Entecavir for Subjects With Chronic Hepatitis B Infection: An Early Access Program

Hepatitis B Clinical Trial

Official title:

A Treatment Use Protocol of Entecavir in Subjects With Chronic Hepatitis B Infection Who Have Failed or Who Are Intolerant of Available Therapies

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT00096811
• Other study ID #: AI463-900
• Status: No longer available
• Phase: N/A
• First received: November 15, 2004
• Last updated: September 20, 2016
• Start date: September 2003
• Est. completion date: August 2008

Study information

• Verified date: September 2016
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Expanded Access

Clinical Trial Summary

The purpose of this clinical research study is to provide entecavir to subjects with chronic Hepatitis B infection who have failed or who have demonstrated intolerance of marketed therapies or for those in whom use of these agents is contraindicated and that have no other available treatment options.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Hepatitis B Early Access Program

Study Design

N/A

Related Conditions & MeSH terms

• Chronic Disease
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Entecavir
Tablets, Oral, 1 mg once daily. Until subject achieves a complete response or until ETV approved and marketed in a given country.

Locations

Country	Name	City	State
Israel	Local Institution	Jerusalem
Israel	Local Institution	Nazareth
Israel	Local Institution	Petach Tikva
Israel	Local Institution	Tel Aviv
Israel	Local Institution	Zefat

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Israel, 

External Links

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