A Follow-Up Study to WV19432, to Evaluate Long Term Post-Treatment Effects of PEGASYS (Peginterferon Alfa-2a(40KD))in Patients With HBeAg Positive Chronic Hepatitis B

Roche

Status and phase

Completed

Phase 4

Conditions

Hepatitis B, Chronic

Treatments

Drug: peginterferon alfa-2a [Pegasys]

Study type

Interventional

Funder types

Industry

Identifiers

NCT00927082

MV22430

Details and patient eligibility

About

This study is a long-term post-treatment follow-up to study WV19432, which evaluated the efficacy and safety of PEGASYS in patients with HBeAg positive chronic hepatitis B (CHB).Patients who received treatment with PEGASYS, and completed follow-up, are eligible to enter this post-treatment follow-up study. The anticipated time on study was 5 years, and the target sample size is 100-500 individuals.

Enrollment

383 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Informed consent for Study WV19432
Patients who have completed treatment and follow-up on study WV19432

Exclusion criteria

As for Study WV19432

Trial design

383 participants in 4 patient groups

PEG-IFN 90mcg 24 Wks

Experimental group

Description:

Participants received Pegasys (Pegylated interferon alfa-2a \[PEG-IFN\]) 90 micrograms (mcg) subcutaneously (SC) once a week for 24 weeks in Study WV19432 and entered follow-up (FU) Study MV22430.

Treatment:

Drug: peginterferon alfa-2a [Pegasys]

PEG-IFN 180mcg 24 Wks

Experimental group

Description:

Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.

Treatment:

Drug: peginterferon alfa-2a [Pegasys]

PEG-IFN 90mcg 48 Wks

Experimental group

Description:

Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.