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Sponsored by: |
Bristol-Myers Squibb |
Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00388674 |
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.
Condition | Intervention |
Chronic Hepatitis B |
Drug: entecavir Drug: Other anti-HBV medication |
MedlinePlus related topics: | Hepatitis Hepatitis B |
ChemIDplus related topics: | Hepatitis B Vaccines Entecavir |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
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 |
buccal
Estimated Enrollment: | 12500 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | December 2016 |
Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
A |
Drug: entecavir
Tablets / Oral Solution, Oral, ETV = 0.5 mg - 1 mg, once daily, Investigator/Patient decision
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B |
Drug: Other anti-HBV medication
Tablets / Oral Solution, Oral, depends on chosen active comparator, depends on chosen active comparator, Investigator/Patient decision
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Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Chronic hepatitis B patients receiving nucleoside therapy
Inclusion Criteria:
Exclusion Criteria:
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:
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: | Clinical.Trials@bms.com | |
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time. |
Show 324 Study Locations |
Bristol-Myers Squibb |
Study Chair: | Bristol-Myers Squibb | Bristol-Myers Squibb |
BMS Clinical Trials Disclosure 
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For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm 
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Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | AI463-080 |
First Received: | October 4, 2006 |
Last Updated: | September 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00388674 |
Health Authority: | United States: Food and Drug Administration |
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