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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hepatitis B

Intervention / Treatment
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* Drug: Hepsera
* Drug: Hepsera and lamivudine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mono therapy<br>Hepsera | Drug: Hepsera<br> <br> |
| Active Comparator: Combo therapy<br> | Drug: Hepsera and lamivudine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | 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. |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis B