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COMPLETED Phase 2

Hydroxychloroquine and Phlebotomy for Treating Porphyria Cutanea Tarda

NCT01573754 · View on ClinicalTrials.gov ↗

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.

Conditions Studied

Interventions

  • PROCEDURE Phlebotomy
  • DRUG Hydroxychloroquine

Study Locations (1)

Texas

  • University of Texas Medical Branch — Galveston

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2006-03-21
Est. Completion 2021-07-06
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01573754

The ClinicalTrials.gov registry entry for NCT01573754 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Medical Branch, Galveston, which has 132 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01573754 reports 1 study location spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01573754?

The interventions under investigation include: Phlebotomy (PROCEDURE), Hydroxychloroquine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01573754?

This trial is sponsored by The University of Texas Medical Branch, Galveston, which has 132 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial