Clinical Trials Register

Summary
EudraCT Number:	2021-004138-12
Sponsor's Protocol Code Number:	TAK-330-3001
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:	2022-07-12
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

2021-004138-12

A.3

Full title of the trial

A Phase 3, Prospective, Randomized, Open-label, Adaptive Group Sequential, Multicenter Trial with Blinded Endpoint Assessment to Evaluate the Efficacy and Safety of PROTHROMPLEX TOTAL for the Reversal of Direct Oral Factor Xa Inhibitor-induced Anticoagulation in Patients Requiring Urgent Surgery/Invasive Procedure

Ensayo en fase III, multicéntrico, prospectivo, aleatorizado, abierto, secuencial por grupos adaptativos con evaluación ciega de los criterios de
valoración para evaluar la eficacia y la seguridad de PROTHROMPLEX TOTAL en la neutralización de la anticoagulación causada por los inhibidores del factor Xa por vía oral directa en pacientes que requieren cirugía urgente o una intervención invasiva

A.3.1

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

Phase 3 Trial of PROTHROMPLEX TOTAL for Reversal of Direct Oral Factor Xa Inhibitor-induced Anticoagulation

Ensayo de fase 3 de PROTHROMPLEX TOTAL para revertir la anticoagulación inducida por inhibidores orales directos del factor Xa

A.4.1

Sponsor's protocol code number

TAK-330-3001

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	Takeda Development Center Americas, Inc.
B.1.3.4	Country	United States
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	Takeda Development Center Americas, Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Takeda Development Center Americas, Inc.
B.5.2	Functional name of contact point	Head of Global Clinical Operations
B.5.3	Address:
B.5.3.1	Street Address	95 Hayden Ave
B.5.3.2	Town/ city	Lexington
B.5.3.3	Post code	MA 02421
B.5.3.4	Country	United States
B.5.4	Telephone number	34669747386
B.5.6	E-mail	medinfoUS@takeda.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	Prothromplex TOTAL 600 IU powder and solvent for solution for injection
D.2.1.1.2	Name of the Marketing Authorisation holder	[To be completed nationally]
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	Prothromplex TOTAL
D.3.2	Product code	TAK-330
D.3.4	Pharmaceutical form	Powder and solvent for solution for injection
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	Human Coagulation Factors II, VII, IX, and X
D.3.9.2	Current sponsor code	TAK-330
D.3.9.3	Other descriptive name	HUMAN PROTHROMBIN COMPLEX
D.3.9.4	EV Substance Code	SUB12044MIG
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	500
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	Yes
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	Comparator
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	OCTAPLEX
D.2.1.1.2	Name of the Marketing Authorisation holder	OCTAPLEX
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
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	Human Coagulation Factors II, VII, IX, and X
D.3.9.3	Other descriptive name	HUMAN PROTHROMBIN COMPLEX
D.3.9.4	EV Substance Code	SUB12044MIG
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	Yes
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

Patients on treatment with Factor Xa Inhibitor needing for an urgent intervention associated with a high risk of bleeding.

Pacientes en tratamiento con Inhibidor del Factor Xa que necesiten una intervención urgente asociada a un alto riesgo de sangrado.

E.1.1.1

Medical condition in easily understood language

Patients on treatment with certain blood thinners called Factor 10a inhibitors are at increased risk of developing serious bleeding during urgent surgery.

Los pacientes en tratamiento con ciertos anticoagulantes llamados inhibidores del Factor 10a tienen un mayor riesgo de desarrollar sangrado grave durante la cirugía de urgencia.

E.1.1.2

Therapeutic area

Diseases [C] - Blood and lymphatic diseases [C15]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10075279
E.1.2	Term	Anticoagulant reversal therapy
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

To evaluate intraoperative efficacy of PROTHROMPLEX TOTAL in comparison with standard of care (SOC) 4-factor prothrombin complex concentrate (4F-PCC), for reversal of anticoagulation in patients receiving direct oral Factor Xa inhibitors and requiring urgent surgery/invasive procedure within 15 hours from the last dose of Factor Xa inhibitor.

Evaluar la eficacia intraoperatoria de PROTHROMPLEX TOTAL en comparación con el concentrado de complejo protrombínico de 4 factores (CCP-4F) estándar para la reversión de la anticoagulación en pacientes que reciben inhibidores orales directos del factor Xa y que requieren una intervención quirúrgica urgente o invasiva en las 15 horas siguientes a la última dosis del inhibidor del factor Xa.

E.2.2

Secondary objectives of the trial

To assess the safety and postoperative efficacy of PROTHROMPLEX TOTAL in comparison with SOC 4F-PCC, for reversal of anticoagulation in patients receiving direct oral Factor Xa inhibitors and requiring urgent surgery/invasive procedure within 15 hours of the last dose of Factor Xa inhibitor.

Evaluar la seguridad y la eficacia postoperatoria de PROTHROMPLEX TOTAL en comparación con el CCP-4F estándar para la reversión de la anticoagulación en pacientes que reciben inhibidores orales directos del factor Xa y que requieren una intervención quirúrgica o invasiva urgente en las 15 horas siguientes a la última dosis del inhibidor del factor Xa.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Subject or legally authorized representative willing to sign e-consent/written informed consent form.
2. Subjects ≥18 years of age at enrollment.
3. Subject currently on treatment with oral Factor Xa inhibitor (rivaroxaban, apixaban, edoxaban).
4. In the opinion of the surgeon, the subject requires urgent surgery/procedure within 15 hours of the last Factor Xa inhibitor dose and requires a reversal agent for suspected direct oral Factor Xa inhibitor-related coagulopathy.
5. Women of childbearing potential should have a negative pregnancy test documented prior to enrollment.

1.El participante o su representante legalmente autorizado está dispuesto a firmar el consentimiento informado
electrónico o por escrito.
2. El participante tiene ≥18 años en el momento de la inscripción.
3. El participante está actualmente en tratamiento con un inhibidor del factor Xa oral (rivaroxabán, apixabán o
edoxabán).
4. En opinión del cirujano, el participante requiere una intervención quirúrgica o un procedimiento
urgente en las 15 horas siguientes a la última dosis de inhibidor del factor Xa y requiere un fármaco de
reversión por sospecha de coagulopatía relacionada con el inhibidor del factor Xa oral directo.
5. Las mujeres con posibilidad de quedarse embarazadas deben contar con una prueba de embarazo negativa
documentada antes de la inscripción.

E.4

Principal exclusion criteria

1. The subject has an expected survival of less than 30 days, even with best available medical and surgical care.
2. Recent history (within 90 days before screening) of venous thromboembolism, myocardial infarction, disseminated intravascular coagulation, ischemic stroke, transient ischemic attack, hospitalization for unstable angina pectoris, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, or severe peripheral vascular disease.
3. Acute major bleeding, defined as bleeding that requires surgery or transfusion of ≥2 units of packed red blood cells (PRBCs) or is associated with a decrease in hemoglobin of ≥1.0 g/dL, or intracranial hemorrhage.
4. Acute trauma for which reversal of Factor Xa-inhibition alone would not be sufficient to achieve hemostasis.
5. Known prothrombotic disorder including primary antiphospholipid syndrome, antithrombin-3 deficiency, homozygous protein C deficiency, homozygous protein S deficiency, and homozygous factor V Leiden.
6. Known bleeding disorder (eg, platelet function disorder, hemophilia, Von Willebrand disease, or coagulation factor deficiency).
7. Platelet count <100,000/μL.
8. History of heparin-induced thrombocytopenia.
9. Administration of procoagulant drugs (eg, Vitamin K, non-study prothrombin complex concentrates (PCCs), recombinant Factor VIIa, tranexamic acid) or blood products (transfusion of whole blood, fresh frozen plasma, cryoglobulins, plasma fractions, or platelets) within 7 days before enrollment. (Note: administration of PRBCs for hemoglobin correction is not an exclusion criterion).
10. Planned use of procoagulant drugs (eg, Vitamin K, non-study PCCs, recombinant Factor VIIa, tranexamic acid) or blood products (transfusion of whole blood, fresh frozen plasma, cryoglobulins, plasma fractions, or platelets) after enrollment but before the investigational product infusion is initiated (Note: administration of PRBCs for hemoglobin correction is not an exclusion criterion).
11. Administration of unfractionated or low molecular weight heparin within 24 hours before randomization.
12. Hypersensitivity to PCC constituents or any excipient of PROTHROMPLEX TOTAL.
13. Confirmed or suspected sepsis.

1. La supervivencia prevista del participante es inferior a 30 días, incluso con la mejor atención médica y quirúrgica disponibles.
2. Antecedentes recientes (en los 90 días previos a la selección) de tromboembolia venosa, infarto de miocardio, coagulación intravascular diseminada, accidente cerebrovascular isquémico, accidente isquémico transitorio, hospitalización por angina de pecho inestable, infección por coronavirus del síndrome respiratorio agudo grave de tipo 2 ( SARS-CoV-2) o vasculopatía periférica grave.
3. Hemorragia grave aguda, definida como hemorragia que requiere intervención quirúrgica o transfusión ≥2 unidades de concentrado de eritrocitos o que está relacionada con una disminución de la hemoglobina ≥1,0 g/dl o hemorragia intracraneal.
4. Traumatismos agudos en los que la reversión de la inhibición del factor Xa por sí sola no sería suficiente para lograr la hemostasia.
5. Trastorno protrombótico conocido, incluido el síndrome antifosfolipídico primario, deficiencia de antitrombina III, deficiencia homocigótica de proteína C, deficiencia homocigótica de proteína S y factor V Leiden homocigótico.
6. Trastorno hemorrágico conocido (p. ej., trastorno de la función plaquetaria, hemofilia, enfermedad de Von Willebrand o deficiencia del factor de coagulación).
7. Cifra de trombocitos <100 000/μl.
8. Antecedentes de trombocitopenia inducida por heparina.
9. Administración de fármacos procoagulantes (p. ej., vitamina K, concentrados de complejo protrombínico [CCP] no relacionados con el estudio, factor VIIa recombinante, ácido tranexámico) o hemoderivados (transfusión de sangre completa, plasma congelado en fresco,
crioglobulinas, fracciones de plasma o trombocitos) en los 7 días previos a la inscripción (Nota: la administración de concentrado de eritrocitos
para la corrección de la hemoglobina no es un criterio de exclusión).
10. Uso previsto de fármacos procoagulantes (p. ej., vitamina K, CCP no relacionado con el estudio, factor VIIa recombinante, ácido tranexámico) o hemoderivados (transfusión de sangre completa, plasma congelado en fresco, crioglobulinas, fracciones plasmáticas o
trombocitos) después de la inscripción, pero antes de que se inicie la infusión del producto en investigación (Nota: la administración de
concentrado de eritrocitos para la corrección de la hemoglobina no es un criterio de exclusión).
11. Administración de heparina no fraccionada o de bajo peso molecular en las 24 horas anteriores a la aleatorización.
12. Hipersensibilidad a los componentes del CCP o a cualquier excipiente de PROTHROMPLEX TOTAL.
13. Sospecha o confirmación de septicemia

E.5 End points

E.5.1

Primary end point(s)

Occurrence of intraoperative effective hemostasis based on the surgeon's assessment at the end of the
surgery/invasive procedure using the Four Point Intraoperative Hemostatic Efficacy Scale.

Ocurrencia de hemostasia efectiva intraoperatoria basada en la evaluación del cirujano al final del cirugía/procedimiento invasivo utilizando la escala de eficacia hemostática intraoperatoria de cuatro puntos.

E.5.1.1

Timepoint(s) of evaluation of this end point

End of the surgery

Fin de la cirugia

E.5.2

Secondary end point(s)

Key Secondary Endpoint: Occurrence of postoperative effective hemostasis based on the surgeon's assessment at 24 hours after the end of investigational product infusion (PROTHROMPLEX TOTAL or comparator 4F-PCC) using the Four Point Postoperative Hemostatic Efficacy Scale.

1. Occurrence of intraoperative effective hemostasis based on the surgeon’s assessment using the Hemostatic Efficacy Rating Algorithm.
2. Usage of blood products or non-study hemostatic agents for bleeding control within 24 hours after the end of investigational product infusion.
3. Number of units of packed red blood cells administered to achieve bleeding control within 24 hours after the end of investigational product infusion.
4. Occurrence of serious adverse events (SAEs), and/or adverse events (AEs), treatment-emergent AEs (TEAEs), and adverse events of special interest (AESIs) within 30 days after the end of the surgery/invasive procedure.
5. Occurrence of thrombotic events within 30 days after the end of the surgery/invasive procedure.
6. All-cause deaths within 30 days post-surgery/invasive procedure.

Criterio de valoracion secundario: Aparición de hemostasia posoperatoria eficaz evaluada a las 24 horas de finalizada la infusión del producto
en investigación (PROTHROMPLEX TOTAL o el comparador CCP-4F) con base en la evaluación del cirujano mediante la escala de eficacia hemostática intraoperatoria de cuatro puntos.
1 Aparición de hemostasia intraoperatoria eficaz evaluada al final de la intervención quirúrgica o procedimiento invasivo con base en la evaluación del cirujano utilizando el algoritmo de clasificación de la eficacia hemostática.
2 Uso de hemoderivados o fármacos hemostáticos no relacionados con el estudio para el control de la hemorragia en las 24 horas siguientes a la
finalización de la infusión del producto en investigación.
3 Número de unidades de concentrado de eritrocitos administradas para lograr el control de la hemorragia en las 24 horas siguientes a la
finalización de la infusión del producto en investigación.
4 Aparición de acontecimientos adversos graves (AAG) o acontecimientos adversos (AA), AA surgidos durante el tratamiento (AAST) y acontecimientos adversos de especial interés (AAEI) en los 30 días posteriores al final de la intervención quirúrgica o el procedimiento invasivo.
5 Aparición de acontecimientos trombóticos en los 30 días posteriores al final de la intervención quirúrgica o el procedimiento invasivo
6. Muertes por cualquier causa en un plazo de 30 días después de la intervención quirúrgica o el procedimiento invasivo.

E.5.2.1

Timepoint(s) of evaluation of this end point

Key Secondary Endpoint: 24 hours after the end of investigational product infusion
1. End of the surgery
2. & 3. Within 24 hours after the end of investigational product infusion.
4.- 6. Within 30 days post-surgery/invasive procedure.

Criterio secundario clave: 24 horas después del final de la infusión del producto en investigación
1. Fin de la cirugía
2. y 3. Dentro de las 24 horas posteriores al final de la infusión del producto en investigación.
4.- 6. Dentro de los 30 días posteriores a la cirugía/procedimiento invasivo.

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)

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

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

Yes

E.8.1.7.1

Other trial design description

El cirujano y el Comité independiente de adjudicación de criterios de valoración no conocerán el tto

The surgeon and the Independent Endpoint Adjudication Committee will be blinded to the treatment.

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

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

Canada

China

India

Japan

Korea, Republic of

Taiwan

Thailand

United States

Viet Nam

Austria

Finland

France

Sweden

Bulgaria

Netherlands

Spain

Germany

Italy

Belgium

Russian Federation

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

The study completion date is defined as the date on which the last subject in the study completes the final protocol-defined assessment(s). This includes the follow-up visit or contact, whichever is later.

La fecha de finalización del estudio se define como la fecha en la que el último sujeto del estudio completa las evaluaciones finales definidas por el protocolo. Esto incluye la visita de seguimiento o el contacto, lo que ocurra más tarde.

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)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

400

F.4.2.2

In the whole clinical trial

550

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)

None

Ninguno

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

2022-09-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-09-07

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

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