Lamivudine and Adefovir to Treat Chronic Hepatitis B

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Marc Ghany, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00023309
First received: September 3, 2001
Last updated: February 21, 2013
Last verified: February 2013
Results First Received: July 7, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: HBV (Hepatitis B Virus)
Hepatitis B
Hepatitis
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
No text entered.

Reporting Groups
  Description
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  
NOT COMPLETED     0     0  



  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


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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.  


Results Point of Contact:  
Name/Title: Marc G. Ghany, M.D
Organization: National Institute of Diabetes and Digestive and Kidney Diseases, NIH
phone: 3014961721
e-mail: marcg@mail.nih.gov


Publications:

Responsible Party: Marc Ghany, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00023309     History of Changes
Other Study ID Numbers: 010246, 01-DK-0246
Study First Received: September 3, 2001
Results First Received: July 7, 2011
Last Updated: February 21, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration