Status:
COMPLETED
Hepsera Versus Hepsera Plus Lamivudine for Treatment of Chronic Hepatitis B in Patients With Normal ALT
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Gilead Sciences
GlaxoSmithKline
Conditions:
Hepatitis B
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
This project is a randomized, open-label trial of adefovir dipivoxil (Hepsera) and lamivudine combination therapy versus adefovir dipivoxil (Hepsera) monotherapy. Both adefovir dipivoxil and lamivudin...
Eligibility Criteria
Inclusion
- older than 18 years
- HBsAg+ at screening and for at least 6 months prior to study entry
- HBeAg+
- HBV DNA greater than 6 log10 copies/mL
- Platelet count greater than 50,000 platelets/mm3
- Hemoglobin greater than 7.5 g/dL
- ALT less than ULN
- Estimated creatine clearance\>50 mL/min as estimated by the Crockcroft-Gault equation ((140-age) x (kg)/(serum creatine x 72) (for women x 0.85))
- Female and male participants must be practicing an effective form of contraception (male or female condom with spermicide, diaphragm or cervical cap with spermicide, intrauterine device, hormonal contraception)
- Serum alpha-fetoprotein less than 50 ng/mL within 30 days of study entry
- Childs-Pugh score less than 7 and no ascites, variceal bleeding, or hepatic encephalopathy
- able to give written informed consent and to comply with the study protocol
Exclusion
- history or evidence of HIV, hepatitis C or hepatitis D
- known or suspected hypersensitivity to adefovir or other nucleoside/nucleotide analogs.
- history of clinically significant renal dysfunction
- any active medical or psychiatric illness that, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance with the protocol
- pregnancy or breastfeeding
- receipt of systemic corticosteroids within 90 days of study entry
- receipt of nephrotoxic drugs within 8 weeks prior to study screening or expected use of these agents during the course of the study
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00230477
Start Date
April 1 2003
End Date
August 1 2007
Last Update
November 15 2007
Active Locations (1)
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1
Harborview Medical Center
Seattle, Washington, United States, 98104