Lamivudine and Adefovir to Treat Chronic Hepatitis B

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marc Ghany, M.D., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00023309
First received: September 3, 2001
Last updated: July 18, 2014
Last verified: July 2014
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
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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
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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.
No text entered.

Reporting Groups
  Description
Lamivudine and Adefovir Patients to receive combination lamivudine and adefovir
Adefovir Patients to receive adefovir alone
Total Total of all reporting groups

Baseline Measures
    Lamivudine and Adefovir     Adefovir     Total  
Number of Participants  
[units: participants]
  22     19     41  
Age  
[units: years]
Mean ± Standard Deviation
  46  ± 14     45  ± 13     45  ± 14  
Gender  
[units: participants]
     
Female     6     1     7  
Male     16     18     34  
Race/Ethnicity, Customized  
[units: participants]
     
White     9     8     17  
Asian     9     10     19  
Black     4     1     5  
Region of Enrollment  
[units: participants]
     
United States     22     19     41  
Treatment Naive  
[units: participants]
     
Yes     17     14     31  
No     5     5     10  
HBeAg positive  
[units: participants]
     
Yes     17     14     31  
No     5     5     10  
ALT [1]
[units: IU/ml]
Mean ± Standard Deviation
  183  ± 250     87  ± 56     139  ± 187  
HBV DNA Log 10 copies per ml [2]
[units: log10(copies/ml)]
Mean ± Standard Deviation
  8.1  ± 1.3     7.8  ± 1.6     8.0  ± 1.4  
HAI [3]
[units: Units on a scale]
Mean ± Standard Deviation
  8.1  ± 2.7     7.9  ± 2.4     8.0  ± 2.6  
Ishak [4]
[units: Units on a scale]
Mean ± Standard Deviation
  3.3  ± 1.7     2.4  ± 1.5     2.9  ± 1.6  
Cirrhosis  
[units: participants]
     
Yes     5     2     7  
No     17     17     34  
[1] Alanine transaminase
[2] Hepatitis B virus DNA logarithm 10 copies per ml
[3] HAI Fibrosis score for liver histology, which has a range 0–18 and higher values represent a worse outcome
[4] Ishak Fibrosis Score, (range 0–6, where 0 = no fibrosis and 6 = cirrhosis)



  Outcome Measures
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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
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Lamivudine and Adefovir Patients to receive combination lamivudine and adefovir
Adefovir Patients to receive adefovir alone

Other Adverse Events
    Lamivudine and Adefovir     Adefovir  
Total, other (not including serious) adverse events      
# participants affected / at risk     0/22     0/19  



  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