Clinical Trials Register

Summary
EudraCT Number:	2021-000591-10
Sponsor's Protocol Code Number:	CNIS793B12301
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Temporarily Halted
Date on which this record was first entered in the EudraCT database:	2021-08-31
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

2021-000591-10

A.3

Full title of the trial

A randomized, double-blind, phase III study comparing NIS793 in combination with gemcitabine and nab-paclitaxel versus placebo combined with gemcitabine and nab-paclitaxel for first line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC)

Estudio de fase III aleatorizado y doble ciego que compara NIS793 en combinación con gemcitabina y nab-paclitaxel frente a placebo combinado con gemcitabina y nab-paclitaxel para el tratamiento de primera línea del adenocarcinoma ductal de páncreas metastásico.

A.3.1

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

Study of efficacy and safety of NIS793 in combination with standard of care (SOC) chemotherapy in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC)

Estudio de la eficacia y la seguridad de NIS793 en combinación con la quimioterapia de referencia para el adenocarcinoma ductal de páncreas metastásico en tratamiento de primera línea.

A.4.1

Sponsor's protocol code number

CNIS793B12301

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 Via 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	34 90 0353036
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	No
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.3.2	Product code	NIS793
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	not yet defined
D.3.9.2	Current sponsor code	NIS793
D.3.9.3	Other descriptive name	NIS793
D.3.9.4	EV Substance Code	SUB184323
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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.2.5	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	Abraxane
D.3.4	Pharmaceutical form	Powder for dispersion for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Paclitaxel
D.3.9.1	CAS number	33069-62-4
D.3.9.3	Other descriptive name	PACLITAXEL ALBUMIN-BOUND
D.3.9.4	EV Substance Code	SUB127678
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	100
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.2.5	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	gemcitabine
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	GEMCITABINE
D.3.9.1	CAS number	95058-81-4
D.3.9.3	Other descriptive name	gemcitabine
D.3.9.4	EV Substance Code	SUB07892MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Pancreatic ductal adenocarcinoma

adenocarcinoma ductal de páncreas

E.1.1.1

Medical condition in easily understood language

Pancreatic cancer

Cáncer de páncreas

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.0
E.1.2	Level	LLT
E.1.2	Classification code	10033604
E.1.2	Term	Pancreatic cancer
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

safety run in: to confirm the recommended phase 3 dose (RP3D) of NIS793 in combination with gemcitabine and nab-paclitaxel
randomized part: to compare OS in participants with mPDAC treated as the first line treatment with the combination of NIS793, gemcitabine and nab-paclitaxel to the combination of placebo with gemcitabine and nab-paclitaxel

Parte de preinclusión de seguridad:
El objetivo principal de la parte de preinclusión de seguridad es confirmar la dosis recomendada para la fase 3 (RP3D) de NIS793 en combinación con gemcitabina y nab-paclitaxel (SOC).
Parte aleatorizada:
El objetivo principal de la parte aleatorizada es comparar la OS en participantes con ADPm tratado con la combinación de NIS793, gemcitabina y nab-paclitaxel como el tratamiento de primera línea respecto a la combinación de placebo con gemcitabina y nab-paclitaxel.

E.2.2

Secondary objectives of the trial

safety run in:
1. safety and tolerability of NIS793 in combination with SoC
2. PK of NIS793 in combination with SoC
3. preliminary anti-tumor activity of NIS793 in combination with SoC

randomized part:
1. efficacy (PFS, ORR, DCR; DOR, TTR) of NIS793 in combination with SoC versus placebo in combination with SoC
2. safety and tolerability in each treatment arm
3. health-related QoL and other PROs in each treatment arm

Parte de preinclusión de seguridad:
1. La seguridad y la tolerabilidad de NIS793 en combinación con gemcitabina y nab-paclitaxel.
2. La actividad antitumoral preliminar de NIS793 en combinación con gemcitabina y nab-paclitaxel.
3. La farmacocinética (PK) de NIS793 en combinación con gemcitabina y nab-paclitaxel.
Parte aleatorizada:
1. Eficacia (PFS, ORR, DCR, DOR, TTR) de NIS793 en combinación con gemcitabina y nab-paclitaxel frente a placebo más gemcitabina y nab-paclitaxel.
2. Seguridad y la tolerabilidad en cada grupo de tratamiento.
3. Evaluar la calidad de vida relacionada con la salud y otros resultados comunicados por el paciente en cada grupo de tratamiento.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Participants eligible must meet all of the following criteria:
1. signed ICF prior to study treatment
2. age >= 18 years at the time of ICF
3. histologically or cytologically confirmed mPDAC eligible for treatment in first line setting and not amenable for potentially curative surgery
4. presence of at least one measurable lesion assessed by CT and/or MRI according to RECIST 1.1
5. ECOG performance status 0-1
6. adequate organ function as defined by the following laboratory values:
- ANC >= 1.5 x 10*9 /L
- platelets >= 100 x 10*9/L
- hemoglobin >= 9g /dL
- calculated creatinine clearance >= 60 mL/min
- albumin >= 3 g/dL
- PT/INR and PTT <= 1.5 x ULN
- total bilirubin <= 1.5 X ULN
- AST and/or ALT <= 3.0 x ULN
7. WCBP must have negative pregnancy test during screening and before starting study treatment
8. able to adhere to study visit schedule and other protocol requirements
9. must have recovered from treatment-related toxicities of prior anticancer therapies to grade <= 1 (CTCAE v 5.0), except alopecia

Los pacientes elegibles deberan cumplir todos los criterios siguientes:
1. Firmar el consentimiento informado antes del tratamiento de estudio
2. Edad >/=18 años en el momento de la firma del consentimiento
3. ADPm confirmado histológica o citológicamente elegibles para el tratamiento de primera línea y no susceptibles de cirugía posiblemente curativa.
4. Al menos una lesión medible evaluada mediante tomografía computarizada (TC) o resonancia magnética (RM) según RECIST 1.1.
5. Estado funcional del Grupo Cooperativo Oncológico del Este (ECOG) de 0-1.
6. Función orgánica adecuada definida segun los siguientes valores de laboratorio:
- ANC >= 1.5 x 10*9 /L
- Plaquetas>= 100 x 10*9/L
- hemoglobina >= 9g /dL
- Aclaramiento de creatinina claculado >= 60 mL/min
- albumina >= 3 g/dL
- PT/INR y PTT <= 1.5 x ULN
- Bilirrubina total <= 1.5 X ULN
- AST y/o ALT <= 3.0 x ULN
7. Las mujeres con posibilidad de quedarse embarazadas deben obtener un resultado negativo en la prueba de embarazo durante la selección y antes de comenzar el tratamiento del estudio.
8. Capacidad de cumplir el calendario de las visitas del estudio y otros requisitos del protocolo.
9. Los participantes deben haberse recuperado de toxicidades relacionadas con tratamientos anteriores contra el cáncer a grado </=1 (CTCAE v 5.0) en el momento de la selección, excepto la alopecia.

E.4

Principal exclusion criteria

participants meeting any of the following criteria are not eligible for inclusion:
1. previous systemic anti-cancer treatment for mPDAC
2. pancreatic neuroendocrine, acinar or inslet tumors
3. known status of MSI-H or MMR-deficient pancreatic cancer
4. presence of symptomatic CNS metastases, or CNS metastases that requires direct therapy or increasing doses of corticosteroids 2 weeks prior to study entry
5. known history of severe allergy or hypersensitivity to any of the study drug or their excipients
6. currently receiving any of the prohibited medications which cannot be discontinued within >= 7 days or 5 half-lifes, whichever is longer
7. not recovered from a major surgery or has a major surgery within 4 weeks prior to start of the study
8. radiation therapy or brain radiotherapy <= 4 weeks prior to study start
9. impaired cardiac function or clinically significant cardio-vascular disease, such as:
- congestive heart failure requiring treatment (NYHA grade >= 2), or clinically significant arrhythmia
- acute myocardial infarction, unstable angina pectoris, coronary stenting or bypass surgery < 3 months prior to study entry
- LVEF < 50%
- elevated cardiac enzymes (troponin I) > 2 x ULN
- cardiac valvulopathy >= grade 2
- uncontrolled hypertension
10. history of positive test for HIV infection
11. active or chronic HBV or HCV infections
12. active untreated or uncontrolled systemic fungal, bacterial or viral infections
13. use of hematopoietic growth factors or transfusion support <= 2 weeks prior to start the study
14. conditions that are considered to have a high risk of clinically significant gastrointestinal track bleeding or any other condition associated with or history of significant bleeding
15. serious, non-healing wounds
16. pre-existing peripheral neuropathy > grade 1
17. concurrent malignancy other than disease under treatment
18. any significant medical condition, laboratory abnormality or psychiatric or social condition that would constitute unacceptable risk to the patients, contraindicate participation, limit patient's ability to comply with study requirements or compromise patient's compliance with the study protocol
19. pregnant or breast-feeding woman
20. WCBP, unless using highly effective method of contraception during and up to 90 days after the study drug treatment (NIS793)
21. currently receiving other anti-cancer therapy or received other investigational product within 30 days or 5 half-lives prior to study treatment, whichever is longer

Los participantes que cumplan cualquiera de los siguientes cliterios no será elegible:
1.Tratamiento sistémico previo contra el cáncer para ADP metastásico.
2. Tumores pancreáticos neuroendocrinos , de células acinares o de células insulares.
3. Estado conocido de inestabilidad de microsatélites alta (IMS-A) o cáncer pancreático con deficiencia en la reparación de errores de replicación
4. 4. Presencia de metástasis sintomáticas del SNC o metástasis del SNC que requieran tratamiento directo o aumento de las dosis de corticosteroides 2 semanas antes de entrar en el estudio.
5. Antecedentes conocidos de alergia grave o hipersensibilidad a alguno de los fármacos del estudio o sus excipientes.
6. Estar recibiendo actualmente algún medicamento prohibido que no se pueda discontinuar durante ≥7 días o 5 vidas medias, aquello que sea más largo.
7. No haberse recuperado de una cirugía mayor ni haberse sometido a una cirugía mayor durante las 4 semanas anteriores al inicio del estudio.
8. Terapia de radiación o radioterapia de cerebro ≤4 semanas antes del inicio del estudio.
9. Deterioro de la función cardíaca o enfermedad cardiovascular clínicamente significativa, como:
- Insuficiencia cardíaca congestiva que requiera tratamiento (grado de la NYHA ≥2), o arritmia clínicamente significativa.
- Infarto agudo de miocardio, angina de pecho inestable, stent coronario u operación de bypass <3 meses antes de la admisión en el estudio.
- FEVI <50 %.
- Enzimas cardíacas elevadas (troponina I) >2 x LSN.
- Valvulopatía cardíaca de grado ≥2.
- Hipertensión no controlada.
10. Antecedentes de resultado positivo en la prueba de infección por VIH.
11. Infecciones por VHB o VHC activas o crónicas.
12. Infecciones por hongos, bacterianas o víricas sistémicas y activas, no tratadas o incontroladas.
13. Uso de factores de crecimiento hematopoyético o soporte transfusional ≤2 semanas antes del inicio del estudio.
14. Enfermedades con alto riesgo de sangrado clínicamente significativo en el tracto gastrointestinal o cualquier otra enfermedad asociada a sangrado significativo o antecedentes de ello.
15. Heridas graves no cicatrizadas.
16. Neuropatía periférica preexistente de grado >1.
17. Tumor maligno concurrente que no sea la enfermedad en tratamiento.
18. Cualquier enfermedad, anomalía de laboratorio, enfermedad psiquiátrica o condición social significativas que constituyan un riesgo inaceptable para los pacientes, contraindiquen su participación, limiten la capacidad del paciente para cumplir los requisitos del estudio o comprometan el cumplimiento del paciente con el protocolo del estudio.
19. Mujeres embarazadas o en periodo de lactancia.
20. Mujeres con posibilidad de quedarse embarazadas, a menos que utilicen un método anticonceptivo altamente eficaz durante los 90 días posteriores al tratamiento con el fármaco del estudio (NIS793).
21. Estar recibiendo actualmente otro tratamiento contra el cáncer o haber recibido otro producto en investigación durante los 30 días o 5 vidas medias anteriores al tratamiento del estudio, aquello que sea más largo.

E.5 End points

E.5.1

Primary end point(s)

safety run in: incidence of DLTs in the first cycle
randomized part: OS

preinclusión de seguridad: incidencia de toxicidad limitante de dosis (DLT) en el primer ciclo
Parte aleatorizada: OS

E.5.1.1

Timepoint(s) of evaluation of this end point

safety run in: 4 weeks of treatment
randomized part: at participants' death

preinclusión de seguridad: 4 semanas de tratamiento
Parte aleatorizada: muerte del paciente

E.5.2

Secondary end point(s)

safety run in:
1. safety: incidence and severity of AEs
2. tolerability: dose interruptions, dose reductions, dose intensity
3. PK parameters for NIS793 in combination with SoC
4. PFS, ORR, DCR, DOR, TTR

randomized part:
1. PFS, ORR, DCR, DOR, TTR
2. incidence and severity of AEs and SAEs, dose interruptions, dose reductions
3. change from baseline of individual domain scores in the PROMIS-29 profile and EQ-5D-5L at week 12
4. time to deterioration

Preinclusión de seguridad
1. Seguridad: incidencia y gravedad de los AA.
2. Tolerabilidad: interrupciones, reducciones e intensidad de las dosis.
3. Parámetros de PK de NIS793 en combinación con el SoC.
4. PFS, ORR, DCR, DOR y TTR.

E.5.2.1

Timepoint(s) of evaluation of this end point

safety run in:
1-3. first 4 weeks of treatment
4. end of study

randomized part
at protocol defined timepoints (12 weeks)
end of study

Preinclusión de seguridad
1-3. Primeras 4 semanas de tratamiento.
4. Fin de estudio.
Parte aleatorizada.
En los momentos definidos en el protocolo (12 semanas).
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

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Australia

Brazil

Canada

China

Israel

Japan

Korea, Republic of

Russian Federation

Singapore

Taiwan

Turkey

United States

Belgium

Finland

France

Germany

Hungary

Italy

Netherlands

Norway

Slovakia

Spain

Sweden

Switzerland

United Kingdom

Czechia

Argentina

Greece

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

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

Study completion is defined when the last participant finishes their safety and follow up periods 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.

la finalización del estudio se define como el momento en que el último participante finaliza los periodos de seguridad y de seguimiento y el investigador ha documentado y realizado el seguimiento debido de las evaluaciones repetidas asociadas a esta visita o en el caso de que se haya decidido finalizar el estudio prematuramente, la fecha de dicha 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 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:

200

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

290

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

200

F.4.2.2

In the whole clinical trial

490

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)

n/a

no aplica

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

2021-11-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-10-14

P. End of Trial
P.	End of Trial Status	Temporarily Halted

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Orphan Designation Number:
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