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NCT02180412 · ClinicalTrials.gov registry record · Phase 2
Controlled Trial of Panhematin in Treatment of Acute Attacks of Porphyria
A Phase 2 study, sponsored by The University of Texas Medical Branch, Galveston.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT02180412: Completed Phase 2 study, sponsored by The University of Texas Medical Branch, Galveston.
NCT02180412 is a Phase 2 study that has completed, run by The University of Texas Medical Branch, Galveston. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02180412, a Phase 2 study, has completed, sponsored by The University of Texas Medical Branch, Galveston.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
This study aims to provide high quality evidence for the effectiveness and safety of hemin (PanhematinTM , Recordati) for treatment of acute attacks of porphyria. These types of studies have not been done before with either PanhematinTM or the hemin preparation available in Europe (NormosangTM, Orphan Europe). There are two treatment groups in this study. One group will be treated with PanhematinTM plus glucose, and the other group will be treated with glucose plus an inactive salt solution (called a "placebo"). To avoid prejudice, the treatment given to each participant will be blinded (meaning the participants and most of the hospital staff will not know which treatment the participant will receive) and randomized (meaning participants will have an equal chance of receiving either treatment, like the flip of a coin). A placebo-controlled, randomized study is the standard method used to prove treatments are effective and safe. PanhematinTM and glucose will be given in the same manner as is usual for treating an attack of porphyria. For participants who are chosen to receive the placebo, their treatment will be switched to real PanhematinTM at any time if their symptoms do not improve. This is called "rescue" treatment, and assures that they study is safe and patients who need hemin will receive it. Treatment with hemin will be for 4 days, or longer if needed. Since the study treatment is started as soon as possible after symptoms appear, there will be very little delay in providing hemin to those who need it. Funding Source - Office of Orphan Products Development (FDA OOPD)
Primary Outcome
The difference in the pre-infusion NRS pain scores and NRS pain score 12 hours from the infusion start time. To define this variable, all blinded study treatment infusion times were compared with the pain score survey times. The pain score closest to but prior to the infusion time was the pre-infusion pain score. Numeric rating scale for pain (0-10; 0=no pain, 10=most severe pain).
Interventions
- OTHER Glucose
- BIOLOGICAL Panhematin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2014-04-28 |
| Est. Completion | 2022-02-03 |
| Phase | Phase 2 |
What the finished NCT02180412 record still lists
NCT02180412 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Glucose is the first listed.
NCT02180412 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02180412 about?
NCT02180412 is a clinical study titled "Controlled Trial of Panhematin in Treatment of Acute Attacks of Porphyria". This study aims to provide high quality evidence for the effectiveness and safety of hemin (PanhematinTM , Recordati) for treatment of acute attacks of porphyria. These types of studies have not been done before with either PanhematinTM or the hemin preparation available in Europe (NormosangTM, Orph...
What is the current status of trial NCT02180412?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2014-04-28. Estimated completion is 2022-02-03.
What interventions are being tested in trial NCT02180412?
The interventions under investigation include: Glucose (OTHER), Panhematin (BIOLOGICAL).
Who is sponsoring clinical trial NCT02180412?
This trial is sponsored by The University of Texas Medical Branch, Galveston, which has 203 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02180412's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 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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