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RHIV A Pilot Study Refractory or Intolerant to Highly Active Antiretroviral Therapy (HAART) [Withdrawn]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.
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