ORION-PH-1

Overview
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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.

SEEK ID: https://ldh.zks-mhh.imise.uni-leipzig.de/projects/6

Public web page: Not specified

NFDI4Health PALs: No PALs for this Project

Project start date: 27th Mar 2018

Project end date: 19th Mar 2020

Extended Metadata (Nfdi4Health MDS 3.3)

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Resource classification(*)

Type of the resource : Study

Title(s)/name(s) of the Project

Title/name : 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
Language of the title/name : English

Acronym(s) of the Project

Acronym : ORION-PH-1
Language of the acronym : English

Description(s) of the Project

Description : 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.
Language of the description : English

Keyword(s) describing the Project

Keyword(*) : Pulmonary Hypertension

Keyword(*) : Iron Deficiency

Language(s) of the project : English

Contributor(s) of the Project

Is it a personal or organisational contribution?(*) : Personal
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Not specified
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Not specified
Details about the contributing person(s)
Contributor type(*) : Principal investigator
Given name(*) : Marius
Family name(s)(*) : Hoeper
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : Not specified
Phone number : Not specified
Organisation(s) associated with the contributor
Name(*) : Hannover Medical School, Department of Pneumology
Address : Carl-Neuberg-Str. 1, 30625 Hannover
Web page : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified

Is it a personal or organisational contribution?(*) : Personal
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Not specified
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Not specified
Details about the contributing person(s)
Contributor type(*) : Sponsor (primary)
Given name(*) : Christoph
Family name(s)(*) : Schindler
Digital identifier(s)
Identifier(*) : orcid.org/0000-0002-6779-0057
Scheme(*) : ORCID
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : Schindler.Christoph@mh-hannover.de
Phone number : Not specified
Organisation(s) associated with the contributor
Name(*) : Medical School Hannover, Center for Clinical Studies
Address : Carl-Neuberg-Str. 1, 30625 Hannover
Web page : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Identifier(*) : Not specified
Scheme(*) : Not specified
Name(*) : Not specified
Address : Not specified
Web page : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Identifier(*) : Not specified
Scheme(*) : Not specified

Alternative identifiers

Type of the registry(*) : EudraCT
Identifier(*) : 2016-005100-26

Characteristics of the Project

Is it an interventional or non-interventional Project? : Interventional
Specification of the type of the Project
Interventional Project type : Single group
Non-interventional Project type : []
Primary health condition(s) or disease(s) considered in the Project
Primary health condition or disease name(*) : Iron deficiency anemia
Terminology/classification(*) : MedDRA
Code of the health condition or disease : 10022974
Primary health condition or disease name(*) : Pulmonary hypertensions
Terminology/classification(*) : MedDRA
Code of the health condition or disease : 10037401
Groups of diseases or conditions(*)
Which groups of diseases or conditions were the data collected on? : Diseases of the blood or blood-forming organs and certain disorders involving the immune mechanism (III), Diseases of the respiratory system (X)
On which diseases or conditions were the data collected? : []
Collects mortality data? : Not specified
Administrative information about the Project
Status of the ethics committee approval : Request for approval submitted, approval granted
Overall Project status : Terminated: Recruitment, data collection, data and quality management halted prematurely and will not resume
Participants enrolled by invitation? : Not specified
Start date : 27 March 2018
End date : 19 March 2020
Mono- or multicentric? : Monocentric
Number of centers : Not specified
One or more data providers? : Not specified
Number of data providers : Not specified
Primary subject(*) : Not specified
Eligibility criteria for Project participants
Eligibility criteria: Minimum age
Minimum eligible age(*) : 18
Unit of age(*) : Years
Eligibility criteria: Maximum age
Maximum eligible age(*) : Not specified
Unit of age(*) : Not specified
Eligible gender : Male, Female, Diverse
Inclusion criteria : 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 criteria : 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 Ages Eligible for Study 18 Years and older (Adult, Older Adult ) Sexes Eligible for Study All Accepts Healthy Volunteers No
Population of the Project(*)
Coverage : National
Country(ies) : Germany
Region(s) and/or city(ies) : Not specified
Interventions of the Project
Name of the intervention(*) : Ferric maltol 30 mg (Feraccru®)
Type of the intervention : Drug (including placebo)
Additional information about the intervention : 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
Name(s) of the arm(s) associated with the given intervention : Not specified
Exposures of the Project
Name of the exposure : Not specified
Type of the exposure : Not specified
Additional information about the exposure : Not specified
Name(s) of the group(s) associated with the given exposure : Not specified
Outcome measures in the Project
Name of the outcome measure(*) : Change in hemoglobin level from baseline to week 12
Description of the outcome measure : measurement of hemoglobin in blood
Type of the outcome measure : Primary
Time point(s) of assessment : baseline to week 12
Name of the outcome measure(*) : Change in hemoglobin from baseline to week 6
Description of the outcome measure : measurement of hemoglobin in blood
Type of the outcome measure : Secondary
Time point(s) of assessment : baseline to week 6
Name of the outcome measure(*) : Change in serum ferritin levels from baseline to week 6 and 12
Description of the outcome measure : measurement of serum ferritin levels
Type of the outcome measure : Secondary
Time point(s) of assessment : baseline to week 6 and baseline to week 12
Name of the outcome measure(*) : Change in transferrin saturation from baseline to week 6 and 12
Description of the outcome measure : measurement of transferrin saturation
Type of the outcome measure : Secondary
Time point(s) of assessment : baseline to week 6 and baseline to week 12
Name of the outcome measure(*) : Change in 6 min walking distance from baseline to week 12
Description of the outcome measure : measurement of functional exercise capacity
Type of the outcome measure : Secondary
Time point(s) of assessment : baseline to week 12
Name of the outcome measure(*) : Change in serum NT-proBNP from baseline to weeks 6 and 12
Description of the outcome measure : measurement of serum NT-proBNP
Type of the outcome measure : Secondary
Time point(s) of assessment : baseline to week 6 and baseline to week 12
Name of the outcome measure(*) : Change in echocardiographic markers of right ventricular function from baseline to week 12 (1)
Description of the outcome measure : measurement of right atrial area
Type of the outcome measure : Secondary
Time point(s) of assessment : from baseline to week 12
Name of the outcome measure(*) : Change in echocardiographic markers of right ventricular function from baseline to week 12 (2)
Description of the outcome measure : measurement of right ventricular diameter
Type of the outcome measure : Secondary
Time point(s) of assessment : from baseline to week 12
Name of the outcome measure(*) : Change in echocardiographic markers of right ventricular function from baseline to week 12 (3)
Description of the outcome measure : measurement of fractional area change
Type of the outcome measure : Secondary
Time point(s) of assessment : from baseline to week 12
Name of the outcome measure(*) : Change in echocardiographic markers of right ventricular function from baseline to week 12 (4)
Description of the outcome measure : measurement of tricuspid annular plane systolic excursion
Type of the outcome measure : Secondary
Time point(s) of assessment : from baseline to week 12
Name of the outcome measure(*) : Change in World Health Organization Functional Class (WHO FC) from baseline to week 6 and week 12
Description of the outcome measure : measurement of different parameter according to an evaluated process
Type of the outcome measure : Secondary
Time point(s) of assessment : from baseline to week 6 and week 12
Name of the outcome measure(*) : Incidence of Adverse Events [Safety and Tolerability]
Description of the outcome measure : Number of Adverse Events
Type of the outcome measure : Other
Time point(s) of assessment : first application of IMP until 4 weeks after treatment discontinuation
Name of the outcome measure(*) : Incidence of Serious Adverse Events [Safety and Tolerability]
Description of the outcome measure : Number of Serious Adverse Events
Type of the outcome measure : Other
Time point(s) of assessment : first application of IMP until 4 weeks after treatment discontinuation
Additional information about the Project : Not specified
Additional assessments/measurements in the Project : []
Data sharing strategy of the Project(*)
Is it planned to share the data?(*) : Not specified
Supporting documents available in addition to the data : []
When and for how long will the data be available? : Not specified
Criteria for data access : Not specified
Additional information about data sharing : Not specified
DataSHIELD/Opal infrastructure available? : Not specified
Link to data request application : Not specified
Web page with additional information about data sharing : Not specified
Record linkage possible? : false
Non-interventional aspects of the Project
Temporal design : []
Target follow-up duration of the Project
Target follow-up duration(*) : Not specified
Unit of time(*) : Not specified
Number of follow-ups conducted : Not specified
Biosamples retained in a biorepository : []
Specific types of retained biosamples : Not specified
Interventional aspects of the Project
Numerical phase : Phase-3
Masking of intervention(s) assignment
Masking implemented? : false
Who is masked? : []
Additional information about masking : Not specified
Type of allocation of participants to an arm : Not applicable (for single-arm trials)
Off-label use of a drug product : Not specified

ORION-PH-1

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