Clinical Trials Register

Summary
EudraCT Number:	2021-006906-58
Sponsor's Protocol Code Number:	PHA022121-C303
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:	2022-05-04
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

2021-006906-58

A.3

Full title of the trial

A Phase II/III, Extension Study of Orally Administered PHA-022121 for Acute Treatment of Angioedema Attacks in Patients with Hereditary Angioedema due to C1-Inhibitor Deficiency (Type I or Type II)

Estudio de extensión de fase II/III de PHA-022121 administrado por vía oral para el tratamiento agudo de las crisis de angioedema en pacientes con angioedema hereditario debido a un déficit del inhibidor de C1 (tipo I o tipo II)

A.3.1

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

An extension phase 2/3 study to test the safety of long term administration of oral PHA-022121 for acute treatment of angioedema attacks in patients with hereditary angioedema

Estudio de extensión de fase II/III para probar la seguridad de la administración a largo plazo de PHA-022121 oral para el tratamiento agudo de los ataques de angioedema en pacientes con angioedema hereditario.

A.3.2

Name or abbreviated title of the trial where available

RAPIDe-2

A.4.1

Sponsor's protocol code number

PHA022121-C303

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	Pharvaris Netherlands BV
B.1.3.4	Country	Netherlands
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	Pharvaris Netherlands BV
B.4.2	Country	Netherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Pharvaris Netherlands BV
B.5.2	Functional name of contact point	Pharvaris Clinical
B.5.3	Address:
B.5.3.1	Street Address	J.H. Oortweg 21
B.5.3.2	Town/ city	Leiden
B.5.3.3	Post code	2333 CH
B.5.3.4	Country	Netherlands
B.5.5	Fax number	+31(0)712036410
B.5.6	E-mail	clinical@pharvaris.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.3.1	Product name	PHVS416
D.3.2	Product code	PHA-022121
D.3.4	Pharmaceutical form	Capsule, soft
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	PHA-022121
D.3.9.1	CAS number	2340111-58-0
D.3.9.2	Current sponsor code	PHA-022121
D.3.9.3	Other descriptive name	PHA-022121
D.3.9.4	EV Substance Code	SUB206489
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	10
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	Capsule, soft
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Hereditary angioedema attacks caused by Type 1 and 2 C1-Inhibitor
Deficiency

Ataques de angioedema hereditario causados por la deficiencia del inhibidor C1 tipo 1 y 2

E.1.1.1

Medical condition in easily understood language

Hereditary angioedema (HAE) is a disorder that results in recurrent
attacks of severe swelling

El angioedema hereditario (AEH) es un trastorno que provoca ataques recurrentes de inflamación grave

E.1.1.2

Therapeutic area

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

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	23.1
E.1.2	Level	PT
E.1.2	Classification code	10019860
E.1.2	Term	Hereditary angioedema
E.1.2	System Organ Class	10010331 - Congenital, familial and genetic disorders

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	10080956
E.1.2	Term	Hereditary angioedema type I
E.1.2	System Organ Class	10010331 - Congenital, familial and genetic disorders

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	10080957
E.1.2	Term	Hereditary angioedema C1 inhibitor deficiency
E.1.2	System Organ Class	10010331 - Congenital, familial and genetic disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	24.0
E.1.2	Level	LLT
E.1.2	Classification code	10080960
E.1.2	Term	Hereditary angioedema type II
E.1.2	System Organ Class	10010331 - Congenital, familial and genetic disorders

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

To evaluate the safety of long-term on-demand treatment with PHA-022121 for acute hereditary angioedema (HAE) attacks including laryngeal attacks.

Evaluar la seguridad del tratamiento a demanda a largo plazo con PHA-022121 para las crisis agudas del angioedema hereditario (AEH), incluidas las crisis laríngeas.

E.2.2

Secondary objectives of the trial

• To evaluate the efficacy of PHA-022121 in achieving symptom relief in patients with acute HAE attacks including laryngeal attacks,
• To evaluate the maintenance of PHA-022121 efficacy in achieving symptom relief for any subsequent acute HAE attacks including laryngeal attacks,
• To evaluate the proportion of PHA-022121-treated attacks requiring a second dose of PHA-022121 to achieve symptom relief.

• Evaluar la eficacia de PHA-022121 para conseguir el alivio de los síntomas en pacientes con crisis agudas del AEH, incluidas las crisis laríngeas.
• Evaluar el mantenimiento de la eficacia de PHA-022121 para conseguir el alivio de los síntomas en las crisis agudas posteriores del AEH, incluidas las crisis laríngeas.
• Evaluar la proporción de crisis tratadas con PHA-022121 que precisaron una segunda dosis de PHA-022121 para conseguir el alivio de los síntomas.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Provision of written informed consent.
2. Male or female, aged ≥ 18 years at the time of providing written informed consent.
3. Patients must have received at least 1 dose of study drug (including the non-attack visit) in Study PHA022121-C201.
4. Female patients of childbearing potential must agree to the protocol specified pregnancy testing and to be abstinent from heterosexual intercourse or to use an acceptable form of contraception methods from enrollment until 30 days after the last study drug administration. Methods acceptable for this study include male condom with or without spermicide, cervical cap, diaphragm or sponge with spermicide, a combination of male condom with cap, diaphragm or sponge with spermicide (double-barrier methods), progestin-only hormonal methods (oral, injectable, or implantable), intrauterine device (IUD, all types), intrauterine hormone releasing systems (IUS).
Females of non-childbearing potential, defined as surgically sterile (status post hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or post-menopausal (defined as no menses for at least 12 months without an alternative medical cause and a follicle-stimulating hormone (FSH) test result indicative of post-menopausal status) do not require contraception during the study. There are no contraceptive requirements for male patients.
5. In the opinion of the investigator is willing and able to comply with the protocol.

1- Entrega del consentimiento informado por escrito.
2- Hombre o mujer, mayor de 18 años en el momento de dar el consentimiento informado por escrito.
3- Los pacientes deben haber recibido al menos una dosis del fármaco del estudio (incluida la visita sin ataque) del estudio PHA022121-C201
4 Las pacientes mujeres en edad fertil deben aceptar las pruebas de embarazo especificadas en el protocolo y abstenerse de tener relaciones heterosexuales o usar una forma aceptable de métodos anticonceptivos desde la inscripción hasta 30 días después de la última administración del fármaco del estudio. Los métodos aceptables para este estudio incluyen condón masculino con o sin espermicida, capuchón cervical, diafragma o esponja con espermicida, una combinación de condón masculino con capuchón, diafragma o esponja con espermicida (métodos de doble barrera), métodos hormonales de progestágeno solo (orales, inyectable o implantable), dispositivo intrauterino (DIU, todos los tipos), sistemas intrauterinos de liberación de hormonas (IUS).
Mujeres sin potencial fértil, definidas como quirúrgicamente estériles (estado poshisterectomía, ooforectomía bilateral o ligadura de trompas bilateral) o posmenopáusicas (definidas como sin menstruación durante al menos 12 meses sin una causa médica alternativa y una hormona estimulante del folículo ( FSH) resultado de la prueba indicativo del estado posmenopáusico) no requieren anticoncepción durante el estudio. No hay requisitos anticonceptivos para los pacientes masculinos.
5- En opinión del investigador está dispuesto y es capaz de cumplir con el protocolo

E.4

Principal exclusion criteria

1. Any female who is pregnant or is breast-feeding.
2. Presence of any medical condition that could interfere with the assessment of safety or efficacy or negatively affect the patient’s safety, including clinically significant abnormal ECG, most notably a QTcF > 470 ms (for females) or > 450 ms (for males), cardiovascular disease, abnormal liver function and abnormal kidney function.
3. Any other systemic disease (e.g., gastrointestinal, renal, respiratory, neurological) or significant disease or disorder that would interfere with the patient’s safety or ability to participate in the study.
4. Use of lanadelumab for long-term HAE prophylactic therapy within 12 weeks prior to study enrollment.
Patients who have recently used short or long-term HAE prophylaxis or on-demand HAE treatment will not be excluded from the study provided the following washout period is observed (i.e., study screening or enrollment should be delayed allowing for washout):
• 2-week washout period before enrollment should be respected for patients who have used any C1-INH product, oral kallikrein inhibitors, attenuated androgens, or anti-fibrinolytics for long-term prophylactic HAE therapy.
• 1-week washout period before enrollment should be respected for patients who have used plasma derived C1-INH concentrates (Berinert, Cinryze, Haegarda) for on-demand treatment or short-term prophylaxis.
• 24-hour washout period before enrollment should be respected for patients who have used recombinant C1-INH (Ruconest) for on-demand treatment or short-term prophylaxis.
6. History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse.
7. Discontinued from Study PHA022121-C201 after enrollment for any study drug-related safety reason.
8. Participation in any other investigational drug study (except with PHA-022121) currently, within the last 30 days prior to the first PHA-022121 dose or within 5 half-lives of study drug at enrollment, whichever is longer.
9. Use of concomitant medications that are potent CYP3A4 inhibitors (e.g., clarithromycin, erythromycin, itraconazole, ketoconazole, ritonavir, grapefruit) or potent CYP3A4 inducers (e.g., phenytoin, rifampicin, St. John's Wort).

1- Cualquier mujer que esté embarazada o amamantando.
2- Presencia de cualquier indicación médica que pueda interferir con la evaluación de la seguridad o eficacia o afectar negativamente la seguridad de los pacientes, includido un ECG anormal clínicamente significativo , en particular un QTcF > 470 ms (para mujeres) o > 450 ms (para hombres), enfermedad cardiovascular , función hepática anormal y función renal anormal.
3- Cualquier otra enfermedad sistémica (p. ej., gastrointestinal, renal, respiratoria, neurológica) o enfermedad o trastorno importante que pudiera interferir con la seguridad del paciente o su capacidad para participar en el estudio.
4- Uso de lanadelumab para la terapia profiláctica de AEH a largo plazo dentro de las 12 semanas anteriores a la inscripción en el estudio. Los pacientes que hayan utilizado recientemente profilaxis contra el AEH a corto o largo plazo o tratamiento a demanda para el AEH no serán excluidos del estudio siempre que se observe el siguiente período de lavado (es decir, la selección o inscripción en el estudio debe retrasarse para permitir el lavado):
•Se debe respetar un período de lavado de 2 semanas antes de la inscripción para los pacientes que han usado cualquier producto C1-INH, inhibidores orales de la calicreína, andrógenos atenuados o antifibrinolíticos para la terapia profiláctica a largo plazo del AEH.
• Debe respetarse un período de lavado de 1 semana antes de la inscripción para los pacientes que han usado concentrados de C1-INH derivados de plasma (Berinet, Cinryze, Haegarda) para tratamiento a demanda o profilaxis a corto plazo.
• Se debe respetar el período de lavado de 24 horas antes de la inscripción para los pacientes que han usado C1-INH recombinante (Ruconest) para el tratamiento a demanda o la profilaxis a corto plazo.
6. Historial de abuso de alcohol o drogas en el año anterior, o evidencia actual de dependencia o abuso de sustancias.
7. Descontinuado del estudio PHA022121-C201 después de la inscripción por cualquier motivo de seguridad relacionado con el fármaco del estudio.
8. Participación en cualquier otro estudio de fármaco en investigación (excepto con PHA-022121) actualmente, dentro de los últimos 30 días antes de la primera dosis de PHA-022121 o dentro de las 5 vidas medias del fármaco del estudio en el momento de la inscripción, lo que sea más largo.
9. Uso de medicamentos concomitantes que son inhibidores potentes de CYP3A4 (p. ej., claritromicina, eritromicina, itraconazol, ketoconazol, ritonavir, toronja) o inductores potentes de CYP3A4 (p. ej., fenitoína, rifampicina, hierba de San Juan).

E.5 End points

E.5.1

Primary end point(s)

The primary endpoints of the study are
•TEAEs, treatment-related TEAEs, treatment-emergent serious adverse events (TESAEs), and treatment-related TESAEs
• Clinical laboratory tests
• Vital signs

Los criterios de valoración principales del estudio son
•TEAE, TEAE relacionados con el tratamiento, eventos adversos graves emergentes del tratamiento (TESAE) y TESAE relacionados con el tratamiento
• Pruebas de laboratorio clínico
• Signos vitales

E.5.1.1

Timepoint(s) of evaluation of this end point

• TEAES will be evaluated when taking place
• Clinical laboratory tests will be evaluated as follows:
Part A: at Screening visit and every 3 months
Part B: when patients transition to Part B, then every 3 months for the first 6 months, and every 6 months thereafter and 14 to 28 days after the last treatment administration
• Vital signs
Part A: at Screening visit and every 3 months
Part B: when patients transition to Part B, then every 3 months for the first 6 months, and every 6 months thereafter

- Evaluación de los TEAES cuando tengan lugar.
- Las pruebas de labaratorio clinico se evaluarán de la siguiente manera:
Parte A: en la visita de selección y cada 3 meses
Parte B: cuando los pacientes hacen la transición a la Parte B, luego cada 3 meses durante los primeros 6 meses, y luego cada 6 meses y 14 a 28 días después de la última administración del tratamiento
- Constantes vitales
Parte A: en la visita de selección y cada 3 meses.
Parte B: cuando los pacientes hacen la transición a la Parte B, luego cada 3 meses durante los primeros 6 meses y cada 6 meses a partir de entonces

E.5.2

Secondary end point(s)

•Time to onset of symptom relief (TOSR) defined as ≥ 50% reduction in VAS-3 or VAS-5
• Time to almost complete (defined as all individual VAS scores are ≤10) or complete (defined as all individual VAS scores = 0) symptom relief (TACSR and TCSR) assessed by VAS-3 or VAS-5
• Time to symptom improvement based on PGI-S
• Time to symptom improvement based on PGI-C
• Change of VAS-3 score and individual VAS score from pre-treatment to 4 h post-treatment for non-laryngeal attacks
• Change in MSCS score at 4 h post-treatment
• TOS at 4 h post-treatment
• Proportion of PHA-022121-treated attacks requiring a second dose of PHA-022121
• TSQM scores at 48 h post-treatment

•Tiempo hasta el inicio del alivio de los síntomas (TOSR) definido como ≥ 50 % de reducción en VAS-3 o VAS-5
• Tiempo hasta casi completar (definido como que todas las puntuaciones VAS individuales son ≤10) o completar (definido como todas las puntuaciones VAS individuales = 0) el alivio de los síntomas (TACSR y TCSR) evaluado por VAS-3 o VAS-5
• Tiempo hasta la mejoría de los síntomas según PGI-S
• Tiempo hasta la mejoría de los síntomas según PGI-C
• Cambio de la puntuación VAS-3 y la puntuación VAS individual desde el pretratamiento hasta 4 h después del tratamiento para ataques no laríngeos
• Cambio en la puntuación MSCS a las 4 h después del tratamiento
• TOS a las 4 h postratamiento
• Proporción de ataques tratados con PHA-022121 que requieren una segunda dosis de PHA-022121
• Puntuaciones TSQM a las 48 h después del tratamiento

E.5.2.1

Timepoint(s) of evaluation of this end point

-VAS-3 *; VAS-5**, PGI-S and PGI-C: every hour (±30 min) up to 6 h from initiation of PHA-022121 treatment and then at 8 (±1.5 h), 12 h (±2.5 h), 24 h (±9.5 h), and 48 h (±14.5 h) from initiation of treatment
-MSCS-TOS: at 4 h (±30 min), 12 h (±2.5 h), 24 h (±9.5 h), and 48 h (±14.5 h) from initiation of the PHA-022121 treatment
-TSQM score: at 48 h (±14.5 h) from initiation of the PHA-022121 treatment

* Non-laryngeal Attacks only
** Laryngeal attacks only

--VAS-3 *; VAS-5**, PGI-S y PGI-C: cada hora (±30 min) hasta 6 horas desde el inicio del tratamiento con PHA-022121 y luego a las 8 ( ±1.5 h), 12 h (±2.5 h), 24 h (±9.5 h), y 48 h (±14.5 h) desde el inicio del tratamiento.
- MSCS-TOS: a las 4 h (±30 min), 12 h (±2.5 h), 24 h (±9.5 h), y 48 h (±14.5 h) desde el inicio del tratamiento con PHA-022121
- Puntuación TSQM: a las 48 h (±14.5 h) desde el inicio del tratamiento con PHA-022121

* Solo ataques no laríngeos
** Solo ataques laríngeos

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

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)

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)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Dosis diferente del mismo producto

Different dosage of the same product

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

Israel

United States

France

Poland

Bulgaria

Spain

Czechia

Germany

Italy

Hungary

United Kingdom

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 End-of-Study visit is to occur between 14 to 28 days after the last treatment administration and if possible in case of withdrawal from the study.

La visita finalización del estudio debe realizarse entre los días 14 y 28 después de la última adminsitración del tratamiento y si es posible, en caso de abandono del estudio.
.

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

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

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

The study is planned to continue until the availability of commercial supply, or another means of continued treatment can be provided

Está previsto que el estudio continúe hasta que haya disponibilidad de suministro comercial, o se pueda proporcionar otro medio de tratamiento continuo.

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

2022-07-01

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-06-29

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

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Clinical trials