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This trial is complete. It is no longer accepting participants.

NCT00004396

NCT00004396
Completed Phase 2

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with acute intermittent porphyria (a rare genetic condition affecting the body's ability to produce a substance called heme) and your condition has been in remission for at least 1 month
  • Your body is producing higher than normal levels of certain substances related to porphyria that show up in urine tests
  • You have had no symptoms of porphyria (such as stomach pain or nerve problems) for at least 1 month
  • It has been at least 1 month since you last received a heme-based treatment
  • If you are taking other medications for a different condition, you may still be eligible as long as the dose and schedule stay the same throughout the study
  • Your urine test shows a specific level of a substance called porphobilinogen of at least 20 mg over a 24-hour period

Who may not be able to join:

  • You are currently pregnant
  • You are a woman who could become pregnant and are not willing or able to use effective birth control during the study and for at least 6 months before joining
  • You are currently experiencing an active bleeding condition, such as bleeding in the stomach or intestines, or bleeding in the brain
  • You have a known allergy or sensitivity to heme arginate, tin mesoporphyrin, or any similar heme-based substance
  • You have another health condition that could put you at greater risk by taking part in this study (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 2
Sponsor
National Center for Research Resources (NCRR)
Registry
clinicaltrials_gov
Start date
1 September 1997

Where this trial is recruiting

🇺🇸 United States

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov