At a glance
ClinicalIndex Comparison Record- ✓Confirmed chronic HBV infection
- ✓Age 16 and older (or minimum age required in given country)
- ✓Appropriate candidate for initiating or modifying HBV therapy with nucleoside/nucleotide monotherapy (entecavir or other standard-of-care agent)
- ✓Treatment-naive or treatment-experienced with nucleoside/nucleotide antivirals
- ✕Pregnant or breastfeeding women
- ✕HIV coinfection
- ✕History of malignancy, including hepatocellular carcinoma (HCC) and carcinoma in situ (CIS), excluding non-melanoma skin cancers
- ✕History of dysplastic liver nodules
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Observational Study of Entecavir to Assess Long-term Outcomes Associated With Nucleoside/Nucleotide Monotherapy for Patients With Chronic HBV Infection: The REALM Study
In Brief
An observational study evaluating entecavir and Other anti-HBV medication for Chronic Hepatitis B. Completed, enrolled 12,522 participants across 290 sites in 24 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
Tablets / Oral Solution, Oral, ETV = 0.5 mg - 1 mg, once daily, Investigator/Patient decision
Tablets / Oral Solution, Oral, depends on chosen active comparator, depends on chosen active comparator, Investigator/Patient decision