A Phase IIIb: Long-Term Outcomes for Hepatitis B (HepB) Patients in Some Previous Entecavir (ETV) Trials

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Hepatitis B

Study type: Observational

Funder types: Industry

Identifiers

NCT01337479

AI463-049

Details and patient eligibility

About

The purpose of this study is to follow patients treated in entecavir Phase III and rollover studies for safety experience and Hepatitis B virus (HBV)-related complications.

Full description

Observational Model: Only subjects who participated in Entecavir Phase III studies AI463022, AI463023, AI463026, and AI463027.

Number of groups/cohorts: 1 (All subjects were observed in the same manner).

Enrollment: 1,097 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• All subjects who participated in Entecavir Phase III studies AI463022, AI463023, AI463026, and AI463027.

Trial design

1,097 participants in 1 patient group

Participants of specific phase III entecavir studies

Description:

Those who participated in the specific Phase III entecavir studies as described; all had Hepatitis B infections