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Post-marketing Surveillance of HIV-infected Patients With Chronic Hepatitis C Treated With PegIntron Pen and Rebetol (Study P04584)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00736242
First received: July 30, 2008
Last updated: November 3, 2014
Last verified: November 2014
Results First Received: December 21, 2012  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Conditions: Chronic Hepatitis C
Hepatitis C
HIV Infections
Interventions: Biological: PEG-IFN alfa-2b
Drug: RBV

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 232 participants enrolled, only 229 patients were included in the Safety Analysis Set and had documented baseline data. Three participants were excluded due to violation of inclusion criteria, violation of exclusion criteria and no application of peginterferon alfa-2b (PEG-IFN alfa-2b).

Reporting Groups
  Description
PEG-IFN Alfa-2b + RBV Participants received a combination of PEG-IFN alfa-2b plus ribavirin (RBV) according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.

Participant Flow:   Overall Study
    PEG-IFN Alfa-2b + RBV  
STARTED     232  
Participants in Safety Analysis Set     229  
COMPLETED     107  
NOT COMPLETED     125  



  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
PEG-IFN Alfa-2b + RBV Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.

Baseline Measures
    PEG-IFN Alfa-2b + RBV  
Number of Participants  
[units: participants]
  229  
Age, Customized  
[units: participants]
 
≤40 years     108  
≥40 years     119  
Missing Data     2  
Gender  
[units: participants]
 
Female     41  
Male     188  



  Outcome Measures
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1.  Primary:   Number of Participants With Sustained Virologic Response (SVR)   [ Time Frame: From End of Treatment to 24 weeks post-treatment (up to 72 weeks) ]

2.  Secondary:   Number of Participants With Rapid Virologic Response (RVR)   [ Time Frame: At Treatment Week 4 ]

3.  Secondary:   Number of Participants With Early Virologic Response (EVR)   [ Time Frame: From Treatment Week 1 to Treatment Week 12 ]

4.  Secondary:   Participant Study Status at End of Follow-up (EOF)   [ Time Frame: From EOT to EOF (up to 72 weeks) ]

5.  Secondary:   Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment   [ Time Frame: From the Baseline Visit up to EOF (up to 72 weeks) ]

6.  Secondary:   Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment   [ Time Frame: From the Baseline Visit up to EOF (up to 72 weeks) ]

7.  Secondary:   Median Cluster of Differentiation 4 (CD4) Cell Count During PEG-IFN Alfa-2b/RBV Treatment   [ Time Frame: From the Baseline Visit up to EOF (up to 72 weeks) ]

8.  Secondary:   Number of Participants With A Serious Adverse Event (SAE) During PEG-IFN Alfa-2b/RBV Treatment   [ Time Frame: From First Participant Visit (12/30/2005) up to 30 days after Last Participant Visit (12/31/2011). ]


  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


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00736242     History of Changes
Other Study ID Numbers: P04584
Study First Received: July 30, 2008
Results First Received: December 21, 2012
Last Updated: November 3, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices