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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Bristol-Myers Squibb Identifier:
First received: October 4, 2006
Last updated: November 6, 2014
Last verified: November 2014

October 4, 2006
November 6, 2014
December 2006
December 2016   (final data collection date for primary outcome measure)
  • 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 ]
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Complete list of historical versions of study NCT00388674 on Archive Site
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Study of Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection
Randomized, Observational Study of Entecavir to Assess Long-term Outcomes Associated With Nucleoside/Nucleotide Monotherapy for Patients With Chronic HBV Infection: The REALM Study

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.

Not Provided
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA


Non-Probability Sample

Chronic hepatitis B patients receiving nucleoside therapy

Chronic Hepatitis B
  • Drug: entecavir
    Tablets / Oral Solution, Oral, ETV = 0.5 mg - 1 mg, once daily, Investigator/Patient decision
    Other Names:
    • Baraclude
    • BMS-200475
  • Drug: Other anti-HBV medication
    Tablets / Oral Solution, Oral, depends on chosen active comparator, depends on chosen active comparator, Investigator/Patient decision
  • A
    Intervention: Drug: entecavir
  • B
    Intervention: Drug: Other anti-HBV medication
Hou JL, Jia JD, Wei L, Zhao W, Wang YM, Cheng M, Tang X, Tan DM, Ren H, Tang H, Cohen D, Llamoso C. Efficacy and safety of entecavir treatment in a heterogeneous CHB population from a ‘real-world’ clinical practice setting in China. J Viral Hepat. 2013 Nov;20(11):811-20.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
December 2016
December 2016   (final data collection date for primary outcome measure)

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
16 Years and older
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Brazil,   Canada,   China,   Colombia,   Czech Republic,   France,   Germany,   Greece,   India,   Italy,   Korea, Republic of,   Mexico,   Philippines,   Poland,   Portugal,   Romania,   Russian Federation,   Singapore,   Spain,   Taiwan,   Thailand,   Turkey
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Chair: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP