← Back to Search

Other

Panhematin for Porphyria Prevention

Phase 2
Recruiting
Led By Karl E Anderson, MD
Research Sponsored by The University of Texas Medical Branch, Galveston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects will have had frequent attacks in the past, with symptoms such as abdominal, back and/or limb pain and diagnosed after exclusion of other causes, and be on hemin prophylaxis for prevention of frequent attacks
A diagnosis of acute intermittent porphyria, hereditary coproporphyria or variegate porphyria confirmed by clinical features, biochemical findings, and molecular studies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-4 weeks
Awards & highlights

Study Summary

This trial will test whether Panhematin is safe and effective for preventing acute attacks of porphyria.

Who is the study for?
This trial is for adults over 18 who have frequent acute porphyria attacks, causing severe abdominal, back or limb pain. They must already be on hemin prevention and diagnosed with acute intermittent porphyria, hereditary coproporphyria or variegate porphyria. People can't join if they have conditions that could risk their safety or affect the study results, were in this trial before, are allergic to Panhematin™ or human albumin.Check my eligibility
What is being tested?
The study tests whether Panhematin (hemin for injection) is safe and effective at preventing acute porphyria attacks compared to a placebo. Participants will receive either the real treatment or a placebo without knowing which one they're getting.See study design
What are the potential side effects?
Possible side effects of Panhematin may include reactions at the injection site, general discomforts like headaches or fever, and potential allergic reactions for those sensitive to its components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have frequent attacks of severe pain and am on hemin to prevent them.
Select...
I have been diagnosed with a specific type of porphyria based on symptoms, lab tests, and genetic studies.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Occurrence of an acute attack of porphyria after treatment
Secondary outcome measures
Effects on levels of porphobilinogen
Other outcome measures
Effects of age
Effects of the nature of the porphobilinogen deaminase (PBGD) mutation
Frequency of injection site complications

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Hemin for injectionExperimental Treatment1 Intervention
Double blind doses of Panhematin 4 mg/kg body weight reconstituted with 25% human albumin and infused over at least one hour.
Group II: PlaceboPlacebo Group1 Intervention
A double blind dose of saline.

Find a Location

Who is running the clinical trial?

The University of Texas Medical Branch, GalvestonLead Sponsor
241 Previous Clinical Trials
56,578 Total Patients Enrolled
Karl E Anderson, MDPrincipal InvestigatorUniversity of Texas
2 Previous Clinical Trials
73 Total Patients Enrolled

Media Library

Hemin for injection (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02922413 — Phase 2
Acute Intermittent Porphyria Research Study Groups: Hemin for injection, Placebo
Acute Intermittent Porphyria Clinical Trial 2023: Hemin for injection Highlights & Side Effects. Trial Name: NCT02922413 — Phase 2
Hemin for injection (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02922413 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what afflictions is Hemin for injection typically administered?

"Hemin for injection is an effective therapeutic approach to address variegate porphyria, various types of porphyrias, acute cases and coryza."

Answered by AI

How many individuals are currently participating in this medical experiment?

"Affirmative. Clinicaltrials.gov provides evidence that this clinical trial is currently enrolling patients, with the initial advertisement posted on October 30th 2015 and most recently updated November 23rd 2021. The experiment requires 20 participants to be sourced from a single medical site."

Answered by AI

Have there been any other investigations into Hemin as an injectable treatment?

"Currently, there are 2 trials underway researching Hemin for injection. Neither of these studies have reached the Phase 3 stage yet. The majority of research is being conducted in Galveston, Texas but two other locations are also running experiments on this medication."

Answered by AI

Are recruitment efforts for this study still underway?

"Clinicaltrials.gov provides evidence that this clinical trial is currently recruiting patients, having been posted on October 30th 2015 and last modified on November 23rd 2021."

Answered by AI

What potential hazards might be associated with Hemin injections?

"Hemin for injection's safety rating is 2, as this Phase 2 trial indicates that there are some data points to back its security but none asserting effectiveness."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Panhematin for Prevention of Acute Attacks of Porphyria
2015. "Panhematin for Prevention of Acute Attacks of Porphyria". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02922413.
~2 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top