We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004398
First Posted: October 19, 1999
Last Update Posted: December 9, 2005
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.
Collaborator:
University of Texas
Information provided by:
Office of Rare Diseases (ORD)
  Purpose

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004398


Sponsors and Collaborators
National Center for Research Resources (NCRR)
University of Texas
Investigators
Study Chair: Karl Elmo Anderson University of Texas
  More Information

ClinicalTrials.gov Identifier: NCT00004398     History of Changes
Other Study ID Numbers: 199/13191
UTMB-97-118
UTMB-FDR001459
First Submitted: October 18, 1999
First Posted: October 19, 1999
Last Update Posted: December 9, 2005
Last Verified: June 2000

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

Additional relevant MeSH terms:
Porphyrias
Porphyria, Erythropoietic
Metabolic Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
Tin mesoporphyrin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action