CLINICAL TRIALS PROFILE FOR PANHEMATIN

All Clinical Trials for PANHEMATIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00467610 ↗	Phase 2, Open-Label, Multi-Dose Study of Panhematin in Patients With MDS	Terminated	H. Lundbeck A/S	Phase 2	2007-05-01	This is a Phase II, open-label clinical trial examining the role of Panhematin® in patients with MDS. The objective of this study is to evaluate the safety and efficacy of Panhematin® (hematin for injection) in the treatment of adult patients (≥ 18 years of age) with low-risk MDS. The study will be conducted on an outpatient basis and will consist of the following: - A Screening Period (within 28 days of the Day 1) - Screening bone marrow aspiration and biopsy up to 60 days prior to receiving study medication - An 8-week Treatment Period (Days 1 through 4 of Week 1, and weekly visits during Weeks 2 through 8); partial and complete responders in any of the three cell lines may continue treatment for an additional 4 weeks - A 6-month Post treatment Follow-up Period (monthly clinic visits during Weeks 12 40)
NCT00467610 ↗	Phase 2, Open-Label, Multi-Dose Study of Panhematin in Patients With MDS	Terminated	Rush University Medical Center	Phase 2	2007-05-01	This is a Phase II, open-label clinical trial examining the role of Panhematin® in patients with MDS. The objective of this study is to evaluate the safety and efficacy of Panhematin® (hematin for injection) in the treatment of adult patients (≥ 18 years of age) with low-risk MDS. The study will be conducted on an outpatient basis and will consist of the following: - A Screening Period (within 28 days of the Day 1) - Screening bone marrow aspiration and biopsy up to 60 days prior to receiving study medication - An 8-week Treatment Period (Days 1 through 4 of Week 1, and weekly visits during Weeks 2 through 8); partial and complete responders in any of the three cell lines may continue treatment for an additional 4 weeks - A 6-month Post treatment Follow-up Period (monthly clinic visits during Weeks 12 40)
NCT00882804 ↗	Hemin in Healthy Subjects	Completed	Mayo Clinic	Phase 1	2009-02-01	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.
NCT02935400 ↗	Acute Porphyria Biomarkers for Disease Activity	Active, not recruiting	The University of Texas Medical Branch, Galveston		2014-04-28	The long term objective of the research is to identify new biomarkers of disease activity in the human acute porphyrias. This pilot study is intended to provide pilot and feasibility data needed to plan larger and more definitive future studies.

Clinical Trial Conditions for PANHEMATIN

Condition Name

Condition Name for PANHEMATIN
Intervention	Trials
Healthy Volunteers	1
Hereditary Coproporphyria	1
Myelodysplastic Syndrome	1
Variegate Porphyria	1

Condition MeSH

Condition MeSH for PANHEMATIN
Intervention	Trials
Porphyria, Acute Intermittent	1
Coproporphyria, Hereditary	1
Syndrome	1
Preleukemia	1

Clinical Trial Locations for PANHEMATIN

Trials by Country

Trials by Country for PANHEMATIN
Location	Trials
United States	3

Trials by US State

Trials by US State for PANHEMATIN
Location	Trials
Texas	1
Minnesota	1
Illinois	1

Clinical Trial Progress for PANHEMATIN

Clinical Trial Phase

Clinical Trial Phase for PANHEMATIN
Clinical Trial Phase	Trials
Phase 2	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for PANHEMATIN
Clinical Trial Phase	Trials
Active, not recruiting	1
Completed	1
Terminated	1

Clinical Trial Sponsors for PANHEMATIN

Sponsor Name

Sponsor Name for PANHEMATIN
Sponsor	Trials
The University of Texas Medical Branch, Galveston	1
H. Lundbeck A/S	1
Rush University Medical Center	1

Sponsor Type

Sponsor Type for PANHEMATIN
Sponsor	Trials
Other	3
Industry	1