Hemin in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Hemin infusion; Drug: placebo infusion

• Registration Number: NCT00882804
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Heme-oxygenase 1 (HO-1) degrades heme, protects cells against oxidative stress, and is beneficial in several experimental models but has not been pharmacologically activated in humans. The objectives of this study were to evaluate the effects of hemin on HO-1 activity in healthy subjects. Hemin is the most powerful inducer of HO-1. Hemin is FDA-approved to treat acute intermittent porphyria. In addition, hemin has also been used to treat thalassemia intermedia, myelodysplastic syndrome, and to control liver allograft failure due to recurrence of erythropoietic prototheria. Our hypothesis is that compared to placebo, hemin will increase HO-1 in humans. Ten healthy subjects will be randomized to hemin (n = 5, Panhematin®, Ovation Pharmaceuticals, 3 mg/kg i.v. in 25% albumin) or placebo (n = 5, 25% albumin) infusion. HO-1 activity will be assessed before and after (4, 6, 24, and 48 hours) infusions.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2009-02
• Status Verified: 2009-04
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Study First Submitted: 2009-04-16
• Study First Submitted QC: 2009-04-16
• Last Update Submitted: 2009-04-16
• Study First Posted: 2009-04-17
• Last Update Posted: 2009-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hemin	Hemin infusion	-
placebo	placebo infusion	-

Primary Outcome Measures

Name	Time	Method
Venous carboxyhemoglobin concentrations	at 6 hours
HO-1 protein concentration in leukocytes from venous blood	at 6 hours
Serum bilirubin	at 6 hours

Secondary Outcome Measures

Name	Time	Method
Venous carboxyhemoglobin concentrations	at 4, 24, and 48 hours
HO-1 activity in leukocytes from venous blood	at 4, 24, and 48 hours
Serum bilirubin	at 4, 24, and 48 hours

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States