A Study to Compare Tenofovir Versus Hepsera (Adefovir) for the Treatment of Hepatitis Be Antigen (HBeAg) Positive Chronic Hepatitis B

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Gilead Sciences.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00116805
First received: June 30, 2005
Last updated: October 31, 2011
Last verified: October 2011
Results First Received: February 11, 2010  
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: tenofovir disoproxil fumarate
Drug: adefovir dipivoxil

  Participant Flow


  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
TDF 300 mg QD Double-blind TDF 300 mg QD for 48 weeks, followed by OL TDF 300 mg for an additional 336 weeks
ADV 10 mg QD Double-blind ADV 10 mg QD for 48 weeks, then switch to OL TDF 300 mg for an additional 336 weeks
Total Total of all reporting groups

Baseline Measures
    TDF 300 mg QD     ADV 10 mg QD     Total  
Number of Participants  
[units: participants]
  176     90     266  
Age  
[units: participants]
     
<=18 years     3     1     4  
Between 18 and 65 years     173     89     262  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  34  ± 11.3     34  ± 12.2     34  ± 11.6  
Gender  
[units: participants]
     
Female     57     26     83  
Male     119     64     183  
Region of Enrollment  
[units: participants]
     
United States     30     14     44  
Greece     1     2     3  
Spain     7     2     9  
Turkey     10     4     14  
Italy     0     1     1  
United Kingdom     6     1     7  
France     11     3     14  
Czech Republic     3     5     8  
Canada     17     10     27  
Poland     16     8     24  
Australia     22     6     28  
Bulgaria     17     11     28  
Germany     20     8     28  
Netherlands     6     4     10  
New Zealand     10     11     21  
Baseline Alanine Aminotransferase (ALT) above the Upper Limit of the Normal (ULN) Range [1]
[units: Participants]
     
Yes     169     90     259  
No     7     0     7  
Prior Lamivudine or Emtricitabine Exposure [1]
[units: Participants]
     
Yes     8     1     9  
No     168     89     257  
Baseline Hepatitis B Deoxyribonucleic Acid (HBV DNA) [1]
[units: Log10 copies/mL]
Mean ± Standard Deviation
  8.64  ± 1.076     8.88  ± 0.930     8.72  ± 1.033  
Baseline Knodell Necroinflammatory Score [2]
[units: Units on a scale]
Mean ± Standard Deviation
  8.3  ± 2.11     8.5  ± 2.07     8.4  ± 2.09  
[1] Randomized-and-treated analysis set
[2] Randomized-and-treated analysis set. Based on Knodell numerical scoring of liver biopsy specimens. This scale consists of 5 domains (Periportal with or without Bridging Necrosis [scored numerically from best to worst 0, 1, 3, 4, 5, 6, or 10]; Intralobular Degeneration and Focal Necrosis [scored best to worst 0 to 4]; Portal Inflammation [also scored best to worst 0 to 4]; and Fibrosis [also scored best to worst 0 to 4]). The necroinflammatory score is the combined score for Necrosis and Inflammation, excluding the Fibrosis score. Scores may range from 0 (best) to 14 (worst).



  Outcome Measures
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1.  Primary:   Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) <400 Copies/mL and Histological Improvement (2-point or Higher Reduction in the Knodell Necroinflammatory Score Without Worsening in Knodell Fibrosis Score) at Week 48   [ Time Frame: Week 48 ]

2.  Secondary:   Percentage of Participants With Histological Response at Week 48   [ Time Frame: Week 48 ]

3.  Secondary:   Percentage of Participants With HBV DNA <400 Copies/mL at Week 48   [ Time Frame: Week 48 ]

4.  Secondary:   Percentage of Participants With HBV DNA <400 Copies/mL at Week 96   [ Time Frame: Week 96 ]

5.  Secondary:   Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48   [ Time Frame: Week 48 ]

6.  Secondary:   Percentage of Participants With ALT Normalization at Week 96   [ Time Frame: Week 96 ]

7.  Secondary:   Percentage of Participants With Hepatitis B E-antigen (HBeAg) Loss/Seroconversion at Week 48   [ Time Frame: Week 48 ]

8.  Secondary:   Percentage of Participants With HBeAg Loss or Seroconversion at Week 96   [ Time Frame: Week 96 ]

9.  Secondary:   Percentage of Participants With Hepatitis B S-Antigen (HBsAg) Loss or Seroconversion at Week 48   [ Time Frame: Week 48 ]

10.  Secondary:   Percentage of Participants With HBsAg Loss or Serconversion to Anti-HBs at Week 96   [ Time Frame: Week 96 ]

11.  Secondary:   Percentage of Participants With HBV Genotypic Changes From Baseline at Week 48 (Resistance Surveillance)   [ Time Frame: Week 48 ]

12.  Secondary:   Number of Participants With HBV Genotypic Changes From Baseline at Week 96 (Resistance Surveillance)   [ Time Frame: Week 96 ]


  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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