Expired Study
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Dallas, Texas 75390


Purpose:

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.


Study summary:

Phlebotomy is the standard therapy for Porphyria Cutanea Tarda (PCT), but it can be inconvenient and cause anemia in some patients. Deferasirox is a new class of tridentate iron chelators with high affinity and selectivity for iron. The medication is administered orally, which if effective for PCT would make it a more convenient and possibly more tolerable option for patients.


Criteria:

Inclusion Criteria: - 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 Exclusion Criteria: - 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.


NCT ID:

NCT00599326


Primary Contact:

Principal Investigator
Amit Pandya, M.D.
UT Southwestern Medical Center at Dallas - Department of Dermatology


Backup Contact:

N/A


Location Contact:

Dallas, Texas 75390
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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