Post-marketing Surveillance Study of Ex-intravenous Drug Abusers With Chronic Hepatitis C Treated With PegIntron Plus Rebetol (P04408/MK-4031-261) (SUPPORT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00726557
First received: July 30, 2008
Last updated: June 2, 2014
Last verified: June 2014
Results First Received: April 15, 2010  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Conditions: Hepatitis C, Chronic
Substance Abuse, Intravenous
Interventions: Biological: PegIntron (pegylated interferon alfa-2b; SCH 54031)
Drug: Rebetol (ribavirin; SCH 18908)

  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
PegIntron + Rebetol PegIntron 1.5 mcg/kg/week + Rebetol 10.6 mg/kg/day administered for a minimum of 12 weeks. Participants who achieved early virological response at Treatment Week 12 continued to receive therapy for a total of 24 or 48 weeks, depending on genotype.

Participant Flow:   Overall Study
    PegIntron + Rebetol  
STARTED     246  
COMPLETED     118 [1]
NOT COMPLETED     128  
Screening failure                 4  
No end of treatment documentation                 37  
No follow-up documentation available                 55  
Treatment less than 3 months                 17  
Inclusion criteria not met                 15  
[1] Completed is defined as those who finished the follow-up period.



  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.
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Reporting Groups
  Description
PegIntron + Rebetol Baseline measures only available for the 118 participants who completed.

Baseline Measures
    PegIntron + Rebetol  
Number of Participants  
[units: participants]
  246  
Age  
[units: years]
Mean ± Standard Deviation
  36.64  ± 8.39  
Gender, Customized  
[units: participants]
 
Female     35  
Male     83  
Unavailable     128  
Region of Enrollment  
[units: participants]
 
Germany     246  



  Outcome Measures
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1.  Primary:   Number of Drug-substituted Participants Who Achieved Sustained Virological Response (SVR) With PegIntron 1.5 μg/kg/Week and Rebetol (10.6 mg/kg/Day) in Substitution Centers Under Routine Conditions   [ Time Frame: End of Follow-up (Week 48 or Week 72, depending on genotype) ]

2.  Primary:   Number of Participants Who Tolerated Treatment With PegIntron 1.5 mcg/kg/Week + Rebetol 10.6 mg/kg/Week   [ Time Frame: Assessed at the end 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: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp.
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00726557     History of Changes
Other Study ID Numbers: P04408
Study First Received: July 30, 2008
Results First Received: April 15, 2010
Last Updated: June 2, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices