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NCT00282503 · ClinicalTrials.gov registry record · Phase 3

Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Acute Graft Versus-Host Disease

A Phase 3 study, sponsored by Mallinckrodt.

Terminated
Registry status
Phase 3
Development phase
19
Enrollment target

NCT00282503: Clinical Trial Phase 3 study, sponsored by Mallinckrodt.

NCT00282503 is a Phase 3 study that was terminated before completion, run by Mallinckrodt. The registered enrollment target is 19 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00282503, a Phase 3 study, was terminated before completion, sponsored by Mallinckrodt.

TERMINATED
Registry status
Phase 3
Development phase
19 participants
Enrollment target

Study Summary

The purpose of this study is to compare the safety and efficacy of ECP treatment combined with high dose corticosteroids versus high dose corticosteroids alone, in the treatment of patients with newly diagnosed acute GvHD (Grades II to III) that developed within 100 days following an allo HPCT.

Primary Outcome

The primary efficacy analysis will be performed on the primary endpoint. The primary efficacy variable in this study is complete resolution of acute GvHD, defined as less than Grade I acute GvHD, according to the Glucksberg-Seattle criteria.

Interventions

  • DRUG Methoxsalen+ECP, Methylprednisolone
  • PROCEDURE Ecp

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2006-01
Phase Phase 3
Mallinckrodt

69 total trials

Why NCT00282503 stopped before completion

NCT00282503 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 2 interventions - of which Methoxsalen+ECP, Methylprednisolone is the first listed.

NCT00282503 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00282503 about?

NCT00282503 is a clinical study titled "Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Acute Graft Versus-Host Disease". The purpose of this study is to compare the safety and efficacy of ECP treatment combined with high dose corticosteroids versus high dose corticosteroids alone, in the treatment of patients with newly diagnosed acute GvHD (Grades II to III) that developed within 100 days following an allo HPCT.

What is the current status of trial NCT00282503?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 19 participants. The study started on 2006-01.

What interventions are being tested in trial NCT00282503?

The interventions under investigation include: Methoxsalen+ECP, Methylprednisolone (DRUG), Ecp (PROCEDURE).

Who is sponsoring clinical trial NCT00282503?

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

How this trial's enrollment target compares

Where NCT00282503's enrollment target sits among peer trials

19 1969th of 2000 higher than 31 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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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Source: ClinicalTrials.gov NCT00282503, the US trial registry maintained by the National Library of Medicine. NCT00282503 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.