Hydroxychloroquine and Phlebotomy for Treating Porphyria Cutanea Tarda

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by The University of Texas, Galveston
Sponsor:
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT01573754
First received: April 5, 2012
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Porphyria Cutanea Tarda
Drug: Hydroxychloroquine
Procedure: Phlebotomy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Comparison of Low Dose Hydroxychloroquine and Phlebotomy in the Treatment of Porphyria Cutanea Tarda. IRB 02-435

Resource links provided by NLM:


Further study details as provided by The University of Texas, Galveston:

Primary Outcome Measures:
  • Normal plasma porphyrin concentration [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2003
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hydroxychloroquine Drug: Hydroxychloroquine
100 mg by mouth twice weekly
Other Name: Plaquenil
Active Comparator: Phlebotomy Procedure: Phlebotomy
450 mL every 2 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented porphyria cutanea tarda (PCT)
  • Willing to give informed consent
  • Age 18 or greater

Exclusion Criteria:

  • Blistering skin lesions due to another condition
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01573754

Locations
United States, Texas
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555
Contact: Karl E Anderson, MD    409-772-4661    kanderso@utmb.edu   
Contact: Csilla K Hallberg, MD    409-772.4661    challberg@utmb.edu   
Principal Investigator: Karl E Anderson, MD         
Sponsors and Collaborators
The University of Texas, Galveston
  More Information

No publications provided by The University of Texas, Galveston

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT01573754     History of Changes
Other Study ID Numbers: FDA-2604, R01FD002604, UTMB, 02-435
Study First Received: April 5, 2012
Last Updated: June 5, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by The University of Texas, Galveston:
Porphyria, rare disease, orphan disease, iron metabolism

Additional relevant MeSH terms:
Porphyrias
Porphyria, Erythropoietic
Porphyria Cutanea Tarda
Porphyrias, Hepatic
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Skin Diseases, Metabolic
Skin Diseases
Metabolic Diseases
Skin Diseases, Genetic
Liver Diseases
Digestive System Diseases
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 28, 2014