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Trial record 11 of 382 for:    FERRIC CATION

ORal IrON Supplementation With Ferric Maltol in Patients With Pulmonary Hypertension (ORION-PH-1) (ORION-PH-1)

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ClinicalTrials.gov Identifier: NCT03371173
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : June 18, 2019
Sponsor:
Collaborator:
Shields, Shields and Associates
Information provided by (Responsible Party):
Hannover Medical School

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 pulmonary hypertension and iron deficiency anemia.

Condition or disease Intervention/treatment Phase
Hypertension, Pulmonary Anemia, Iron Deficiency Drug: Ferric maltol 30 mg (Feraccru®) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Explorative, open-label, uncontrolled monocenter study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Explore Preliminary Safety, Tolerability and Efficacy of ORal IrON Supplementation With Ferric Maltol in Treating Iron Deficiency in Patients With Pulmonary Hypertension and Iron Deficiency Anemia
Actual Study Start Date : March 27, 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ferric maltol 30 mg (Feraccru®)
Treatment with Feraccru® 30 mg hard capsules (Ferric maltol 30 mg). One capsule twice daily, morning and evening, on an empty stomach for 12 weeks
Drug: Ferric maltol 30 mg (Feraccru®)
Feraccru® 30 mg hard capsules will be used. Each capsule contains 30 mg iron (as ferric maltol), 91.5 mg of lactose, 0.5 mg of Allura Red AC (E129) and 0.3 mg Sunset Yellow FCF (E110) as excipients with known effects




Primary Outcome Measures :
  1. Change in hemoglobin level from baseline to week 12 [ Time Frame: baseline to week 12 ]
    measurement of hemoglobin in blood


Secondary Outcome Measures :
  1. Change in hemoglobin from baseline to week 6 [ Time Frame: baseline to week 6 ]
    measurement of hemoglobin in blood

  2. Change in serum ferritin levels from baseline to week 6 and 12 [ Time Frame: baseline to week 6 and baseline to week 12 ]
    measurement of serum ferritin levels

  3. Change in transferrin saturation from baseline to week 6 and 12 [ Time Frame: baseline to week 6 and baseline to week 12 ]
    measurement of transferrin saturation

  4. Change in 6 min walking distance from baseline to week 12 [ Time Frame: baseline to week 12 ]
    measurement of functional exercise capacity

  5. Change in serum NT-proBNP from baseline to weeks 6 and 12 [ Time Frame: baseline to week 6 and baseline to week 12 ]
    measurement of serum NT-proBNP

  6. Change in echocardiographic markers of right ventricular function from baseline to week 12 (1) [ Time Frame: from baseline to week 12 ]
    measurement of right atrial area

  7. Change in echocardiographic markers of right ventricular function from baseline to week 12 (2) [ Time Frame: from baseline to week 12 ]
    measurement of right ventricular diameter

  8. Change in echocardiographic markers of right ventricular function from baseline to week 12 (3) [ Time Frame: from baseline to week 12 ]
    measurement of fractional area change

  9. Change in echocardiographic markers of right ventricular function from baseline to week 12 (4) [ Time Frame: from baseline to week 12 ]
    measurement of tricuspid annular plane systolic excursion

  10. Change in World Health Organization Functional Class (WHO FC) from baseline to week 6 and week 12 [ Time Frame: from baseline to week 6 and week 12 ]
    measurement of different parameter according to an evaluated process


Other Outcome Measures:
  1. Incidence of Adverse Events [Safety and Tolerability] [ Time Frame: first application of IMP until 4 weeks after treatment discontinuation ]
    Number of Adverse Events

  2. Incidence of Serious Adverse Events [Safety and Tolerability] [ Time Frame: first application of IMP until 4 weeks after treatment discontinuation ]
    Number of Serious Adverse Events



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed written informed consent prior to any study-related procedure and willingness to comply with treatment and follow-up procedures
  2. Male and female patients ≥18 years at day of inclusion
  3. Patients capable of understanding the investigational nature, potential risks and benefits of the clinical trial
  4. 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.
  5. 6 min walk distance >50 m
  6. 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
  7. 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 Criteria:

  1. Active hematological disorders other than iron-deficiency anemia
  2. Other medical condition that according to the investigator's assessment is causing or contributing to anemia
  3. Active malignancy
  4. Active infectious disease
  5. Active bleeding
  6. Severe renal insufficiency (glomerular filtration rate <30 ml/min)
  7. Severe liver injury as indicated by serum aminotransferases >3 x upper limit of normal or bilirubin levels >50 µmol/l
  8. Ongoing oral or intravenous iron supplementation
  9. Hemoglobin <7 g/dl in females or <8 g/dl in males at screening
  10. Concomitant erythropoietin medication
  11. Pregnancy or lactation period
  12. 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.
  13. Known or suspected hypersensitivity to any of the active substances or any excipients of the investigational medicinal product
  14. Known haemochromatosis or other iron overload syndromes
  15. Patients who have been receiving repeated (>1) blood transfusions during the past 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03371173


Contacts
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Contact: Marius Hoeper, Prof. Dr. +49 511-532 ext 3530 hoeper.marius@mh-hannover.de

Locations
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Germany
Hannover Medical School Recruiting
Hannover, Germany, 30625
Contact: Marius M Hoeper, MD    0049 511 532 3530    hoeper.marius@mh-hannover.de   
Sponsors and Collaborators
Hannover Medical School
Shields, Shields and Associates
Investigators
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Principal Investigator: Marius Hoeper, Prof. Dr. Hannover Medical School, Department of Pneumology

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Responsible Party: Hannover Medical School
ClinicalTrials.gov Identifier: NCT03371173     History of Changes
Other Study ID Numbers: ORION-PH-1
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Hannover Medical School:
Pulmonary Hypertension
Iron Deficiency
Additional relevant MeSH terms:
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Ferric maltol
Ferric Compounds
Hypertension, Pulmonary
Hypertension
Anemia
Anemia, Iron-Deficiency
Vascular Diseases
Cardiovascular Diseases
Hematologic Diseases
Lung Diseases
Respiratory Tract Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics