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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00004398
• Date of registration: 18/10/1999
• Prospective Registration: No
• Primary sponsor: National Center for Research Resources (NCRR)
• Public title: Phase I Study of Heme Arginate With or Without Tin Mesoporphyrin in Patients With Acute Attacks of Porphyria
• Date of first enrolment: January 1998
• Target sample size: 24
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00004398
• Study type: Interventional
• Study design: Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Contacts

• Name: Karl Elmo Anderson
• Affiliation: University of Texas

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Porphyria

Intervention(s)

Drug: tin mesoporphyrin

Drug: heme arginate

Secondary ID(s)

UTMB-FDR001459

UTMB-97-118

199/13191

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Texas