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

Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00230477
• Other study ID #: 03-5944-A03
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: November 14, 2007
• Start date: April 2003
• Est. completion date: August 2007

Study information

• Verified date: November 2007
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Hepsera

• Hepsera and lamivudine

Locations

Country	Name	City	State
United States	Harborview Medical Center	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	Gilead Sciences, GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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