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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

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.

Condition Intervention Phase
Porphyria Drug: heme arginate Drug: tin mesoporphyrin Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 24
Study Start Date: January 1998
Estimated Study Completion Date: May 2000
Detailed Description:

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00004398

Sponsors and Collaborators
National Center for Research Resources (NCRR)
University of Texas
Study Chair: Karl Elmo Anderson University of Texas
  More Information Identifier: NCT00004398     History of Changes
Other Study ID Numbers: 199/13191
Study First Received: October 18, 1999
Last Updated: June 23, 2005

Keywords provided by Office of Rare Diseases (ORD):
inborn errors of metabolism
rare disease

Additional relevant MeSH terms:
Porphyria, Erythropoietic
Metabolic Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
Tin mesoporphyrin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017