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Adherence in Patients Receiving PegIntron/Rebetol for Hepatitis C in Conjunction With a Psychotherapy Support Program (Study P04252)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00723892
First Posted: July 29, 2008
Last Update Posted: October 30, 2015
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
Results First Submitted: August 25, 2010  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Hepatitis C, Chronic
Hepacivirus
Interventions: Biological: Peginterferon alfa-2b (PegIntron)
Drug: Rebetol (Ribavirin)
Behavioral: Psychotherapy support program

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
614 participants were recruited in this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Only 568 participants were assigned to treatment as they were foreseen to complete treatment, were consulted, and met inclusion criteria.

Reporting Groups
  Description
PegIntron/Rebetol and Psychotherapy Support Program Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
PegIntron/Rebetol Alone (no Psychotherapy) Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.

Participant Flow:   Overall Study
    PegIntron/Rebetol and Psychotherapy Support Program   PegIntron/Rebetol Alone (no Psychotherapy)
STARTED   313   255 
COMPLETED   206   168 
NOT COMPLETED   107   87 
Participant not tracked                33                35 
Virological criterion                24                9 
Withdrawal by Subject                6                9 
End planned                11                7 
Bad tolerance                5                5 
Multiple reasons                17                12 
Not specified                6                3 
Study end                1                3 
Weight loss                1                3 
Alcohol abuse                0                1 
Intercurrent infection                2                0 
Drug addiction                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
PegIntron/Rebetol and Psychotherapy Support Program Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
PegIntron/Rebetol Alone (no Psychotherapy) Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
Total Total of all reporting groups

Baseline Measures
   PegIntron/Rebetol and Psychotherapy Support Program   PegIntron/Rebetol Alone (no Psychotherapy)   Total 
Overall Participants Analyzed 
[Units: Participants]
 313   255   568 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 45.5  (10.7)   48.5  (11.8)   46.8  (11.3) 
[1] Participants foreseen to complete treatment, consulted and assigned to treatment were analyzed.
Gender, Customized [1] 
[Units: Participants]
     
Female   117   80   197 
Male   195   175   370 
Unavailable (missing data)   1   0   1 
[1] Participants foreseen to complete treatment, consulted and assigned to treatment were analyzed.
Region of Enrollment [1] 
[Units: Participants]
     
France   313   255   568 
[1] Participants foreseen to complete treatment, consulted and assigned to treatment were analyzed.


  Outcome Measures
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1.  Primary:   Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C When Administered With a Patient Psychotherapy Support Program as Compared to a Group Without a Psychotherapy Support Program.   [ Time Frame: 12 months after onset of treatment ]

2.  Secondary:   the Average Length of Treatment for Participants on Treatment for Hepatitis C With PegIntron Pen/Rebetol   [ Time Frame: 12 months after onset of treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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 agreement is:
unchecked The only 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 that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only 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 that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
phone: 1-800--672-6372
e-mail: ClinicalTrialsDisclosure@merck.com



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00723892     History of Changes
Other Study ID Numbers: P04252
MK-4031-245 ( Other Identifier: Merck )
First Submitted: July 25, 2008
First Posted: July 29, 2008
Results First Submitted: August 25, 2010
Results First Posted: September 20, 2010
Last Update Posted: October 30, 2015