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

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

Status

NO_LONGER_AVAILABLE

Phases

Unknown

Study type

Expanded Access

Source

ClinicalTrials.gov

Registry ID

NCT00096811

Enrollment

Unknown

Registered

2004-11-16

Start date

2003-09-30

Completion date

2008-08-31

Last updated

2016-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Disease, Hepatitis B

Brief 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.

Interventions

DRUGEntecavir

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

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

* Hepatitis B Early Access Program

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026