Clinical Trials Register

Summary
EudraCT Number:	2016-001467-36
Sponsor's Protocol Code Number:	FER-CARS-06
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2017-12-01
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

Spain - AEMPS

A.2

EudraCT number

2016-001467-36

A.3

Full title of the trial

A Randomised, Double-blind Placebo Controlled Trial Comparing the Effect of Intravenous Ferric Carboxymaltose on Hospitalisations and Mortality in Iron Deficient Patients Admitted for Acute Heart Failure (Affirm-AHF)

Ensayo aleatorizado, en doble ciego y controlado con placebo, comparativo del efecto de la carboximaltosa férrica intravenosa sobre las hospitalizaciones y la mortalidad en pacientes con ferropenia ingresados por insuficiencia cardiaca aguda (AFFIRM-AHF)

A.3.1

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

A study to compare the use of ferric carboxymaltose with placebo in patients with acute heart failure and iron deficiency

Estudio para comparar el uso de carboximaltosa férrica con placebo en pacientes con insuficiencia cardiaca aguda y ferropenia.

A.3.2

Name or abbreviated title of the trial where available

AFFIRM-AHF

A.4.1

Sponsor's protocol code number

FER-CARS-06

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	Vifor (International) Inc.
B.1.3.4	Country	Switzerland
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	Vifor (International) Inc.
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Vifor (International) Inc.
B.5.2	Functional name of contact point	Clinical Trial Information Desk
B.5.3	Address:
B.5.3.1	Street Address	Flughofstrasse 61
B.5.3.2	Town/ city	Glattbrugg
B.5.3.3	Post code	CH-8152
B.5.3.4	Country	Switzerland
B.5.4	Telephone number	+4158851 81 26
B.5.5	Fax number	+4158851 80 01
B.5.6	E-mail	ClinicalResearch@viforpharma.com

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 France SA
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	Injection
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	FERRIC CARBOXYMALTOSE
D.3.9.1	CAS number	9007-72-1
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.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	Solution for injection
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Acute heart failure with iron deficiency

Insuficiencia cardiaca aguda con ferropenia (iron deficiency, ID

E.1.1.1

Medical condition in easily understood language

Acute heart failure with iron deficiency

Insuficiencia cardiaca aguda con ferropenia (iron deficiency, ID

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	SOC
E.1.2	Classification code	10007541
E.1.2	Term	Cardiac disorders
E.1.2	System Organ Class	10007541 - Cardiac disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10000803
E.1.2	Term	Acute heart failure
E.1.2	System Organ Class	10007541 - Cardiac disorders

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	10022970
E.1.2	Term	Iron deficiency
E.1.2	System Organ Class	10027433 - Metabolism and nutrition 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

To evaluate, relative to placebo, the effect of intravenous (IV) FCM on repeated heart failure (HF) hospitalisations and cardiovascular (CV) death.

Evaluar, en comparación con el placebo, el efecto de la FCM intravenosa (IV) sobre las hospitalizaciones recurrentes por insuficiencia cardiaca (heart failure, HF) y las muertes por causa cardiovascular (CV)

E.2.2

Secondary objectives of the trial

To evaluate, relative to placebo, the effect of IV FCM on: HF hospitalizations, CV hospitalizations, CV mortality and all cause mortality Quality of life and New York Heart Association Classification (NYHA) Tolerability and safety.

Evaluar, en comparación con el placebo, el efecto de la FCM IV sobre: Hospitalizaciones por insuficiencia cardiaca, hospitalización por causa CV, mortalidad por causa CV y mortalidad por todas las causas; calidad de vida y New York Heart Association Classification (NYHA); Tolerabilidad y seguridad.

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Biomarker Blood Samples
It is planned to perform biomarker analyses in blood samples from approximately 60% of randomised subjects. The decision concerning which biomarkers will be analysed will be made by in collaboration with the Study Steering Committee, together with the Sponsor. If the biomarker samples will not be analysed, they will be destroyed. Details concerning the blood samples storage will be provided in an instruction manual. If conducted, the statistical analysis for the biomarker blood samples will be detailed in a separate biomarker SAP and results of these exploratory analyses will be not part of the clinical study report of the main study .

Muestras sanguíneas para biomarcadores.
Se planea en efectuar un análisis de biomarcadores en sangre en aproximadamente un 60% de los pacientes aleatorizados. La decisión referente a que biomarcadores se analizaran se hará en colaboración con el Comité de Dirección del Estudio junto con el Promotor. Si el biomarcador no se analizara seria destruido. Los detalles del almacenaje de las muestras de sangre se facilitaran en un “Manual de Instrucciones”. Si se llevara a cabo, el análisis estadístico de los biomarcadores en sangre se detallaran en un SAP separado de biomarcadores y los resultados de este análisis exploratorio no serán parte del “Informe Clínico del Estudio” del estudio principal.

E.3

Principal inclusion criteria

1 Currently hospitalised for an episode of acute heart failure (AHF) where AHF was the primary reason for hospitalisation. All of the following (i.e., items a to d) must apply:
a. Upon admission for the AHF episode, persistent dyspnoea at rest in a recumbent sitting position (30-45°) or with minimal exertion
b. Upon or during the AHF admission, at least two (2) of the following clinical findings were present:
i. Congestion on chest x-ray
ii. Rales on chest auscultation
iii. Oedema ≥1+ on a 0-3+ scale, indicating indentation of skin with mild digital pressure that requires 10 or more seconds to resolve in any dependent area including extremities or sacral region
iv. Elevated jugular venous pressure (≥8 cm H2O)
c Natriuretic peptide levels, measured ≤24 hours of the AHF admission must have been:
i. Brain natriuretic peptide (BNP) ≥400 pg/mL or N-terminal-pro-brain natriuretic peptide (NT-proBNP) ≥1,600 pg/mL or
ii. BNP ≥600 pg/mL or NT-proBNP ≥2,400 pg/mL for subjects presenting with atrial fibrillation when the blood sample was taken
iii. For subjects treated with an angiotensin receptor neprilysin inhibitor (ARNI) in the previous 4 weeks prior to randomisation only NT-proBNP values should be considered.
d AHF episode treated with minimally 40 mg of IV furosemide (or equivalent IV loop diuretic defined as 20 mg of torsemide or 1 mg of bumetanide)
2. Subject is iron deficient defined as serum ferritin <100 ng/mL or 100 ng/mL ≤ serum ferritin ≤299 ng/mL if TSAT <20%.
3. Left ventricular ejection fraction <50% (assessed and documented within 12 months prior to randomisation).
4. Male or female aged ≥18 years old.
5. Subject (or legally acceptable representative)* has provided the appropriate written informed consent. Subject must provide written informed consent before any study-specific procedures are performed.
*Following section in Italics are applicable for the Netherlands only (NL only): The option that legally accepted representatives of subjects can sign the written informed consent is not valid for sites in the Netherlands

1. Sujeto actualmente ingresado por un episodio de insuficiencia cardiaca aguda (acute heart failure, AHF) en el que la insuficiencia cardiaca fue la causa principal de la hospitalización. Deberá cumplir todo lo siguiente (es decir, puntos ‘a’ hasta ‘d’):
a. En el momento de ingreso por el episodio de insuficiencia cardiaca aguda, disnea persistente en reposo, semisentado en decúbito (30-45°), o en ocasión de un ejercicio mínimo
b. En el momento o durante el ingreso por insuficiencia cardiaca aguda, presencia de como mínimo dos (2) de los siguientes hallazgos clínicos:
i. Retención de líquidos en la radiografía de tórax
ii. Crepitantes en la auscultación pulmonar
iii. Edema ≥1+ en una escala 0-3+, evidenciado por fóvea tras presión digital ligera que precisa 10 o más segundos para desaparecer en cualquier zona dependiente, incluidas extremidades o región sacra
iv. Aumento de la presión venosa yugular (≥8 cm de H2O)
c. Los niveles de péptido natriurético, medidos ≤24 horas del ingreso por insuficiencia cardiaca aguda, deberán haber sido:
i. Péptido natriurético cerebral (Brain natriuretic peptide, BNP) ≥400 pg/ml o propéptido natriurético cerebral N-terminal (N-terminal-pro-brain natriuretic peptide, NT-proBNP) ≥1.600 pg/ml, o
ii. BNP ≥600 pg/ml o NT-proBNP ≥2.400 pg/ml en los sujetos con fibrilación auricular en el momento de la extracción de la muestra de sangre
iii. En los sujetos tratados con un inhibidor de la neprilisina y del receptor de angiotensina (angiotensin receptor neprilysin inhibitor, ARNI) en las 4 semanas anteriores a la aleatorización sólo se deberán considerar los valores de NT-proBNP.
d. Episodio de insuficiencia cardiaca aguda tratado como mínimo con 40 mg de furosemida IV (o dosis equivalente de un diurético del asa administrado IV, lo que equivale a 20 mg de torasemida o 1 mg de bumetanida)
2. Sujeto con ferropenia, lo que se define como ferritina sérica <100 ng/ml o 100 ng/ml ≤ ferritina sérica ≤299 ng/ml si TSAT <20%.
3. Fracción de eyección de ventrículo izquierdo <50% (medida y documentada en el plazo de los 12 meses anteriores a la aleatorización).
4. Hombre o mujer ≥18 años de edad.
5. El sujeto (o su representante legal)* ha otorgado su consentimiento informado por escrito pertinente. El sujeto deberá otorgar su consentimiento informado por escrito antes de la práctica de cualquier procedimiento específico del estudio.
* El siguiente texto en cursiva sólo es aplicable en Holanda (NL) (sólo en NL): La opción de que el representante legal del sujeto pueda firmar el documento de consentimiento informado por escrito no es válida para los centros de Holanda.

E.4

Principal exclusion criteria

1. Dyspnoea due to non-cardiac causes such as acute or chronic respiratory disorders or infections (i.e., severe chronic obstructive pulmonary disease, acute bronchitis, pneumonia, primary pulmonary hypertension).
2. Temperature >38°C (oral or equivalent), active infective endocarditis, sepsis, systemic inflammatory response syndrome, or any other active infection requiring anti-microbial treatment at any time during an Index hospitalisation.
3. Clinical evidence of acute coronary syndrome, transient ischemic attack or stroke, within the last 30 days prior randomisation.
4. Coronary-artery bypass graft, cardiac resynchronisation therapy device implantation, percutaneous intervention (e.g., cardiac, cerebrovascular, aortic; diagnostic catheters are allowed) or major surgery that led to significant blood loss, including thoracic and cardiac surgery, within the last 3 months prior to randomisation.
5. Subject has a body weight <35 kg at randomisation.
6. Subject at an immediate need of transfusion or with a Hb <8 g/dL* or with a Hb >15 g/dL.
7. Subject with a known anaemia not attributed to ID (e.g., other microcytic anaemia) or with an evidence of iron overload (e.g., haemochromatosis) or disturbances in the utilisation of iron.
8. Subject has known hypersensitivity to any of the study products to be administered or known serious hypersensitivity to other parenteral iron products.
9. Renal dialysis (previous, current or planned within the next 6 months).
10. Chronic liver disease (including active hepatitis) and/or alanine transaminase or aspartate transaminase above 3 times the upper limit of the normal range.
11. Subjects with known hepatitis B surface antigen positivity and/or hepatitis C virus ribonucleic acid positivity.
12. Subject is pregnant (e.g., positive human chorionic gonadotropin test) or breast feeding.
*Following section in Italics are applicable for the Netherlands only (NL only): The lower threshold of Hb values is set to 10 g/dL.

1.Disnea de origen no cardiaco, como la debida a trastorno o proceso infeccioso respiratorio agudo o crónico (por ejemplo, enfermedad pulmonar obstructiva crónica severa, bronquitis aguda, neumonía, hipertensión pulmonar primaria).
2.Temperatura >38°C (oral o equivalente), endocarditis infecciosa aguda, sepsis, síndrome de respuesta inflamatoria sistémica o cualquier otra infección activa que precise tratamiento antimicrobiano en cualquier momento durante la hospitalización Índice.
3.Evidencia clínica de síndrome coronario agudo, accidente isquémico transitorio o ictus en el plazo de los 30 últimos días antes de la aleatorización.
4.Revascularización coronaria quirúrgica, implantación de dispositivo para terapia de resincronización cardíaca, intervención percutánea (por ejemplo, cardiaca, cerebrovascular, aórtica; se permiten los cateterismos diagnósticos) o cirugía mayor que ha ocasionado una pérdida importante de sangre, incluidas la cirugía torácica y la cardiaca, en el plazo de los 3 últimos meses antes de la aleatorización.
5.Sujeto con un peso corporal <35 kg en la aleatorización.
6.Sujeto con necesidad inmediata de transfusión o con Hb <8 g/dL* o con Hb >15 g/dL.
7.Sujeto con anemia que se sabe que no es atribuible a ferropenia (por ejemplo, otra anemia microcítica) o con evidencia de sobrecarga férrica (por ejemplo, hemocromatosis) o trastorno de la utilización del hierro.
8.Sujeto con hipersensibilidad conocida a cualquiera de los productos del estudio a administrar o con hipersensibilidad grave conocida a otros preparados de hierro parenteral.
9.Diálisis renal (previa, actual o prevista en el plazo de los 6 próximos meses).
10.Hepatopatía crónica (incluida la hepatitis activa) y/o alanina transaminasa o aspartato transaminasa más de 3 veces por encima del límite superior de la normalidad.
11.Sujeto con positividad del antígeno de superficie de la hepatitis B y/o del ácido ribonucleico del virus de la hepatitis C.
23.Sujeto que está embarazada (por ejemplo, positividad de la prueba de la gonadotropina coriónica humana) o amamantando.
* El siguiente texto en cursiva sólo es aplicable en Holanda (NL) (sólo en NL): El umbral inferior de los valores de Hb se ha fijado en 10 g/dL.

E.5 End points

E.5.1

Primary end point(s)

The composite of recurrent HF hospitalizations and CV death up to 52 weeks after randomization.

Criterio combinado de las hospitalizaciones recurrentes por insuficiencia cardíaca y las muertes por causa CV hasta 52 semanas después de la aleatorización.

E.5.1.1

Timepoint(s) of evaluation of this end point

Up to 52 weeks after randomization.

hasta 52 semanas después de la aleatorización.

E.5.2

Secondary end point(s)

Safety Endpoints :
• Summary of adverse events (AEs): by system organ class and preferred term (Medical Dictionary for Regulatory Activities (MedDRA) coded term), by severity and relation to study product.
• Summary of serious adverse events (SAEs) by study treatment group presented by system organ class and preferred terms (MedDRA coded term).
• Summary of clinical laboratory panels and cardiac biomarkers (absolute and change from baseline).

Criterios de valoración secundariosde seguridad:
•Resumen de acontecimientos adversos (adverse events, AEs): por órganos/aparatos y por término preferido (términos codificados según el Medical Dictionary for Regulatory Activities, MedDRA), por severidad y por relación con el producto del estudio.
•Resumen de acontecimientos adversos graves (serious adverse events, SAEs) por grupo de tratamiento del estudio, presentados por órganos/aparatos y por término preferido (términos codificados según el MedDRA).
•Resumen de valores de laboratorio y de biomarcadores cardíacos (valores absolutos y cambios frente al basal).

E.5.2.1

Timepoint(s) of evaluation of this end point

Up to 52 weeks after randomization

hasta 52 semanas después de la aleatorización.

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)

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Argentina

Brazil

Croatia

Israel

Italy

Lebanon

Netherlands

Poland

Romania

Singapore

Spain

Sweden

United Kingdom

E.8.7

Trial has a data monitoring committee

Yes

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 - last patient last visit

LPLV - Última visita del último 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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial 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:

500

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

600

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.4.2

For a multinational trial

F.4.2.1

In the EEA

450

F.4.2.2

In the whole clinical trial

650

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)

Should patients require additional iron post repletion and completion of the study, either Ferinject or alternative iron replacement therapies are available for use by treating physicians.

Si los pacientes requiriesen un aporte adicional de hierro después de la repleción y la finalización del estudio, los médicos que tratan a los pacientes del estudio pueden usar Feringjet u otras terapias alternativas de reemplazo de hierro están disponibles para su uso.

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

2018-01-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-01-15

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2020-07-21

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