Phase I Study of Tin Mesoporphyrin in Patients on Long Term Heme Therapy for Prevention of Acute Attacks of Porphyria

Brief Title

Phase I Study of Tin Mesoporphyrin in Patients on Long Term Heme Therapy for Prevention of Acute Attacks of Porphyria


Brief Summary

      OBJECTIVES: I. Evaluate the effectiveness of tin mesoporphyrin in reducing the number of heme
      infusions needed to prevent acute attacks of porphyria.

      II. Evaluate the safety and tolerability of tin mesoporphyrin in these patients.
    

Detailed Description

      PROTOCOL OUTLINE: This is an unblinded study. Patients start a preventive heme regimen and
      are followed for 6 months prior to tin mesoporphyrin. The frequency of attacks is recorded.

      Patients receive tin mesoporphyrin once a week for 6 months. Patients must avoid sunlight
      during treatment and for 2 months thereafter. The frequency of heme infusions is reduced by
      half and the frequency of attacks of porphyria is monitored.

      Patients are followed for 6 months after last 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

20

Start Date

January 1998

Completion Date

May 2000


Eligibility Criteria

        PROTOCOL ENTRY CRITERIA:

        --Disease Characteristics-- Documented acute intermittent porphyria, variegate porphyria,
        or hereditary coproporphyria causing 6 or more attacks per year Fewer than 2 attacks in the
        preceding 6 months if already on preventive heme therapy --Prior/Concurrent Therapy-- See
        Disease Characteristics --Patient Characteristics-- Performance status: Not specified Life
        expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal:
        Urinary porphobilinogen at least 20 mg/24 hours during acute symptoms Other: Not pregnant
        Fertile female patients must use effective contraception during and for 6 months prior to
        study No recurrent symptoms due to another illness No continuous (for longer than 1 month)
        symptoms of porphyria unless it is in addition to acute exacerbations No acute hemorrhagic
        disorder such as: Gastrointestinal bleeding Intracerebral hemorrhage No known
        hypersensitivity to tin mesoporphyrin No known hypersensitivity to any intravenous heme
        preparation No other condition which may increase risk to patient
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Karl Elmo Anderson, , 



Administrative Informations


NCT ID

NCT00004397

Organization ID

199/13187

Secondary IDs

UTMB-97-117


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