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

LONG-TERM EVALUATION OF THE RESULTS OBTAINED WHEN EMPLOYING ENTECAVIR AND LAMIVUDINE IN THE TREATMENT OF CHRONIC HEPATITIS B INFECTION IN PATIENTS WHO WERE ENROLLED IN CLINICAL TRIALS PHASE III OF ENTECAVIR

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-044-03
Enrollment
Unknown
Registered
2003-08-13
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

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

Conditions

None listed

Interventions

Entecavir Type of group
Five years of follow-up for all patients who were randomized and began receiving treatment in one of the Phase III studies of entecavir (AI463022, 023, 026, 027). This group will be treated with entecavir. Group name:Lamivudine Type of group
Five years of follow-up for all patients who were randomized and began receiving treatment in one of the Phase III studies of entecavir (AI463022, 023, 026, 027). This group will be treated with lamivudine.

Sponsors

BRISTOL MYERS SQUIBB COMPANY,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All subjects who participated in the phase III studies of Entecavir AI463022, AI463023, AI463026 and AI463027.

Exclusion criteria

Exclusion criteria: it is not relevant

Design outcomes

Primary

MeasureTime frame
Outcome name:number of weeks Measure:Determine the number of weeks of exposure to anti-HBV therapy, including the treatment received in Phase III. Timepoints:5 years—

Secondary

MeasureTime frame
Outcome name:ALT Measure:The proportion of patients achieving normalization of ALT at the end of the blind treatment, and remaining with normal ALT [<1.25 X ULN] during the follow-up period. Timepoints:5 years—

Countries

Argentina, India, Peru, United Kindgdom

Outcome results

None listed

Source: REPEC (via WHO ICTRP)