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

This study has been completed.
Sponsor:
Collaborator:
University of Texas
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004398
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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Complete list of historical versions of study NCT00004398 on ClinicalTrials.gov Archive Site
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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.

Interventional
Phase 1
Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Porphyria
  • Drug: heme arginate
  • Drug: tin mesoporphyrin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
May 2000
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PROTOCOL ENTRY CRITERIA:

--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

Other:

  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00004398
199/13191, UTMB-97-118, UTMB-FDR001459
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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