Clinical Trials Register

Summary
EudraCT Number:	2021-002450-81
Sponsor's Protocol Code Number:	73763989PAHPB2007
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-08-05
Trial results	View 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

2021-002450-81

A.3

Full title of the trial

A Phase 2, Open-label, Multicenter Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of Treatment With JNJ-73763989, Nucleos(t)ide Analogs, and Pegylated Interferon Alpha-2a in Patients With Chronic Hepatitis B Virus Infection.

Plataforma: “Estudio Plataforma para evaluar la eficacia y seguridad de las intervenciones en pacientes con infección crónica de hepatitis B”
Apéndice específico de intervención: “Estudio de fase 2, abierto, multicéntrico para evaluar la eficacia, seguridad, Tolerabilidad y farmacocinética del tratamiento con JNJ-73763989, análogos de núcleos(t)ido e Interferón alfa-2a pegilado en pacientes con infección crónica por el virus de la hepatitis B”

A.3.1

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

A Clinical Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Treatment With JNJ-73763989, Nucleos(t)ide Analogs, and Pegylated Interferon Alpha-2a in Patients With Chronic Hepatitis B Virus Infection.

Estudio clínico para evaluar la eficacia, seguridad, tolerabilidad y farmacocinética del tratamiento con JNJ-73763989, análogos de nucleos(t)ido e interferón pegilado alfa-2a en pacientes con infección crónica por el virus de la hepatitis B.

A.3.2

Name or abbreviated title of the trial where available

The PENGUIN-2 Study

Estudio PENGUIN-2

A.4.1

Sponsor's protocol code number

73763989PAHPB2007

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	Janssen-Cilag International NV
B.1.3.4	Country	Belgium
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	Janssen Research and Development LLC
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	JANSSEN CILAG, S.A.
B.5.2	Functional name of contact point	Global Development
B.5.3	Address:
B.5.3.1	Street Address	Pº de las Doce Estrellas, 5-7
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28042
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034917228000
B.5.5	Fax number	0034917228628
B.5.6	E-mail	ebellonm@its.jnj.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	JNJ-73763989
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Not yet assigned
D.3.9.2	Current sponsor code	JNJ-73763989
D.3.9.3	Other descriptive name	JNJ-73763989
D.3.9.4	EV Substance Code	SUB197801
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	200
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	Entecavir Mylan 0.5 mg film-coated tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	Mylan S.A.S.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Film-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	Entecavir
D.3.9.3	Other descriptive name	ENTECAVIR MONOHYDRATE
D.3.9.4	EV Substance Code	SUB25434
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	0.5
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	Viread 245 mg film-coated tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	Gilead Sciences Ireland UC
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Film-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	TENOFOVIR DISOPROXIL
D.3.9.3	Other descriptive name	TENOFOVIR DISOPROXIL
D.3.9.4	EV Substance Code	SUB20643
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	245
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: 4
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	Vemlidy 25 mg film-coated tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	Gilead Sciences Ireland UC
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Film-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	TENOFOVIR ALAFENAMIDE
D.3.9.1	CAS number	379270-37-8
D.3.9.3	Other descriptive name	TENOFOVIR ALAFENAMIDE
D.3.9.4	EV Substance Code	SUB121761
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	25
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: 5
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	Pegasys 180 micrograms solution for injection in pre-filled syringe
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration GmbH
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PEGINTERFERON ALFA-2A
D.3.9.1	CAS number	198153-51-4
D.3.9.3	Other descriptive name	PEGINTERFERON ALFA-2A
D.3.9.4	EV Substance Code	SUB16452MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	360
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.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

Chronic Hepatitis B Virus Infection

Infección crónica por el virus de la hepatitis B

E.1.1.1

Medical condition in easily understood language

Chronic Hepatitis B Virus Infection

Infección crónica por el virus de la hepatitis B

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	PT
E.1.2	Classification code	10008910
E.1.2	Term	Chronic hepatitis B
E.1.2	System Organ Class	10021881 - Infections and infestations

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 the efficacy in terms of HBsAg changes from baseline for the treatment regimens.

Evaluar la eficacia, en términos de cambio de HBsAg desde la visita basal para las pautas de tratamiento.

E.2.2

Secondary objectives of the trial

1. To evaluate the safety and tolerability of the study intervention.
2. To evaluate the efficacy of the study intervention during the follow-up period.
3. To evaluate the efficacy of the study intervention as measured by blood markers during the study intervention and follow-up (FU) period.
4. To evaluate the frequency of virologic breakthrough throughout the study.
5. To evaluate the PK of JNJ-3989, and optionally of NA and PegIFN-α2a.

1. Evaluar la seguridad y tolerabilidad del tratamiento del estudio.
2. Evaluar la eficacia del tratamiento del estudio durante el periodo de seguimiento.
3. Evaluar la eficacia del tratamiento del estudio determinada a partir de marcadores sanguíneos durante el tratamiento del estudio y el periodo de seguimiento.
4. Evaluar la frecuencia de recaída virológica a lo largo del estudio.
5. Evaluar la farmacocinética (FC) de JNJ-3989 y, opcionalmente, de AN y PegIFN-α2a.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

A01. Adult male or female participants ≥18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 65 years of age, inclusive.
M02. Participants must be medically stable based on physical examination, medical history, vital signs, and 12-lead ECG performed at screening.
A03. Participants must have chronic HBV infection.
M04. Participants must have a body mass index between 18.0 and 35.0 kg/m2, extremes included.
A05. Participants must sign a Master ICF and must sign the ICF specific for this intervention cohort, indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.

Please refer to the study protocol for a full list of inclusion criteria.

A01. Pacientes adultos varones o mujeres ≥18 (o la mayoría de edad en la jurisdicción en la que tenga lugar el estudio) hasta 65 años inclusive.
M02. Estar clínicamente estable de acuerdo con la exploración física, la historia clínica, las constantes vitales y el ECG de 12 derivaciones efectuado en la selección.
A03. Tener una infección crónica por el VHB.
M04. Tener un índice de masa corporal entre 18,0 y 35,0 kg/m2, ambos incluidos.
A05. Firmar un DCI general y un DCI específico para esta cohorte de tratamiento donde se indique que comprenden el objetivo y los procedimientos necesarios del estudio y están dispuestos a participar en este.

Por favor, consulte el protocolo del estudio para ver la lista completa de criterios de inclusión.

E.4

Principal exclusion criteria

A01. Participants with evidence of hepatitis A virus infection, HCV infection, hepatitis D virus infection, hepatitis E virus infection, or HIV-1 or HIV-2 infection at screening.
A02. Participants with evidence of hepatic decompensation at any time point prior to or at the time of screening.
M03. History or evidence of clinical signs or symptoms of hepatic decompensation.
M04. Participants with evidence of liver disease of non-HBV etiology.
A05. Participants with history or signs of cirrhosis or portal hypertension or signs of hepatocellular carcinoma (HCC) or clinically relevant renal abnormalities.

Please refer to the study protocol for a full list of exclusion criteria.

A01. Tener indicios de infección por el virus de la hepatitis A, infección por el VHC, infección por el virus de la hepatitis D (VHD), infección por el virus de la hepatitis E o por el VIH-1 o VIH-2 en la selección.
A02. Mostrar indicios de descompensación hepática en cualquier momento antes de la selección o en el momento de esta.
M03. Tener antecedentes o evidencias de signos o síntomas clínicos de descompensación hepática.
M04. Mostrar indicios de enfermedad hepática de etiología no relacionada con el VHB.
A05. Tener antecedentes o signos de cirrosis o hipertensión portal o signos de carcinoma hepatocelular (CHC) o anomalías renales de relevancia clínica.

Por favor, consulte el protocolo del estudio para ver la lista completa de criterios de exclusión.

E.5 End points

E.5.1

Primary end point(s)

Proportion of participants with an HBsAg level <100 IU/mL at Week 24.

Proporción de pacientes con un nivel de HBsAg <100 UI/ml en la semana 24

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 24.

Semana 24.

E.5.2

Secondary end point(s)

1. Safety and tolerability including but not limited to the proportion of participants with (S)AEs and abnormalities in clinical laboratory tests, 12-lead ECGs, vital signs, and ophthalmic and physical examinations throughout the study.

2a. Proportion of participants with HBsAg seroclearance at FU Week 24 and 48 without re-starting NA treatment.
2b. Proportion of participants with HBV DNA <LLOQ at FU Week 24 and 48 without re-starting NA treatment.
2c. Frequency of virologic and/or biochemical flares.
2d. Proportion of participants requiring NA re treatment.

3a. Proportion of participants with HBsAg, HBeAg, HBV DNA, and ALT levels below/above different cut-offs over time.
3b. Proportion of participants with HBsAg seroconversion.
3c. Change from baseline over time in HBsAg.
3d. Time to achieve HBsAg seroclearance/ seroconversion, and/or HBV DNA <LLOQ.

4. Proportion of participants with virologic breakthrough.

5a. PK parameters of JNJ-3989.
5b. Optionally, PK parameters of NA and/or PegIFN-α2a.

1. La seguridad y tolerabilidad incluyen, entre otras cosas, la proporción de pacientes con AA(G) y anomalías en las pruebas analíticas clínicas electrocardiogramas (ECG) de 12 derivaciones, constantes vitales y exploraciones físicas y oftalmológicas durante todo el estudio.
2a. Proporción de pacientes con aclaramiento sérico de HBsAg en las semanas 24 y 48 del periodo de seguimiento sin reanudar el tratamiento con AN.
2b. Proporción de pacientes con unos niveles de ADN del VHB <límite inferior de cuantificación (LIC) en las semanas 24 y 48 del periodo de seguimiento sin reanudar el tratamiento con AN.
2c. Frecuencia de exacerbaciones víricas o bioquímicas.
2d. Proporción de pacientes que precisan la reanudación del tratamiento con AN.
3a. Proporción de pacientes con niveles de HBsAg, HBeAg, ADN del VHB y ALT superiores o inferiores a ciertos límites a lo largo del tiempo.
3b. Proporción de pacientes con seroconversión de HBsAg.
3c. Cambio a lo largo del tiempo de HBsAg desde el momento de referencia.
3d. Tiempo hasta lograr el aclaramiento sérico/seroconversión del HBsAg o ADN del VHB <LIC
4. Proporción de pacientes con recaída virológica.
5a. Parámetros FC de JNJ-3989.
5b. Opcionalmente, parámetros FC de AN o PegIFN-α2a.

E.5.2.1

Timepoint(s) of evaluation of this end point

Throughout the duration of the study.

Durante toda la duración del 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

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

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

Information not present in EudraCT

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

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

Hong Kong

Japan

Korea, Republic of

Russian Federation

Taiwan

Thailand

United States

Poland

Spain

United Kingdom

E.8.7

Trial has a data monitoring committee

E.8.8

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

LVLS

Última visita del último paciente.

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

F.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

F.4.2.2

In the whole clinical trial

102

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)

Participants will be instructed that study intervention will not be made available to them after they have completed/discontinued study intervention and that they should return to their primary physician to determine standard of care.

Se informará a los participantes que el tratamiento del estudio no estará disponible para ellos después de que hayan completado/discontinuado la intervención del estudio y que deben volver a su médico de cabecera para determinar el tratamiento médico a seguir.

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

2021-10-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-10-04

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-12-29

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IMP with orphan designation in the indication
Orphan Designation Number:
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