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Hemin in Healthy Subjects

Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteers

Intervention: Hemin infusion (Drug); placebo infusion (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Mayo Clinic

Official(s) and/or principal investigator(s):
Adil E Bharucha, M.D., Principal Investigator, Affiliation: Mayo Clinic

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.

Clinical Details

Official title: Effect of Hemin on Heme-Oxygenase-1 Activity in Healthy Subjects

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Primary outcome:

Venous carboxyhemoglobin concentrations

HO-1 protein concentration in leukocytes from venous blood

Serum bilirubin

Secondary outcome:

Venous carboxyhemoglobin concentrations

HO-1 activity in leukocytes from venous blood

Serum bilirubin

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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

1. Healthy non pregnant not breast feeding, and non-smoking subjects aged 18 - 65 years

old without clinical evidence of significant cardiovascular, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns. No symptoms of functional GI disorder as assessed by a validated questionnaire. 2. No medications except for stable doses of oral contraceptives or thyroid supplementation. Because ascorbic acid can induce HO-1 activity, multivitamins will need to be discontinued for 1 week before and for the duration of the study. 3. No intolerance or allergy to eggs 4. Able to provide written informed consent before participating in the study 5. Able to communicate adequately with the investigator and to comply with the requirements for the entire study 6. Screening weight < 96 kg

Locations and Contacts

Mayo Clinic, Rochester, Minnesota 55905, United States
Additional Information

Starting date: February 2009
Last updated: April 16, 2009

Page last updated: August 23, 2015

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