Clinical Trials Register

Summary
EudraCT Number:	2016-002503-26
Sponsor's Protocol Code Number:	X16082
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:	2017-01-04
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

2016-002503-26

A.3

Full title of the trial

Phase Ib/II trial to evaluate safety and efficacy of oral ixazomib in combination with sirolimus and tacrolimus in the prophylaxis of chronic graft-versus-host disease

Ensayo de fase Ib/II para evaluar la eficacia y seguridad de ixazomib oral en combinación con sirolimus y tacrolimus como profilaxis de la enfermedad injerto contra huésped crónica.

A.3.1

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

Trial to evaluate the safety and efficacy of a new drug in combination with the standard therapy to prevent the rejection which could occur after a transplantation.

Ensayo para evaluar la seguridad y eficacia de un fármaco en investigación en combinación con el tratamiento habitual para prevenir el rechazo que puede ocurrir tras un trasplante.

A.4.1

Sponsor's protocol code number

X16082

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	Fundación Pública Andaluza para la Gestión en Salud de Sevilla (FISEVI)
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	Own funding
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	Unidad de Investigación Clínica y ensayos Clínicos
B.5.2	Functional name of contact point	UICEC-HUVR
B.5.3	Address:
B.5.3.1	Street Address	AVENIDA MANUEL SIUROT S/N
B.5.3.2	Town/ city	SEVILLA
B.5.3.3	Post code	41013
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034955013414
B.5.5	Fax number	0034954232992
B.5.6	E-mail	claram.rosso.sspa@juntadeandalucia.es

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	Ninlaro
D.2.1.1.2	Name of the Marketing Authorisation holder	Takeda
D.2.1.2	Country which granted the Marketing Authorisation	Denmark
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	Ninlaro
D.3 Description of the IMP
D.3.1	Product name	Ixazomib
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	IXAZOMIB
D.3.9.1	CAS number	1072833-77-2
D.3.9.3	Other descriptive name	IXAZOMIB
D.3.9.4	EV Substance Code	SUB121332
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	3 to 4
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	RAPAMUNE
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Limited
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	RAPAMUNE
D.3.2	Product code	724534
D.3.4	Pharmaceutical form	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	SIROLIMUS
D.3.9.1	CAS number	53123-88-9
D.3.9.3	Other descriptive name	RAPAMICINE
D.3.9.4	EV Substance Code	SUB10537MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	4 to 6
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	PROGRAF
D.2.1.1.2	Name of the Marketing Authorisation holder	Astellas Pharma, S.A.
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.3.2	Product code	680678
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use 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	range
D.3.10.3	Concentration number	0.02 to 0.12
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

Adult patiens after allogeneic stem cell transplantation

Pacientes adultos tras traplante alogénico de médula osea

E.1.1.1

Medical condition in easily understood language

Adult patients who receive bone marrow transplantation from a donor

Pacientes adultos que reciben trasplante de médula ósea de un donante

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	19.1
E.1.2	Level	LLT
E.1.2	Classification code	10018653
E.1.2	Term	Graft-versus-host disease <GVHD>
E.1.2	System Organ Class	100000004870

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.1
E.1.2	Level	LLT
E.1.2	Classification code	10067859
E.1.2	Term	Allogenic stem cell transplantation
E.1.2	System Organ Class	100000004865

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Phase I:
To identify the optimal dose and to evaluate the safety profile of ixazomib in combination with sirolimus and tacrolimus in patients undergoing allogeneic stem cell transplantation.
Phase II:
To evaluate the efficacy of ixazomib in combination with sirolimus and tacrolimus to reduce the risk of moderate or severe chronic graft-versus-host disease (cGVHD) after 1 year postransplant.

Fase I:
Identificar la dosis óptima y evaluar el perfil de seguridad de ixazomib en combinación con sirolimus y tacrolimus en pacientes sometidos a trasplante alogénico de médula ósea.
Fase II:
Evaluar la eficacia de ixazomib en combinación con sirolimus y tacrolimus de reducir el riesgo de la enfermedad injerto contra huésped (EICH) crónica moderada o severa a un año postrasplante.

E.2.2

Secondary objectives of the trial

Phase I:
-To evaluate the efficacy of ixazomib in combination with sirolimus and tacrolimus in terms of incidence of moderate or severe chronic GVHD according to NIH scale after 9 months postransplant.
-To evaluate the effect of ixazomib on immune response as compared to a control group of patients receiving sirolimus and tacrolimus.
Phase II:
-To evaluate the effect of ixazomib in combination with sirolimus and tacrolimus on the incidence of moderate or severe GVHD after 2 years postransplant.
-To evaluate the effect of ixazomib in combination with sirolimus and tacrolimus on GVHD free survival and relapse-free GVHD-free survival as compared to a control group after 1 and 2 years postransplant.
-To evaluate the effect of ixazomib in combination with sirolimus and tacrolimus on the immune response after transplantation
-To describe the exposure to immunosuppressive treatment at 1 and 2 years postransplant.
-Overall and disease free survival at 2 years postransplant.

Fase I
-Evaluar la eficacia de ixazomib en combinación con sirolimus y tacrolimus, en términos de incidencia de EICH crónica moderada o severa de acuerdo a la escala NIH a los 9 meses postrasplante.
-Evaluar el efecto de ixazomib en la respuesta inmune comparado con un grupo control de pacientes que reciben sirolimus y tacrolimus.
Fase II:
-Evaluar el efecto de ixazomib en combinación con sirolimus y tacrolimus en la incidencia de EICH crónica moderada o severa a los 2 años postrasplante.
-Evaluar el efecto de ixazomib en combinación con sirolimus y tacrolimus en la supervivencia libre de EICH crónica y supervivencia libre de recidiva de EICH crónica en comparación con un grupo control (1 y 2 años postrasplante)
-Evaluar el efecto de ixazomib en combinación con sirolimus y tacrolimus en la respuesta inmune tras el trasplante.
-Describir la exposición al tratamiento inmunosupresor (1 o 2 años postrasplante).
-Supervivencia global y libre de enfermedad a los 2 años postrasplante.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female patients 18 years or older.
2. Patients having received reduced intensity conditioning (RIC) peripheral blood allogeneic stem cell transplantation.
3. Patients undergoing hematopoietic stem cell transplant from a matched or a single mismatched related or unrelated donor as definition accepted by protocol.
4. Patients receiving GVHD prophylaxis with sirolimus and tacrolimus and on stable levels during the last 2 weeks before inclusion.
5. Voluntary written consent must be given before performance of any study related procedure.
6. Female patients who accomplish with requisitions for not possibility of pregnancy (menopausia, effective methods of contraception), as detailed by protocol.
7. Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2.
8. Patients must meet the following clinical laboratory criteria:
• Absolute neutrophil count (ANC) 1,000/mm3 and platelet count 75,000/mm3. Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment.
• Total bilirubin 1.5 the upper limit of the normal range (ULN).
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 3 ULN.
• Calculated creatinine clearance 30 mL/min (see Section 11.2).
9. Ability to swallow and tolerate oral medication.
10. Absence of gastrointestinal symptoms that precludes oral intake and absorption.
11. Off antibiotics and amphotericin B formulations, voriconazole or other anti-fungal therapy for the treatment of active proven, probable or possible infections.

1. Paciente hombre o mujer ≥ 18 años .
2. Pacientes que hayan recibido un trasplante alogénico con acondicionamiento de intensidad reducida (AIR).
3. Pacientes que hayan recibido un trasplante hematopoyético de médula ósea compatible o no, de donante emparentado o no, de acuerdo a requisitos detallados en el protocolo.
4. Pacientes que estén recibiendo profilaxis para EICH con sirolimus y tacrolimus con niveles estables en las 2 semanas previas a la inclusión.
5. Consentimiento voluntario por escrito y firmado antes de realizar ningún procedimiento relacionado con el estudio.
6. Pacientes mujeres que cumplan requisitos detallados para que no sea posible el embarazo (menoapusia, métodos anticonceptivos aceptados)
7. ECOG (Eastern Cooperative Oncology Group) y/o otros performance status debe ser 0, 1, o 2.
8. Los pacientes deben cumplir los siguientes criterios de laboratorio:
• Recuento absoluto de neutrófilos (RAN) 1,000/mm3 y recuento de plaquetas 75,000/mm3. No se permiten las transfusiones de plaquetas para ayudar a que los pacientes cumplan criterios de inclusión en los 3 días previos a la inclusión en el estudio.
• Bilirrubina total 1.5 límite superior de la normalidad (LSN).
• Alanino aminotransferasa (ALT) y aspartato aminotransferasa (AST) 3 LSN.
a. Aclaramiento de creatinina calculado 30 mL/min (ver Sección 11.2).
9. Capacidad para ingerir y tolerar medicación por vía oral.
10. Ausencia de síntomas gastrointestinales que impidan la absorción e ingesta oral.
11. Pacientes que no estén recibiendo antibióticos ni formulaciones de anfotericina B, voriconazol u otra terapia antifúngica para el tratamiento de infecciones probadas, probables o posibles.
Durante el período de tratamiento del estudio se requiere profilaxis antiviral (desde el inicio hasta la discontinuidad de la terapia, ver Sección 6.5).

E.4

Principal exclusion criteria

1. Female patients who are lactating or have a positive serum pregnancy test during the screening period.
2. Major surgery within 14 days before enrollment.
3. Central nervous system involvement with malignant cells.
4. Uncontrolled infection within 14 days before study enrollment.
5. Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.
6. Systemic treatment, within 14 days before the first dose of ixazomib, with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John’s wort.
7. Ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive.
8. Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol.
9. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
10. Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
11. Patient has Grade 1 peripheral neuropathy.
12. Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial.
13. Patients that have previously been treated with ixazomib, or participated in a study with ixazomib whether treated with ixazomib or not.
14. Active Graft versus host disease at the time of inclusion: patients are allowed to be included if acute GVHD is in complete remission and are receiving systemic steroids at < 0.25 mg / kg.
15. Active hematologic malignancy at the time of inclusion.
16. Active microangiopathy at the time of inclusion (according to IWG criteria)
17. Gastrointestinal disease or procedure than can interfere with oral absortion , intolerance to the ixazomib or difficulty to swallow.

1. Mujeres en período de lactancia o test de embarazo positivo durante el período de screening.
2. Cirugía mayor realizada en los 14 días previos a la inclusión en el estudio.
3. Afectación de sistema nervioso central con células neoplásicas.
4. Infección no controlada en los 14 días previos a la inclusión en el estudio.
5. Evidencia de problemas cardiovasculares no controlados, incluyendo hipertensión, arritmias cardíacas, insuficiencia cardíaca congestiva sintomática, angina inestable o infarto miocárdico en de los 6 últimos meses.
6. Tratamiento sistémico, en los 14 días antes de la primera dosis de ixazomib, con inductores potentes del CYP3A (rifampicina, rifapentina, rifabutina, carbamazepina, fenitoína, fenobarbital), o uso de Ginkgo biloba o Hierba de San Juan.
7. Infección sistémica activa o persistente, infección por virus B o C activa, o presencia de Virus de la Inmunodeficiencia Humana (VIH).
8. Cualquier enfermedad grave médica o psiquiátrica que pudiera, en la opinión del investigador, interferir potencialmente en el cumplimiento del tratamiento de acuerdo al protocolo.
9. Alergia conocida a cualquiera de los medicamentos del estudio, sus análogos, o excipientes en las formulaciones de cualquiera de los agentes.
10. Que el paciente haya sido diagnosticado o tratado de otra neoplasia en los dos años antes de la inclusión en el estudio o previamente diagnosticado de otra neoplasia y que aún presente evidencia de enfermedad residual. Los pacientes con enfermedad de piel no melanoma o carcinoma in situ de cualquier tipo no se excluyen del estudio si han recibido tratamiento con resección completa.
11. Paciente con neuropatía periférica Grado 1.
12. Participación en otros ensayos clínicos, incluyendo aquellos con otros agentes en investigación no incluidos en este ensayo, en los 30 días previos al inicio y durante todo el periodo de duración del mismo.
13. Pacientes que hayan sido tratados previamente con ixazomib, o participado en estudios con ixazomib aún habiendo sido tratados con o sin ixazomib.
14. Enfermedad injerto contra huésped activa en el momento de la inclusión: sólo se permite la inclusión de pacientes si la EICH aguda se encuentra en remisión completa y está recibiendo una dosis de esteroides inferior a 0.25 mg/kg.
15. Enfermedad hematológica activa en el momento de la inclusión.
16. Microangiopatía activa en el momento de la inclusión (de acuerdo a los criterios IWG o International Working Group).
17. Enfermedad GI conocida o procedimiento GI que pueda interferir con la absorción oral o tolerancia del ixazomib, incluyendo dificultad para tragar.

E.5 End points

E.5.1

Primary end point(s)

Phase I:
-To identify the optimal dose and evaluate the safety of ixazomib used after transplantation.
-To evaluate the efficacy of ixazomib used after transplantation, measured in terms of risk of moderate or severe GVHD according to NIH scale.
-To evaluate the immune recovery of the 12 patients included in the safety expansion cohort and compare it with a cohort of 12 patients receiving sirolimus and tacrolimus out of the trial.
Phase II.
-To evaluate the reduction of risk of moderate or severe GVHD according to NIH scale

Fase I:
-Identificar la dosis óptima y evaluar la seguridad de ixazomib utilizado tras el trasplante.
-Evaluar la eficacia de ixazomib utilizado después del trasplante , y medido en términos de riesgo de EICH crónica moderada o severa de acuerdo a la escala NIH.
-Evaluar la recuperación inmune en los 12 pacientes incluidos en la cohorte de seguridad y compararlo con una cohorte de 12 pacientes que reciban sirólimus y tacrólimus fuera del ensayo.
Fase II:
Evaluar la reducción del riesgo de EICH crónica moderada o severa de acuerdo a la escala NIH.

E.5.1.1

Timepoint(s) of evaluation of this end point

Nine months after transplantation.

Nueve meses post transplante

E.5.2

Secondary end point(s)

Phase I study:
-To evaluate the risk of moderate or revere cGVHD according to NIH scale at 2 years postrasplantation,this is, 6 months after ixazomib discontinuation.
-To evaluate the effect of ixazomib on cGVHD free survival
-To evaluate the immune recovery after transplantation among patients exposed or not to ixazomib.
-To describe exposure to immunosuppressive treatment at 1 and 2 years postransplant.
-To describe the overall and disease free survival at 2 years postransplant among patients exposed or not to ixazomib.

Fase I:
-Evaluar el riesgo de EICHc moderada o severa de acuerdo a la escala NIH
-Evaluar el efecto de ixazomib en la supervivencia libre de EICHc.
-Evaluar la recuperación inmune tras el trasplante en pacientes expuestos y no expuestos a ixazomib.
-Describir la exposición al tratamiento inmunosupresor a 1 y 2 años postrasplante.
-Describir la supervivencia global y libre de enfermedad entre pacientes expuestos y no expuestos a ixazomib.

E.5.2.1

Timepoint(s) of evaluation of this end point

1 and 2 years postransplant.

1 y 2 años postrasplante.

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

Yes

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

Yes

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)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

Searching for optimized dosage.

Búsqueda de dosis optima.

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

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

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

tratamiento recomendado

recommended treatment

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

Final visit of the last patient included.

El día de la visita final del último paciente incluido.

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

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:

124

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

152

F.4.2

For a multinational trial

F.4.2.1

In the EEA

152

F.4.2.2

In the whole clinical trial

152

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)

Treatment after study as per investigators juice according to GCP

A juicio del investigador de acuerdo a BPCs

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

2017-03-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-03-07

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

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Orphan Designation Number:
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