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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: Completed Early Phase 1 study, sponsored by Mallinckrodt.
NCT01380535 is a Early Phase 1 study that has completed, run by Mallinckrodt. The registered enrollment target is 60 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (13% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Participants with overall response included those with partial response or complete response, according to study staff who did not know which treatment they received (blinded assessment).
Interventions
- DRUG Standard of Care
- DRUG ECP Methoxsalen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2011-11 |
| Est. Completion | 2015-03 |
| Phase | Early Phase 1 |
What the finished NCT01380535 record still lists
NCT01380535 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (13% higher).
The record links to 0 conditions, and to 2 interventions - of which Standard of Care is the first listed.
NCT01380535 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01380535's enrollment target sits among peer trials
60 403rd of 2000 higher than 1,565 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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