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

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

heme arginate

tin mesoporphyrin

About this trial

This is an interventional treatment trial for Porphyria focused on measuring inborn errors of metabolism, porphyria, rare disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00004398

First Posted

October 18, 1999

Last Updated

June 23, 2005

Sponsor

National Center for Research Resources (NCRR)

Collaborators

University of Texas

1. Study Identification

Unique Protocol Identification Number

NCT00004398

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2000

Overall Recruitment Status

Completed

Study Start Date

January 1998 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

May 2000 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

National Center for Research Resources (NCRR)

Collaborators

University of Texas

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Porphyria

Keywords

inborn errors of metabolism, porphyria, rare disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Masking

None (Open Label)

Allocation

Randomized

Enrollment

24 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

heme arginate

Intervention Type

Drug

Intervention Name(s)

tin mesoporphyrin

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karl Elmo Anderson

Organizational Affiliation

University of Texas

Official's Role

Study Chair

Porphyria

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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