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Trial record 36 of 382 for:    IFNA2 AND RBV AND genotype

Efficacy and Safety of 24 vs 48 Weeks of Pegetron® (Peginterferon Alfa-2b + Ribavirin) in Naïve Genotype 1 Hepatitis C (Study P05016)(TERMINATED)

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: NCT00423800
Recruitment Status : Terminated (The study was terminated due to difficulty in recruiting participants.)
First Posted : January 18, 2007
Results First Posted : February 23, 2011
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C, Chronic
Intervention Drug: Combination of pegylated interferon alfa-2b (PEG) and ribavirin (RBV)
Enrollment 56
Recruitment Details  
Pre-assignment Details 56 participants were enrolled. 51 participants were screening failures, were not randomized and are not included in the study. Of the 5 participants randomized, 2 did not meet inclusion/exclusion criteria. All 5 are included in the intent-to-treat (ITT) population.
Arm/Group Title Pegetron® - 24 Weeks Pegetron® - 48 Weeks
Hide Arm/Group Description Participants are treated for 8 weeks and then randomized to an additional 16 weeks of treatment Participants are treated for 8 weeks and then randomized to an additional 40 weeks of treatment
Period Title: Overall Study
Started 3 2
Completed 3 1
Not Completed 0 1
Reason Not Completed
Protocol Violation             0             1
Arm/Group Title Pegetron® - 24 Weeks Pegetron® - 48 Weeks Total
Hide Arm/Group Description Participants are treated for 8 weeks and then randomized to an additional 16 weeks of treatment Participants are treated for 8 weeks and then randomized to an additional 40 weeks of treatment Total of all reporting groups
Overall Number of Baseline Participants 3 2 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 2 participants 5 participants
54.0  (9.5) 22  (0) 41.2  (18.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 2 participants 5 participants
Female
2
  66.7%
2
 100.0%
4
  80.0%
Male
1
  33.3%
0
   0.0%
1
  20.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 3 participants 2 participants 5 participants
3 2 5
1.Primary Outcome
Title Number of Participants With a Sustained Virologic Response
Hide Description

Participants were tested for the presence of Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) in blood by Qualitative Polymerase Chain Reaction (qPCR). If the HCV-RNA is not detectable, the participant is negative for HCV-RNA.

Sustained virologic responders were participants negative for HCV-RNA at 24 weeks following the completion of therapy. A Participant that withdrew prior to 24 weeks following the completion of therapy was considered a non-responder.

Time Frame 24 weeks following completion of 24 or 48 weeks of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pegetron® - 24 Weeks Pegetron® - 48 Weeks
Hide Arm/Group Description:
Participants are treated for 8 weeks and then randomized to an additional 16 weeks of treatment
Participants are treated for 8 weeks and then randomized to an additional 40 weeks of treatment
Overall Number of Participants Analyzed 3 2
Measure Type: Number
Unit of Measure: Participants
Responders 3 1
Non-responders 0 1
2.Secondary Outcome
Title Number of Participants With a Virological Relapse
Hide Description

Participants were tested for the presence of Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) in blood by Qualitative Polymerase Chain Reaction (qPCR).

Virological relapse in participants was defined as having negative virology (HCV-RNA) at end of treatment, but positive virology (HCV-RNA) again at 24 weeks of follow up post treatment.

Time Frame 24 weeks following completion of 24 or 48 weeks of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population that completed the study.
Arm/Group Title Pegetron® - 24 Weeks Pegetron® - 48 Weeks
Hide Arm/Group Description:
Participants are treated for 8 weeks and then randomized to an additional 16 weeks of treatment
Participants are treated for 8 weeks and then randomized to an additional 40 weeks of treatment
Overall Number of Participants Analyzed 3 1
Measure Type: Number
Unit of Measure: Participants
Participants with Virological Relapse 0 0
Participants with No Virological Relapse 3 1
Time Frame [Not Specified]
Adverse Event Reporting Description Included are the adverse events (AEs) for all randomized participants (Pegetron® - 24 weeks and Pegetron® - 48 weeks). Also included are two (2) Serious Adverse Events (SAEs) for 2 participants on commercial Pegetron® who were screen fails for this study and were never randomized (Screen Failures).
 
Arm/Group Title Screen Failures Pegetron® - 24 Weeks Pegetron® - 48 Weeks
Hide Arm/Group Description Two participants on commercial Pegetron® who were screen fails and were never randomized had SAEs. Both SAEs were are reported here. Participants are treated for 8 weeks with Pegetron® and then randomized to an additional 16 weeks of treatment. Participants are treated for 8 weeks with Pegetron® and then randomized to an additional 40 weeks of treatment.
All-Cause Mortality
Screen Failures Pegetron® - 24 Weeks Pegetron® - 48 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Screen Failures Pegetron® - 24 Weeks Pegetron® - 48 Weeks
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/2 (100.00%)      0/3 (0.00%)      0/2 (0.00%)    
Infections and infestations       
GROIN ABSCESS  1  1/2 (50.00%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0
Metabolism and nutrition disorders       
HYPOGLYCAEMIC SEIZURE  1  1/2 (50.00%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Screen Failures Pegetron® - 24 Weeks Pegetron® - 48 Weeks
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2 (0.00%)      2/3 (66.67%)      1/2 (50.00%)    
Eye disorders       
EYE IRRITATION  1  0/2 (0.00%)  0 1/3 (33.33%)  1 0/2 (0.00%)  0
VISION BLURRED  1  0/2 (0.00%)  0 1/3 (33.33%)  1 0/2 (0.00%)  0
Gastrointestinal disorders       
ABDOMINAL PAIN UPPER  1  0/2 (0.00%)  0 1/3 (33.33%)  1 0/2 (0.00%)  0
NAUSEA  1  0/2 (0.00%)  0 1/3 (33.33%)  1 1/2 (50.00%)  1
General disorders       
CHILLS  1  0/2 (0.00%)  0 1/3 (33.33%)  2 0/2 (0.00%)  0
FATIGUE  1  0/2 (0.00%)  0 2/3 (66.67%)  3 0/2 (0.00%)  0
IRRITABILITY  1  0/2 (0.00%)  0 1/3 (33.33%)  1 0/2 (0.00%)  0
PYREXIA  1  0/2 (0.00%)  0 2/3 (66.67%)  4 0/2 (0.00%)  0
Metabolism and nutrition disorders       
DECREASED APPETITE  1  0/2 (0.00%)  0 0/3 (0.00%)  0 1/2 (50.00%)  1
Musculoskeletal and connective tissue disorders       
ARTHRALGIA  1  0/2 (0.00%)  0 1/3 (33.33%)  2 0/2 (0.00%)  0
MYALGIA  1  0/2 (0.00%)  0 1/3 (33.33%)  2 0/2 (0.00%)  0
Nervous system disorders       
DIZZINESS  1  0/2 (0.00%)  0 1/3 (33.33%)  1 0/2 (0.00%)  0
DYSGEUSIA  1  0/2 (0.00%)  0 1/3 (33.33%)  2 0/2 (0.00%)  0
HYPOAESTHESIA  1  0/2 (0.00%)  0 0/3 (0.00%)  0 1/2 (50.00%)  1
Psychiatric disorders       
AFFECT LABILITY  1  0/2 (0.00%)  0 0/3 (0.00%)  0 1/2 (50.00%)  2
INSOMNIA  1  0/2 (0.00%)  0 1/3 (33.33%)  1 1/2 (50.00%)  1
Respiratory, thoracic and mediastinal disorders       
DYSPNOEA  1  0/2 (0.00%)  0 0/3 (0.00%)  0 1/2 (50.00%)  1
NASAL CONGESTION  1  0/2 (0.00%)  0 0/3 (0.00%)  0 1/2 (50.00%)  1
OROPHARYNGEAL PAIN  1  0/2 (0.00%)  0 0/3 (0.00%)  0 1/2 (50.00%)  1
Skin and subcutaneous tissue disorders       
ALOPECIA  1  0/2 (0.00%)  0 0/3 (0.00%)  0 1/2 (50.00%)  1
PRURITUS  1  0/2 (0.00%)  0 1/3 (33.33%)  1 0/2 (0.00%)  0
PSORIASIS  1  0/2 (0.00%)  0 1/3 (33.33%)  2 0/2 (0.00%)  0
RASH  1  0/2 (0.00%)  0 1/3 (33.33%)  1 0/2 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Due to the small sample size (n=5), no conclusions should be drawn.
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 disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period of 45 days from the time submitted to the sponsor for review.
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: NCT00423800     History of Changes
Other Study ID Numbers: P05016
First Submitted: January 17, 2007
First Posted: January 18, 2007
Results First Submitted: January 27, 2011
Results First Posted: February 23, 2011
Last Update Posted: April 7, 2017