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Uvadex (Methoxsalen) - Summary

 
 



UVADEX ® (methoxsalen) Sterile Solution should be used only by physicians who have special competence in the diagnosis and treatment of cutaneous T-cell lymphoma and who have special training and experience in the THERAKOS® UVAR XTS ® or THERAKOS ® CELLEX ® Photopheresis System. Please consult the appropriate Operator's Manual before using this product.

 

UVADEX SUMMARY

Methoxsalen is a naturally occurring photoactive substance found in the seeds of the Ammi majus (Umbelliferae) plant. It belongs to a group of compounds known as psoralens or furocoumarins.

UVADEX™ (methoxsalen) Sterile Solution is indicated for extracorporeal administration with the UVAR™ XTS™ or THERAKOS™ CELLEX™ Photopheresis System in the palliative treatment of the skin manifestations of Cutaneous T-Cell Lymphoma (CTCL) that is unresponsive to other forms of treatment.


See all Uvadex indications & dosage >>

NEWS HIGHLIGHTS

Clinical Trials Related to Uvadex (Methoxsalen)

Safety and Efficacy of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Crohn's Disease [Completed]
his study will explore the safety and activity of ECP treatment with UVADEX in inducing a clinical response (i. e., a CDAI decrease greater than or equal to 100 from baseline and/or a CDAI < 150) over a 12-week period in moderately active Crohn's disease (CDAI greater than or equal to 220 to < 450) patients who are refractory or intolerant to immunosuppressants and/or anti-TNF agents. This study will also assess response to continued treatment during a 12-week Extension Period in patients who have a clinical response at Week 12 of the Treatment Period and elect to participate in the Extension Period.

A Safety and Efficacy Study of Uvadex and Extracorporeal Photopheresis (ECP) in Chronic Graft Versus Host Disease [Active, not recruiting]
The purpose of this study is to evaluate the safety and effectiveness of extracorporeal photopheresis therapy when added to standard drug therapies administered to patients with moderate to severe chronic graft-versus-host disease.

Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Acute Graft Versus-Host Disease [Terminated]
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.

RHIV A Pilot Study Refractory or Intolerant to Highly Active Antiretroviral Therapy (HAART) [Withdrawn]
The objectives of this clinical trial are to:

- Assess the safety of using extracorporeal photoimmune therapy with the photosensitizing

agent Uvadex in the treatment of HIV-1 infection;

- Evaluate the effects of this therapy on HIV-1 viral load by polymerase chain reaction

(PCR) analysis;

- Evaluate the effects of this therapy on CD4+, CD8+ cells and CD4/CD8 ratio;

- Evaluate the effects of this therapy on the patient's immune system, by skin reactivity

to a standard anergy panel.

UVADEX and ECP for the Treatment of Pediatric Patients With Steroid Refractory Acute Graft Versus Host Disease [Not yet recruiting]
This is a single-arm, open-label, multicenter study of the efficacy of UVADEX (methoxsalen) Sterile Solution in conjunction with THERAKOS CELLEX Photopheresis Systems in pediatric patients with steroid-refractory aGvHD. The study is composed of Screening, Treatment, and Follow-up Periods.

more trials >>


Page last updated: 2014-06-18

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