Clinical Trials Register

Summary
EudraCT Number:	2017-002972-15
Sponsor's Protocol Code Number:	Omalin-01
National Competent Authority:	Greece - EOF
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2017-09-26
Trial results	View 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

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A. Protocol Information

A.1

Member State Concerned

Greece - EOF

A.2

EudraCT number

2017-002972-15

A.3

Full title of the trial

Ferrous Acetyl-Aspartylated Casein Formulation Evaluation over Ferrous Sulfate in Iron Deficiency Anemia (Access): A Double-Dummy Randomized Clinical Trial

Μία συγκριτική με double-dummy κλινική μελέτη της αποτελεσματικότητας ενός σκευάσματος σιδήρου συζευγμένου με ακετυλ-ασπαρτυλ-καζεϊνη με το θειϊκό σίδηρο σε ασθενεές με σιδηροπενική αναιμία: η μελέτη ACCESS

A.3.1

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

Comparison of the efficacy of anew oral formulation of iron aspartylate to oral ferrous sulfate in patients with Iron Deficiency Anemia for the restoration of low hemoglobin

Σύγκριση της αποτελεσματικότητας της νέας μορφής Fe-ASP από του στόματος με την από του στόματος χορήγηση θειϊκού σιδήρου σε ασθενείς με Σιδηροπενική αναιμία για την αποκατάσταση της μειωμένης αιμοσφαιρίνης

A.3.2

Name or abbreviated title of the trial where available

ACCESS

A.4.1

Sponsor's protocol code number

Omalin-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	Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
B.1.3.4	Country	Greece
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
B.4.2	Country	Greece
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
B.5.2	Functional name of contact point	Regulatory Affairs department
B.5.3	Address:
B.5.3.1	Street Address	14th Km National Road 1
B.5.3.2	Town/ city	Kifissia/Athens
B.5.3.3	Post code	14564
B.5.3.4	Country	Greece
B.5.4	Telephone number	302108072512374
B.5.5	Fax number	302108078907
B.5.6	E-mail	soumelas@uni-pharma.gr

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Comparator
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.2.1.2	Country which granted the Marketing Authorisation	Greece
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.3.4	Pharmaceutical form	Modified-release 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	Ferrous sulfate
D.3.9.1	CAS number	7720-78-7
D.3.9.3	Other descriptive name	FERROUS SULFATE
D.3.9.4	EV Substance Code	SUB13877MIG
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	150
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	Omalin
D.2.1.1.2	Name of the Marketing Authorisation holder	Uni-Pharma SA
D.2.1.2	Country which granted the Marketing Authorisation	Greece
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.3.4	Pharmaceutical form	Oral solution in single-dose container
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	Iron protein acetyl aspartilate
D.3.9.3	Other descriptive name	IRON PROTEIN ACETYL ASPARTATE
D.3.9.4	EV Substance Code	SUB168526
D.3.10	Strength
D.3.10.1	Concentration unit	millilitre(s)/gram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	800
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Modified-release capsule, hard
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Oral solution in single-dose container
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Iron deficiency anemia

Σιδηροπενική αναιμία

E.1.1.1

Medical condition in easily understood language

Anemia due to reduced iron in the body

Αναιμία που οφείλεται σε μειωμένο σίδηρο στον οργανισμό

E.1.1.2

Therapeutic area

Diseases [C] - Blood and lymphatic diseases [C15]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10022972
E.1.2	Term	Iron deficiency anaemia
E.1.2	System Organ Class	10005329 - Blood and lymphatic system disorders

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 scope of this study is to compare the efficacy of the new oral formulation of Fe-ASP to oral ferrous sulfate in patients with IDA for the restoration of decreased circulating Hb.

Ο σκοπός αυτής της μελέτης είναι να συγκρίνει την αποτελεσματικότητα της νέας μορφής Fe-ASP από του στόματος με τη χορήγηση από του στόματος θειϊκού σιδήρου σε ασθενείς με ΣΠΑ αναφορικά με την αποκατάσταση της Hb αίματος.

E.2.2

Secondary objectives of the trial

The improvement of symptoms of anemia, the restoration of biomarkers of iron deficiency into the normal range and the incidence of GI tract side effects.

Η βελτίωση των συμπτωμάτων της αναιμίας, η αποκατάσταση των βιοδεικτών της σιδηροπενίας και η επίπτωση των ανεπιθυμήτων ενεργειών από το ΓΕΣ.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female
2. Age equal to or more than 18 years
3. Written informed consent provided by the patient
4. Hb below 10g/dl, as defined by other trials
5. Absolute red blood cell (RBC) count below 4.7 x 106/mm3 for men or 4.2 x 106/mm3 for women
6. Mean corpuscular volume (MCV) of RBCs below 80 fl
7. Mean corpuscular Hb (MCH) of RBCs below 27 pg
8. Total ferritin below 30 ng/ml; this criterion is associated with sensitivity more than 99% for iron deficiency
9. In the case of patients with anemia after GI tract hemorrhage, inclusion criteria 6 and 7 DO NOT apply for study inclusion

1. Άνδρες ή γυναίκες
2. Ηλικία ίση ή μεγαλύτερη από 18 έτη
3. Παροχή έγγραφης συγκατάθεσης από τον ασθενή
4. Hb μικρότερη από 10g/dl, όπως ορίζεται και από άλλες μελέτες
5. Απόλυτος αριθμός ερυθρών αιμοσφαιρίων (RBC) μικρότερος από 4.7 x 106/mm3 για τους άνδρες ή από 4.2 x 106/mm3 για τις γυναίκες
6. Μέσος όγκος ερυθρών αιμοσφαιρίων (MCV) μικρότερος από 80 fl
7. Μέση περιεκτικότητα σε Hb ανά ερυθρό αιμοσφαίριο (MCH) μικρότερη από 27 pg
8. Φερριτίνη μικρότερη από 30 ng/ml. Αυτό το κριτήριο συνδέεται με ευαισθησία μεγαλύτερη από 99% για σιδηροπενία
9. Στην περίπτωση ασθενών με αναιμία λόγω αιμορραγίας από το ΓΕΣ, τα κριτήρια εισαγωγής 6 και 7 ΔΕΝ ισχύουν

E.4

Principal exclusion criteria

• Age below 18 years
• Denial to provide written informed consent
• Acute myelogenous or lymphoblastic leukemia
• Multiple myeloma
• Primary or secondary myelodysplastic syndrome
• Planning for start of chemotherapy within the first 30 days after inclusion in the trial
• Planning for start of radiotherapy within the first 30 days after inclusion in the trial
• Intake of erythropoietin
• Planning for start of erythropoietin within the first 30 days after inclusion in the trial
• Intake of chemotherapy the last six months
• Intake of radiotherapy the last six months
• Known hemochromatosis
• Known celiac disease
• Liver cirrhosis of Child-Pugh stage II or III
• Any active overt bleeding
• Pregnancy or lactation

• Ηλικία μικρότερη των 18 ετών
• Άρνηση παροχής εγγράφου συγκατάθεσης συμμετοχής
• Οξεία μυελογενής ή λεμφογενής λευχαιμία
• Πολλαπλούν μυέλωμα
• Πρωτοπαθές ή δευτεροπαθές μυελοδυσπλαστικό σύνδρομο
• Σχεδιασμός για έναρξη συστηματικής χημειοθεραπείας εντός των πρώτων 30 ημερών από την ένταξη στη μελέτη
• Σχεδιασμός για έναρξη ακτινοθεραπείας εντός των πρώτων 30 ημερών από την ένταξη στη μελέτη
• Λήψη ερυθροποιητίνης
• Σχεδιασμός για έναρξη ερυθροποιητίνης εντός των πρώτων 30 ημερών από την ένταξη στη μελέτη
• Λήψη χημειοθεραπείας τους τελευταίους 6 μήνες
• Λήψη ακτινοθεραπείας τους τελευταίους 6 μήνες
• Γνωστή αιμοχρωμάτωση
• Γνωστή κοιλιοκάκη
• Κίρρωση ήπατος σταδίων ΙΙ ή ΙΙΙ κατά Child-Pugh
• Οποιαδήποτε ενεργός αιμορραγία
• Εγκυμοσύνη ή θηλασμός

E.5 End points

E.5.1

Primary end point(s)

The primary study endpoint is the comparative increase of baseline Hb in each study group after the first 4 weeks of treatment. Since the daily amount of elemental iron delivered with the ferrous sulfate regimen is 94 mg and with the Fe-ASP regimen 80 mg, the increase of baseline Hb will be adjusted per mg of delivered elemental iron.

Το πρωτογενές καταληκτικό σημείο είναι η συγκριτική αύξηση της βασικής Hb έναρξης σε κάθε ομάδα μελέτης μετά τις πρώτες 4 εβδομάδες θεραπείας. Επειδή η ποσότητα στοιχειακού σιδήρου που χορηγείται ημερησίως στο σκεύασμα του θειϊκού σιδήρου είναι 94 mg και του Fe-ASP 80 mg, η αύξηση της βασικής Hb θα εκφραστεί ανά mg χορηγούμενου στοιχειακού σιδήρου.

E.5.1.1

Timepoint(s) of evaluation of this end point

4 weeks

4 εβδομάδες

E.5.2

Secondary end point(s)

The secondary study endpoints will be the differences between the two groups of treatment in the following:
• Normalization of Hb; this is defined as Hb≥13 g/dl for mean and ≥12 g/dl for women
• Ferritin levels at weeks 4 and 12
• Absolute reticulocyte count at weeks 1, 4 and 12
• Absolute RBC count, Hb, MCV and MCH at weeks 4 and 12
• Change of the fatigue symptoms of IDA at weeks 4 and 12
• Change of physical findings of IDA at weeks 4 and 12
• The incidence of GI side effects at weeks 4 and 12

Τα δευτερογενή καταληκτικά σημεία θα είναι οι διαφορές μεταξύ των δύο ομάδων θεραπείας στα ακόλουθα:
• Επάνοδος Hb στα φυσιολογικά όρια η οποία ορίζεται ως Hb≥13 g/dl προκειμένου περί ανδρών και and ≥12 g/dl προκειμένου περί γυναικών
• Συγκεντρώσεις φερριτίνης στις εβδομάδες 4 και 12
• Απόλυτος αριθμός ΔΕΚ στις εβδομάδες 1, 4 και 12
• Απόλυτος αριθμός RBC, Hb, MCV και MCH στις εβδομάδες 4 και 12
• Μεταβολή των συμπτωμάτων της κόπωσης της ΣΠΑ στις εβδομάδες 4 και 12
• Μεταβολή των αντικειμενικών ευρημάτων της ΣΠΑ στις εβδομάδες 4 και 12
• Εκδήλωση ανεπιθυμήτων ενεργειών από το ΓΕΣ στις εβδομάδες 4 και 12

E.5.2.1

Timepoint(s) of evaluation of this end point

12 weeks

12 εβδομάδες

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

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

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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

Yes

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

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in 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)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

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

F.3.3.2

Women of child-bearing potential using contraception

Yes

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)

None

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

2017-10-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-09-15

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-01-08

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