Hemin in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00882804
First received: April 16, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Drug: Hemin infusion
Drug: placebo infusion
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: Effect of Hemin on Heme-Oxygenase-1 Activity in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Venous carboxyhemoglobin concentrations [ Time Frame: at 6 hours ]
  • HO-1 protein concentration in leukocytes from venous blood [ Time Frame: at 6 hours ]
  • Serum bilirubin [ Time Frame: at 6 hours ]

Secondary Outcome Measures:
  • Venous carboxyhemoglobin concentrations [ Time Frame: at 4, 24, and 48 hours ]
  • HO-1 activity in leukocytes from venous blood [ Time Frame: at 4, 24, and 48 hours ]
  • Serum bilirubin [ Time Frame: at 4, 24, and 48 hours ]

Enrollment: 10
Study Start Date: February 2009
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hemin 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.
Placebo Comparator: placebo Drug: placebo infusion
25 % albumin will be administered through a large-caliber peripheral vein at a dose at a rate of 60 mL/hour.

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00882804

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Adil E Bharucha, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Adil E. Bharucha, M.D., Mayo Clinic, Rochester
ClinicalTrials.gov Identifier: NCT00882804     History of Changes
Other Study ID Numbers: 09-000230
Study First Received: April 16, 2009
Last Updated: April 16, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
hemin, heme oxygenase, humans, HO-1

ClinicalTrials.gov processed this record on September 18, 2014