Trials / Terminated
TerminatedNCT00460850
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Lamivudine Resistant HBeAg-Negative Chronic Hepatitis B.
An Open Label Study to Evaluate the Effect of PEGASYS on ALT and HBV DNA Levels in Patients With Lamivudine-Resistant HbeAg-Negative Chronic Hepatitis B
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This single arm study will evaluate the efficacy and safety of PEGASYS in patients with lamivudine resistant HBeAg negative chronic hepatitis B. Patients will receive PEGASYS 180 micrograms s.c. weekly for 48 weeks; following this, there will be a 48 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | peginterferon alfa-2a (40KD) [PEGASYS] | 180 micrograms sc weekly for 48 weeks |
Timeline
- Start date
- 2007-09-01
- Completion
- 2008-06-01
- First posted
- 2007-04-17
- Last updated
- 2008-06-30
Locations
4 sites across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT00460850. Inclusion in this directory is not an endorsement.