Lamivudine and Adefovir to Treat Chronic Hepatitis B

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00023309
Recruitment Status : Completed
First Posted : September 3, 2001
Results First Posted : April 4, 2013
Last Update Posted : September 23, 2016
Information provided by (Responsible Party):
Marc Ghany, M.D., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: HBV (Hepatitis B Virus)
Hepatitis B
Interventions: Drug: Lamivudine and adefovir
Drug: Adefovir alone

  Participant Flow

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

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

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