Continue Entecavir Rollover From China

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00975091
First received: September 8, 2009
Last updated: January 29, 2010
Last verified: November 2009
  Purpose

The purpose of the study is to determine if treatment with entecavir is safe and well tolerated in patients who completed dosing in a previous entecavir study in China, but are requiring further treatment of their chronic hepatitis B virus infection.


Condition Intervention Phase
Chronic Hepatitis B Virus
Drug: Entecavir
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of the Safety and Antiviral Activity of Open-Label Entecavir (BMS-200475) in Adults With Chronic Hepatitis B Infection Who Have Completed Dosing in a Previous Phase II/III Study in China

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • The number and percentage of subjects with adverse events, laboratory abnormalities, and discontinuations due to adverse events [ Time Frame: Through 3 years of dosing and up to 48 weeks of off treatment follow up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The change in the mean HBV DNA measured by PCR assay from baseline for each entecavir cohort [ Time Frame: Through 3 years of dosing ] [ Designated as safety issue: No ]

Enrollment: 600
Study Start Date: May 2004
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Entecavir 0.5 Drug: Entecavir
Tablets, Oral, 0.5 mg, once daily, Until ETV is commercially available in China or when Post Study Drug Program is started
Other Names:
  • Baraclude
  • BMS-200475
Active Comparator: Entecavir 1.0 Drug: Entecavir
Tablets, Oral, 1.0 mg, once daily, Until ETV is commercially available in China or when Post Study Drug Program is started
Other Names:
  • Baraclude
  • BMS-200475

  Eligibility

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who had completed the required dosing period in a previous ETV Phase 2 or 3 study in China (studies AI463012, AI463023, AI463056), and had been assessed by the Investigators as likely to benefit from additional therapy for treatment of their HBV infection
  • ALT ≤ 15 x upper limit of normal
  • Compensated liver disease

Exclusion Criteria:

  • Coinfection with HIV, HCV, or HDV
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00975091

Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00975091     History of Changes
Other Study ID Numbers: AI463-050
Study First Received: September 8, 2009
Last Updated: January 29, 2010
Health Authority: China: Food and Drug Administration

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 April 23, 2014