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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: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT00962871 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An acute virologic response was determined by change from baseline in viral antigen/antibody laboratory data.
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 |
What the finished NCT00962871 record still lists
NCT00962871 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which tenofovir is the first listed.
NCT00962871 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00962871's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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