Pilot Trial of Deferasirox in the Treatment of Porphyria Cutanea Tarda
Completed · Phase 3
Conditions studied: Porphyria Cutanea Tarda
In brief
To determine the efficacy and tolerability of deferasirox in the treatment of Porphyria Cutanea Tarda. Primary objective - the elimination of all blistering within 6 months of treatment. Secondary objective - decrease in total body iron levels.
Key facts
- Study ID
- NCT00599326
- Run by
- University of Texas Southwestern Medical Center
- People needed
- 10
- Starts
- 2008-01-01
- Expected to finish
- 2010-04-01
- Last updated by the study team
- 2014-02-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- diagnosis of Porphyria Cutanea Tarda based on clinical exam and 24-hour urine porphyrin levels
- have Porphyria Cutanea Tarda for at least 3 months prior to enrollment with active blistering (3 blisters or erosions per month)
- women of childbearing potential must use an effective method of contraception during the study, however this cannot include hormonal contraception (oral contraceptives, hormone patches, Depo-Provera injections, NUVA Ring, etc.)
- treatment naive patients or patients unresponsive or intolerant of phlebotomy
- Ferritin level is greater than or equal to 25ng/mL
You may not qualify if…
- patients with serum creatinine above the upper limit of normal
- patients receiving phlebotomy who are controlled on this therapy
- pregnant or breast feeding females
- patients with liver transaminases more than 5 times the upper limit of normal
- patients with a history of hypersensitivity to deferasirox
- patients with a history of pre-existing renal condition, or receiving medication that depresses renal function
- patients on other chelators
- history of non-compliance to medical regimens.
Where it is running
- UT Southwestern Medical Center at Dallas - Dermatology Clinical Trials — Dallas, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.