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


  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
  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