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

Brief Title

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


Brief Summary

      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.
    

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.
    

Study Phase

Phase 1

Study Type

Interventional




Condition

Porphyria

Intervention

heme arginate


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

24

Start Date

January 1998

Completion Date

May 2000


Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Karl Elmo Anderson, , 



Administrative Informations


NCT ID

NCT00004398

Organization ID

199/13191

Secondary IDs

UTMB-97-118


Study Sponsor

National Center for Research Resources (NCRR)

Collaborators

 University of Texas

Study Sponsor

Karl Elmo Anderson, Study Chair, University of Texas


Verification Date

June 2000