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

NCT00388674 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12522

Last updated 2018-07-30

Study results available
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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.

Conditions

Interventions

DRUG

entecavir

Tablets / Oral Solution, Oral, ETV = 0.5 mg - 1 mg, once daily, Investigator/Patient decision

DRUG

Other anti-HBV medication

Tablets / Oral Solution, Oral, depends on chosen active comparator, depends on chosen active comparator, Investigator/Patient decision

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-18
Primary Completion
2016-10-26
Completion
2016-10-26
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • China
  • Colombia
  • Czechia
  • France
  • Germany
  • Greece
  • India
  • Italy
  • Mexico
  • Philippines
  • Poland
  • Portugal
  • Romania
  • Russia
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00388674 on ClinicalTrials.gov