Clinical Trials Register

Summary
EudraCT Number:	2017-001454-33
Sponsor's Protocol Code Number:	DEXBASU
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2017-06-22
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2017-001454-33

A.3

Full title of the trial

A randomized, non-blinded, 24-week pilot study to evaluate the effect of dapagliflozin (10 mg once daily) plus exenatide (2.0 mg once weekly) on type 2 diabetic patients awaiting for bariatric surgery. DEXBASU study

Estudio piloto aleatorizado, sin enmascaramiento, de 24 semanas de duración para evaluar el efecto de la dapagliflozina (10 mg en dosis única diaria) asociada a exenatida (2,0 mg en dosis única semanal) en pacientes con diabetes mellitus tipo 2 candidatos a cirugía bariátrica (estudio DEXBASU).

A.3.1

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

A 24-week study to evaluate the effect of dapagliflozin (10 mg once daily) plus exenatide (2.0 mg once weekly) on type 2 diabetic patients awaiting for bariatric surgery.

Estudio de 24 semanas de duración para evaluar el efecto de la dapagliflozina (10 mg en dosis única diaria) asociada a exenatida (2,0 mg en dosis única semanal) en pacientes con diabetes mellitus tipo 2 candidatos a cirugía bariátrica.

A.3.2

Name or abbreviated title of the trial where available

DEXBASU

A.4.1

Sponsor's protocol code number

DEXBASU

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	Dr. Albert Lecube Torello
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Astra Zeneca
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Dynamic Science SL..
B.5.2	Functional name of contact point	Raúl Montalbán Casado
B.5.3	Address:
B.5.3.1	Street Address	Avinguda Josep Tarradellas 8-10 Planta 5 Puerta 4
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08029
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034914561105
B.5.5	Fax number	0034914561126
B.5.6	E-mail	raul.m@dynasolutions.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	Forxiga
D.2.1.1.2	Name of the Marketing Authorisation holder	Astrazeneca Ab
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DAPAGLIFLOZIN
D.3.9.1	CAS number	461432-26-8
D.3.9.3	Other descriptive name	DAPAGLIFLOZIN
D.3.9.4	EV Substance Code	SUB31650
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	10
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	Bydureon
D.2.1.1.2	Name of the Marketing Authorisation holder	Astrazeneca Ab
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Powder and solution for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	EXENATIDE
D.3.9.1	CAS number	141758-74-9
D.3.9.4	EV Substance Code	SUB21818
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	2
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

Type 2 Diabetes mellitus

Diabetes mellitus tipo 2

E.1.1.1

Medical condition in easily understood language

Diabetes mellitus

E.1.1.2

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

MedDRA Classification

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	10012613
E.1.2	Term	Diabetes mellitus non-insulin-dependent
E.1.2	System Organ Class	100000004861

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 the effect of 24-week GLP-1ra plus SGLT2i based therapy (exenatide 2.0 mg once weekly plus dapaglifozine 10 mg once daily) compared to traditional management of the disease in the proportion of patients with T2D awaiting for bariatric surgery who will run off the National Institutes of Health criteria.

Evaluar el efecto de un tratamiento de 24 semanas basado en la combinación de un análogo del receptor de GLP-1 (arGLP1) y un inhibidor del cotransportador de sodio y glucosa a nivel renal (iSGLT2) GLP-1ra y SGLT2i (2,0 mg de exenatida una vez a la semana y 10 mg de dapagliflozina una vez al día) frente al tratamiento tradicional de la diabetes mellitus de tipo 2 en la proporción de pacientes candidatos a cirugía bariátrica que dejarán de cumplir los criterios de los Institutos Nacionales de Salud de EE. UU

E.2.2

Secondary objectives of the trial

1. To assess Changes in body weight and classification of weight category by BMI.
2. To assess the percentage of patients who achieve both a 5% and 10% decrease in body weight.
3. Changes in neck circumference
4. To assess the percentage of patients, who achieve a decrease of 1% in their HbA1c level.
5. To assess the changes in glucose metabolism, therapy, and diabetes
6. To assess the changes in blood pressure, therapy, and hypertensive status.
7. To assess the changes in fasting lipids, therapy.
8. To assess the changes on the obstructive apnoea syndrome severity.
9. To assess the changes in quality of life and proportion of patients that refuse the surgery option.
10. To assess the proportion of patients who achieve the composite objective of a significantly decrease in both body weight (5% decrease in body weight or higher) and/or HbA1c levels (1% decrease in HbA1c or higher) from baseline to 24-weeks of therapy.

1. Evaluar los cambios en el peso corporal y en la clasificación de la categoría de peso según el IMC.
2. Evaluar el porcentaje de pacientes que consiguen una disminución de peso corporal del 5% y del 10%.
3. Evaluar descenso del perímetro cervical
4. Evaluar el porcentaje de pacientes que consiguen una disminución del 1% de la HbA1c.
5. Evaluar los cambios en el metabolismo de la glucosa, el tratamiento y el estado de la diabetes.
6. Evaluar los cambios en la presión arterial, el tratamiento y el estado de la hipertensión.
7. Evaluar los cambios en los lípidos en ayunas, el tratamiento.
8. Evaluar los cambios en la gravedad del síndrome de apnea obstructiva.
9. Evaluar los cambios en la calidad de vida y en la proporción de pacientes que rechazan la opción de cirugía.
10. Evaluar la proporción de pacientes que consiguen una disminución significativa del peso corporal (5% o más) y/o de niveles de HbA1c (1% de disminución en la HbA1c o más) a las 24 semanas de tratamiento.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1 Male or female subjects aged between 18 and 60 years.
2 BMI of ≥ 35.0 - ≤ 42.5 Kg/m2.
3 Type-2 diabetes mellitus
4 HbA1c ≥ 7.0 - ≤ 10.0%.
5 Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements

1. Pacientes de edad comprendida entre los 18 y los 60 años.
2. IMC ≥ 35,0 y ≤ 42,5 Kg/m2.
3. Pacientes con diabetes de tipo 2.
4. HbA1c ≥7,0 - ≤ 10,0%.
5. Los pacientes deberán haber firmado y fechado personalmente un formulario de consentimiento informado.

E.4

Principal exclusion criteria

1 Known type-1 diabetes or LADA diabetes
2 Medication-induced obesity: Glucocorticoid and antipsychothic therapies
3 Patients with a change of ≥5% of their reported body weight reported change within the previous 3 months.
4 Previous surgical obesity treatment
5 Use of approved weight lowering pharmacotherapy
6 Active treatment with GLP-1RA
7 Active treatment with SGLT2i
8 Current drug or alcohol abuse
9 Uncontrolled psychiatric illness
10 History of acute or chronic pancreatitis, cholelithiasis, personal or familial history of medullary thyroid carcinoma, multiple endocrine neoplasia type 2, or recurrent genital infections
11 An estimated Glomerular Filtration Rate < 60 ml/min, calculated with the Modifications of Diet Renal Disease (MDRD-4) formula.
12 Inadequate liver function as shown by: Serum or plasma ALT and AST > 2.5 x ULN; Serum or plasma total bilirubin >3 x ULN
13 Major medical conditions (i) vascular disease within 3 months prior to signing the consent at visit 1: myocardial infarction, cardiac surgery or revascularization, unstable angina, heart failure, any significant cerebrovascular disesase; (ii) significant hepatic disease, including but not limited to chronic active hepatitis and/or severe hepatic insufficiency; (iii) history of hemoglobinopathy; and (iv) malignancy within 5 years of enrollment visit (with exception of treated basal cell or treated squamous cell carcionoma).
14 Recurrent urinary tract or genital infections
15 Active treatment with warfarin
16 Pregnant women
17 Women of childbearing potential (those who are not surgically sterilized or postmenopausal for at least 2 years) who do not agree to abstain from sexual intercourse with a male partner or use a medically acceptable method of birth control (such as condom, diaphragm or cervical/vault cap with spermicide) until 28 days post-treatment.

1. Pacientes con diabetes mellitus tipo 1 o diabetes autoinmune latente del adulto (diabetes tipo LADA).
2. Obesidad inducida por glucocorticoides y/o antipsicóticos.
3. Pacientes con un cambio ≥5% en su peso corporal comunicado durante los 3 meses anteriores.
4. Tratamiento quirúrgico previo para la obesidad.
5. Pacientes que tomen fármacos aprobados para la reducción de peso.
6. Tratamiento activo con un GLP-1ra.
7. Tratamiento activo con un SGLT2i.
8. Alcoholismo o toxicomanía actuales.
9. Enfermedades psiquiátricas no controladas.
10. Antecedentes de pancreatitis aguda o crónica, colelitiasis, antecedentes personales o familiares de carcinoma medular de tiroides, neoplasia endocrina múltiple tipo 2.
11. Filtración glomerular estimada < 60 ml/min, calculada mediante la tasa de filtración glomerular MDRD.
12. Función hepática inadecuada, definida como: ALT/GOT y AST/GPT > 2.5 x límite superior normal (LSN); Bilirrubina total: >3 x LSN
13. Enfermedades importantes, tales como (i) enfermedad vascular en los 3 meses previos a la firma del consentimiento informado: infarto de miocardio, cirugía cardíaca o revascularización, angina inestable, fallo cardíaco, cualquier patología cerebrovascular significativa; (ii) enfermedad hepática significativa, incluyendo, pero no limitándose a, hepatitis activa crónica y / o insuficiencia hepática grave; (iii) historia de hemoglobinopatía; y (iv) enfermedad neoplásica en los 5 años previos a la visita basal, con excepción del carcinoma tratado de células escamosas o células basales).
14. Infecciones genitales o de las vías urinarias frecuentes.
15. Tratamiento activo con warfarina.
16. Mujeres embarazadas.
17. Mujeres en edad fértil que no usen métodos anticonceptivos de barrera eficaces, es decir, métodos con barreras físicas o químicas que impidan que los espermatozoides atraviesen el cuello uterino, lleguen al útero y las trompas de Falopio y fecunden un óvulo, e incluyen el diafragma, la esponja, el capuchón cervical y los preservativos.

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint for the study is the proportion of patients who do not accomplish with the National Health criteria for bariatric surgery. This is the proportion of patients who achieve, after 24-weeks of therapy, a BMI ≤ 35.0 kg/m2 or a BMI ≤ 40.0 kg/m2 plus an HbA1c ≤ 6.0%.

Proporción de pacientes que no cumplen los criterios de los Institutos Nacionales de Salud de EE. UU para cirugía bariátrica. Especialmente, la proporción de pacientes que han conseguido, tras 24 semanas de tratamiento, un IMC ≤ 35,0 kg/m2 o un IMC ≤ 40,0 kg/m2 junto con un HbA1c ≤ 6,0%.

E.5.1.1

Timepoint(s) of evaluation of this end point

After 24 weeks of treatment

Tras 24 semanas de tratamient0

E.5.2

Secondary end point(s)

1. Anthropometric data: body weight, classification of weight category by BMI (< 35 kg/m2, ≥ 35 - < 40 kg/m2, and ≥ 40 kg/m2), waist circumference and neck circumference. We will also evaluate decreases of both 5% and 10% of baseline body weight and waist circumference at the end of the treatment period.

2. Parameters from glucose metabolism (fasting plasma glucose, fasting insulin, and HbA1c), hypoglycaemic therapy requirements, and diabetes status. Percentage of patients who decrease their baseline HbA1c more than 1%, and percentage of patients with HbA1c ≤ 7.0% and HbA1c ≤ 6.0% at the end of the treatment period. We will also classify patients on complete and partial remission.

3. Systolic and diastolic blood pressure, antihypertensive therapy requirements, and we will classify patients according to their hypertensive status (complete or partial remission).

4. Parameters from lipid metabolism (fasting total cholesterol, low-density lipoprotein cholesterol, very-low density lipoprotein cholesterol, and triglycerides), and hypolipemic therapy requirements.

5. Parameters from a non-attended respiratory polygraphy [apnoea-hypopnea index (AHI) and cumulative percentage of sleeping time spent with oxygen saturations below 90% (CT90)] and the obstructive apnoea syndrome severity. The daytime sleepiness will also be assessed through the Epworth Sleepiness Test (ESS).

6. Quality of life assessed by the Impact of Weight Quality of Life (IWQOL) questionnaire.

7. The proportion of patients awaiting bariatric surgery that still fulfilling the National Institutes of Health criteria refuses this treatment option.

8. The proportion of patients who achieve the composite objective of a significantly decrease in both body weight (5% decrease in body weight or higher) and/or HbA1c (1% decrease in HbA1c or higher) levels from baseline to 24-weeks of therapy.

1. Datos antropométricos: peso corporal, clasificación de la categoría de peso según el IMC (< 35 kg/m2, ≥ 35 - < 40 kg/m2, y ≥ 40 kg/m2), circunferencia de cintura y cervical. En cuanto al peso corporal y al perímetro de cintura, se evaluará también el porcentaje de pacientes que consigue descensos del 5% y del 10% en el momento de finalizar su participación en el estudio.

2. Parámetros relacionados con el metabolismo glucémico (glucosa plasmática en ayunas, y HbA1c), requisitos de tratamiento hipoglucémico y estado de la diabetes (remisión completa o parcial). Porcentaje de pacientes que reducen su nivel inicial de HbA1c más de un 1%, y porcentaje de pacientes con HbA1c ≤ 7,0% y HbA1c ≤ 6,0% al final del período de tratamiento.

3. Presión arterial sistólica y diastólica, necesidad de tratamiento para la hipertensión y estado de la hipertensión (remisión completa o parcial).

4. Parámetros del metabolismo lipídico (colesterol total en ayunas, colesterol de las lipoproteínas de baja densidad, colesterol de las lipoproteínas de muy baja densidad y triglicéridos), requisitos de tratamiento hipolipemiante.

5. Parámetros de poligrafía respiratoria no asistida [índice de apnea-hipopnea (IAH) y porcentaje acumulado de tiempo de sueño con saturaciones de oxígeno por debajo del 90% (CT90)] y gravedad de síndrome de apnea obstructiva. También se evaluará la somnolencia diurna mediante la escala de somnolencia de Epworth.

6. Se valorará la calidad de vida mediante el cuestionario Impact of Weight Quality of Life (IWQOL).

7. Proporción de pacientes candidatos a cirugía bariátrica que siguen cumpliendo los criterios de los Institutos Nacionales de Salud de EE. UU pero rechazan esta opción de tratamiento.

8. Proporción de pacientes que consiguen el objetivo combinado de disminución significativa del peso corporal (5% de disminución del peso corporal, o más) y/o de niveles de HbA1c (1% de disminución en la HbA1c o más) desde el inicio del tratamiento hasta las 24 semanas de tratamiento, sin valor de corte predefinido

E.5.2.1

Timepoint(s) of evaluation of this end point

After 24 weeks of treatment

Tras 24 semanas de tratamiento

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)

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

Yes

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

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Dieta baja en grasa con un déficit energético de 500 kcal por día.

Low-fat diet with about 500 kcal per day deficit

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

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:

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.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)

Post trial tretment according to standard clinical care

Tratamiento después de la finalización del ensayo clínico según la práctica clínica habitual

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

2017-08-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-08-01

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

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