Clinical Trials Register

Summary
EudraCT Number:	2016-000340-34
Sponsor's Protocol Code Number:	OPTIMUS
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:	2016-04-20
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

2016-000340-34

A.3

Full title of the trial

Dose optimization of tacrolimus using Bayesian prediction including pharmacogenetic variables in renal transplant patients.

OPTImización de la dosis de tacroliMUS mediante predicción bayesiana en pacientes trasplantados renales incluyendo las variables farmacogenéticas.

A.3.1

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

Dose optimization of tacrolimus using Bayesian prediction including pharmacogenetic variables in renal transplant patients.

OPTImización de la dosis de tacroliMUS mediante predicción bayesiana en pacientes trasplantados renales incluyendo las variables farmacogenéticas.

A.3.2

Name or abbreviated title of the trial where available

OPTIMUS

A.4.1

Sponsor's protocol code number

OPTIMUS

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	HOSPITAL UNIVERSITARI DE BELLVITGE
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	INSTITUTO DE SALUD CARLOS III
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	INSTITUT DE RECERBA BIOMÈDICA DE BELLVITGE-IDIBELL
B.5.2	Functional name of contact point	CAROLINA POLO
B.5.3	Address:
B.5.3.1	Street Address	FEIXA LLARGA, S/N
B.5.3.2	Town/ city	L'HOSPITALET DE LLOBREGAT
B.5.3.3	Post code	08907
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34932607385
B.5.5	Fax number	+34932607607
B.5.6	E-mail	cpolo@idibell.cat

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	Prograf
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.3.1	Product name	Prograf
D.3.4	Pharmaceutical form	Capsule
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	TACROLIMUS
D.3.9.1	CAS number	104987-11-3
D.3.9.4	EV Substance Code	SUB10797MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/kg milligram(s)/kilogram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.1
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	Adoport
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.3.1	Product name	Adoport
D.3.4	Pharmaceutical form	Capsule
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	TACROLIMUS
D.3.9.1	CAS number	104987-11-3
D.3.9.4	EV Substance Code	SUB10797MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/kg milligram(s)/kilogram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.1
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

PROPHYLAXIS OF ALLOGRAFT REJECTION AFTER RENAL TRASPLANT.

PROFILAXIS DEL RECHAZO DEL INJERTO TRAS EL TRASPLANTE RENAL

E.1.1.1

Medical condition in easily understood language

PROPHYLAXIS OF ALLOGRAFT REJECTION AFTER RENAL TRASPLANT.

PROFILAXIS DEL RECHAZO DEL INJERTO TRAS EL TRASPLANTE RENAL

E.1.1.2

Therapeutic area

Body processes [G] - Immune system processes [G12]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.0
E.1.2	Level	PT
E.1.2	Classification code	10038533
E.1.2	Term	Renal transplant
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Assess whether the optimization of the dosage of Tac in renal transplant patients, based on a population pharmacokinetic model previously developed that includes the CYP3A5 * 3 and CYP3A4 * 22 polymorphisms and hematocrit (as responsible for some of the variability in exposure to Tac) significantly increases the percentage of patients in therapeutic target with a margin of 30% superior, compared to standard dosing Tac. The percentage of patients in therapeutic target after 5 oral doses of Tac after the first dose post-transplant (defined as therapeutic Diana Co: 6-10 ng / ml) will be evaluated.

Evaluar si la optimización de la posología de Tac en pacientes trasplantados renales, en base a un modelo farmacocinético poblacional previamente desarrollado que incluye los polimorfismos CYP3A5*3 y CYP3A4*22, y hematocrito como responsables de parte de la variabilidad en la exposición a Tac alcanzada, incrementa significativamente el porcentaje de pacientes en diana terapéutica con un margen de superioridad del 30%, comparado con la dosificación estándar de Tac. Se evaluará en porcentaje de pacientes en diana terapéutica después de 5 dosis orales de Tac después de la primera dosis post-trasplante (Diana terapéutica definida como Co: 6-10 ng/ml).

E.2.2

Secondary objectives of the trial

1. Pharmacokinetic variables
- Co at day 6, 10, 15, 30, 60 and 90 after the start of post transplant tacrolimus.
- Time to achieve the therapeutic target.
- Number of dose modifications to achieve the therapeutic target.
2. Clinical variables:
- Severity of delayed graft function defined as the number of dialysis sessions required after transplantation.
- Protocol biopsies at 3 months follow-up. The presence of sub-clinical rejection or nephrotoxicity by calcineurin will be studied.
- Incidence of biopsy-confirmed acute rejection.
- Renal function at days 30, 60 and 90 after the start of post transplant tacrolimus.
- Loss of graft.
- EXITUS
3. Pharmaco-economic variables. Analysis of drug-economic impact of dose adjustment depending on the model of population kinetics.

1. Variables farmacocinéticas
- Co en el día 6, 10, 15, 30, 60 y 90 tras el inicio post trasplante de tacrolimus.
- Tiempo necesario para alcanzar la diana terapéutica.
- Número de modificaciones de dosis realizadas para alcanzar la diana terapéutica.
2. Variables clínicas:
- Severidad de la función retardada del injerto definida como el número de sesiones de diálisis requeridas después del trasplante.
- Biopsias de protocolo a los 3 meses de seguimiento. Se estudiará la presencia de rechazo sub-clínico o nefrotoxicidad por anticalcineurínicos.
- Incidencia de rechazo agudo confirmado por biopsia.
- Función renal en los días 30, 60 y 90 tras el inicio post trasplante de tacrolimus.
- Pérdida del injerto.
- Éxitus
3. Variables Fármaco-económicas. Análisis del impacto fármaco-económico del ajuste de dosis según el modelo de cinética poblacional.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

? Adult patients (? 18 years).
? Recipients of a renal graft from a cadaveric or living donor with more than 6 months post-transplant evolution.
? Patients who received a non-interrupted stable oral dose of immediate release tacrolimus (Prograf / Adoport®) and have had stable TAC trough concentrations between 6-10ng / ml for at least 10 days (steady state conditions).
? Patients receiving allowed concomitant immunosuppressive medication : mofetil or sodium mycophenolate and corticosteroids.
? May receive induction therapy with basiliximab.
? Subjects must be willing to give written informed consent for the trial. If a subject can not give written informed consent, a legal representative can sign instead.
? Women of childbearing potential should have a negative pregnancy test result at the time of inclusion and accept the use of a medically acceptable method of contraception during the selection and while receiving medication specified in the protocol.

? Pacientes adultos (? 18 años).
? Receptores de un injerto renal de donante cadáver o donante vivo con más de 6 meses de evolución post-trasplante.
? Pacientes que reciban una dosis oral no-interrumpida estable de Tacrolimus de liberación inmediata (Prograf®/Adoport®), con concentraciones mínimas estables de TAC entre 6-10ng/ml, durante al menos 10 días (condiciones de estado estacionario).
? Que estén recibiendo medicación inmunosupresora concomitante permitida: mofetil micofenolato o micofenolato sódico y corticosteroides.
? Pueden recibir tratamiento de inducción con basiliximab.
? Los sujetos deberán estar dispuestos a otorgar su consentimiento informado por escrito para el ensayo y ser capaces de hacerlo. Si un sujeto no puede otorgar su consentimiento informado por escrito de forma independiente, podrá hacerlo su representante legal en su lugar.
? Las mujeres en edad fértil deberán realizar un test de embarazo en el momento de la inclusión y aceptar el uso de un método anticonceptivo médicamente aceptable durante el periodo de selección y mientras reciban la medicación especificada en el protocolo.

E.4

Principal exclusion criteria

? Patients on dialysis or treatment of rejection after transplantation.
? Patients treated with substances with potential interaction with TAC, particularly potent inhibitors of CYP3A4 (such as telaprevir, boceprevir, ritonavir, ketoconazole, voriconazole, itraconazole, telithromycin or clarithromycin) or inducers of CYP3A4 (such as rifampin or rifabutin).
? Patients with induction therapy with ATG or rituxumab.
? Patients participating in another clinical trial or who were treated with any investigational drug within 30 days prior to inclusion.
? Patients with liver disease.
? Patient or donor with a current diagnosis or history of malignancy within the last 5 years except non-metastatic basal or squamous cell skin carcinoma successfully treated.
? Pregnant or lactating women and all women of childbearing potential unless they use reliable contraception. A pregnancy test will be performed in the selection and end of the study.
? Recipient of any other organ apart from kidney.
? Recipients of bone marrow or stem cell transplant.
? Recipients of a kidney from a ABO incompatible donor.
? Patients with donor specific anti-HLA antibodies.
? Anticipated cold ischemia time of ? 24 hours.
? Patients with a concomitant uncontrolled infection, systemic infection requiring treatment, or any other unstable medical condition that may interfere with the study objectives.
? Patients with severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of TAC.
? Patients with white blood cell count ? 2.8 x 109 / L unless the absolute neutrophil count (ANC) is ? 1.0 x 109 / L
? Patients with platelet count ? 50 x 109 / L.
? Patients with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) exceeding> 3 times the upper limit of normal during the 30 days prior to the transplant procedure.
? Patients with known hypersensitivity to TAC or any of the excipients in the formulation
? Patients unable to swallow study medication.
? Patients with any form of current substance abuse, psychiatric disorder or a condition that, in the investigator's opinion, may invalidate the communication with the investigator.
? Patients who require a high intake of potassium or potassium-sparing diuretics.
? Patients treated with substances with known nephrotoxic or neurotoxic effects.
? Recipients that are positive for hepatitis C virus (HCV-RNA positive) and / or hepatitis B virus (HBV DNA or HBsAg positive).
? Recipients positive for human immunodeficiency virus (HIV-Ab positive).
? Patients unable to understand the effects and risks of the study, who can not give informed consent in writing, or who are unwilling to comply with the study protocol patients.

? Pacientes en diálisis o tratamiento del rechazo desde el trasplante.
? Pacientes tratados con sustancias con potencial interacción con TAC, particularmente inhibidores potentes de CYP3A4 (tales como telaprevir, boceprevir, ritonavir, ketoconazol, voriconazol, itraconazol, telitromicina o claritromicina) o inductores de CYP3A4 (tales como rifampicina o rifabutina).
? Pacientes con tratamiento de inducción con ATG o rituxumab.
? Pacientes que participaran en otro ensayo clínico o que fueron tratados con cualquier otro fármaco de investigación en los 30 días anteriores a la inclusión.
? Pacientes con enfermedad hepática.
? El paciente o el donante con el diagnóstico actual o antecedentes de neoplasia maligna en los últimos 5 años, excepto el carcinoma de células basales o escamosas no metastásico de la piel tratada con éxito.
? Mujeres embarazadas o en periodo de lactancia y todas las mujeres en edad fértil a menos que usen métodos anticonceptivos fiables. Una prueba de embarazo se realizará en la selección y al final del estudio.
? Receptor de cualquier órgano trasplantado aparte del riñón.
? Los beneficiarios de trasplante de médula ósea o trasplante de células madre.
? Los receptores de un riñón de un donante incompatible ABO.
? Pacientes con anticuerpos anti-HLA específicos del donante.
? Los receptores de un riñón con un tiempo de isquemia fría anticipado ? 24 horas.
? Pacientes con una infección no controlada concomitante, infección sistémica en tratamiento, o cualquier otra condición médica inestable que podría interferir con los objetivos del estudio.
? Pacientes con diarrea severa, vómitos, úlcera péptica activa o un trastorno gastrointestinal que pueden afectar la absorción de TAC.
? Pacientes con un recuento de glóbulos blancos ? 2,8 x 109 / L a menos que el recuento absoluto de neutrófilos (RAN) sea ? 1,0 x 109 / L.
? Pacientes con un recuento de plaquetas ? 50 x 109 / L.
? Pacientes con niveles de aspartato aminotransferasa (AST) o de alanina aminotransferasa (ALT) que superen > 3 veces el límite superior de lo normal durante los 30 días anteriores al procedimiento de trasplante.
? Pacientes con hipersensibilidad conocida a TAC o a cualquiera de los excipientes presentes en su formulación
? Pacientes incapaces de tragar la medicación del estudio.
? Pacientes con cualquier forma de abuso de sustancias actual, trastorno psiquiátrico o una condición que, en opinión del investigador, puede invalidar la comunicación con el investigador.
? Pacientes que requieren de una ingesta elevada de potasio o diuréticos ahorradores de potasio.
? Pacientes tratados con sustancias con reconocidos efectos nefrotóxicos o neurotóxicos.
? Receptores positivos para el virus de la hepatitis C (VHC-ARN positivo) y / o hepatitis B virus (ADN-VHB o HBsAg positivo).
? Receptores positivos para virus de inmunodeficiencia humana (VIH-Ab positivo).
? Pacientes incapaces de comprender los efectos y riesgos del estudio, que no pueden dar su consentimiento informado por escrito, o que no están dispuestos a cumplir con el protocolo de estudio.

E.5 End points

E.5.1

Primary end point(s)

Measurement of plasma concentration of tacrolimus. Pre-dose samples will be obtained after reaching the Steady State, at the following times: after 5 doses of oral Tac after the first dose post-transplant on day 6 and on day 10 , 15, 30, 60 and 90 after initiation of treatment.

Medición de concentraciones plasmáticas de tacrolimus. Se extraerán muestras pre-dosis una vez alcanzado el Estado estacionario, en los siguientes tiempos: después de 5 dosis de Tac oral después de la primera dosis post-trasplante en el día 6 y en los días 10, 15, 30, 60 y 90 tras el inicio del tratamiento.

E.5.1.1

Timepoint(s) of evaluation of this end point

90 days after the initiation of tacrolimus

90 días después del inicio de tacrolimus

E.5.2

Secondary end point(s)

? Time to achieve the therapeutic target within the 90 days follow-up period.
? Number of dose modifications necessary to achieve the target.
? Efficacy endpoints.
Delayed graft function severity defined by the number of dialysis sessions required after transplantation, incidence of acute rejection confirmed by biopsy, incidence of subclinical rejection, incidence of CNI nephrotoxicity, renal function, graft loss and exitus will be evaluated.
? Security Settings
The incidence of adverse events and serious adverse events, including acute rejection, will be evaluated.

? Tiempo necesario para alcanzar la diana terapéutica Co en el período de seguimiento, 90 días.
? Número de modificaciones de dosis necesarias para alcanzar la diana.
? Variables de eficacia.
Se evaluará la gravedad de los episodios de función retardada del injerto según el número de sesiones de diálisis requeridas después del trasplante, la incidencia de rechazo agudo confirmado por biopsia, la incidencia de rechazo subclínico, los episodios de nefrotoxicidad por CNI, la función renal, la pérdida del injerto y los éxitus.
? Parámetros de Seguridad
Se evaluará la incidencia de eventos adversos y eventos adversos graves, incluyendo el rechazo agudo.

E.5.2.1

Timepoint(s) of evaluation of this end point

90 days after the initiation of tacrolimus

90 días después del inicio de tacrolimus

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

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

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

Yes

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

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

Yes

E.8.2.3.1

Comparator description

UNA DOSIS SIFERENTE DE LA MISMA SUSTANCIA ACTIVA

A DIFERENT DOSE OF THE SAME ACTIVE SUBSTANCE

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

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

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

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.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)

the expected normal treatment of that condition

EL TRATAMIENTO HABITUAL SEGUN PRÁCTICA CLÍNICA

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

2016-06-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-04-21

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

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