Clinical Trials Register

Summary
EudraCT Number:	2017-000994-35
Sponsor's Protocol Code Number:	06032017
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2017-12-21
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

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2017-000994-35

A.3

Full title of the trial

Study of tolerability of iron liposome compared to ferrous sulphate in pregnant women with iron deficiency anemia.

Estudio de la tolerabilidad del hierro liposomado en comparación con sulfato ferroso en gestantes con
anemia ferropénica

A.3.1

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

Study to compare two treatments in iron deficiency anemia in pregnant women

Estudio para comparar dos tratamientos en la anemia ferropénica en la embarazada

A.4.1

Sponsor's protocol code number

06032017

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	Hospital General Universitario de Alicante
B.1.3.4	Country	Spain
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	Hospital General de Alicante
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Hospital General Universitario de Alicante
B.5.2	Functional name of contact point	Lucía Perez Silvestre
B.5.3	Address:
B.5.3.1	Street Address	Calle Pintor Baeza 12
B.5.3.2	Town/ city	Alicante
B.5.3.3	Post code	03010
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34699438496
B.5.6	E-mail	perezsilvestre.lucia@gmail.com

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.2.1.1.1	Trade name	Tardyferon
D.2.1.1.2	Name of the Marketing Authorisation holder	PIERRE FABRE IBÉRICA, S.A
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Tablet
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	Dried ferrous sulphate BP
D.3.9.1	CAS number	79102-61-7
D.3.9.2	Current sponsor code	52994
D.3.9.3	Other descriptive name	DRIED FERROUS SULPHATE BP
D.3.9.4	EV Substance Code	SUB178765
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	80
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	Fisiogen ferro forte
D.2.1.1.2	Name of the Marketing Authorisation holder	Zambon
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Fisiogen Ferro Forte
D.3.2	Product code	164328
D.3.4	Pharmaceutical form	Capsule
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	Ferric Pyrophosphate
D.3.9.1	CAS number	10058-44-3
D.3.9.2	Current sponsor code	164328
D.3.9.3	Other descriptive name	FERRIC PYROPHOSPHATE
D.3.9.4	EV Substance Code	SUB13847MIG
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	30
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

Iron deficiency anaemia

Anemia ferropénica

E.1.1.1

Medical condition in easily understood language

Iron deficiency anaemia

Anemia ferropénica

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	HLT
E.1.2	Classification code	10002042
E.1.2	Term	Anaemia deficiencies
E.1.2	System Organ Class	100000004851

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 main objective of this study is to compare the tolerability of oral liposome iron versus oral ferrous sulfate in pregnant women diagnosed with iron deficiency anemia during the second trimester of pregnancy, based on the occurrence of side effects and adherence to treatment.
A low-level clinical trial of pregnant women is proposed for this purpose, since the investigational drugs are authorized and used in accordance with the terms of the marketing authorization, and their use is supported by published scientific data on the safety and efficacy of the stated drugs. Moreover, no additional diagnostic procedures involving an additional risk or burden for the safety of the subjects will be carried out.

El objetivo principal de este estudio es comparar la tolerabilidad del hierro liposomado oral frente al sulfato ferroso oral en gestantes diagnosticadas de anemia ferropénica durante el segundo trimestre de embarazo, en función de la aparición de efectos secundarios y la adherencia al tratamiento.
Se propone para ello un ensayo clínico de bajo nivel de intervención en gestantes, ya que los medicamentos en investigación están autorizados y se utilizan en conformidad con los términos de autorización de comercialización, estando su uso respaldado por datos científicos publicados sobre seguridad y eficacia de dichos medicamentos. Además no se llevarán a cabo procedimientos complementarios de diagnóstico adicionales que entrañen un riesgo o carga adicional para la seguridad de los sujetos.

E.2.2

Secondary objectives of the trial

- To compare the efficacy of oral ferric pyrophosphate versus oral ferrous sulfate in pregnant women diagnosed with iron deficiency anemia during the second trimester of pregnancy, depending on the
hemoglobin and hematocrit numbers.
- Evaluate the quality of life of the patients according to the treatment administered.
- Analyze the obstetric and perinatal outcomes in each treatment group.

- Comparar la eficacia del hierro liposomado oral frente al sulfato ferroso oral en gestantes diagnosticadas de anemia ferropénica durante el segundo trimestre de embarazo, en función de las cifras de hemoglobina y hematocrito.
- Evaluar la calidad de vida de las pacientes según el tratamiento administrado.
- Analizar los resultados obstétricos y perinatales en cada grupo de tratamiento.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-Pregnant women diagnosed with iron deficiency anemia in second trimester analysis (week 24-28), understood as hemoglobin <11 g / dL, serum ferritin <12 and hematocrit <33%.
-Pregnant women aged 18 or over.
- Single pregnancy.

· Gestantes diagnosticadas de anemia ferropénica en la analítica del segundo trimestre (semana 24-
28), entendida como hemoglobina <11 g/dL, ferritina sérica < 12 y hematocrito < 33%.
· Gestantes con edad igual o mayor a 18 años.
· Gestaciones únicas.

E.4

Principal exclusion criteria

· Anemia from other causes.
· Blood transfusion, treatment with oral or intravenous iron one month prior to analytical analysis of the second quarter.
· Chronic maternal medical pathology prior to gestation (clinical and/or analitic evidence of hepatic, renal, pulmonary, haematological or cardiovascular abnormalities, history of peptic ulcer
• Women with dietary restrictions (allergies or food intolerances). Women with specific dietary patterns (vegetarian or vegan).
• Hypersensitivity to iron supplements.
• Lactose intolerance.
• Severe anemia: hemoglobin <9 g/dl
· Fetal pathology: chromosomal abnormalities or fetal malformations on ultrasound.

· Anemia por otras causas.
· Transfusión sanguínea, tratamiento con hierro oral o intravenoso un mes previo a la analítica del segundo trimestre.
· Patología médica materna crónica previa a la gestación (evidencia clínica y/o analítica de patología hepática, renal, pulmonar, hematológica o anomalías cardiovasculares, historia de úlcera péptica)
· Mujeres con restricciones en la dieta (alergias
o intolerancias alimenticias).Mujeres con patrones de dieta específica (vegetarianas o veganas).
· Hipersensibilidad a los suplementos de hierro.
· Intolerancia a la lactosa.
· Anemia severa: hemoglobina < 9 g/dl
· Patología fetal: anomalías cromosómicas o malformaciones fetales en la ecografía.

E.5 End points

E.5.1

Primary end point(s)

The tolerability of oral ferric pyrophosphate versus oral ferrous sulfate will be compared in pregnant women diagnosed with iron deficiency anemia during the second trimester of pregnancy

Se comparará la tolerabilidad del hierro liposomado oral frente al sulfato ferroso oral en gestantes diagnosticadas de anemia ferropénica durante el segundo trimestre de embarazo

E.5.1.1

Timepoint(s) of evaluation of this end point

Baseline, month 1, month 2, month 3

Basal, mes 1, mes 2 y mes 3.

E.5.2

Secondary end point(s)

Eficacy
Quality of life
Obstetrical and perinatal outcomes

Eficacia
Calidad de vida
Resultados obstétricos y perinatológicoser information in other language that is applicable

E.5.2.1

Timepoint(s) of evaluation of this end point

Baseline, month 3

Basal, mes 3.

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

Yes

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Complemento alimenticio

Dietary supplement

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

The last visit of the last patient

La última visita de la última paciente

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:

130

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

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

Yes

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

130

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

Ninguno

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

2018-08-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-05-31

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

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