Efficacy Optimizing Research of Lamivudine Therapy

Study Overview
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Brief Summary
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The purpose of this study is to compare the adefovir early add-on to rescue therapy strategy, and also explore the efficacy of Lamivudine and adefovir de-novo combination therapy.

Official Title
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A Prospective, Randomised, Open-label, Multi-centre Study to Compare Three Chronic Hepatitis B (CHB) Treatment Strategies Over a 2year Period in Chinese HBeAg Positive CHB Patients

Conditions
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Compensated Chronic Hepatitis B

Intervention / Treatment
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* Drug: lamivudine
* Drug: lamivudine
* Drug: lamivudine, adefovir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged 18-65 years; Capable of understanding and signing the informed consent. Willing to comply with the study requirements; Serum HBsAg and HBeAg positive at study screening; Documented chronic hepatitis B infection determined by the presence of serum HBsAg for at least 6 months; Exclusion Criteria: History of decompensated liver function, or current signs/symptoms of decompensation e.g. ascites, variceal bleeding, encephalopathy or spontaneous peritonitis; other protocol defined inclusion/exclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Experimental: early add-on<br> | Drug: lamivudine<br>* patients in this arm will receive oral lamivudine 100mg,daily for 24 weeks; if patients with HBV DNA higher than 1000 copies/ml at week 24, add on adefovir to week 104; otherwise, keep lamivudine monotherapy to week 104<br>|
| Active Comparator: SOC<br>Patients will receive oral lamivudine 100mg,daily for 104 weeks, if HBV DNA breakthrough, add on oral adefovir 10mg daily | Drug: lamivudine<br>* Patients will receive oral lamivudine 100mg,daily for 104 weeks, if HBV DNA breakthrough, add on oral adefovir 10mg daily<br>|
| Other: De-novo combination<br>patients in this arm will receive oral lamivudine 100mg and adefovir 10mg for 104 weeks | Drug: lamivudine, adefovir<br>* patients in this arm will receive oral lamivudine 100mg daily and adefovir 10mg for 104 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the proportion of virological breakthrough with confirmed Lamivudine resistant mutants |  | during 104 weeks study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of subjects with hepatitis B virus (HBV) DNA≤300 copies/mL |  | week 104 | 
| Reduction of serum HBV DNA level from baseline (log10 copies/mL) to week 104 |  | baseline, week 104 | 
| The proportion of subjects with ALT normalization at week 104 |  | week 104 | 
| The proportion of subjects with HBeAg loss and seroconversion at week 104 |  | week 104 | 
| The proportion of subjects with HBsAg loss and seroconversion rates at week 104 |  | week 104 | 

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