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NCT01161628 · ClinicalTrials.gov registry record · Phase 2

Rituximab for the Primary Treatment of Denovo Extensive Chronic Graft Versus Host Disease (GVHD)

A Phase 2 study, sponsored by Northside Hospital.

Completed
Registry status
Phase 2
Development phase
25
Enrollment target

NCT01161628 is a Phase 2 study that has completed, run by Northside Hospital. The registered enrollment target is 25 participants.

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The verdict

NCT01161628, a Phase 2 study, has completed, sponsored by Northside Hospital.

COMPLETED
Registry status
Phase 2
Development phase
25 participants
Enrollment target

Study Summary

Rituximab is an attractive agent to bring to the upfront treatment of chronic graft-versus-host disease (cGVHD) due to its favorable toxicity profile, its proven efficacy in the treatment of steroid-refractory cGVHD, and its ability to serve as a steroid sparing agent in other autoimmune diseases. The investigators hope to demonstrate that Rituximab has significant activity in cGVHD when utilized early in the course of the process. In addition, the investigators hope to show that the early use of Rituximab may allow for the earlier discontinuation of immunosuppression while obviating the need for long courses of systemic corticosteroids, which should translate into reduced treatment-related morbidity and mortality associated with cGVHD.

Interventions

  • DRUG Rituximab

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2011-04
Est. Completion 2015-07
Phase Phase 2

Sponsor

Northside Hospital

26 total trials

What the Registry Record Tells You About NCT01161628

The ClinicalTrials.gov registry entry for NCT01161628 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 Northside Hospital, which has 26 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Rituximab is the first listed.

NCT01161628 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01161628 about?

NCT01161628 is a clinical study titled "Rituximab for the Primary Treatment of Denovo Extensive Chronic Graft Versus Host Disease (GVHD)". Rituximab is an attractive agent to bring to the upfront treatment of chronic graft-versus-host disease (cGVHD) due to its favorable toxicity profile, its proven efficacy in the treatment of steroid-refractory cGVHD, and its ability to serve as a steroid sparing agent in other autoimmune diseases. T...

What is the current status of trial NCT01161628?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2011-04. Estimated completion is 2015-07.

What interventions are being tested in trial NCT01161628?

The interventions under investigation include: Rituximab (DRUG).

Who is sponsoring clinical trial NCT01161628?

This trial is sponsored by Northside Hospital, which has 26 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.