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Adefovir Dipivoxil Tablets (10mg) In Chinese Subjects With HBe Antigen Negative Chronic Hepatitis B

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00324961
First received: May 9, 2006
Last updated: October 26, 2009
Last verified: October 2009
History of Changes
Results First Received: August 27, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chronic Hepatitis B
Intervention: Drug: adefovir dipivoxil tablets

  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
10 mg Adefovir Dipivoxil (ADV) 10 mg ADV tablets once daily for 104 weeks

Participant Flow:   Overall Study
    10 mg Adefovir Dipivoxil (ADV)  
STARTED     533  
COMPLETED     490  
NOT COMPLETED     43  
Adverse Event                 5  
Consent Withdrawn                 11  
Lost to Follow-up                 22  
Protocol Violation                 3  
Other                 2  



  Baseline Characteristics
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Reporting Groups
  Description
10 mg Adefovir Dipivoxil (ADV) 10 mg ADV tablets once daily for 104 weeks

Baseline Measures
    10 mg Adefovir Dipivoxil (ADV)  
Number of Participants  
[units: participants]
 		  533  
Age  
[units: years]
Mean ± Standard Deviation 		  38.7  ± 10.4  
Gender  
[units: participants]
 		 
Female     121  
Male     412  
Race/Ethnicity, Customized  
[units: participants]
 		 
Asian     533  



  Outcome Measures
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1.  Primary:   Number of Participants Achieving HBV DNA ≤300 Copies/mL at Week 104   [ Time Frame: Week 104 ]
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2.  Secondary:   Number of Participants Achieving Histological Improvement After the 104-week Treatment   [ Time Frame: Week 104 ]
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3.  Secondary:   Liver Histology Scores in HBeAg Negative Participants With Two Sequential Liver Biopsies During the Period of 104 Weeks   [ Time Frame: Baseline to Week 104 ]
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4.  Secondary:   Change From Baseline in Median Serum HBV DNA Over Time   [ Time Frame: Baseline and Weeks 13, 26, 39, 52, 65, 78, 91, and 104 ]
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5.  Secondary:   Number of Participants Achieving ALT Normalization at Week 104   [ Time Frame: Week 104 ]
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6.  Secondary:   Number of Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 104   [ Time Frame: Week 104 ]
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7.  Secondary:   Number of Participants With ADV-associated Resistance at Week 104   [ Time Frame: Week 104 ]
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8.  Secondary:   Number of Participants Achieving HBV DNA ≤300 Copies/mL Over Time   [ Time Frame: Weeks 13, 26, 39, 52, 65, 78, 91, and 104 ]
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9.  Secondary:   Number of Participants Achieving Complete Response at Week 104   [ Time Frame: Week 104 ]
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10.  Secondary:   Time to Protocol-defined Complete Response Over a 104-week Treatment Period   [ Time Frame: Baseline to Week 104 ]
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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
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Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00324961     History of Changes
Other Study ID Numbers: ADF106632
Study First Received: May 9, 2006
Results First Received: August 27, 2009
Last Updated: October 26, 2009
Health Authority: China: Food and Drug Administration