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Phase I Study of Heme Arginate With or Without Tin Mesoporphyrin in Patients With Acute Attacks of Porphyria

This study has been completed.
University of Texas
Information provided by:
Office of Rare Diseases (ORD) Identifier:
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: June 2000

October 18, 1999
June 23, 2005
January 1998
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Phase I Study of Heme Arginate With or Without Tin Mesoporphyrin in Patients With Acute Attacks of Porphyria
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OBJECTIVES: I. Evaluate the efficacy of tin mesoporphyrin in patients with acute porphyria attacks who are also treated with a standard course of heme arginate.

II. Evaluate the safety and tolerability of tin mesoporphyrin when administered to these patients.

PROTOCOL OUTLINE: This is an randomized, unblinded, multicenter study. Patients are randomized to receive heme arginate alone or both heme arginate and tin mesoporphyrin.

Patients receive a single intravenous dose of tin mesoporphyrin immediately before the first dose of heme arginate. Heme arginate is administered daily for 4 days.

Patients are followed at 3 and 6 days after treatment.

Phase 1
Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
  • Drug: heme arginate
  • Drug: tin mesoporphyrin
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2000
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--Disease Characteristics--

Documented acute intermittent porphyria, variegate porphyria, or hereditary coproporphyria

No chronic or subacute symptoms (present for longer than 2 weeks)

--Prior/Concurrent Therapy--

At least 3 weeks since prior treatment with heme arginate or tin mesoporphyrin

--Patient Characteristics--

Renal: Urinary porphobilinogen at least 40 mg/24 hr


  • Not pregnant
  • Fertile female patients must use effective contraception during and 6 months before study
  • No evidence that symptoms are due to another acute illness
  • No acute hemorrhagic disorder such as: Gastrointestinal bleeding Intracerebral hemorrhage
  • No known sensitivity to heme preparation or tin mesoporphyrin
  • No other medical condition that might increase risk to patient
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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National Center for Research Resources (NCRR)
University of Texas
Study Chair: Karl Elmo Anderson University of Texas
Office of Rare Diseases (ORD)
June 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP