Status:
TERMINATED
ORal IrON Supplementation With Ferric Maltol in Patients With Pulmonary Hypertension (ORION-PH-1)
Lead Sponsor:
Hannover Medical School
Collaborating Sponsors:
Shields, Shields and Associates
Conditions:
Hypertension, Pulmonary
Anemia, Iron Deficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is an explorative, open-label, uncontrolled, single center study to explore the preliminary safety, tolerability and efficacy of oral ferric maltol in treating iron deficiency in patients with pu...
Eligibility Criteria
Inclusion
- Signed written informed consent prior to any study-related procedure and willingness to comply with treatment and follow-up procedures
- Male and female patients ≥18 years at day of inclusion
- Patients capable of understanding the investigational nature, potential risks and benefits of the clinical trial
- Patients with a diagnosis of PH confirmed by a (historical) right heart catheterization showing a mean pulmonary artery pressure ≥25 mmHg at rest and stable PH medication for at least 3 months.
- 6 min walk distance \>50 m
- Mild-to-moderate iron-deficiency anemia as defined by a hemoglobin concentration ≥7 g/dl and \<12 g/dl in females or ≥8 g/dl and \<13 g/dl in males, and serum ferritin \<100 µg/l, or 100-300 µg/l and transferrin saturation \<20% at screening
- Prevention of pregnancy:
- Women without childbearing potential defined as follows:
- at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy or
- hysterectomy or uterine agenesis or
- ≥ 50 years and in postmenopausal state ≥ 1 year or
- \< 50 years and in postmenopausal state ≥ 1 year with serum FSH \> 40 IU/l and serum oestrogen \< 30 ng/l or a negative oestrogen test or
- Women of childbearing potential with a negative ß-HCG pregnancy test at screening who agree to meet one of the following criteria from the time of screening, during the study and for a period of four weeks following the last administration of study medication:
- correct use of contraception methods. The following are acceptable: hormonal contraceptives (combined oral contraceptives and oestrogen-free pills with desogestrel, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release), intrauterine device (IUS) or a barrier method, e.g. condom or occlusive cap (diaphragm or cervical/vault caps) with spermicide (foam, gel, film, cream or suppository)
- true abstinence (periodic abstinence and withdrawal are not acceptable methods of contraception)
- sexual relationship only with female partners and/or sterile male partners
Exclusion
- Active hematological disorders other than iron-deficiency anemia
- Other medical condition that according to the investigator's assessment is causing or contributing to anemia
- Active malignancy
- Active infectious disease
- Active bleeding
- Severe renal insufficiency (glomerular filtration rate \<30 ml/min)
- Severe liver injury as indicated by serum aminotransferases \>3 x upper limit of normal or bilirubin levels \>50 µmol/l
- Ongoing oral or intravenous iron supplementation
- Hemoglobin \<7 g/dl in females or \<8 g/dl in males at screening
- Concomitant erythropoietin medication
- Pregnancy or lactation period
- Subject has received any investigational medication or any investigational device within 30 days prior to the first dose of study medication or is actively participating in any investigational drug/devices trial, or is scheduled to receive an investigational drug/device during the course of the study.
- Known or suspected hypersensitivity to any of the active substances or any excipients of the investigational medicinal product
- Known haemochromatosis or other iron overload syndromes
- Patients who have been receiving repeated (\>1) blood transfusions during the past 6 months
Key Trial Info
Start Date :
March 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2020
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03371173
Start Date
March 27 2018
End Date
March 19 2020
Last Update
April 21 2020
Active Locations (1)
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1
Hannover Medical School
Hanover, Germany, 30625