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Treatment of Chronic Hepatitis C With Pegylated Interferon and Ribavirin in Participants With/Without Substitution Therapy (P05255)

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ClinicalTrials.gov Identifier: NCT00725751
Recruitment Status : Completed
First Posted : July 30, 2008
Results First Posted : April 23, 2012
Last Update Posted : October 2, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Hepatitis C, Chronic
Interventions Biological: Pegylated interferon alfa-2b (PegIFN-2b)
Drug: Ribavirin
Enrollment 353
Recruitment Details  
Pre-assignment Details 353 participants were enrolled on the study; 348 were treated.
Arm/Group Title PegIFN-2b/Ribavirin With Substitution Therapy PegIFN-2b/Ribavirin Without Substitution Therapy
Hide Arm/Group Description Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine) Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
Period Title: Overall Study
Started 90 258
Completed 56 150
Not Completed 34 108
Arm/Group Title PegIFN-2b/Ribavirin With Substitution Therapy PegIFN-2b/Ribavirin Without Substitution Therapy Total
Hide Arm/Group Description Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine) Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine) Total of all reporting groups
Overall Number of Baseline Participants 90 258 348
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 90 participants 258 participants 348 participants
32.38  (9.51) 42.26  (12.62) 39.71  (12.64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants 258 participants 348 participants
Female
29
  32.2%
96
  37.2%
125
  35.9%
Male
61
  67.8%
162
  62.8%
223
  64.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Austria Number Analyzed 90 participants 258 participants 348 participants
90 258 348
1.Primary Outcome
Title Number of Participants Who Completed Treatment With PegIFN-2b/Ribavirin
Hide Description For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24.
Time Frame 24 to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of PegIFN-2b/ribavirin
Arm/Group Title PegIFN-2b/Ribavirin With Substitution Therapy PegIFN-2b/Ribavirin Without Substitution Therapy
Hide Arm/Group Description:
Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
Overall Number of Participants Analyzed 90 258
Measure Type: Number
Unit of Measure: participants
56 150
2.Secondary Outcome
Title Number of Participants Who Achieved Sustained Virologic Response (SVR)
Hide Description SVR was defined as a hepatitis C virus (HCV) ribonucleic acid (RNA) value below the limit of detection by polymerase chain reaction (PCR) analysis. For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24.
Time Frame 24 weeks after the end of treatment (i.e. 48 or 72 weeks depending on genotype)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants.
Arm/Group Title PegIFN-2b/Ribavirin With Substitution Therapy PegIFN-2b/Ribavirin Without Substitution Therapy
Hide Arm/Group Description:
Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
Overall Number of Participants Analyzed 90 258
Measure Type: Number
Unit of Measure: participants
42 111
3.Secondary Outcome
Title Number of Participants Who Received Antiviral Treatment Who Were Also on Substitution Therapy
Hide Description This measure was the number of all of the participants who received antiviral treatment who also received substitution therapy.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of antiviral treatment.
Arm/Group Title All Participants
Hide Arm/Group Description:

Participants who received at least one dose of antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)

Participants who received at least one dose of antiviral treatment and did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)

Overall Number of Participants Analyzed 348
Measure Type: Number
Unit of Measure: participants
90
Time Frame [Not Specified]
Adverse Event Reporting Description All participants who received at least one dose of study therapy.
 
Arm/Group Title PegIFN-2b/Ribavirin With Substitution Therapy PegIFN-2b/Ribavirin Without Substitution Therapy
Hide Arm/Group Description Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine) Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
All-Cause Mortality
PegIFN-2b/Ribavirin With Substitution Therapy PegIFN-2b/Ribavirin Without Substitution Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
PegIFN-2b/Ribavirin With Substitution Therapy PegIFN-2b/Ribavirin Without Substitution Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/90 (1.11%)      10/258 (3.88%)    
Blood and lymphatic system disorders     
Anaemia  1  0/90 (0.00%)  0 3/258 (1.16%)  3
Blood disorder  1  1/90 (1.11%)  1 0/258 (0.00%)  0
Ear and labyrinth disorders     
Vertigo  1  0/90 (0.00%)  0 1/258 (0.39%)  1
General disorders     
Accidental death  1  0/90 (0.00%)  0 1/258 (0.39%)  1
Infections and infestations     
Staphylococcal sepsis  1  0/90 (0.00%)  0 1/258 (0.39%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Hepatic neoplasm malignant  1  0/90 (0.00%)  0 1/258 (0.39%)  1
Nervous system disorders     
Cerebrovascular accident  1  0/90 (0.00%)  0 1/258 (0.39%)  1
Epilepsy  1  0/90 (0.00%)  0 1/258 (0.39%)  1
Renal and urinary disorders     
Nephrolithiasis  1  0/90 (0.00%)  0 1/258 (0.39%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PegIFN-2b/Ribavirin With Substitution Therapy PegIFN-2b/Ribavirin Without Substitution Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/90 (20.00%)      35/258 (13.57%)    
General disorders     
Fatigue  1  8/90 (8.89%)  8 12/258 (4.65%)  12
Influenza like illness  1  10/90 (11.11%)  10 14/258 (5.43%)  15
Investigations     
Weight decreased  1  5/90 (5.56%)  5 6/258 (2.33%)  6
Nervous system disorders     
Headache  1  5/90 (5.56%)  5 5/258 (1.94%)  5
Psychiatric disorders     
Depression  1  5/90 (5.56%)  5 7/258 (2.71%)  7
Skin and subcutaneous tissue disorders     
Alopecia  1  8/90 (8.89%)  8 7/258 (2.71%)  7
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
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.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00725751    
Other Study ID Numbers: P05255
First Submitted: July 25, 2008
First Posted: July 30, 2008
Results First Submitted: March 23, 2012
Results First Posted: April 23, 2012
Last Update Posted: October 2, 2015