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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.

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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

FieldValue
Enrollment Target 30 participants
Start Date 2009-08
Est. Completion 2012-02
Phase Phase 1

Sponsor

Hoffmann-La Roche

909 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.