Hepsera Versus Hepsera Plus Lamivudine for Treatment of Chronic Hepatitis B in Patients With Normal ALT

University of Washington

Status and phase

Completed

Phase 4

Conditions

Hepatitis B

Treatments

Drug: Hepsera and lamivudine

Drug: Hepsera

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00230477

03-5944-A03

Details and patient eligibility

About

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 lamivudine are nucleoside analogues approved by the U.S. FDA for the treatment of chronic hepatitis B.

The primary hypothesis is that subjects treated with combination therapy will see their viral DNA count decrease in an amount greater than subjects treated with monotherapy. The secondary hypothesis is that subjects treated with combination therapy will have a higher HBeAg conversion rate compared to historical controls of subjects treated with lamivudine or adefovir dipivoxil monotherapy.

Enrollment

19 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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