NCT00054613 is a Phase 2 clinical trial of Methoxsalen in Graft-versus-Host Disease, sponsored by Mallinckrodt.

Who is sponsoring NCT00054613?

NCT00054613 is sponsored by Mallinckrodt.

What drugs are being tested in NCT00054613?

Interventions in NCT00054613: Methoxsalen, Extracorporeal Photopheresis.

What condition does NCT00054613 study?

NCT00054613 studies Graft-versus-Host Disease.

Is NCT00054613 still recruiting?

NCT00054613 is currently completed. Last updated 14 August 2017.

Last reviewed 2017-08-14 · How we verify

NCT00054613

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomized Single-Blind Study of Extracorporeal Photoimmune Therapy With UVADEX in Conjunction With Standard Therapy Alone for the Treatment of Patients With Corticosteroid-Refractory, Corticosteroid-Dependent, or Corticosteroid-Intolerant Chronic Graft-versus-Host Disease

Completed Phase 2 Last updated 14 August 2017

What this trial tests

Phase 2 trial testing Methoxsalen in Graft-versus-Host Disease in 72 participants. Completed in 1 March 2004.

Timeline

1 June 2002

1 March 2004

Quick facts

Lead sponsor	Mallinckrodt
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	72
Start date	1 June 2002
Estimated completion	1 March 2004
Sites	31 locations across United States, Australia, Austria, France, Germany, Italy, Portugal, Slovakia

Drugs / interventions tested

Methoxsalen (METHOXSALEN) — full drug profile →
Extracorporeal Photopheresis — full drug profile →

Conditions studied

Graft-versus-Host Disease — all drugs for Graft-versus-Host Disease →

Sponsor

Mallinckrodt — full company profile →

Who can join

Eligibility, any sex, with Graft-versus-Host Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to determine whether extracorporeal photoimmune therapy with UVADEX (ECP) added to standard therapy is effective in the treatment of chronic graft-versus-host disease (GvHD).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

A multicenter prospective phase 2 randomized study of extracorporeal photopheresis for treatment of chronic graft-versus-host disease.
Flowers ME, Apperley JF, van Besien K, Elmaagacli A, et al · · 2008 · cited 235× · PMID 18621929 · DOI 10.1182/blood-2008-03-141481
Extracorporeal photophoresis: an evidence-based analysis.
Medical Advisory Secretariat. · · 2006 · cited 1× · PMID 23074497
Physicians Poster SessionsPoster session / Day 2.
· 2015 · PMID 25794253 · DOI 10.1038/bmt.2015.30

Verify or expand the search:

Other trials of Methoxsalen

Trials testing the same drug.

NCT06646016 — EPIC- Extracorporeal Photopheresis (ECP) for Immune-related Colitis · Phase 2 · withdrawn
NCT03563040 — Study of Photopheresis in the Treatment of Erythrodermic MF and SS · Phase 2 · withdrawn
NCT02524847 — Methoxsalen and Extracorporeal Photopheresis (ECP) for the Treatment of Pediatric Participants With Steroid Refractory A · Phase 3 · terminated
NCT02322190 — Biomarkers in Acute Graft-Versus-Host Disease and Extracorporeal Photopheresis Added to Investigator Chosen Therapies of · Phase 2 · terminated

Other recruiting trials for Graft-versus-Host Disease

Currently open trials in the same condition.

NCT06910969 — Multidisciplinary Intervention for Adults With Chronic Graft-versus-host Disease · NA · recruiting
NCT05621733 — A PMS of Jakavi® in Patients With Steroid-Refractory Graft-versus-Host Disease (SR-GvHD) in Korea · recruiting

Other Mallinckrodt trials

Trials by the same sponsor.

NCT04169061 — Impact of Acthar on Everyday Life of Participants With Severe Keratitis · Phase 4 · completed
NCT03712280 — MNK6106 for Liver Disease (Hepatic Cirrhosis) That in the Past Has Affected the Brain (Hepatic Encephalopathy) · Phase 2 · completed
NCT03656692 — Safety and Effectiveness of Acthar Gel for Inflammation of the Eye's Uvea (Middle Layer) · Phase 4 · terminated
NCT03320070 — Acthar Gel in Participants With Pulmonary Sarcoidosis · Phase 4 · completed
NCT03132428 — Registry to Evaluate INOmax in Newborn Babies With Pulmonary Hypertension · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00054613 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mallinckrodt
Last refreshed: 14 August 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00054613.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing