Peg-Intron and Rebetol Therapy in Treatment of Naive Hepatitis C Patients: A Comparison of Race and Genotype on Treatment Outcome (Study P04212)(TERMINATED)

This study has been terminated.
(Slow enrollment)
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00255008
First received: November 15, 2005
Last updated: December 2, 2009
Last verified: December 2009
Results First Received: December 5, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatitis C, Chronic
Interventions: Biological: peginterferon alfa-2b
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
Genotype 1 SEA PEG-IFN/RIB 48 w Genotype 1 hepatitis C virus (HCV)-infected Southeastern Asian (SEA) subjects treated for up to 48 weeks with PegIntron (peginterferon alfa-2b; PEG-IFN) REDIPEN and REBETOL (ribavirin; RIB) combination therapy
Genotype 1 Caucasian PEG-IFN/RIB 48 w Genotype 1 HCV-infected Caucasian subjects treated for up to 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 24 w Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 24 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 48 w Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy

Participant Flow:   Overall Study
    Genotype 1 SEA PEG-IFN/RIB 48 w     Genotype 1 Caucasian PEG-IFN/RIB 48 w     Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 24 w     Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 48 w  
STARTED     45     9     33     34  
COMPLETED     13 [1]   0     17     12  
NOT COMPLETED     32     9     16     22  
Adverse Event                 1                 1                 2                 0  
Lost to Follow-up                 1                 0                 1                 2  
Did not meet viral reduction criteria                 4                 5                 0                 1  
Withdrew consent                 0                 0                 2                 0  
Sponsor request                 18                 3                 8                 17  
Adverse lab experience                 1                 0                 0                 0  
Other                 7                 0                 3                 2  
[1] The study was terminated early and as a result only 42 patients completed the study.



  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
Genotype 1 SEA PEG-IFN/RIB 48 w Genotype 1 hepatitis C virus (HCV)-infected Southeastern Asian (SEA) subjects treated for up to 48 weeks with PegIntron (peginterferon alfa-2b; PEG-IFN) REDIPEN and REBETOL (ribavirin; RIB) combination therapy
Genotype 1 Caucasian PEG-IFN/RIB 48 w Genotype 1 HCV-infected Caucasian subjects treated for up to 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 24 w Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 24 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 48 w Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
Total Total of all reporting groups

Baseline Measures
    Genotype 1 SEA PEG-IFN/RIB 48 w     Genotype 1 Caucasian PEG-IFN/RIB 48 w     Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 24 w     Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 48 w     Total  
Number of Participants  
[units: participants]
  45     9     33     34     121  
Age  
[units: years]
Mean ± Standard Deviation
  43.6  ± 11.06     43.6  ± 12.30     46.8  ± 10.56     46.3  ± 10.71     45.2  ± 10.89  
Gender  
[units: participants]
         
Female     19     4     15     12     50  
Male     26     5     18     22     71  



  Outcome Measures

1.  Primary:   Number of Subjects Who Achieved a Sustained Virologic Response (SVR)   [ Time Frame: 24 weeks after completion of either up to 24 or 48 weeks of therapy ]


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Head, Clinical Trials Registry & Results Disclosure Group
Organization: Schering-Plough
e-mail: ClinicalTrialsDisclosure@spcorp.com


No publications provided


Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00255008     History of Changes
Other Study ID Numbers: P04212
Study First Received: November 15, 2005
Results First Received: December 5, 2008
Last Updated: December 2, 2009
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration