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NCT01380535 · ClinicalTrials.gov registry record · Early Phase 1

Extracorporeal Photopheresis (ECP) With Methoxsalen for Chronic Graft Versus Host Disease (cGVHD)

A Early Phase 1 study, sponsored by Mallinckrodt.

Completed
Registry status
Early Phase 1
Development phase
60
Enrollment target

NCT01380535 is a Early Phase 1 study that has completed, run by Mallinckrodt. The registered enrollment target is 60 participants.

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The verdict

NCT01380535, a Early Phase 1 study, has completed, sponsored by Mallinckrodt.

COMPLETED
Registry status
Early Phase 1
Development phase
60 participants
Enrollment target

Study Summary

Chronic graft-versus-host disease (cGVHD) is a long-lasting complication that can occur after transplants. The transplanted cells seem to fight with the patient's own cells. Extracorporeal photopheresis (ECP) is a fairly new procedure for cGVHD. The participant gets a port to hook up to a machine. The machine removes the white blood cells, mixes them with a light-sensitive drug, shines light on it, and puts all the blood back in. This study will find out if patients respond better if they get ECP with methoxsalen, in addition to the pills normally used to treat cGVHD.

Interventions

  • DRUG Standard of Care
  • DRUG ECP Methoxsalen

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2011-11
Est. Completion 2015-03
Phase Early Phase 1

Sponsor

Mallinckrodt

69 total trials

What the Registry Record Tells You About NCT01380535

The ClinicalTrials.gov registry entry for NCT01380535 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mallinckrodt, which has 69 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Standard of Care is the first listed.

NCT01380535 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01380535 about?

NCT01380535 is a clinical study titled "Extracorporeal Photopheresis (ECP) With Methoxsalen for Chronic Graft Versus Host Disease (cGVHD)". Chronic graft-versus-host disease (cGVHD) is a long-lasting complication that can occur after transplants. The transplanted cells seem to fight with the patient's own cells. Extracorporeal photopheresis (ECP) is a fairly new procedure for cGVHD. The participant gets a port to hook up to a machine. ...

What is the current status of trial NCT01380535?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 60 participants. The study started on 2011-11. Estimated completion is 2015-03.

What interventions are being tested in trial NCT01380535?

The interventions under investigation include: Standard of Care (DRUG), ECP Methoxsalen (DRUG).

Who is sponsoring clinical trial NCT01380535?

This trial is sponsored by Mallinckrodt, which has 69 total clinical trials registered on ClinicalTrials.gov.

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

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