PegIntron Versus Adefovir in the Treatment of Chronic Hepatitis B (CHB) e Antigen Positive Patients in Taiwan (Study P04498)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00371761
First received: August 31, 2006
Last updated: November 18, 2010
Last verified: November 2010
Results First Received: July 15, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatitis B, Chronic (CHB)
Interventions: Drug: Pegylated interferon alfa-2b (PegIntron)
Drug: Adefovir dipivoxil (adefovir)

  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
No text entered.

Reporting Groups
  Description
PegIntron PegIntron, 1.5 micrograms/kg weekly, for up to 24 weeks followed by a 48-week observation phase
Adefovir Adefovir, 10 mg daily, for up to 48 weeks followed by a 24-week observation phase

Participant Flow:   Overall Study
    PegIntron     Adefovir  
STARTED     13     12  
COMPLETED     5     2  
NOT COMPLETED     8     10  
Adverse Event                 1                 1  
Withdrawal by Subject                 1                 3  
Investigator Judgment                 2                 3  
Study termination                 4                 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
PegIntron PegIntron, 1.5 micrograms/kg weekly, for up to 24 weeks followed by a 48-week observation phase
Adefovir Adefovir, 10 mg daily, for up to 48 weeks followed by a 24-week observation phase
Total Total of all reporting groups

Baseline Measures
    PegIntron     Adefovir     Total  
Number of Participants  
[units: participants]
  13     12     25  
Age  
[units: years]
Mean ± Standard Deviation
  36.7  ± 8.5     36.7  ± 13.6     36.7  ± 11.0  
Gender  
[units: participants]
     
Female     4     1     5  
Male     9     11     20  
Region of Enrollment  
[units: participants]
     
Taiwan     13     12     25  



  Outcome Measures

1.  Primary:   Number of Participants With a Combined Response Consisting of All Three Responses - (a) Serological Response, (b) Virological Response, and (c) Biochemical Response   [ Time Frame: At Week 72 [for Pegylated interferon alfa-2b (PegIntron), at 48 weeks post PegIntron treatment for up to 24 weeks; for Adefovir, at 24 weeks post adefovir treatment for up to 48 weeks] ]


  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 of Late Stage Development
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@spcorp.com


No publications provided


Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00371761     History of Changes
Other Study ID Numbers: P04498
Study First Received: August 31, 2006
Results First Received: July 15, 2010
Last Updated: November 18, 2010
Health Authority: Taiwan: Department of Health