Clinical Trial: Hydroxychloroquine and Phlebotomy for Treating Porphyria Cutanea Tarda

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Prospective Comparison of Low Dose Hydroxychloroquine and Phlebotomy in the Treatment of Porphyria Cutanea Tarda. IRB 02-435

Brief Summary: Porphyria cutanea tarda (PCT) is an iron-related disorder that responds to treatment by phlebotomy or low-dose hydroxychloroquine, but comparative data on these treatments are limited. The hypothesis is that hydroxychloroquine is noninferior to phlebotomy in terms of time to remission. Patients with well documented PCT are assigned to treatment by randomization if specific criteria are met. All patients are followed until remission - defined as achieving a normal plasma porphyrin concentration.

Detailed Summary:
Sponsor: The University of Texas Medical Branch, Galveston

Current Primary Outcome: Normal plasma porphyrin concentration [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: The University of Texas Medical Branch, Galveston

Dates:
Date Received: April 5, 2012
Date Started: April 2003
Date Completion: August 2020
Last Updated: February 5, 2016
Last Verified: February 2016