Clinical Trials Register

Summary
EudraCT Number:	2018-003459-39
Sponsor's Protocol Code Number:	AG348-C-011
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:	2019-04-12
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

2018-003459-39

A.3

Full title of the trial

An Open-Label, Multicenter, Extension Study of AG-348 in Adult Subjects with Pyruvate Kinase Deficiency Previously Enrolled in AG-348 Studies

Estudio de extensión, abierto, multicéntrico de AG 348 en sujetos adultos con deficiencia de piruvato cinasa incluidos previamente en estudios con AG-348

A.3.1

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

An Extension Study of AG-348 in Adult Subjects with Pyruvate Kinase Deficiency Previously Enrolled in AG-348 Studies

Estudio de extensión, abierto, multicéntrico de AG 348 en sujetos adultos con deficiencia de piruvato cinasa incluidos previamente en estudios con AG-348

A.4.1

Sponsor's protocol code number

AG348-C-011

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	Agios Pharmaceuticals, Inc.
B.1.3.4	Country	United States
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	Agios Pharmaceuticals, Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Agios Pharmaceuticals, Inc.
B.5.2	Functional name of contact point	Director, Scientific Communications
B.5.3	Address:
B.5.3.1	Street Address	88 Sidney Street
B.5.3.2	Town/ city	Cambridge
B.5.3.3	Post code	MA 02139-4169
B.5.3.4	Country	United States
B.5.4	Telephone number	+1844633 2332
B.5.6	E-mail	medinfo@agios.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	No
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	AG-348 sulfate hydrate
D.3.2	Product code	AG-348
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	Mitapivat
D.3.9.1	CAS number	2151847-10-6
D.3.9.2	Current sponsor code	AG-348 sulfate hydrate
D.3.9.3	Other descriptive name	AGI-1480, AGX-0841, AG-348, AG-348 hemisulfate
D.3.9.4	EV Substance Code	SUB181978
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	5
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	No
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	AG-348 sulfate hydrate
D.3.2	Product code	AG-348
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	Mitapivat
D.3.9.1	CAS number	2151847-10-6
D.3.9.2	Current sponsor code	AG-348 sulfate hydrate
D.3.9.3	Other descriptive name	AGI-1480, AGX-0841, AG-348, AG-348 hemisulfate
D.3.9.4	EV Substance Code	SUB181978
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	20
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: 3
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	No
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	AG-348 sulfate hydrate
D.3.2	Product code	AG-348
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	Mitapivat
D.3.9.1	CAS number	2151847-10-6
D.3.9.2	Current sponsor code	AG-348 sulfate hydrate
D.3.9.3	Other descriptive name	AGI-1480, AGX-0841, AG-348, AG-348 hemisulfate
D.3.9.4	EV Substance Code	SUB181978
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	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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Pyruvate Kinase Deficiency
Haemolytic anaemia

Deficiencia de piruvato cinasa
Anemia hemlítica

E.1.1.1

Medical condition in easily understood language

Lack of Pyruvate Kinase enzyme
Lack of red blood cells following their destruction and removal from the bloodstream

Carencia de la enzima de piruvato cinasa
Carencia de células rojas de la sangre seguido de su destucción y eliminación del torrente sanguíneo

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	10037682
E.1.2	Term	Pyruvate kinase deficiency anaemia
E.1.2	System Organ Class	10010331 - Congenital, familial and genetic disorders

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the long-term safety and tolerability of AG-348

Evaluar la seguridad y tolerabilidad a largo plazo de AG-348

E.2.2

Secondary objectives of the trial

• To evaluate the long-term efficacy of AG-348
• To evaluate the efficacy of AG-348 in increasing hemoglobin (Hb) concentrations in subjects who previously received placebo in Study AG348-C-006 (ie, Cohort 1)
• To determine the effect of AG-348 on health-related quality of life (HRQoL) using patient reported outcomes (PROs)
• To evaluate the pharmacokinetics of AG-348 after oral administration (Cohort 1 only)
• To evaluate the relationship between AG-348 pharmacokinetics and safety parameters
(Cohort 1 only)

• Evaluar la eficacia a largo plazo de AG-348
• Evaluar la eficacia de AG-348 a la hora de aumentar las concentraciones de hemoglobina (Hb) en sujetos que hayan recibido anteriormente placebo en el estudio AG348-C-006 (es decir, cohorte 1).
• Determinar el efecto de AG-348 en la calidad de vida relacionada con la salud (CVRS) [Health-related quality of life (HRQoL) en inglés] usando los resultados comunicados por los pacientes [Patient-reported outcomes (PROs) en inglés]
• Evaluar la farmacocinética de AG-348 tras la administración oral (solo cohorte 1)
• Evaluar la relación entre la farmacocinética de AG-348 y los parámetros de seguridad (solo cohorte 1)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Have signed written informed consent prior to participating in this extension study;

2. Have completed either antecedent study AG348-C-006 or AG348-C-007 through the Part 2 Week 24 Visit;

3. Cohorts 2 and 3: Have demonstrated clinical benefit from AG-348 treatment in the antecedent study, in the opinion of the Investigator;

4. For women of reproductive potential, have a negative pregnancy test at the Screening/Day 1 Visit;

5. For women of reproductive potential as well as men with partners who are women of reproductive potential, be abstinent as part of their usual lifestyle, or agree to use 2 forms of contraception, 1 of which must be considered highly effective, from the time of giving informed consent, during the study, and for 28 days (both men and women) following the last dose of study drug.

1. Haber firmado el consentimiento informado por escrito antes de participar en este estudio de extensión

2. Haber completado el estudio AG348-C-006 o AG348-C-007 precedente hasta la visita de la semana 24 de la parte 2

3. Cohortes 2 y 3: Haber obtenido beneficio clínico demostrado derivado del tratamiento AG-348 en el estudio precedente, en opinión del investigador.

4. Las mujeres con capacidad reproductiva deben tener un resultado negativo en una prueba local de embarazo en la visita de selección/día 1

5. Las mujeres con capacidad reproductiva, así como los hombres con parejas que son mujeres con capacidad reproductiva, no deben mantener relaciones sexuales como parte de su estilo de vida habitual o deben aceptar el uso de 2 anticonceptivos, 1 de los cuales debe considerarse altamente efectivo, desde el momento de otorgar el consentimiento informado, durante el estudio y durante 28 días (tanto hombres como mujeres) tras la última dosis del fármaco del estudio

E.4

Principal exclusion criteria

1. Have a significant medical condition (including clinically significant laboratory abnormality) that developed during his/her antecedent AG-348 study that confers an unacceptable risk to participating in this extension study, that could confound the interpretation of the study data, and/or that compromises the ability of the subject to complete study visits and procedures;

2. Are currently pregnant or breastfeeding;

3. Have a splenectomy scheduled during the study treatment period;

4. Meet the withdrawal criteria of his/her antecedent AG-348 study at the Screening/Day 1 Visit of this study;

5. Are currently receiving medications that are strong inhibitors of cytochrome P450 (CYP)3A4, strong inducers of CYP3A4, strong inhibitors of P-glycoprotein (P-gp), or digoxin (a P-gp sensitive substrate medication) that have not been stopped for a duration of at least 5 days or a timeframe equivalent to 5 half-lives (whichever is longer) prior to Screening/Day 1 of this extension study;

6. Have received anabolic steroids, including testosterone preparations, within 28 days prior to Screening/Day 1 of this extension study;

7. Have received hematopoietic stimulating agents (eg, erythropoietins, granulocyte colony stimulating factors, thrombopoietins) within 28 days prior to Screening/Day 1 of this extension study;

8. Have exposure to any investigational drug other than AG-348, device, or procedure within 3 months prior to Screening/Day 1 of this extension study.

1. Tener una afección médica significativa (incluida una anomalía analítica clínicamente significativa) desarrollada durante su estudio AG-348 precedente que conlleve un riesgo inaceptable para participar en este estudio de extensión, que pueda confundir la interpretación de los datos del estudio, y/o que comprometa la capacidad del sujeto para completar los procedimientos y las visitas del estudio

2. Estar embarazada o en periodo de lactancia materna

3. Tener programada una esplenectomía durante el periodo de tratamiento del estudio

4. Cumplir los criterios de retirada de su estudio AG-348 precedente en el momento de la visita de selección/día 1 de este estudio

5. Estar actualmente recibiendo medicamentos que sean inhibidores potentes del citocromo P450 (CYP) 3A4, inductores potentes de CYP3A4, inhibidores potentes de la glucoproteína P (P-gp) o digoxina (un sustrato sensible a la P-gp) o que no se hayan dejado de tomar durante un tiempo de al menos 5 días o un tiempo equivalente a 5 semividas (lo que dure más) antes de la selección/día 1 de este estudio de extensión

6. Haber recibido esteroides anabólicos, incluidos preparados de testosterona, en los 28 días anteriores a la selección/día 1 de este estudio de extensión

7. Haber recibido estimulantes hematopoyéticos (p. ej., eritropoyetinas, factores estimulantes de colonias de granulocitos, trombopoyetinas) durante al menos 28 días antes de la selección/día 1 de este estudio de extensión

8. Haberse expuesto a algún medicamento, dispositivo o procedimiento en investigación distinto de AG-348 en los 3 meses anteriores a la selección/día 1 de este estudio de extensión

E.5 End points

E.5.1

Primary end point(s)

1) Number of Subjects with Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)
2) Number of Subjects with AEs Leading to Dose Reduction, Treatment Interruption and Treatment Discontinuation

1) Número de sujetos con acontecimientos adversos (AA) y acontecimientos adversos de especial interés (AAEI)
2) Número de sujetos con AA que provocan la reducción de la dosis, la interrupción del tratamiento y la suspensión del tratamiento

E.5.1.1

Timepoint(s) of evaluation of this end point

From baseline to end of study (Week 197)

Desde el inicio hasta el fin del estudio (semana 197)

E.5.2

Secondary end point(s)

1) Percentage of Subjects Achieving a Hemoglobin (Hb) Response in Subjects Who Previously Received Placebo in Study AG348-C-006
2) Area Under the Concentration-Time Curve (AUC) of AG-348 in Subjects Who Previously Received Placebo in Study AG348-C-006
3) Maximum Observed Concentration of AG-348 in Subjects Who Previously Received Placebo in Study AG348-C-006
4) Change from Baseline in Hb Concentration
5) Change from Baseline in Bilirubin
6) Change from Baseline in Lactate Dehydrogenase (LDH)
7) Change from Baseline in Haptoglobin Levels
8) Change from Baseline in Reticulocyte Percentages
9) Change from Baseline in Number of Transfusion Events
10) Change from Baseline in Number of Red Blood Cell (RBC) Units Transfused
11) Change from Baseline in Health-Related Quality of Life (HRQoL) Patient-Reported Outcome (PRO) Scores: Pyruvate Kinase Deficiency Diary (PKDD)
12) Change from Baseline in HRQoL PRO Scores: Pyruvate Kinase Deficiency Impact Assessment (PKDIA)

1) Porcentaje de sujetos que alcanzan una respuesta de hemoglobina (Hb) en sujetos que recibieron previamente placebo en el estudio AG348-C-006
2) Área bajo curva Concetración-tiempo (AUC) de AG-348 en sujetos que recibieron previamente placebo en el estudio AG348-C-006
3) Concentración máxima observada de AG-348 en sujetos que recibieron previamente placebo en el estudio AG348-C-006
4)Cambio desde el valor basal en la concentración de Hb
5) Cambio desde el valor basal en bilirrubina
6) Cambio desde el valor basal en lactato deshidrogenasa (LDH)
7) Cambio desde el valor basal en niveles de haptoglobina
8) Cambio desde el valor basal en los porcentajes de reticulocitos
9) Cambio desde el valor basal en el número de episodios de transfusiones
10) Cambio desde el valor basal en el número unidades de hematíes transfundidas
11) Cambio desde el valor basal en en la calidad de vida relacionada con la salud (CVRS), resultados comunicados por los pacientes: diario de la deficiencia de piruvato cinasa (DDPC)
12) Cambio desde el valor basal en en las puntuaciones en la CVRS: valoración del impacto de la deficiencia de piruvato cinasa (VIDPC)

E.5.2.1

Timepoint(s) of evaluation of this end point

1) Weeks 16, 20, 24
2) Week 12: pre-dose, post-dose at 30 minutes, 1 hour (h), 2 h, 4 h, 8 h
3) Week 12: pre-dose, post-dose at 30 minutes, 1 h, 2 h, 4 h, 8 h
4) From baseline up to Week 197
5) From baseline up to Week 197
6) From baseline up to Week 197
7) From baseline up to Week 197
8) From baseline up to Week 197
9) From baseline up to Week 197
10) From baseline up to Week 197
11) From baseline up to Week 193
12) From baseline up to Week 193

1) Semanas 16, 20, 24
2) Semana 12: pre-dosis, post-dosis a los 30 minutos, 1 hora (h), 2 h, 4 h, 8 h
3) Semana 12: pre-dosis, post-dosis a los 30 minutos, 1 h, 2 h, 4 h, 8 h
4) Desde el inicio hasta la semana 197
5) Desde el inicio hasta la semana 197
6) Desde el inicio hasta la semana 197
7) Desde el inicio hasta la semana 197
8) Desde el inicio hasta la semana 197
9) Desde el inicio hasta la semana 197
10) Desde el inicio hasta la semana 197
11) Desde el inicio hasta la semana 193
12) Desde el inicio hasta la semana 193

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

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

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)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

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

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

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

Canada

Denmark

France

Germany

Ireland

Italy

Korea, Republic of

Netherlands

Portugal

Spain

Switzerland

Thailand

United Kingdom

United States

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

Última visita del último participante

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

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

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

F.4.2.2

In the whole clinical trial

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

2019-04-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-03-22

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

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Clinical trials