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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004398
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
University of Texas
Information provided by:
Office of Rare Diseases (ORD)

October 18, 1999
October 19, 1999
June 24, 2005
January 1998
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No Changes Posted
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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: None (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.
Same as current
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, Older Adult)
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