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Continue Entecavir Rollover From China

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ClinicalTrials.gov Identifier: NCT00975091
Recruitment Status : Completed
First Posted : September 11, 2009
Last Update Posted : February 2, 2010
Sponsor:
Information provided by:
Bristol-Myers Squibb

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Hepatitis B Virus Drug: Entecavir Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2004
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Entecavir
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. The change in the mean HBV DNA measured by PCR assay from baseline for each entecavir cohort [ Time Frame: Through 3 years of dosing ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT00975091


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

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00975091     History of Changes
Other Study ID Numbers: AI463-050
First Posted: September 11, 2009    Key Record Dates
Last Update Posted: February 2, 2010
Last Verified: November 2009

Additional relevant MeSH terms:
Hepatitis
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Entecavir
Antiviral Agents
Anti-Infective Agents