search
Back to results

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

Primary Purpose

Hepatitis B

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Hepsera
Hepsera and lamivudine
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B focused on measuring Hepatitis B

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Harborview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Mono therapy

Combo therapy

Arm Description

Hepsera

Outcomes

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.

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.

Full Information

First Posted
September 12, 2005
Last Updated
November 14, 2007
Sponsor
University of Washington
Collaborators
Gilead Sciences, GlaxoSmithKline
search

1. Study Identification

Unique Protocol Identification Number
NCT00230477
Brief Title
Hepsera Versus Hepsera Plus Lamivudine for Treatment of Chronic Hepatitis B in Patients With Normal ALT
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 Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Washington
Collaborators
Gilead Sciences, GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
Keywords
Hepatitis B

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mono therapy
Arm Type
Active Comparator
Arm Description
Hepsera
Arm Title
Combo therapy
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Hepsera
Intervention Type
Drug
Intervention Name(s)
Hepsera and lamivudine
Primary Outcome Measure Information:
Title
Subjects treated with combination therapy will have a decrease in the viral DNA that is greater than the subjects treated with monotherapy.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Subjects treated with combination therapy will have an improved HBeAg conversion rate compared to historical controls treated with either lamivudine or adefovir dipivoxil monotherapy.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John D Scott, MD, MS
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs