Clinical Trials Register

Summary
EudraCT Number:	2020-000201-84
Sponsor's Protocol Code Number:	AT2020_01
National Competent Authority:	Austria - BASG
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2020-01-30
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Austria - BASG

A.2

EudraCT number

2020-000201-84

A.3

Full title of the trial

Oral and intravenous iron substitution for the treatment of iron deficiency symptoms in the context of fertility treatment - an exploratory pilot study

Orale und intravenöse Eisensubstitution zur Behandlung von Eisenmangelerscheinungen im Rahmen einer Kinderwunschbehandlung – eine explorative Pilotstudie

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Iron deficiency in fertility treatment

Eisenmangel in der Kinderwunschbehandlung

A.4.1

Sponsor's protocol code number

AT2020_01

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Das Kinderwunsch Institut Schenk GmbH
B.1.3.4	Country	Austria
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Das Kinderwunsch Institut Schenk GmbH
B.4.2	Country	Austria
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Das Kinderwunsch Institut Schenk GmbH
B.5.2	Functional name of contact point	Department Research and Development
B.5.3	Address:
B.5.3.1	Street Address	Am Sendergrund 11
B.5.3.2	Town/ city	Dobl
B.5.3.3	Post code	8143
B.5.3.4	Country	Austria
B.5.6	E-mail	gregor.weiss@kinderwunsch-institut.at

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Ferinject
D.2.1.1.2	Name of the Marketing Authorisation holder	Vifor Pharma
D.2.1.2	Country which granted the Marketing Authorisation	Austria
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Ferinject
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Eisen(III)-Carboxymaltose
D.3.9.1	CAS number	9007-72-1
D.3.9.3	Other descriptive name	FERRIC CARBOXYMALTOSE
D.3.9.4	EV Substance Code	SUB66620
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Ferretab
D.2.1.1.2	Name of the Marketing Authorisation holder	G.L. Pharma GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Austria
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Ferretab
D.3.2	Product code	13811-051-30
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Eisen(II)-fumarat
D.3.9.1	CAS number	141-01-5
D.3.9.3	Other descriptive name	FERROUS FUMARATE
D.3.9.4	EV Substance Code	SUB13865MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	304.2
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

infertility

Unfruchtbarkeit

E.1.1.1

Medical condition in easily understood language

infertility

Unfruchtbarkeit

E.1.1.2

Therapeutic area

Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The aim of the study is to compare hemoglobin, transferrin and ferritin concentrations, as well as TSAT four weeks after oral or intravenous iron substitution for the treatment of iron deficiency in patients undergoing fertility treatment.

Ziel der Studie ist der Vergleich der Hämoglobin-, Transferrin- und Ferritinkonzentrationen, sowie TSAT vier Wochen nach oraler oder intravenöser Eisensubstitution zur Behandlung eines Eisenmangels bei Patientinnen im Rahmen einer Kinderwunschbehandlung.

E.2.2

Secondary objectives of the trial

In addition to the main aim of the study, the evaluation and correlation of additional patient efficiency data obtained in the context of fertility treatment will be evaluated. These data are routinely obtained and logged. These include:
• patient age
• Weight and height
• Time to start treatment
• Ovarian stimulation
• ovulation induction
oocyte retrieval (number of MII oocytes)
• fertilization
• Day of embryo transfer
• Change in embryo morphokinetics (time-lapse data)
• implantation rate
• Pregnancy
• Baby take home rate

Neben dem Hauptziel der Studie ist auch die Evaluierung und Korrelation von zusätzlich im Rahmen der Kinderwunschbehandlung gewonnenen Effizienzdaten der Patienten dokumentiert. Diese Daten werden routinemäßig gewonnen und mitprotokolliert. Dazu zählen:
• Patientenalter
• Gewicht und Körpergröße
• Zeit bis zum Behandlungsbeginn
• Ovarielle Stimulation
• Ovulationsinduktion
• Eizellentnahme (Anzahl der MII Oozyten)
• Fertilisation
• Tag des Embryotransfers
• Veränderung der Embryo Morphokinetik (Time-Lapse Daten)
• Implantationsrate
• Schwangerschaftsnachweise
• Baby-Take-Home Rate

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Patients with iron deficiency (with and without anemia) defined by serum ferritin <30ng / ml and / or transferrin saturation (TSAT) <20%
• Primarily and secondarily sterile patients
• Patients with fertility treatment
• Age 18-40 at the time of enrollment
• Signed informed consent
• BMI between 19 and 29.9

• Patientinnen mit Eisenmangel (mit und ohne Anämie) definiert durch Serum-Ferritin < 30ng/ml und/oder Transferrinsättigung (TSAT) <20 %
• Primär und sekundär sterile Patientinnen
• Patientinnen mit Kinderwunschbehandlung
• Alter von 18-40 Jahren zum Zeitpunkt des Studieneinschlusses
• Unterschriebene Einverständniserklärung
• BMI zwischen 19 und 29,9

E.4

Principal exclusion criteria

• Patients with severe acute or chronic inflammation
• obesity
• hirsutism
• Mental inability, unwillingness or language barrier that prevents or makes it difficult to understand the declaration of consent or the necessary cooperation
• Current iron substitution
• Simultaneous use of other dietary supplements that contain iron
• Allergies to iron supplements
• pregnancy
• Patients taking proton inhibitors
Anemia not caused by iron deficiency e.g. (microcytic anemia)
• Evidence of iron overload or iron disruption

• Patientinnen mit schweren akuten oder chronischen Entzündungen
• Adipositas
• Hirsutismus
• Geistige Unfähigkeit, Unwillen oder sprachliche Barriere, die das Verstehen der Einwilligungserklärung oder der notwendigen Mitarbeit verhindert oder erschwert
• Aktuelle Eisensubstitution
• Gleichzeitige Verwendung anderer Nahrungsergänzungsmittel, welche Eisen enthalten
• Allergien gegen Eisenpräparate
• Vorliegende Schwangerschaft
• Einnahme von Protonenhemmer
• Nicht durch Eisenmangel bedingte Anämie z.B. (mikrozytäre Anämie)
• Anhaltspunkte für eine Eisenüberladung oder Eisenverwertungsstörung

E.5 End points

E.5.1

Primary end point(s)

hemoglobin
transferrin
ferritin
TSAT

Hämoglobin
Transferrin
Ferritin
TSAT

E.5.1.1

Timepoint(s) of evaluation of this end point

Between 2nd-5th day of the cycle hemoglobin, transferrin and ferritin values and TSAT are determined. If there is iron deficiency, the patients are treated with either Ferretab® (oral) or Ferinject® (intravenous). 4 weeks after the first treatment (administration of Ferinject® or Ferretab®), bhemoglobin, transferrin and ferritin values, as well as TSAT will be again determined.

Zwischen 2.-5. Zyklustag wird die Hämoglobin-, Transferrin- und Ferritinwerte, sowie TSAT bestimmt. Bei Vorliegen eines Eisenmangels werden die Patientinnen entweder mit Ferretab® (oral) oder Ferinject® (intravenös) behandelt. 4 Wochen nach der ersten Behandlung (Verabreichung Ferinject® oder Ferretab®) wird erneut eine Blutabnahme durchgeführt und ein Aliquot zur Bestimmung der Hämoglobin-, Transferrin- und Ferritinwerte, sowie TSAT durchgeführt

E.5.2

Secondary end point(s)

• Ovarian stimulation
• ovulation induction
oocyte retrieval (number of MII oocytes)
• fertilization
• Day of embryo transfer
• Change in embryo morphokinetics (time-lapse data)
• implantation rate
• Pregnancy
• Baby take home rate

• Ovarielle Stimulation
• Ovulationsinduktion
• Eizellentnahme (Anzahl der MII Oozyten)
• Fertilisation
• Tag des Embryotransfers
• Veränderung der Embryo Morphokinetik (Time-Lapse Daten)
• Implantationsrate
• Schwangerschaftsnachweise
• Baby-Take-Home Rate

E.5.2.1

Timepoint(s) of evaluation of this end point

All end points will be evaluated within one treatment cycle (1month).
Baby take home rate will be evaluated after child birth (9months)

Alle Endpunkte werden innerhalb eines Behandlungszyklus ermittelt (1 Monat).
Die Baby take home Rate wird nach der Geburt ermittelt (9Monate)

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

Yes

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Patients will continue fertility treatment.

Patienten bleiben in der Kinderwunschbehandlung

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2020-03-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-04-07

P. End of Trial
P.	End of Trial Status	Ongoing

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials