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NCT01573754 · ClinicalTrials.gov registry record · Phase 2
Hydroxychloroquine and Phlebotomy for Treating Porphyria Cutanea Tarda
A Phase 2 study of Porphyria Cutanea Tarda, sponsored by The University of Texas Medical Branch, Galveston.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT01573754: Completed Phase 2 study of Porphyria Cutanea Tarda, sponsored by The University of Texas Medical Branch, Galveston.
NCT01573754 is a Phase 2 study of Porphyria Cutanea Tarda that has completed, run by The University of Texas Medical Branch, Galveston. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01573754, a Phase 2 study of Porphyria Cutanea Tarda, has completed, sponsored by The University of Texas Medical Branch, Galveston.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Time to a decrease in plasma porphyrin concentration to less than 0.9 mcg/dL
Conditions Studied
Interventions
- PROCEDURE Phlebotomy
- DRUG Hydroxychloroquine
Study Locations (1)
Texas
- University of Texas Medical Branch - Galveston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2006-03-21 |
| Est. Completion | 2021-07-06 |
| Phase | Phase 2 |
What the finished NCT01573754 record still lists
NCT01573754 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
The record links to 1 condition, with Porphyria Cutanea Tarda appearing as the primary indexed condition, and to 2 interventions - of which Phlebotomy is the first listed.
NCT01573754 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01573754 about?
NCT01573754 is a clinical study titled "Hydroxychloroquine and Phlebotomy for Treating Porphyria Cutanea Tarda". 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...
What is the current status of trial NCT01573754?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2006-03-21. Estimated completion is 2021-07-06.
What conditions does trial NCT01573754 study?
This clinical trial studies the following conditions: Porphyria Cutanea Tarda.
What interventions are being tested in trial NCT01573754?
The interventions under investigation include: Phlebotomy (PROCEDURE), Hydroxychloroquine (DRUG).
Who is sponsoring clinical trial NCT01573754?
This trial is sponsored by The University of Texas Medical Branch, Galveston, which has 203 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01573754 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01573754's enrollment target sits among peer trials
48 1265th of 2000 higher than 718 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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