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Impact of Patient Support by the Medical Staff on Adherence to Therapy With PegIntron Plus Rebetol (Study P04413) (@dhere)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00704964
First received: June 23, 2008
Last updated: June 3, 2011
Last verified: June 2011
History of Changes
Results First Received: March 24, 2011  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Conditions: Hepatitis C
Chronic Hepatitis C
Interventions: Biological: PegIntron
Drug: Rebetol

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
All Participants

Each site will be evaluated by a site questionnaire and assigned as either a high or low participant management site. Participants are not randomized to a group. However, treatment completion rates will be evaluated based on the high vs low participant management sites.

Completers are considered those with documentation who finished the study on time.

Participant Flow:   Overall Study
    All Participants  
STARTED     746 [1]
COMPLETED     418 [2]
NOT COMPLETED     328  
Not completed on time                 328  
[1] Number of participants who took at least one dose of study medication.
[2] Number of participants who completed therapy as scheduled.



  Baseline Characteristics
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Reporting Groups
  Description
All Participants Each site will be evaluated by a site questionnaire and assigned as either a high or low participant management site. Participants are not randomized to a group. However, treatment completion rates will be evaluated based on the high vs low participant management sites.

Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
 		  746  
Age  
[units: years]
Mean ± Standard Deviation 		  42.3  ± 11.44  
Gender  
[units: participants]
 		 
Female     297  
Male     449  
Region of Enrollment  
[units: participants]
 		 
Germany     746  



  Outcome Measures
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1.  Primary:   Number of Participants With Biometrical Adherence to Therapy   [ Time Frame: Up to 48 weeks for Hepatitis C Virus (HCV) genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3 ]
  Show Outcome Measure 1

2.  Primary:   Number of Participants With Adherence to Therapy According to Physician Approximation   [ Time Frame: Up to 48 weeks for HCV genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3 ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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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 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.


Limitations and Caveats
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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Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00704964     History of Changes
Other Study ID Numbers: P04413
Study First Received: June 23, 2008
Results First Received: March 24, 2011
Last Updated: June 3, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices