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Panhematin for Prevention of Acute Attacks of Porphyria

NCT02922413 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2026-01-30

Study results available
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Summary

The purpose of this study is to determine if Panhematin is safe and effective for prevention of acute attacks of porphyria.

The study aims to provide high quality evidence for the use on hemin for prevention of acute attacks of porphyria. High quality studies have not been done previously for treating or preventing acute attacks with hemin. The lack of strong evidence for efficacy of hemin for treatment and prevention of attacks limits its availability for patients with acute porphyrias. Funding source: FDA Office of Orphan Product Development (FDA OOPD) FD-R-03720

Conditions

  • Acute Intermittent Porphyria
  • Hereditary Coproporphyria
  • Variegate Porphyria

Interventions

BIOLOGICAL

Hemin for injection

Panhematin 4 mg/kg body weight reconstituted with 25% human albumin infused intravenously over at least 1 hour.

OTHER

Placebo

Saline infusion

Sponsors & Collaborators

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Principal Investigators

  • Karl E Anderson, MD · University of Texas

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-30
Primary Completion
2023-12-27
Completion
2023-12-27

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02922413 on ClinicalTrials.gov