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Lamivudine and Adefovir to Treat Chronic Hepatitis B

This study has been completed.
Information provided by (Responsible Party):
Marc Ghany, M.D., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Identifier:
First received: September 3, 2001
Last updated: September 22, 2016
Last verified: July 2014
Results First Received: July 7, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: HBV (Hepatitis B Virus)
Hepatitis B
Interventions: Drug: Lamivudine and adefovir
Drug: Adefovir alone

  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
Forty-one patients were enrolled, twenty-two were randomized to receive the combination lamivudine and adefovir and nineteen to receive adefovir alone.

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
Lamivudine and Adefovir Patients to receive combination lamivudine and adefovir, with lamivudine of 100 mg daily and adefovir of 10 mg daily
Adefovir Patients to receive adefovir alone (10 mg daily).

Participant Flow:   Overall Study
    Lamivudine and Adefovir   Adefovir
STARTED   22   19 
COMPLETED   22   19 

  Baseline Characteristics

  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maintained Combined Response (Virological, Biochemical and Histological Response).   [ Time Frame: 196 weeks from randomization ]

2.  Secondary:   HBeAg Loss at Week 196   [ Time Frame: Week 196 from randomization ]

3.  Secondary:   Virological Response   [ Time Frame: Week 196 from randomization ]

4.  Secondary:   Biological Response   [ Time Frame: week 196 from randomization ]

5.  Secondary:   Histological Response   [ Time Frame: week 196 from randomization ]

  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