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NCT01713400 · ClinicalTrials.gov registry record · Phase 2

Tacrolimus, Sirolimus and Ustekinumab vs. Tacrolimus and Sirolimus for the Prevention of Acute Graft-Versus-Host Disease

A Phase 2 study of Graft Vs Host Disease, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Completed
Registry status
Phase 2
Development phase
54
Enrollment target
1
Study location

NCT01713400 is a Phase 2 study of Graft Vs Host Disease that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 54 participants, below the 137-participant average among 36 other Graft Vs Host Disease trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01713400, a Phase 2 study of Graft Vs Host Disease, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

COMPLETED
Registry status
Phase 2
Development phase
54 participants
Enrollment target
1
Study location

Study Summary

To determine whether treatment with ustekinumab will alter the ratio of T Regulatory Cell (Treg)/total cluster of differentiation 4 (CD4)+ cells in peripheral blood at day 30 post-hematopoietic cell transplantation (HCT).

Conditions Studied

Interventions

  • DRUG Sirolimus
  • DRUG Placebo
  • DRUG Ustekinumab
  • DRUG Tacrolimus (TAC)

Study Locations (1)

Florida

  • H. Lee Moffitt Cancer Center & Research Institute - Tampa

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2013-02-25
Est. Completion 2018-06-14
Phase Phase 2

What the Registry Record Tells You About NCT01713400

The ClinicalTrials.gov registry entry for NCT01713400 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 137-participant average among 36 other Graft Vs Host Disease trials with a reported enrollment target (61% lower). The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Graft Vs Host Disease appearing as the primary indexed condition, and to 4 interventions - of which Sirolimus is the first listed.

NCT01713400 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT01713400 about?

NCT01713400 is a clinical study titled "Tacrolimus, Sirolimus and Ustekinumab vs. Tacrolimus and Sirolimus for the Prevention of Acute Graft-Versus-Host Disease". To determine whether treatment with ustekinumab will alter the ratio of T Regulatory Cell (Treg)/total cluster of differentiation 4 (CD4)+ cells in peripheral blood at day 30 post-hematopoietic cell transplantation (HCT).

What is the current status of trial NCT01713400?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2013-02-25. Estimated completion is 2018-06-14.

What conditions does trial NCT01713400 study?

This clinical trial studies the following conditions: Graft Vs Host Disease.

What interventions are being tested in trial NCT01713400?

The interventions under investigation include: Sirolimus (DRUG), Placebo (DRUG), Ustekinumab (DRUG), Tacrolimus (TAC) (DRUG).

Who is sponsoring clinical trial NCT01713400?

This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01713400 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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