Clinical Trials Register

Summary
EudraCT Number:	2018-003975-36
Sponsor's Protocol Code Number:	9766-CL-0107
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:
Date on which this record was first entered in the EudraCT database:	2019-07-26
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

Spain - AEMPS

A.2

EudraCT number

2018-003975-36

A.3

Full title of the trial

A Phase 2, Open-Label, Non-Comparative, Multicenter Study to Evaluate the Safety and Tolerability, Efficacy and Pharmacokinetics of Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or Invasive Mucormycosis (IM) in Pediatric Subjects

Estudio de fase II, sin enmascaramiento, no comparativo y multicéntrico para evaluar la seguridad, la tolerabilidad, la eficacia y la farmacocinética del sulfato de isavuconazonio en el tratamiento de la aspergilosis invasiva (AI) o la mucormicosis invasiva (MI) en pacientes pediátricos

A.3.1

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

A study to Evaluate the Safety, Tolerability and Efficacy of an investigational drug Isavuconazonium Sulfate for the Treatment of Invasive Fungal Infections

Estudio para evaluar la seguridad, tolerabilidad y eficacia de un medicamento en investigación, el sulfato de isavuconazonio, en el tratamiento de las infecciones fúngicas invasoras

A.4.1

Sponsor's protocol code number

9766-CL-0107

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/100/2019

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Astellas Pharma Global Development, 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	Astellas Pharma Global Development, 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	Astellas Pharma Europe B.V. - Clinical Trial Unit Regulatory Affairs
B.5.2	Functional name of contact point	Service Desk
B.5.3	Address:
B.5.3.1	Street Address	Sylviusweg 62
B.5.3.2	Town/ city	Leiden
B.5.3.3	Post code	2333 BE
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	+34913908569
B.5.5	Fax number	.
B.5.6	E-mail	pablo.rojo@salud.madrid.org

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	Cresemba® (isavuconazonium sulfate) for injection for intravenous administration
D.2.1.1.2	Name of the Marketing Authorisation holder	Astellas Pharma US, Inc.
D.2.1.2	Country which granted the Marketing Authorisation	United States
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	EU/3/14/1284
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Powder for 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	Isavuconazonium sulfate
D.3.9.3	Other descriptive name	Cresemba
D.3.9.4	EV Substance Code	SUB167941
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	372
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

Invasive Aspergillosis and Invasive Mucormycosis

Aspergilosis invasiva y Mucormicosis invasiva

E.1.1.1

Medical condition in easily understood language

Invasive Fungal infections

Infecciones fúngicas invasoras

E.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	LLT
E.1.2	Classification code	10062642
E.1.2	Term	Invasive mycosis
E.1.2	System Organ Class	100000004862

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

Safety Objective
To evaluate the safety and tolerability of isavuconazonium sulfate in pediatric subjects

Efficacy Objective
To assess the efficacy of isavuconazonium sulfate for the treatment of invasive aspergillosis (IA) or invasive mucormycosis (IM) in pediatric subjects

Pharmacokinetic Objective
To evaluate the pharmacokinetics of isavuconazole by monitoring the plasma concentrations in pediatric subjects during treatment with isavuconazonium sulfate

Objetivo de seguridad
Evaluar la seguridad y la tolerabilidad del sulfato de isavuconazonio en niños

Objetivo de eficacia
Evaluar la eficacia del sulfato de isavuconazonio en el tratamiento de la aspergilosis invasiva (AI) o la mucormicosis invasiva (MI) en niños

Objetivo de farmacocinética
Evaluar la farmacocinética del isavuconazol mediante la supervisión de las concentraciones plasmáticas en niños enfermos durante el tratamiento con sulfato de isavuconazonio

E.2.2

Secondary objectives of the trial

Not Applicable

No aplica

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Institutional Review Board (IRB)-approved written informed consent and privacy language as required per national regulations (e.g., Health Insurance Portability and Accountability Act authorization) must be obtained from the subject’s parent or legal guardian and, if required, subject’s assent, prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
2. Male or female subject 1 year to < 18 years of age diagnosed with IA or IM. A positive diagnosis is defined as follows:
- Proven, probable or possible invasive fungal infection (IFI) per the European Organisation for Research and Treatment of Cancer/Mycoses Study Group [EORTC/MSG], 2008 criteria
Note: Subjects with “possible” IFI will be eligible for enrollment; however, diagnostic tests to confirm the invasive fungal disease as “probable” or “proven” according to the EORTC/MSG criteria must be completed within 7 days after the first dose of study drug
- Note: In addition to the criteria set for mycological criteria by the EORTC/MSG in 2008, and only for subjects with an underlying hematologic malignancy or recipients of hematopoietic stem cell transplant who also have clinical and radiologic features consistent with invasive fungal infection, the following are acceptable:
i. Galactomannan (GM) levels (optical density index) meeting the below criteria are acceptable mycological evidence for enrollment or upgrading the diagnosis to probable IA:
1. A single value for serum or bronchoalveolar lavage (BAL) fluid of ≥ 1.0 or
2. Two serum GM values of ≥ 0.5 from 2 separate samples
3. Subject has sufficient venous access to permit administration of study drug and monitoring of safety laboratories.
4. A female subject is eligible to participate if she is not pregnant and at least one of the following conditions applies:
a. Not a subject who is of childbearing potential as defined in the protocol [Appendix 12.3 Contraception Requirements].
OR
b. Subject who is of childbearing potential who agrees to follow the contraceptive guidance as defined in the protocol [Appendix 12.3 Contraception Requirements] throughout the treatment period and for at least 30 days after the final study drug administration.
5. Female subject who is of childbearing potential must agree not to breastfeed starting at screening and throughout the study and for 30 days after the final study drug administration.
6. Female subject who is of childbearing potential must not donate ova starting at screening, throughout the study, and for 30 days after the final study drug administration.
7. A male subject with female partner(s) of childbearing potential must agree to use contraception as detailed in the protocol [Appendix 12.3 Contraception Requirements] during the treatment period and for at least 30 days after the final study drug administration.
8. Male subject who is of childbearing potential must not donate sperm starting at screening and throughout the study and for 30 days after the final study drug administration.
9. Subject and subject’s parent(s) or legal guardian agree that the subject will not participate in another interventional study while on treatment with the exception of oncology trials.
Waivers to the inclusion criteria will NOT be allowed.

1. El progenitor o tutor legal del paciente deberá firmar un consentimiento informado y una cláusula de confidencialidad aprobados por el CEI (comité de ética en la investigación), según exija la normativa nacional (como la autorización de la Ley de transferencia y responsabilidad de los seguros médicos), y, de ser necesario, se obtendrá también el asentimiento del paciente antes de realizar ningún procedimiento del estudio (incluida la retirada de medicamentos prohibidos, si procede).
2. Pacientes de ambos sexos de 1 a <18 años con diagnóstico de AI o MI. Diagnóstico de AI o MI se define como:
• Micosis invasiva demostrada, probable o posible según los criterios de la Organización Europea de Investigación y Tratamiento del Cáncer/Grupo de estudio de micosis [EORTC/MSG] de 2008.
Nota: los pacientes con micosis invasiva «posible» podrán ser incluidos. Sin embargo, deberán realizarse pruebas diagnósticas para confirmar si la micosis invasiva es «probable» o «demostrada» según los criterios de la EORTC/MSG en un plazo de 7 días tras la administración de la primera dosis del fármaco del estudio.
o Nota: además de los criterios establecidos para los criterios micológicos de la EORTC/MSG en 2008, y solo para los pacientes con una neoplasia hemática subyacente o receptores de un trasplante de células madre hematopoyéticas con rasgos clínicos y radiográficos compatibles con una micosis invasiva, se aceptará lo siguiente:
i. Se aceptan niveles de galactomanano (GM, índice de densidad óptica) que cumplan con los siguientes criterios como pruebas micóticas para la inclusión o el cambio del diagnóstico a AI probable:
1. un valor único de suero o líquido de lavado broncoalveolar (BAL) de  1,0; o
2. dos valores de GM en suero de  0,5 de 2 muestras distintas.

3. Paciente con acceso venoso suficiente que permita la administración del fármaco del estudio y la supervisión por parte de los laboratorios de seguridad.
4. Las pacientes mujeres podrán participar si no están embarazadas y cumplen al menos una de las siguientes condiciones:
a. no estar en edad fértil según se define en [Anexo 12.3 Requisitos de anticoncepción];
O
b. estar en edad fértil y aceptar seguir las directrices de anticoncepción definidas en [Anexo 12.3 Requisitos de anticoncepción] durante el periodo de tratamiento y durante al menos 30 días tras terminar la administración del fármaco del estudio.
5. Las pacientes en edad fértil deberán aceptar no dar el pecho desde la selección, durante el estudio y durante al menos 30 días tras terminar la administración del fármaco del estudio.
6. Las pacientes en edad fértil no deberán donar óvulos desde la selección, durante el estudio y durante al menos 30 días tras terminar la administración del fármaco del estudio.
7. Los pacientes varones con parejas en edad fértil deberán aceptar usar métodos anticonceptivos según se define en [Anexo 12.3Requisitos de anticoncepción] durante el periodo de tratamiento y durante al menos 30 días tras terminar la administración del fármaco del estudio.
8. Los pacientes varones en edad fértil no deberán donar esperma desde la selección, durante el estudio y durante al menos 30 días tras terminar la administración del fármaco del estudio.
9. El paciente y su progenitor o tutor legal aceptan que el paciente no participará en ningún otro estudio intervencionista durante el periodo de tratamiento, a excepción de ensayos oncológicos.
NO se admiten renuncias a los criterios de inclusión.

E.4

Principal exclusion criteria

1. Subject has familial short QT syndrome, is receiving medications that are known to shorten the QT interval, or has a clinically significant abnormal ECG.
2. Subject has evidence of hepatic dysfunction defined as any of the following:
- Total bilirubin ≥ 3 times the upper limit of normal (ULN)
- Alanine transaminase (ALT) or aspartate transaminase (AST) ≥ 5 times the ULN
- Known cirrhosis or chronic hepatic failure
3. Subject has used strong cytochrome P450 (CYP3A4) inhibitors or inducers such as ketoconazole, high dose ritonavir, rifampin/rifampicin, long acting barbiturates (e.g., phenytoin), carbamazepine and St. John’s Wort in the 5 days prior to the first dose of study drug.
4. Subject has another IFI other than possible, probable or proven IA or IM.
5. Subject has chronic aspergillosis, aspergilloma or allergic bronchopulmonary aspergillosis.
6. Subject has received mould active systemic antifungal therapy, effective against the primary invasive mould infection, for more than 4 days during the 7 days preceding the first dose.
Note: Prior use of prophylactic antifungal therapy is acceptable. In case of breakthrough IA while on prophylatic mould-active azole class drugs, additional documentation will be required to be submitted to the sponsor medical monitor or designee to approve subject enrollment.
7. Subject has known history of allergy, hypersensitivity or any serious reaction to any of the azole class antifungals.
8. Subject has any condition, which, in the investigator’s opinion, makes the subject unsuitable for study participation.
9. Subject is unlikely to survive 30 days in the investigator’s opinion.
10. Subject has received investigational drug, with the exception of oncology drug trials or trials with investigational drugs treating graft versus host disease, within 28 days or 5 half-lives, whichever is longer, prior to screening.
Waivers to the exclusion criteria will NOT be allowed.

1. El paciente padece síndrome de QT corto familiar, está recibiendo fármacos conocidos por recudir el intervalo QT o presenta un ECG anómalo clínicamente significativo.
2. El paciente presenta signos de disfunción hepática, definida por cualquiera de los siguientes:
• Bilirrubina total ≥3 veces el límite superior de la normalidad (LSN)
• Alanina aminotransferasa (ALT) o aspartato transaminasa (AST) ≥5 veces el LSN
• Cirrosis o insuficiencia hepática crónica conocidas
3. El paciente ha utilizado inhibidores o inductores potentes del citocromo P450 (CYP3A4) como ketoconazol, ritonavir a dosis altas, rifampina/rifampicina, barbitúricos de acción prolongada (como la fenitoína), carbamazepina e hipérico en los 5 días previos a la primera dosis del fármaco del estudio.
4. El paciente presenta otra micosis invasiva distinta a la AR o MI posible, probable o demostrada.
5. El paciente presenta aspergilosis crónica, aspergiloma o aspergilosis broncopulmonar alérgica.
6. El paciente ha recibido tratamiento antifúngico sistémico activo para los hongos, eficaz contra los hongos invasivos primarios, durante más de 4 días durante los 7 días anteriores a la primera dosis.
Nota: se acepta el uso anterior de tratamientos antifúngicos preventivos. En caso de progresión de la AI en pacientes que estén tomando azoles preventivos activos para hongos, se exigirá el envío de documentación adicional al supervisor médico o persona designada del promotor para que apruebe la inclusión del sujeto.
7. El paciente tiene antecedentes de alergia, hipersensibilidad o reacciones graves a alguno de los antifúngicos azoles.
8. El paciente padece algún trastorno que, en opinión del investigador, hace que no sea apto para participar en el estudio.
9. En opinión del investigador, no es probable que el paciente consiga sobrevivir 30 días.
10. El paciente ha recibido un fármaco en fase de investigación, a excepción de ensayos con fármacos antineoplásicos o ensayos con fármacos en fase de investigación para tratar la enfermedad de injerto contra huésped en los 28 días o 5 semividas anteriores a la selección, lo que sea más prolongado.
NO se admiten renuncias a los criterios de exclusión.

E.5 End points

E.5.1

Primary end point(s)

1. Safety outcomes will include AEs, vital signs, ECGs and laboratory parameters.
2. The primary efficacy endpoint will be all-cause mortality through day 42.

1. Los resultados de seguridad incluyen los AA, las constantes vitales, los ECG y los parámetros analíticos.
2. El criterio principal de valoración de la eficacia es la mortalidad por cualquier causa hasta el día 42.

E.5.1.1

Timepoint(s) of evaluation of this end point

1. AEs (Screening, (screening and day 1, 2, 3, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 77, 84 or IA EOT and IA follow up); vital signs (screening and day 1, 2, 3, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 77, 84 or IA EOT), ECG (screening, day 1, 7, 14, 28, 56, 84 or IA EOT) and laboratory parameters (screening , Day 7, 28, 56, 84 or IA EOT)
2. Through day 42

1. AA (selección y días 1, 2, 3, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 77 y 84 o al FdT para la AI y seguimiento de la AI); constantes vitales (selección y días 1, 2, 3, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 77 y 84 o FdT para la AI); ECG (selección y días 1, 7, 14, 28, 56 y 84 o FdT para la AI) y parámetros analíticos (selección y días 7, 28, 56 y 84 o FdT para la AI).
2. Hasta el día 42.

E.5.2

Secondary end point(s)

1. The key secondary efficacy endpoint will be all-cause mortality through day 84 and EOT.
2. Additional secondary efficacy endpoints will be overall, clinical, radiological and mycological response through day 42, day 84 and EOT.
3. Other secondary endpoints encompass pharmacokinetic endpoints, including plasma trough (pre-dose) levels on days 7, 14, 21, 42 and 84 or EOT.

1. El principal criterio de valoración secundario de la eficacia es la mortalidad por cualquier causa hasta el día 84 y FdT.
2. Los criterios de valoración secundarios de la eficacia adicionales serán la respuesta general, clínica, radiológica y micológica hasta el día 42, el día 84 y FdT.
3. Otros criterios de valoración secundarios engloban los criterios de valoración farmacocinéticos, incluidos los niveles plasmáticos (predosis) en los días 7, 14, 21, 42 y 84 o FdT.

E.5.2.1

Timepoint(s) of evaluation of this end point

1. through day 84 and EOT
2. through day 42, day 84 and EOT
3. on days 7, 14, 21, 42 and 84 or EOT.

1. Hasta el día 84 y FdT
2. Hasta el día 42, el día 84 y FdT
3. Los días 7, 14, 21, 42 y 84 o FdT

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

Yes

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

Yes

E.6.13.1

Other scope of the trial description

Tolerability

Tolerabilidad

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

Yes

E.8.1.7.1

Other trial design description

No comparativo

Non-Comparative

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

Belgium

Germany

Italy

Spain

United Kingdom

United States

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

The end of the study is defined as the last visit or scheduled procedure shown in the schedule of assessments for the last study participant in the study.

El final del estudio se define como la última visita o el último procedimiento programado que se detalla en el calendario de evaluaciones del último participante del estudio.

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

Yes

F.1.1

Number of subjects for this age range:

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)

Yes

F.1.1.4.1

Number of subjects for this age range:

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Minors

Menores

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

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

2019-11-06

Ethics Committee Opinion of the trial application

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

P. End of Trial
P.	End of Trial Status

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IMP with orphan designation in the indication
Orphan Designation Number:
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