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

Porphyria Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004398
• Other study ID #: 199/13191
• Secondary ID: UTMB-97-118UTMB-
• Status: Completed
• Phase: Phase 1
• First received: October 18, 1999
• Last updated: June 23, 2005
• Start date: January 1998
• Est. completion date: May 2000

Study information

• Verified date: June 2000
• Source: Office of Rare Diseases (ORD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Porphyria
• Porphyria, Erythropoietic
• Porphyrias

Intervention

Drug:
• heme arginate

• tin mesoporphyrin

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Research Resources (NCRR)	University of Texas