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Hemin in Healthy Subjects

NCT00882804 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2009-04-17

No results posted yet for this study

Summary

This study is being done because we want to learn if hemin can increase the production of heme oxygenase 1. Heme oxygenase 1 (HO-1) is an enzyme which protects cells from physical, chemical, and biologic stress. Hemin is produced from red blood cells and is approved by the Food and Drug Administration for treating acute porphyria, which is an inherited condition caused by an enzyme deficiency.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Hemin infusion

Hemin (Panhematin®, Ovation Pharmaceuticals, Deerfield, IL) will be administered through a large-caliber peripheral vein at a dose of 1.25 mL/kg and at a rate of 60 mL/hour. To enhance stability, Panhematin® will be diluted in \~ 132 mL of 25% albumin to obtain a hemin concentration of 2.4 mg/mL.

DRUG

placebo infusion

25 % albumin will be administered through a large-caliber peripheral vein at a dose at a rate of 60 mL/hour.

Sponsors & Collaborators

Principal Investigators

  • Adil E Bharucha, M.D. · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00882804 on ClinicalTrials.gov