NCT00004398

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 1998

Typical duration for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1998

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 18, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 1999

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2000

Completed
Last Updated

June 24, 2005

Status Verified

June 1, 2000

First QC Date

October 18, 1999

Last Update Submit

June 23, 2005

Conditions

Porphyria

Keywords

inborn errors of metabolismporphyriarare disease

Interventions

heme arginateDRUG
tin mesoporphyrinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

PorphyriasMetabolism, Inborn ErrorsRare Diseases

Interventions

heme arginatetin mesoporphyrin

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Karl Elmo Anderson

    University of Texas

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

October 18, 1999

First Posted

October 19, 1999

Study Start

January 1, 1998

Study Completion

May 1, 2000

Last Updated

June 24, 2005

Record last verified: 2000-06