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NCT01550705 · ClinicalTrials.gov registry record · NA

Effect of Isoniazid on Protoporphyrin Levels in Erythropoietic Protoporphyria

A NA study, sponsored by University of Utah.

Terminated
Registry status
NA
Development phase
11
Enrollment target

NCT01550705: Clinical Trial NA study, sponsored by University of Utah.

NCT01550705 is a NA study that was terminated before completion, run by University of Utah. The registered enrollment target is 11 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01550705, a NA study, was terminated before completion, sponsored by University of Utah.

TERMINATED
Registry status
NA
Development phase
11 participants
Enrollment target

Study Summary

In erythropoietic protoporphyria there is an accumulation of protoporphyrin IX (PPIX) in the plasma and liver. The reason it builds up is either the last step to make heme, insertion of iron into PPIX, is rate limiting or there is an increase in activity in the first step in the heme pathway. It may be possible to decrease the amount of PPIX made and see a decrease in symptoms. The first step to make heme is the key step in the pathway and it uses vitamin B6 as a cofactor. If the investigators can limit the amount of vitamin B6 the investigators can possibly reduce the activity of this rate limiting step. With decreased activity of the enzyme it may be possible for the body to utilize all the PPIX that is made so that none builds up.

Primary Outcome

Plasma Protoporphyrin IX will be measured at baseline and at 3 months

Interventions

  • DRUG Isoniazid

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2012-03
Est. Completion 2015-12
Phase NA
University of Utah

818 total trials

Why NCT01550705 stopped before completion

NCT01550705 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Isoniazid is the first listed.

NCT01550705 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01550705 about?

NCT01550705 is a clinical study titled "Effect of Isoniazid on Protoporphyrin Levels in Erythropoietic Protoporphyria". In erythropoietic protoporphyria there is an accumulation of protoporphyrin IX (PPIX) in the plasma and liver. The reason it builds up is either the last step to make heme, insertion of iron into PPIX, is rate limiting or there is an increase in activity in the first step in the heme pathway. It ma...

What is the current status of trial NCT01550705?

This trial is currently terminated. It is a NA study. The enrollment target is 11 participants. The study started on 2012-03. Estimated completion is 2015-12.

What interventions are being tested in trial NCT01550705?

The interventions under investigation include: Isoniazid (DRUG).

Who is sponsoring clinical trial NCT01550705?

This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01550705's enrollment target sits among peer trials

11 1927th of 2000 higher than 74 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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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Source: ClinicalTrials.gov NCT01550705, the US trial registry maintained by the National Library of Medicine. NCT01550705 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.