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NCT00962871 · ClinicalTrials.gov registry record · Phase 1
A Study of Early Immunologic Response in Asian Patients With Chronic Hepatitis B, Treated With Pegasys (Peginterferon Alfa-2a (40KD)), Nucleoside Analogues, or Both
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT00962871 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 30 participants.
The verdict
NCT00962871, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This open-label, randomized, parallel-arm study will assess the early immunologic response in treatment-naïve Asian male patients with chronic hepatitis B after initiation of treatment with Pegasys or tenofovir or Pegasys plus tenofovir. Patients will be randomized to one of 4 cohorts to receive either Pegasys (360mcg subcutaneously weekly) or tenofovir (300mg orally daily) or both or no treatment for 2 weeks. After 2 weeks on study treatment, patients may opt to receive standard of care treatment with Pegasys. Target sample size is \<50.
Interventions
- DRUG tenofovir
- DRUG peginterferon alfa-2a [Pegasys]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2009-08 |
| Est. Completion | 2012-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00962871
The ClinicalTrials.gov registry entry for NCT00962871 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 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 2 interventions - of which tenofovir is the first listed.
NCT00962871 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00962871 about?
NCT00962871 is a clinical study titled "A Study of Early Immunologic Response in Asian Patients With Chronic Hepatitis B, Treated With Pegasys (Peginterferon Alfa-2a (40KD)), Nucleoside Analogues, or Both". This open-label, randomized, parallel-arm study will assess the early immunologic response in treatment-naïve Asian male patients with chronic hepatitis B after initiation of treatment with Pegasys or tenofovir or Pegasys plus tenofovir. Patients will be randomized to one of 4 cohorts to receive eit...
What is the current status of trial NCT00962871?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2009-08. Estimated completion is 2012-02.
What interventions are being tested in trial NCT00962871?
The interventions under investigation include: tenofovir (DRUG), peginterferon alfa-2a [Pegasys] (DRUG).
Who is sponsoring clinical trial NCT00962871?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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