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NCT00435825 · ClinicalTrials.gov registry record · Phase 4
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Hepatitis Be Antigen (HBeAg) Positive Chronic Hepatitis B (CHB).
A Phase 4 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 4
- Development phase
- 551
- Enrollment target
NCT00435825 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 551 participants.
The verdict
NCT00435825, a Phase 4 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 551 participants
- Enrollment target
Study Summary
This 4 arm study will compare the efficacy and safety of PEGASYS given for 24 or 48 weeks, and at doses of 90 or 180 micrograms weekly, in the treatment of HBeAg positive patients with chronic hepatitis B. Patients will be randomized to one of 4 treatment groups: a)PEGASYS 90 micrograms subcutaneous (sc) weekly for 24 weeks, b)PEGASYS 180 micrograms sc weekly for 24 weeks, c)PEGASYS 90 micrograms sc weekly for 48 weeks or d)PEGASYS 180 micrograms sc weekly for 48 weeks. Following treatment there will be a 24 week period of treatment-free follow-up in all treatment groups for the primary endpoint. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Interventions
- DRUG peginterferon alfa-2a [Pegasys]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 551 participants |
| Start Date | 2007-03 |
| Est. Completion | 2010-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00435825
The ClinicalTrials.gov registry entry for NCT00435825 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 551 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which peginterferon alfa-2a [Pegasys] is the first listed.
NCT00435825 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00435825 about?
NCT00435825 is a clinical study titled "A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Hepatitis Be Antigen (HBeAg) Positive Chronic Hepatitis B (CHB).". This 4 arm study will compare the efficacy and safety of PEGASYS given for 24 or 48 weeks, and at doses of 90 or 180 micrograms weekly, in the treatment of HBeAg positive patients with chronic hepatitis B. Patients will be randomized to one of 4 treatment groups: a)PEGASYS 90 micrograms subcutaneous...
What is the current status of trial NCT00435825?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 551 participants. The study started on 2007-03. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00435825?
The interventions under investigation include: peginterferon alfa-2a [Pegasys] (DRUG).
Who is sponsoring clinical trial NCT00435825?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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