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NCT01750697 · ClinicalTrials.gov registry record · Phase 2

A Phase IIa Study of Intravenous Rituximab in Pediatric Participants With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis

A Phase 2 study, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 2
Development phase
25
Enrollment target

NCT01750697 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 25 participants.

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The verdict

NCT01750697, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 2
Development phase
25 participants
Enrollment target

Study Summary

This Phase IIa international multicenter, open-label, uncontrolled study will evaluate the safety and pharmacokinetics of rituximab (MabThera/Rituxan) in pediatric participants with severe granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA). Participants will receive rituximab 375 milligrams per square meter (mg/m\^2) intravenously (IV) on Days 1, 8, 15 and 22.

Interventions

  • DRUG Rituximab

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2013-05-23
Est. Completion 2018-05-10
Phase Phase 2

Sponsor

Hoffmann-La Roche

909 total trials

What the Registry Record Tells You About NCT01750697

The ClinicalTrials.gov registry entry for NCT01750697 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 25 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 Rituximab is the first listed.

NCT01750697 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01750697 about?

NCT01750697 is a clinical study titled "A Phase IIa Study of Intravenous Rituximab in Pediatric Participants With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis". This Phase IIa international multicenter, open-label, uncontrolled study will evaluate the safety and pharmacokinetics of rituximab (MabThera/Rituxan) in pediatric participants with severe granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA). Participants will receive rituximab 3...

What is the current status of trial NCT01750697?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2013-05-23. Estimated completion is 2018-05-10.

What interventions are being tested in trial NCT01750697?

The interventions under investigation include: Rituximab (DRUG).

Who is sponsoring clinical trial NCT01750697?

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 Editorial

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.