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Trial record 93 of 295 for:    IFNA2 AND PEG-interferon alfa-2b

Patient Compliance During PegIntron and Rebetol Combination Therapy in Chronic Hepatitis C (Study P04690)

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ClinicalTrials.gov Identifier: NCT00725205
Recruitment Status : Completed
First Posted : July 30, 2008
Results First Posted : November 18, 2011
Last Update Posted : October 8, 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, Chronic
Hepatitis C
Interventions Biological: PegIntron (Peginterferon alfa-2b)
Drug: Rebetol (Ribavirin)
Enrollment 294
Recruitment Details  
Pre-assignment Details A total of 294 participants were enrolled, 2 participants were not treated.
Arm/Group Title Peginterferon Alfa-2b and Ribavirin
Hide Arm/Group Description Previously untreated Chronic Hepatitis C (CHC) participants treated with a treatment regimen of 1.5 micgrograms (mcg)/killogram (kg) Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
Period Title: Overall Study
Started 294
Completed 207
Not Completed 87
Reason Not Completed
Adverse Event             22
Investigator Discontinued             1
Non-compliance With Protocol             14
Other             8
Protocol Defined Clinical Event             1
Treatment Failure             41
Arm/Group Title Peginterferon Alfa-2b and Ribavirin
Hide Arm/Group Description Previously untreated CHC participants treated with a treatment regimen of 1.5 mcg/kg Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
Overall Number of Baseline Participants 294
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 294 participants
46.7  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 294 participants
Female
165
  56.1%
Male
129
  43.9%
1.Primary Outcome
Title Number of Participants Who Are Triple-80 Compliant
Hide Description Participants who continued treatment beyond Week 12 (i.e., 24 or 48 weeks depending on the viral genotype) were assessed for triple-80 compliance. Triple-80 compliant, or simply compliant, participants were those that received >= 80% of the planned total doses of both pegylated interferon alfa-2b and ribavirin for >=80% of the duration of the therapy. 3 rates were computed: Compliance with study duration, compliance with pegylated interferon dose, and compliance with ribavirin dose. A participant was defined as triple-80 compliant, if none of the 3 rates as defined above were less than 80.
Time Frame 24 or 48 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description

All enrolled participants who received any dose of any medication, had a known viral genotype, and did not discontinue from the study with the status being “treatment

failure”. Of the 294 enrolled participants, 253 participants started treatment and continued treatment beyond Week 12.

Arm/Group Title Peginterferon Alfa-2b and Ribavirin
Hide Arm/Group Description:
Previously untreated CHC participants treated with a treatment regimen of 1.5 mcg/kg Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
Overall Number of Participants Analyzed 253
Measure Type: Number
Unit of Measure: Participants
183
2.Secondary Outcome
Title Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up
Hide Description Sustained virologic response (SVR) was assessed at post-treatment Follow-up Week 24. Day 1 of the Follow-up period was defined as the first day after the last dose day. A participant was considered a sustained responder if the participant had undetectable Hepatitis C virus Ribonucleic acid (HCV-RNA) level (based on qualitative test result) at Follow-up Week 24. If a participant with missing polymerase chain reaction (PCR) data at Follow-up Week 24 had undetectable HCV-RNA level at Follow-up Week 12, the participant was also considered as a sustained responder.
Time Frame 24 Weeks following completion of 24 or 48 weeks of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analyses Set: All enrolled participants who received any dose of any medication (Peginterferon or Ribavirin) and had a known viral genotype. Of the 294 enrolled participants, 2 were not treated.
Arm/Group Title Peginterferon Alfa-2b and Ribavirin
Hide Arm/Group Description:
Previously untreated CHC participants treated with a treatment regimen of 1.5 mcg/kg Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
Overall Number of Participants Analyzed 292
Measure Type: Number
Unit of Measure: Participants
66
3.Secondary Outcome
Title Number Of Participants Self-Administering Pegylated Interferon Alfa-2b
Hide Description Number of participants self-administering Pegylated interferon alfa-2b injection pen. If a participant changed the way he or she administered the injection pen during the course of the study (from self-administering to clinic-administering or the other way around), that participant was also considered as self-administering.
Time Frame Up to 48 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Participants enrolled.
Arm/Group Title Peginterferon Alfa-2b and Ribavirin
Hide Arm/Group Description:
Previously untreated CHC participants treated with a treatment regimen of 1.5 mcg/kg Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
Overall Number of Participants Analyzed 294
Measure Type: Number
Unit of Measure: Participants
291
Time Frame [Not Specified]
Adverse Event Reporting Description The All Patients as Treated (APAT) population included all enrolled participants who took at least one dose of Peginterferon alfa-2b or Ribavirin.
 
Arm/Group Title Peginterferon Alfa-2b and Ribavirin
Hide Arm/Group Description Previously untreated CHC participants treated with a treatment regimen of 1.5 mcg/kg Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
All-Cause Mortality
Peginterferon Alfa-2b and Ribavirin
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Peginterferon Alfa-2b and Ribavirin
Affected / at Risk (%) # Events
Total   9/292 (3.08%)    
Blood and lymphatic system disorders   
Anaemia  2/292 (0.68%)  2
Eosinophilia  1/292 (0.34%)  1
Thrombocytopenia  1/292 (0.34%)  1
Infections and infestations   
Pneumonia  1/292 (0.34%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Hepatic Neoplasm Malignant  2/292 (0.68%)  2
Psychiatric disorders   
Depression  1/292 (0.34%)  1
Respiratory, thoracic and mediastinal disorders   
Asphyxia  1/292 (0.34%)  1
Skin and subcutaneous tissue disorders   
Toxic Skin Eruption  1/292 (0.34%)  1
1
Term from vocabulary, MedDRA (14.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Peginterferon Alfa-2b and Ribavirin
Affected / at Risk (%) # Events
Total   109/292 (37.33%)    
Blood and lymphatic system disorders   
Anaemia  74/292 (25.34%)  87
Thrombocytopenia  15/292 (5.14%)  17
General disorders   
Pyrexia  23/292 (7.88%)  26
Investigations   
Weight Decreased  19/292 (6.51%)  19
1
Term from vocabulary, MedDRA (14.0)
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.
Investigators require the SPONSOR'S written permission to publish any information pertaining to the study during and five years after closure of the study.
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: NCT00725205     History of Changes
Other Study ID Numbers: P04690
First Submitted: July 25, 2008
First Posted: July 30, 2008
Results First Submitted: October 10, 2011
Results First Posted: November 18, 2011
Last Update Posted: October 8, 2015