Trials / Completed
CompletedNCT01519921
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg Positive Chronic Hepatitis B.
An Open Label Phase IV Multicenter Study for Efficacy and Safety of Peginterferon Alfa-2a (40KD) (PEGASYS®) in Patients With HBeAg Positive Chronic Hepatitis B
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 150 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the efficacy and safety of PEGASYS (peginterferon alfa-2a) in patients with HBeAg positive chronic hepatitis B. Patients will be stratified into group A (treatment naïve patients) or B (YMDD mutant patients). All patients will receive PEGASYS 180 micrograms subcutaneously once weekly for 48 weeks, followed by 24 weeks of treatment-free follow up.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | peginterferon alfa-2a [Pegasys] | Peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once a week for 48 weeks |
Timeline
- Start date
- 2005-10-01
- Primary completion
- 2008-06-01
- Completion
- 2008-06-01
- First posted
- 2012-01-27
- Last updated
- 2016-04-21
- Results posted
- 2016-01-25
Locations
7 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01519921. Inclusion in this directory is not an endorsement.