Adefovir Dipivoxil In Compensated Chronic Hepatitis B Patients

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00316719
First received: April 19, 2006
Last updated: October 1, 2009
Last verified: October 2009
Results First Received: June 15, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Hepatitis B
Interventions: Drug: LAM group
Drug: ADV group

  Participant Flow
  Hide Participant Flow

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
Adefovir (ADV) ADV 10 mg orally once daily for 52 weeks
Lamivudine (LAM) LAM 100 mg orally once daily for 52 weeks

Participant Flow:   Overall Study
    Adefovir (ADV)     Lamivudine (LAM)  
STARTED     52     53  
COMPLETED     50     47  
NOT COMPLETED     2     6  
Adverse Event                 0                 6  
Consent withdrawn                 2                 0  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Adefovir (ADV) ADV 10 mg orally once daily for 52 weeks
Lamivudine (LAM) LAM 100 mg orally once daily for 52 weeks
Total Total of all reporting groups

Baseline Measures
    Adefovir (ADV)     Lamivudine (LAM)     Total  
Number of Participants  
[units: participants]
  50     52     102  
Age  
[units: years]
Mean ± Standard Deviation
  44  ± 9.73     43.9  ± 9.95     44  ± 9.79  
Gender  
[units: participants]
     
Female     9     17     26  
Male     41     35     76  
Race/Ethnicity, Customized  
[units: Number¬†of¬†participants]
     
Asian     50     52     102  
Region of Enrollment  
[units: participants]
     
Japan     50     52     102  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change From Baseline in Hepatitis B Virus (HBV) DNA at Week 52   [ Time Frame: Baseline and Week 52 ]

2.  Secondary:   Percentage of Participants With HBV DNA Loss (<400 Copies/mL) at Week 52   [ Time Frame: Week 52 ]

3.  Secondary:   Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 52   [ Time Frame: Week 52 ]

4.  Secondary:   Percentage of Participants With Hepatitis B e Antigen/Antibody (HBeAg/Ab) Seroconversion at Week 52   [ Time Frame: Week 52 ]

5.  Secondary:   Percentage of Participants With Hepatitis B s Antigen (HBsAg) Loss at Week 52   [ Time Frame: Week 52 ]

6.  Secondary:   Percentage of Participants With Hepatitis B s Antigen/ Antibody (HBsAg/Ab) Seroconversion at Week 52   [ Time Frame: Week 52 ]

7.  Secondary:   Mean Alanine Aminotransferase (ALT) Level at Week 52   [ Time Frame: Week 52 ]

8.  Secondary:   Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 52   [ Time Frame: Week 52 ]

9.  Secondary:   Time to Onset of ALT Normalization   [ Time Frame: From Baseline to Week 52 ]

10.  Secondary:   Rate of Emergence of Resistant Virus at Week 52   [ Time Frame: Week 52 ]

11.  Secondary:   Time to Onset of HBV DNA Loss (< 400 Copies/mL)   [ Time Frame: From Baseline to Week 52 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

12.  Secondary:   Time to Onset of HBeAg Loss   [ Time Frame: From Baseline to Week 52 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

13.  Secondary:   Time to Onset of HBeAg/Ab Seroconversion   [ Time Frame: From Baseline to Week 52 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00316719     History of Changes
Other Study ID Numbers: ADF105220
Study First Received: April 19, 2006
Results First Received: June 15, 2009
Last Updated: October 1, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare