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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00388674
Recruitment Status : Completed
First Posted : October 17, 2006
Results First Posted : July 30, 2018
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Chronic Hepatitis B Drug: entecavir Drug: Other anti-HBV medication

Study Design
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Study Type : Observational
Actual Enrollment : 12522 participants
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
Actual Study Start Date : December 18, 2006
Actual Primary Completion Date : October 26, 2016
Actual Study Completion Date : October 26, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Entecavir

Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Adjudicated Overall Malignant Neoplasms [ Time Frame: 10 years ]
    The number of participants with Overall Malignant Neoplasm, as adjudicated by Events Adjudication Committee (EAC)

  2. Number of Deaths [ Time Frame: 10 years ]
    The number of deaths, as adjudicated by Events Adjudication Committee (EAC)

  3. Number of Participants With Liver-related HBV Disease Progression [ Time Frame: 10 years ]
    The number of participants with Liver-related HBV disease progression, as adjudicated by Events Adjudication Committee (EAC)


Secondary Outcome Measures :
  1. Number of Participants With Non-HCC Malignant Neoplasm [ Time Frame: 10 years ]
    The number of participants with non-HCC malignant neoplasm, as adjudicated by Events Adjudication Committee (EAC)

  2. Number of Participants With HCC Malignant Neoplasm [ Time Frame: 10 years ]
    The number of participants with HCC malignant neoplasm, as adjudicated by Events Adjudication Committee (EAC)

  3. Number of Participants With Liver-related Death [ Time Frame: 10 years ]
    The number of participants with Liver-related death, as adjudicated by Events Adjudication Committee (EAC)


Biospecimen Retention:   Samples With DNA
buccal

Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00388674


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00388674    
Other Study ID Numbers: AI463-080
First Posted: October 17, 2006    Key Record Dates
Results First Posted: July 30, 2018
Last Update Posted: July 30, 2018
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
Chronic Hepatitis B Virus
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections
Entecavir
Antiviral Agents
Anti-Infective Agents