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
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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
There were 90 enrolling sites in 15 countries. The first participant was screened on 09 June 2005, and the last participant was randomized on 15 June 2006. The last participant observation (LPO) for the primary endpoint analysis (Week 48) was 11 May 2007. The LPO for the Week 96 analysis was 27 May 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Six of the 272 participants who were successfully screened and randomized discontinued prior to the first dose of study drug due to being erroneously randomized via interactive voice response system, withdrawal of consent, loss to follow-up, or failure to meet screening criteria. The screening process involved a liver biopsy.

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

Participant Flow for 2 periods

Period 1:   Double-blind Period Through Week 48
    TDF 300 mg QD     ADV 10 mg QD  
STARTED     176 [1]   90 [1]
COMPLETED     154 [2]   84 [2]
NOT COMPLETED     22     6  
Lost to Follow-up                 8                 2  
Protocol Violation                 1                 1  
Withdrawal by Subject                 10                 3  
Seroconversion                 2                 0  
Declined extension                 1                 0  
[1] Randomized-and-treated participants
[2] Completed through Week 48 with end-of-double-blind-treatment liver biopsy results

Period 2:   Open-Label TDF Period Through Week 96
    TDF 300 mg QD     ADV 10 mg QD  
STARTED     154 [1]   84 [1]
COMPLETED     145 [2]   83 [2]
NOT COMPLETED     9     1  
Physician Decision                 1                 0  
Lost to Follow-up                 2                 0  
Protocol Violation                 2                 0  
Safety, tolerability, or efficacy reason                 1                 0  
Seroconversion                 1                 0  
Withdrawal by Subject                 2                 1  
[1] Entered the open-label TDF period
[2] Completed through Week 96



  Baseline Characteristics


  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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