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Observational Study of Patients With Chronic Hepatitis C Virus (HCV) Infected With HCV Genotype 1 Low Virus Load (LVL 1) and Effect of PegIntron Plus Rebetol Treatment (Study P04793 Part 2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01054742
First received: January 21, 2010
Last updated: July 18, 2012
Last verified: July 2012
History of Changes
Results First Received: May 15, 2012  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Hepatitis C
Interventions: Drug: Standard of Care PegIntron
Drug: Standard of Care 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two participants who had relapsed at Follow-up Week 24 of study Part 1, and were enrolled in Part 2 to complete 48 weeks of retreatment.

Reporting Groups
  Description
Standard of Care PegIntron Plus Ribavirin [Part 2] Participants who had relapsed during Part 1 of the study, had detectable HCV-RNA on Day 1 of Part 2 of the study, and who were re-treated during Part 2 of the study with standard of care PegIntron plus ribivirin for 48 weeks.

Participant Flow:   Overall Study
    Standard of Care PegIntron Plus Ribavirin [Part 2]  
STARTED     2  
COMPLETED     2  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
Standard of Care PegIntron Plus Ribavirin [Part 2] Participants who had relapsed during Part 1 of the study, had detectable HCV-RNA on Day 1 of Part 2 of the study, and who were re-treated during Part 2 of the study with standard of care PegIntron plus ribivirin for 48 weeks.

Baseline Measures
    Standard of Care PegIntron Plus Ribavirin [Part 2]  
Number of Participants  
[units: participants]
 		  2  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     2  
>=65 years     0  
Gender  
[units: participants]
 		 
Female     0  
Male     2  
Region of Enrollment  
[units: participants]
 		 
Russian Federation     2  



  Outcome Measures

1.  Primary:   Number of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Levels During Part 2 of the Study   [ Time Frame: From Day 1, Week 1 [Part 2 ] through Follow-up Week 24 [ Part 2] ]
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  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 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.


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
No text entered.  


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
ClinicalTrials.gov Identifier: NCT01054742     History of Changes
Other Study ID Numbers: P04793 Part 2
Study First Received: January 21, 2010
Results First Received: May 15, 2012
Last Updated: July 18, 2012
Health Authority: Russia: Ministry of Health of the Russian Federation