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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00388674
First received: October 4, 2006
Last updated: July 23, 2014
Last verified: July 2014
  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:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Rate of liver-related events of HBV disease progression (including HCC and liver-related deaths) [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Rate of mortality (all cause, liver-related) [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

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
Other Names:
  • Baraclude
  • BMS-200475
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388674

  Show 289 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Chair: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: July 23, 2014
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 July 23, 2014