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

Sponsor

University of Washington (Other)

Overall Status

Completed

CT.gov ID

NCT00230477

Collaborator

Gilead Sciences (Industry), GlaxoSmithKline (Industry)

Enrollment

Location

Arms

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B	Drug: Hepsera Drug: Hepsera and lamivudine	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy of Adefovir Dipivoxil Versus Adefovir Dipivoxil Plus Lamivudine for the Treatment of Chronic Hepatitis B in Patients With Normal Baseline ALT

Study Start Date :

Apr 1, 2003

Actual Study Completion Date :

Aug 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Mono therapy Hepsera	Drug: Hepsera
Active Comparator: Combo therapy	Drug: Hepsera and lamivudine

Arm

Intervention/Treatment

Active Comparator: Mono therapy

Hepsera

Drug: Hepsera

Active Comparator: Combo therapy

Drug: Hepsera and lamivudine

Outcome Measures

Primary Outcome Measures

Subjects treated with combination therapy will have a decrease in the viral DNA that is greater than the subjects treated with monotherapy. [one year]

Secondary Outcome Measures

Subjects treated with combination therapy will have an improved HBeAg conversion rate compared to historical controls treated with either lamivudine or adefovir dipivoxil monotherapy. [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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