CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 enrolled
Drug / intervention
Hydroxychloroquine +1 moredrug
Likely dose
Hydroxychloroquine 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01573754
NCT01573754Phase 2Completed
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A Prospective Comparison of Low Dose Hydroxychloroquine and Phlebotomy in the Treatment of Porphyria Cutanea Tarda. IRB 02-435

The University of Texas Medical Branch, Galveston·interventional·Posted Apr 9, 2012·Updated Feb 17, 2023

In Brief

A Phase 2 clinical trial evaluating Hydroxychloroquine and Phlebotomy for Porphyria Cutanea Tarda. Completed, enrolled 48 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPorphyria Cutanea Tarda
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 9, 2012
Enrollment StartMar 21, 2006
Primary CompletionJul 6, 2021
TodayJul 2, 2026
Enrollment to primary: 15.3 yearsPosted 14.2 years ago

Interventions

Hydroxychloroquinedrug

100 mg by mouth twice weekly

Phlebotomyprocedure

450 mL every 2 weeks