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Phase I/II Study of Heme Arginate and Tin Mesoporphyrin for Acute Porphyria

NCT00004789 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2005-06-24

No results posted yet for this study

Summary

OBJECTIVES: I. Evaluate the efficacy and safety of heme arginate in the treatment of 20 patients with acute attacks of porphyria.

II. Evaluate the efficacy and safety of heme arginate in preventing frequent exacerbations of acute porphyria in up to 15 patients.

III. Estimate the lowest effective dose of heme arginate (0.3, 1.0, or 3.0 mg/kg) in reducing porphyrin precursors in 12 stable patients with acute intermittent porphyria in remission.

IV. Evaluate the safety and efficacy of tin mesoporphyrin used in combination with heme arginate in reducing porphyrin precursors in 12 stable patients with acute intermittent porphyria in remission.

Conditions

  • Porphyria

Interventions

DRUG

heme arginate

DRUG

tin mesoporphyrin

Sponsors & Collaborators

  • University of Texas

    collaborator OTHER

  • National Center for Research Resources (NCRR)

    lead NIH

Principal Investigators

  • Karl Elmo Anderson · University of Texas

Study Design

Purpose
TREATMENT

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1993-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00004789 on ClinicalTrials.gov