- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00230477
Hepsera Versus Hepsera Plus Lamivudine for Treatment of Chronic Hepatitis B in Patients With Normal ALT
Efficacy of Adefovir Dipivoxil Versus Adefovir Dipivoxil Plus Lamivudine for the Treatment of Chronic Hepatitis B in Patients With Normal Baseline ALT
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98104
- Harborview Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Mono therapy
Hepsera
|
|
Active Comparator: Combo therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
one year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John D Scott, MD, MS, University of Washington
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis B, Chronic
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Lamivudine
- Adefovir
- Adefovir dipivoxil
Other Study ID Numbers
- 03-5944-A03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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