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Evaluating Safety and Efficacy In Hepatitis C Patients After PegIntron Pen Treatment (Study P04896)

This study has been terminated.
(Terminated early due to low enrollment.)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01340573
First received: November 18, 2010
Last updated: July 21, 2014
Last verified: July 2014
Results First Received: October 4, 2011  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Chronic Hepatitis C
Interventions: Drug: PegIntron Pen
Drug: Ribavirin

  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 Genotype 1 CHC Participants and Non-genotype 1 CHC partipants

Participant Flow:   Overall Study
    All Participants  
STARTED     3  
COMPLETED     0  
NOT COMPLETED     3  



  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
All Participants Genotype 1 CHC Participants and Non-genotype 1 CHC partipants

Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
  3  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     3  
>=65 years     0  
Gender  
[units: participants]
 
Female     2  
Male     1  
Region of Enrollment  
[units: participants]
 
Indonesia     3  



  Outcome Measures
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1.  Primary:   Number of Genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-48 of Study Treatment   [ Time Frame: Week-48 ]

2.  Primary:   Number of Genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-24 Follow-up   [ Time Frame: Week-24 follow-up ]

3.  Primary:   Number of Non-genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-24 of Study Treatment   [ Time Frame: Week-24 ]

4.  Primary:   Number of Non-genotype 1 Participants Who Experienced Serious Adverse Events (SAE) on Week-24 Follow-up   [ Time Frame: Week-24 follow-up ]

5.  Secondary:   Number of Non-genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 of Study Treatment   [ Time Frame: Week-24 ]

6.  Secondary:   Number of Non-genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 Follow-up   [ Time Frame: Week-24 follow-up ]

7.  Secondary:   Number of Genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-48 of Study Treatment   [ Time Frame: Week-48 ]

8.  Secondary:   Number of Genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 Follow-up   [ Time Frame: Week-24 follow-up ]

9.  Secondary:   Participants' Overall Rating of Satisfaction and the Use of Training Materials for the Pegintron Pen, as Provided in a Study Questionnaire   [ Time Frame: Week 12 ]


  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: NCT01340573     History of Changes
Other Study ID Numbers: P04896
Study First Received: November 18, 2010
Results First Received: October 4, 2011
Last Updated: July 21, 2014
Health Authority: Indonesia: Departement Kesehatan (Department of Health)