TerminatedPhase 2

Panhematin for Prevention of Acute Attacks of Porphyria

Stopped: Low accrual

United States13 participantsStarted 2015-10-30

Plain-language 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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female aged 18 years
✓. Willing to provide written informed consent

Exclusion criteria

✕. Symptoms such as abdominal, back or limb pain are explained by another condition, as judged by the investigator
✕. Known or suspected allergy to Panhematin™ or related products
✕. A known or suspected allergy to human albumin
✕. Any disease or condition that the investigator judges would lead to an unacceptable risk to the patient or interfere with the successful collection of data for the trial
✕. Previous randomization in this trial

What they're measuring

Number of Participants Experiencing Acute Attacks of Porphyria After Treatment

Timeframe: 1-4 weeks

Number of Participants With Treatment-Related Serious Adverse Events

Timeframe: 1-4 weeks

Trial details

NCT IDNCT02922413

SponsorThe University of Texas Medical Branch, Galveston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-27

Results submitted2026-01-14

View on ClinicalTrials.gov More Acute Intermittent Porphyria trials