Phase 2
N=48
Hydroxychloroquine and Phlebotomy for Treating Porphyria Cutanea Tarda
Porphyria Cutanea Tarda
Bottom Line
View on ClinicalTrials.gov: NCT01573754 ↗Enrolled (actual)
48
Serious AEs
13.3%
Results posted
Feb 2023
Primary outcome: Primary: Remission — 6.1; 6.9 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Hydroxychloroquine (Drug); Phlebotomy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Medical Branch, Galveston
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Remission |
6.1; 6.9 | — |
| SECONDARY 50% Reduction in Plasma Porphyrin Level |
44; 65 | — |
| SECONDARY 75% Reduction in Plasma Porphyrin Level |
73; 44 | — |
| SECONDARY Number of Days With Normal Urinary Porphyrin Levels |
175; 265 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01573754). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.