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. Identifier: NCT00388674
Recruitment Status : Completed
First Posted : October 17, 2006
Last Update Posted : August 14, 2017
Information provided by (Responsible Party):
Bristol-Myers Squibb

October 4, 2006
October 17, 2006
August 14, 2017
December 18, 2006
October 26, 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 ]
  • Rate of liver-related events of HBV disease progression (including HCC and liver-related deaths) [ Time Frame: Up to 10 years ]
  • Rate of mortality (all cause, liver-related) [ Time Frame: Up to 10 years ]
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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.
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Observational Model: Cohort
Time Perspective: Prospective
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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.
October 26, 2016
October 26, 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
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Argentina,   Brazil,   Canada,   China,   Colombia,   Czechia,   France,   Germany,   Greece,   India,   Italy,   Korea, Republic of,   Mexico,   Philippines,   Poland,   Portugal,   Romania,   Russian Federation,   Singapore,   Spain,   Taiwan,   Thailand,   Turkey,   United States
Czech Republic
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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Bristol-Myers Squibb
Bristol-Myers Squibb
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Study Chair: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
August 2017