measure Data
Hide Analysis Population Description
The planned analysis for this outcome measure was not performed due to insufficient enrollment.
Arm/Group Title Peg-IFN Alfa-2b + Ribavirin
Hide Arm/Group Description:
Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Number of Participants With Positive HCV-RNA at 72 Weeks Off-treatment
Hide Description HCV-RNA virus levels were measured by polymerase chain reaction (PCR) assay 72 weeks post EOT with Peg-IFN alfa-2b + ribavirin. Participants with positive HCV-RNA at Week 72 post EOT were considered late relapsers.
Time Frame 72 weeks post EOT
Hide Outcome Measure Data
Hide Analysis Population Description
77 of 90 participants had a negative HCV-RNA at Week 24 post EOT. These 77 were then evaluated for relapse at Week 72 post EOT.
Arm/Group Title Peg-IFN Alfa-2b + Ribavirin
Hide Arm/Group Description:
Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
Overall Number of Participants Analyzed 77
Measure Type: Number
Unit of Measure: participants
3
Time Frame [Not Specified]
Adverse Event Reporting Description The safety data set included 96 of the 97 participants who started on study; no safety data were available for 1 participant.
 
Arm/Group Title Peg-IFN Alfa-2b + Ribavirin
Hide Arm/Group Description Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
All-Cause Mortality
Peg-IFN Alfa-2b + Ribavirin
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Peg-IFN Alfa-2b + Ribavirin
Affected / at Risk (%) # Events
Total   5/96 (5.21%)    
Endocrine disorders   
Hyperthyroidism  1  1/96 (1.04%)  1
General disorders   
Death  1  1/96 (1.04%)  1
Malaise  1  1/96 (1.04%)  1
Infections and infestations   
Staphylococcal sepsis  1  1/96 (1.04%)  1
Injury, poisoning and procedural complications   
Femoral neck fracture  1  1/96 (1.04%)  1
Road traffic accident  1  1/96 (1.04%)  1
Nervous system disorders   
Aphasia  1  1/96 (1.04%)  1
Cerebrovascular accident  1  1/96 (1.04%)  1
Hemiplegia  1  1/96 (1.04%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Peg-IFN Alfa-2b + Ribavirin
Affected / at Risk (%) # Events
Total   21/96 (21.88%)    
Blood and lymphatic system disorders   
Anaemia  1  6/96 (6.25%)  6
General disorders   
Asthenia  1  15/96 (15.63%)  16
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.1)
Due to low enrollment some planned analyses were not performed.
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.
Study data disclosure is prohibited; data and study results are the exclusive property of the Sponsor.
Results Point of Contact
Name/Title: Senior Vice President,Global Clinical Development
Organization: Merck Sharp & Dohme
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00725842     History of Changes
Other Study ID Numbers: P05484
First Submitted: July 28, 2008
First Posted: July 31, 2008
Results First Submitted: June 13, 2012
Results First Posted: August 7, 2012
Last Update Posted: September 21, 2015