NCT00927082

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

A Follow-up Study to Evaluate the Long-term Post Treatment Effects of Peginterferon Alfa-2a (PEG-IFN) in Patients With HBeAg Positive Chronic Hepatitis B From the Original Study WV19432(NEPTUNE).

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 383 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
DRUG	peginterferon alfa-2a [Pegasys]	90 or 180 micrograms/week sc for 24 or 48 weeks in original study (WV19432). No study treatment in long-term post-treatment follow-up study (MV22430)

Timeline

• Start date: 2009-04-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2009-06-24
• Last updated: 2016-03-09
• Results posted: 2016-03-09

Locations

31 sites across 10 countries: Australia, Brazil, China, Hong Kong, New Zealand, Russia, Singapore, South Korea, Taiwan, Thailand