Clinical Trials Register

Summary
EudraCT Number:	2018-000452-18
Sponsor's Protocol Code Number:	CETB115J2411
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:	2018-08-07
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2018-000452-18

A.3

Full title of the trial

A phase II, open-label, prospective, single-arm, study to assess ability of eltrombopag to induce sustained remission in subjects with ITP who are refractory or relapsed after first-line steroids (TAPER)

Estudio fase II, abierto, prospectivo, con un solo brazo para evaluar la capacidad de eltrombopag de inducir remisión sostenida en sujetos con trombocitopenia inmune primaria que son refractarios o hayan recaído tras una primera línea de esteroides (TAPER)

A.3.1

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

The study will determine if subjects are able to stop eltrombopag treatment while maintaining acceptable platelet levels after their disease has become resistant to treatment (refractory) or has a reoccurrence of symptoms after initial treatment with steroids (relapse)

Estudio para evaluar la capacidad de eltrombopag de inducir remisión sostenida en sujetos con trombocitopenia inmune primaria.

A.4.1

Sponsor's protocol code number

CETB115J2411

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	Novartis Farmacéutica, S.A.
B.1.3.4	Country	Spain
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	Novartis Pharma AG
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	Novartis Farmacéutica, S.A.
B.5.2	Functional name of contact point	Trial Monitoring Organization (TMo)
B.5.3	Address:
B.5.3.1	Street Address	Gran Vía de les Corts Catalanes, 764
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08013
B.5.3.4	Country	Spain
B.5.4	Telephone number	NA
B.5.5	Fax number	NA
B.5.6	E-mail	eecc.novartis@novartis.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	REVOLADE
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Europharm Ltd
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Eltrombopag
D.3.2	Product code	ETB115
D.3.4	Pharmaceutical form	Film-coated 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	ELTROMBOPAG
D.3.9.1	CAS number	496775-62-3
D.3.9.2	Current sponsor code	ETB115
D.3.9.3	Other descriptive name	ELTROMBOPAG OLAMINE
D.3.9.4	EV Substance Code	SUB30141
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	25
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	REVOLADE
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Europharm Ltd
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Eltrombopag
D.3.2	Product code	ETB115
D.3.4	Pharmaceutical form	Film-coated 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	ELTROMBOPAG
D.3.9.1	CAS number	496775-62-3
D.3.9.2	Current sponsor code	ETB115
D.3.9.3	Other descriptive name	ELTROMBOPAG OLAMINE
D.3.9.4	EV Substance Code	SUB30141
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

immune thrombocytopenia

trombocitopenia inmune

E.1.1.1

Medical condition in easily understood language

immune thrombocytopenia

trombocitopenia inmune

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	20.1
E.1.2	Level	LLT
E.1.2	Classification code	10050245
E.1.2	Term	Autoimmune thrombocytopenia
E.1.2	System Organ Class	100000004851

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	10036735
E.1.2	Term	Primary thrombocytopenia
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

To assess ability of eltrombopag to induce sustained remission by month 12 in ITP subjects who relapsed or failed to respond to first-line steroid treatment

Evaluar la capacidad de eltrombopag de inducir remisión sostenida en 12 meses en sujetos con PTI que hayan recaído o no hayan respondido al tratamiento de primera línea de esteroides.

E.2.2

Secondary objectives of the trial

1. To assess the duration of sustained remission after treatment discontinuation
2. To assess the ability of eltrombopag to induce early response by month 1
3. To assess the ability of eltrombopag to induce a recovery response, in case of loss of response during or after tapering of eltrombopag
4. To quantify the platelet count from baseline to 3, 6, 9, 12 months
5. To assess the ability of eltrombopag to maintain platelet count ≥ 30×109/L within 12 months
6. To evaluate patient-Health Related outcome measures for health-related quality
of life (fatigue level of the subjects through FACIT) & FACT-Th6 and SF-36v2 questionnaires
7. To explore the overall impact of side effects on treatment via the GP5 at baseline and EOS
8. To explore treatment satisfaction with TSQM-9
9. To evaluate the safety and tolerability of eltrombopag

1.Evaluar la duración de remisión sostenida después de la discontinuación del tto.
2. Evaluar la capacidad de eltrombopag de inducir una respuesta temprana en el primer mes.
3. Evaluar la capacitad de eltrombopag de recuperar respuesta, en caso de pérdida de respuesta durante o después de disminuir el trombopag.
4. Cuantificar el recuento de plaquetas desde la basal hasta los m 3, 6, 9 y 12.
5. Evaluar la capacidad de eltrombopag de mantener el recuento de plaquetas </=30×109 /L durante 12 m.
6. Evaluar las medidas de los resultados relacionadas con la salud de los pacientes para la calidad de vida relacionada con la salud mediante el uso de los cuestionarios FACIT y versión de 6 ítems del FACT-Th6 y SF-36v2.
7. Explorar el impacto global de los efectos secundarios en la percepción del tratamiento de los sujetos mediante la evaluación GP5 en basal y al final del estudio.
8. Explorar la satisfacción con el tratamiento con TSQM-9.
9. Evaluar la seguridad y tolerabilidad del IMP.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Signed informed consent must be obtained prior to participation in the study
2. Subjects ≥ 18 years old
3. Subjects with a confirmed diagnosis of primary ITP, who are not responsive or in relapse after a first line of steroid therapy ± intravenous immunoglobulin (IVIG) (used as a rescue therapy)
4. Platelet count < 30×109/L and assessed as needing treatment (per physician’s discretion

1. Se deberá obtener el consentimiento informado firmado antes de la participación en el estudio.
2. Sujetos >-= 18 años de edad.
3. Sujetos con un diagnóstico confirmado de PTI primaria que no responden o han recaído después de una terapia de primera línea de esteroides +/- inmunoglobulina intravenosa (IGIV) (utilizada como terapia de rescate).
Se definirá la terapia de primera línea de esteroides como. 0,5 a 1 mg/kg/día de prednisona/prednisolona durante un mínimo de dos semanas, o un mínimo de un ciclo de altas dosis de dexametasona de 20-40 mg/día durante 4 días consecutivos +/- IGIV (utilizada como terapia de rescate). La exposición máxima al tratamiento con dosis alta de esteroides (se ha excluido la disminución progresiva de esteroides) debe estar limitada a: 4 semanas de dosis altas de prednisona/prednisolona o 3 ciclos de altas dosis de dexametasona. La exposición global de esteroides no deber ser superior a 3 meses, incluyendo el periodo de disminución progresiva de la dosis.
4. Recuento de plaquetas < 30×109/L y evaluado como con necesidad de tratamiento (según el criterio del médico).

E.4

Principal exclusion criteria

1. ITP subjects previously treated with any ITP second-line therapies, thrombopoietin receptor (TPO-R) agonists for ITP, except steroids / IVIG
2. Subjects who relapsed more than one year after the end of first-line full course of steroid therapy
3. Subjects with a diagnosis of secondary thrombocytopenia
4. Subjects who have life threatening bleeding complications per investigator discretion
5. Subjects who had a deep vein thrombosis or arterial thrombosis in the 6 months preceding enrollment
6. Serum creatinine ≥ 1.5 mg/dL
7. Total bilirubin > 1.5 × upper limit of normal (ULN)
8. Aspartate transaminase (AST) > 3.0 × ULN
9. Alanine transaminase (ALT) > 3.0 × ULN
10. Subjects who are human immune deficiency virus (HIV), hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg) positive
11. Subjects with hepatic impairment (Child-Pugh score > 5)
12. Subjects who have active malignancy
13. Subjects with any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with subject’s safety, obtaining informed consent or compliance with the study procedures per investigator discretion
14. History or current diagnosis of cardiac disease indicating significant risk of safety for subjects participating in the study
15. Subjects with known active or uncontrolled infections not responding to appropriate therapy
16. Subjects with evidence of current alcohol/drug abuse
17. Women of child-bearing potential and sexually active males unwilling to use adequate contraception during the study
18. Female subjects who are nursing or pregnant (positive serum or urine B-human chorionic gonadotrophin (B-hCG) pregnancy test) at screening or pre-dose on Day 1

Other protocol-defined inclusion/exclusion criteria may apply

1. Sujetos con PTI tratados previamente con cualquier terapia de segunda línea para PTI, agonistas del receptor de trombopoyetina (R-TPO) para PTI, excepto esteroides/IGIV,
2. Sujetos que hayan recaído más de un año después de haber finalizado un ciclo completo de terapia con esteroides.
3. Sujetos con un diagnóstico de trombocitopenia secundaria.
4. Sujetos con complicaciones de sangrado amenazantes para la vida según criterio del investigador.
5. Sujetos con trombosis venosa profunda o trombosis arterial en los 6 meses anteriores a la inclusión.
6. Creatinina en suero ≥ 1,5 g/dl.
7. Bilirrubina total > 1,5 x límite superior de normalidad (LSN).
8. Aspartato transaminasa (AST) > 3,0 × LSN.
9. Alanino transaminasa (ALT) > 3,0 × LSN.
10. Sujetos positivos al virus de inmunodeficiencia humana (VIH), virus de hepatitis C (VHC) y antígeno de superficie de la hepatitis B (HBsAg).
11. Sujetos con deterioro hepático (puntuación de Child-Pugh > 5).
12. Sujetos que tienen un tumor maligno activo.
13. Sujetos con cualquier trastorno médico o psiquiátrico preexistente grave o inestable o cualquier otra condición que pueda interferir en la seguridad del sujeto, obtención del consentimiento informado o cumplimiento con los procedimientos del estudio según el criterio del investigador.
14. Antecedentes o diagnóstico actual de enfermedad cardíaca que indiquen un riesgo significativo en la seguridad de los sujetos que participen en el estudio.
15. Sujetos con infecciones activas conocidas o no controladas que no responden a la terapia adecuada.
16. Sujetos con evidencia de abuso actual de alcohol/drogas.
17. Mujeres en edad fértil y hombres sexualmente activos que no deseen utilizar un método anticonceptivo adecuado durante el estudio.
18. Mujeres que estén en periodo de lactancia o embarazadas (prueba de embarazo de gonadotropina coriónica humana B [B-hCG] positiva en sangre u orina) en la selección o el día 1 antes de la dosis.

E.5 End points

E.5.1

Primary end point(s)

Percentage of participants with sustained remission (R) by 12 months

Proporción de sujetos con remisión sostenida a los 12 meses donde se define la remisión sostenida (R)

E.5.1.1

Timepoint(s) of evaluation of this end point

12 months

12 meses

E.5.2

Secondary end point(s)

1. Median duration of sustained remission
2. Percentage of participants with platelet count ≥ 50×109/L
3. Percentage of participants with at least one platelet count ≥ 30×109/L after eltrombopag is re-introduced without bleeding and no rescue medication
4. Absolute and relative change in platelet count from baseline to various time points
5. Percentage of participants who maintain a platelet count ≥ 30×109/L without bleeding and no rescue medication
6. Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionaire
7. Change from baseline in Functinal Assessment of Cancer Therapy- Thrombocytopenia (FACT-Th6) questionnaire
8. Change from baseline in Short Form 36 Health Survey (SF-36v2) questionnaire
9. Overall change from baseline of the overall impact of side effects on treatment via Functional Assessment of Cancer Therapy-G (GP5)
10. Overall change of treatment satisfaction using Treatment Satisfaction Questionnaire (TSQM-9)

1. Mediana de duración de la remisión sostenida
2. Porcentaje de sujetos con recuento de plaquetas >/= 50×109/L
3. Porcentaje de sujetos con al menos un recuento de plaquetas >/= 30×109/L tras haber reintroducido eltrombopag sin haber sangrado ni medicación de rescate.
4. Cambio absoluto y relativo en el recuento de plaquetas desde basal a distintos puntos.
5. Porcentaje de sujetos que mantienen un recuento de plaquetas >/= 30×109/L sin sangrado y sin medicación de rescate.
6. Cambio en el cuestionario FACIT-Fatigue con respecto al basal.
7. Cambio en el cuestionario FACT-Th6 con respecto al basal.
8. Cambio en el cuestionaro SF-36v2 con respecto al basal.
9. Cambio general desde el inicio del impacto general de los efectos secundarios en el tratamiento a través de la evaluación funcional de la terapia del cáncer-G (GP5).
10. Cambio general de la satisfacción del tratamiento utilizando el Cuestionario de Satisfacción de Tratamiento (TSQM-9).

E.5.2.1

Timepoint(s) of evaluation of this end point

1. 12 months
2. by 1 month
3. 12 months
4. Baseline, 3, 6, 9, 12 months
5. From first time of reaching the level to 3, 6, 9, 12 months
6.Baseline to 3, 6, 9, 12 months
7. Baseline to 3, 6, 9, 12 months
8. Baseline to 3, 6, 9, 12 months
9. Baseline, 12 months or end of study
10. Baseline, 12 months or end of study

1. 12 meses
2. en el primer mes
3. 12 meses
4. basal, 3, 6, 9, 12 meses
5. desde la primera vez alcanzado el nivel y en los meses 3, 6, 9, 12.
6. basal a 3, 6, 9, 12 meses
7. basal a 3, 6, 9, 12 meses
8. basal a 3, 6, 9, 12 meses
9. Basal, 12 meses o fin de estudio
10. Basal, 12 meses o fin de estudio

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

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

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.8.3

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

Austria

Brazil

Chile

France

Germany

Greece

Italy

Japan

Mexico

Norway

Oman

Russian Federation

Saudi Arabia

Spain

Switzerland

Turkey

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

Study completion is defined as when the last subject finishes their EOS visit, and any repeat assessments associated with this visit have been documented and followed-up appropriately by the Investigator, or in the event of an early study termination decision, the date of that decision

Se define el fin de estudio cuando el último paciente acaba la visita de fin de estudio y cualquier prueba repetida asociada a dicha visita ha sido documentada y se ha hecho un seguimiento por el investigador o en caso de un fin de estudio prematuro la fecha de decisión.

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 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)

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.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

101

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)

Continuing care to study participants should be provided by the investigator and/or referring physician. The treating physician can request access to eltrombopag for subjects that are continuing to benefit from treatment. Access will be dependent on the local regulatory authority approval of the product and current reimbursement options.

El investigador y / o el médico remitente deben proporcionar atención continua a los participantes del estudio. El médico tratante puede solicitar acceso a eltrombopag para los sujetos que continúan beneficiándose del tratamiento. El acceso dependerá de la aprobación de la autoridad reguladora local del producto y de las opciones de reembolso actuales.

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

2018-09-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-09-10

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials