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PegIntron Versus Adefovir in the Treatment of Chronic Hepatitis B (CHB) e Antigen Positive Patients in Taiwan (P04498/MK-4031-278)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00371761
First Posted: September 4, 2006
Last Update Posted: April 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
Results First Submitted: July 15, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Hepatitis B, Chronic (CHB)
Interventions: Biological: 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 
Overall Participants Analyzed 
[Units: Participants]
 13   12   25 
Age 
[Units: Years]
Mean (Standard Deviation)
 36.7  (8.5)   36.7  (13.6)   36.7  (11.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      4  30.8%      1   8.3%      5  20.0% 
Male      9  69.2%      11  91.7%      20  80.0% 
Region of Enrollment 
[Units: Participants]
     
Taiwan, Province Of China   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: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00371761     History of Changes
Other Study ID Numbers: P04498
First Submitted: August 31, 2006
First Posted: September 4, 2006
Results First Submitted: July 15, 2010
Results First Posted: December 15, 2010
Last Update Posted: April 6, 2017