Study of Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection
This study is ongoing, but not recruiting participants.
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00388674
First received: October 4, 2006
Last updated: June 18, 2012
Last verified: February 2012
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Purpose
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 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: 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 |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Biospecimen Retention: Samples With DNA
buccal
| Estimated Enrollment: | 12500 |
| Study Start Date: | August 1908 |
| 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
Other Names:
|
| B |
Drug: Other anti-HBV medication
Tablets / Oral Solution, Oral, depends on chosen active comparator, depends on chosen active comparator, Investigator/Patient decision
|
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Chronic hepatitis B patients receiving nucleoside therapy
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00388674
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| United States, California | |
| Scti Research Foundation | |
| Coronado, California, United States, 92118 | |
| Cedars-Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| Kaiser Permanente Medical Center | |
| San Francisco, California, United States, 94118 | |
| United States, Connecticut | |
| University Of Connecticut Health Center | |
| Farmington, Connecticut, United States, 06030 | |
| United States, Florida | |
| University Of Miami Center For Liver Diseases | |
| Miami, Florida, United States, 33136 | |
| Orlando Immunology Center | |
| Orlando, Florida, United States, 32803 | |
| United States, Georgia | |
| Atlanta Gastroenterology Associates | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Illinois | |
| Rush University Med Ctr | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| Indiana University | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Louisiana | |
| Tulane University Health Sciences Center | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, New York | |
| Medical Procare, Pllc | |
| Flushing, New York, United States, 11355 | |
| Office Of Sing Chan Md | |
| Flushing, New York, United States, 11355 | |
| Va New York Harbor Healthcare System | |
| New York, New York, United States, 10010 | |
| Beth Israel Medical Center | |
| New York, New York, United States, 10003 | |
| United States, North Carolina | |
| Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28203 | |
| United States, Oklahoma | |
| Integris Baptist Medical Center | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| United States, Pennsylvania | |
| Thomas Jefferson Medical College | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Phgi Associates, Ltd | |
| Philadelphia, Pennsylvania, United States, 19106 | |
| Upmc Center For Liver Diseases | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Texas | |
| Ut Southwestern Medical Center | |
| Dallas, Texas, United States, 75390 | |
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| Brno, Czech Republic, 625 00 | |
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| Hradec Kralove, Czech Republic, 500 05 | |
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| Ostrava, Czech Republic, 708 52 | |
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| Prague 8, Czech Republic, 180 81 | |
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| Usti Nad Labem, Czech Republic, 400 01 | |
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| Grenoble Cedex 9, France, 38043 | |
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| Ansan-Si, Gyeonggi-Do, Korea, Republic of, 425-707 | |
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| Local Institution | |
| Kayseri, Turkey, 38039 | |
| Local Institution | |
| Trabzon, Turkey, 61080 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Chair: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00388674 History of Changes |
| Other Study ID Numbers: | AI463-080 |
| Study First Received: | October 4, 2006 |
| Last Updated: | June 18, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Bristol-Myers Squibb:
|
Chronic Hepatitis B Virus |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Hepatitis, Chronic Hepatitis B, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections |
Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections Entecavir Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013