Study of Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection

Study Overview
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Brief Summary
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The purpose of this study is to prospectively assess the long-term outcomes (benefits and risks) associated with entecavir (ETV) therapy as compared to other antivirals approved for the treatment of chronic HBV infection. For the China substudy, patients randomized to entecavir will have safety and efficacy assessments performed during the first year of the study.

Official Title
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Randomized, Observational Study of Entecavir to Assess Long-term Outcomes Associated With Nucleoside/Nucleotide Monotherapy for Patients With Chronic HBV Infection: The REALM Study

Conditions
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Chronic Hepatitis B

Intervention / Treatment
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* Drug: entecavir
* Drug: Other anti-HBV medication


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic HBV infection HBV nucleoside/tide-naive or -experienced Patients who, in opinion of investigator, are appropriate for initiating or modifying their HBV therapy and who are appropriate for a treatment regimen comprised of nucleoside/tide monotherapy with either ETV or another standard of care HBV nucleoside/tide analogue Age 16 and older or minimum age required in a given country Exclusion Criteria: Women who are pregnant or breastfeeding Patients who, in the opinion of the investigator, are expected to have a liver transplant-free survival of less than one year Patients who, in the opinion of the investigator, are virologically controlled on their current treatment regimen and clinically responding to treatment, unless the regimen needs to be modified for medication intolerance Coinfection with HIV History of malignant neoplasm(s), including hepatocellular carcinoma (HCC) and carcinoma in situ (CIS), but excluding non-melanoma skin cancers Patients with chronic renal insufficiency, defined as a creatinine clearance < 50 ml/min who do not have either of the following means of dose reducing ETV: i. an approved country-specific ETV label which includes the extended interval ETV dose modification method and/or ii. an approved country specific label for the ETV oral solution AND access to the oral solution History of dysplastic liver nodules Known history of allergy to nucleoside/tide analogues Prior or current treatment with entecavir An investigator proposed study regimen which will include only interferon-alfa An investigator proposed study regimen of combination (two or more) HBV nucleoside/tide analogues

Ages Eligible for Study
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Minimum Age: 16 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br> | Drug: entecavir<br>* Tablets / Oral Solution, Oral, ETV = 0.5 mg - 1 mg, once daily, Investigator/Patient decision<br>* Other names: BMS-200475;|
| B<br> | Drug: Other anti-HBV medication<br>* Tablets / Oral Solution, Oral, depends on chosen active comparator, depends on chosen active comparator, Investigator/Patient decision<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adjudicated Overall Malignant Neoplasms | The number of participants with Overall Malignant Neoplasm, as adjudicated by Events Adjudication Committee (EAC) | 10 years | 
| Number of Deaths | The number of deaths, as adjudicated by Events Adjudication Committee (EAC) | 10 years | 
| Number of Participants With Liver-related HBV Disease Progression | The number of participants with Liver-related HBV disease progression, as adjudicated by Events Adjudication Committee (EAC) | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Non-HCC Malignant Neoplasm | The number of participants with non-HCC malignant neoplasm, as adjudicated by Events Adjudication Committee (EAC) | 10 years | 
| Number of Participants With HCC Malignant Neoplasm | The number of participants with HCC malignant neoplasm, as adjudicated by Events Adjudication Committee (EAC) | 10 years | 
| Number of Participants With Liver-related Death | The number of participants with Liver-related death, as adjudicated by Events Adjudication Committee (EAC) | 10 years | 

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