Continue Entecavir Rollover From China

Chronic Hepatitis B Virus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00975091
• Other study ID #: AI463-050
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2009
• Last updated: January 29, 2010
• Start date: May 2004
• Est. completion date: August 2007

Study information

• Verified date: November 2009
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis B Virus
• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Entecavir
Tablets, Oral, 0.5 mg, once daily, Until ETV is commercially available in China or when Post Study Drug Program is started
• Entecavir
Tablets, Oral, 1.0 mg, once daily, Until ETV is commercially available in China or when Post Study Drug Program is started

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number and percentage of subjects with adverse events, laboratory abnormalities, and discontinuations due to adverse events		Through 3 years of dosing and up to 48 weeks of off treatment follow up	Yes
Secondary	The change in the mean HBV DNA measured by PCR assay from baseline for each entecavir cohort		Through 3 years of dosing	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm