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

Information source: University of Washington
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis B

Intervention: Hepsera (Drug); Hepsera and lamivudine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Washington

Official(s) and/or principal investigator(s):
John D Scott, MD, MS, Principal Investigator, Affiliation: University of Washington

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.

Clinical Details

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 design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study

Primary outcome: Subjects treated with combination therapy will have a decrease in the viral DNA that is greater than the subjects treated with monotherapy.

Secondary outcome: Subjects treated with combination therapy will have an improved HBeAg conversion rate compared to historical controls treated with either lamivudine or adefovir dipivoxil monotherapy.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Harborview Medical Center, Seattle, Washington 98104, United States
Additional Information

Starting date: April 2003
Ending date: August 2007
Last updated: November 14, 2007

Page last updated: June 20, 2008

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