This trial is active, not recruiting.

Condition chronic hepatitis b
Treatments entecavir, other anti-hbv medication
Sponsor Bristol-Myers Squibb
Start date December 2006
End date December 2016
Trial size 12500 participants
Trial identifier NCT00388674, AI463-080


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
entecavir Baraclude
Tablets / Oral Solution, Oral, ETV = 0.5 mg - 1 mg, once daily, Investigator/Patient decision
other anti-hbv medication
Tablets / Oral Solution, Oral, depends on chosen active comparator, depends on chosen active comparator, Investigator/Patient decision

Primary Outcomes

Rate of malignant neoplasms (overall and non-HCC, in each case including CIS but excluding non-melanoma skin cancer, and HCC)
time frame: Up to 10 years
Rate of liver-related events of HBV disease progression (including HCC and liver-related deaths)
time frame: Up to 10 years
Rate of mortality (all cause, liver-related)
time frame: Up to 10 years

Eligibility Criteria

Male or female participants at least 16 years old.

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

Additional Information

Official title Randomized, Observational Study of Entecavir to Assess Long-term Outcomes Associated With Nucleoside/Nucleotide Monotherapy for Patients With Chronic HBV Infection: The REALM Study
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.