Clinical Trials Register

Summary
EudraCT Number:	2017-001642-10
Sponsor's Protocol Code Number:	SMT19969/C005
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:	2019-07-05
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2017-001642-10

A.3

Full title of the trial

A Phase 3, randomized, double-blind, active controlled study to compare the efficacy and safety of ridinilazole (200 mg, bid) for 10 days with vancomycin (125 mg, qid) for 10 days in the treatment of Clostridium difficile infection (CDI).

Estudio de fase III, aleatorizado, con doble enmascaramiento y comparador activo de comparación de la eficacia y la seguridad entre ridinilazol (200 mg, 2 veces/día) durante 10 días y vancomicina (125 mg, 4 veces/día) durante 10 días para el tratamiento de la infección por Clostridium difficile (ICD)

A.3.1

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

Comparison of ridinilazole versus vancomycin treatment for Clostridium difficile infection

Comparación entre el ridinilazol y la vancomicina en el tratamiento de la
ICD

A.4.1

Sponsor's protocol code number

SMT19969/C005

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	Summit (Oxford) Limited
B.1.3.4	Country	United Kingdom
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	BARDA
B.4.2	Country	United States
B.4.1	Name of organisation providing support	Summit (Oxford) Limited
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Summit (Oxford) Limited
B.5.2	Functional name of contact point	Clinical Operations
B.5.3	Address:
B.5.3.1	Street Address	136A Eastern Avenue, Milton Park
B.5.3.2	Town/ city	Abingdon
B.5.3.3	Post code	OX14 4SB
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	00441235443939
B.5.6	E-mail	ridinilazolephase3studies@summitplc.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	Ridinilazole
D.3.2	Product code	SMT19969
D.3.4	Pharmaceutical form	Coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Ridinilazole
D.3.9.1	CAS number	308362-25-6
D.3.9.2	Current sponsor code	SMT19969
D.3.9.3	Other descriptive name	SMT19969
D.3.9.4	EV Substance Code	SUB85907
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	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	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.2.1.2	Country which granted the Marketing Authorisation	United States
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	Vancomycin
D.3.4	Pharmaceutical form	Capsule, hard
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	vancomycin
D.3.9.3	Other descriptive name	VANCOMYCIN HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB05077MIG
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	125
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	Yes
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	Coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
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

Clostridium difficile infection (CDI)

infección por Clostridium difficile (ICD)

E.1.1.1

Medical condition in easily understood language

Infection of the gut by the bacterium Clostridium difficile

infección del colon por la bacteria Clostridium difficile

E.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10054236
E.1.2	Term	Clostridium difficile infection
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 compare the efficacy of 10 days dosing with ridinilazole (200 mg bid) with vancomycin (125 mg qid) in the treatment of patients with CDI

Comparar la eficacia de 10 días de administración de ridinilazol (200 mg,
2 v/d) con vancomicina (125 mg, 4 v/d) en el tratamiento de pacientes
con ICD.

E.2.2

Secondary objectives of the trial

• To compare the safety and tolerability of 10 days dosing with ridinilazole (200 mg bid) with vancomycin (125 mg qid) in the treatment of patients with CDI
• To characterize the systemic exposure of ridinilazole in a subset of patients treated with ridinilazole (200 mg bid) tablets

• Comparar la seguridad y tolerabilidad de 10 días de administración de ridinilazol (200 mg, 2 v/d) con vancomicina (125 mg, 4 v/d) en el tratamiento de pacientes con ICD.
• Describir la exposición sistémica del ridinilazol en un subconjunto de pacientes tratados con comprimidos de ridinilazol (200 mg, 2 v/d).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients are eligible to be included in the study only if all the following criteria apply:
1. Patient must be at least 18 years of age, at the time of signing the informed consent.
2. Have signs and symptoms of CDI including diarrhea such that in the Investigator’s opinion CDI antimicrobial therapy is required. Diarrhea is defined as a change in bowel habits, with ≥3 UBMs (5, 6 or 7 on the Bristol Stool Chart) in the 24 h prior to randomization.
3. Have the presence of either toxin A and/or B of C. difficile in the stool determined by a positive free toxin test (using a Sponsor agreed test). The stool sample must have been produced within 72 hours prior to randomization.
4. Male or Female
Male patients:
• A male patient must agree to use contraception as detailed in Appendix 4 of this protocol during the treatment period and for at least 30 days after the last dose of study treatment and refrain from donating sperm during this period.
Female patients:
• A female patient is eligible to participate if she is not pregnant (see Appendix 4), not breastfeeding, and at least one of the following conditions applies:
i. Not a woman of childbearing potential (WOCBP) as defined in Appendix 4
OR
ii. A WOCBP who agrees to follow the contraceptive guidance in Appendix 4 during the treatment period and for at least 30 days after the last dose of study treatment.
5. Has provided documented signed informed consent and any authorizations required by local law (e.g. Protected Health Information [PHI]).

1. Los pacientes Deben tener al menos 18 años.
2. tener signos y sintomas de ICD incluyendo diarrhea
3. Tener la presencia de toxina A y / o B de C. difficile en las heces determinada por una prueba de toxina libre positiva (usando una prueba acordada por el Patrocinador). La muestra de heces debe haberse producido dentro de las 72 horas previas a la aleatorización.
4. Hombre o mujer
Pacientes masculinos:
• Un paciente masculino debe aceptar el uso de anticonceptivos como se detalla en el Apéndice 4 de este protocolo durante el período de tratamiento y durante al menos 30 días después de la última dosis del tratamiento del estudio y abstenerse de donar esperma durante este período.
Pacientes de sexo femenino:
Una paciente femenina es elegible para participar si no está embarazada (ver Apéndice 4), no está amamantando, y al menos una de las siguientes condiciones se aplica:
yo. No es una mujer en edad fértil (WOCBP) como se define en el Apéndice 4
O
ii. Un WOCBP que acepte seguir la guía de anticoncepción en el Apéndice
4 durante el período de tratamiento y durante al menos 30 días después de la última dosis del tratamiento del estudio.
5. Ha proporcionado el consentimiento informado firmado y
documentado y las autorizaciones requeridas por la ley local (por ejemplo, Información de salud protegida [PHI]).

E.4

Principal exclusion criteria

Patients are excluded from the study if any of the following criteria apply:
1. Have had more than one prior episode of CDI in the previous 3 months or more than 3 episodes in the past 12 months
2. Have a history of chronic diarrheal disease including inflammatory bowel disease (Crohn’s disease or ulcerative colitis).
3. Have had a positive diagnostic test for other GI pathogens considered to be clinically relevant, within 2 weeks of randomization.
4. Have had major gastrointestinal (GI) surgery (e.g. significant bowel resection) within 3 months of randomization (this does not include appendectomy) The presence of a colostomy or ileostomy or likely requirement of an ostomy during the study.
5. Have life threatening or fulminant CDI with evidence of hypotension, septic shock, peritoneal signs or absence of bowel sounds, or toxic megacolon.
6. Have a known current history of significantly compromised immune system e.g.
a. HIV positive with a CD4<200 cells/mm3 within 6 months of randomization.
b. Severe neutropenia with neutrophil count < 500 cells/mL.
c. Are on concurrent immunosuppressive therapy for recent (within previous 6 months) or anticipated solid organ transplant or bone marrow transplant.
d. Are on a concurrent chemotherapy, radiotherapy, or biologic treatment for active malignancy. Or active malignancy with ablative chemotherapy within the past 3 months or anticipated during the study.
7. Have had more than 24 hours of dosing, or equivalent (i.e. four doses of oral vancomycin, two doses of fidaxomicin or three doses of metronidazole) of antimicrobial treatment active against the current episode of CDI prior to randomization.
8. Prior or current use of anti-toxin antibodies including bezlotoxumab
9. Are unable to discontinue products used to affect bowel movement or disease progression (see 6.5.1 for a list of potentially confounding medications).
10. Has been involved in a clinical trial and received an investigational medicinal product for indications other than CDI within 1 month or five half-lives (whichever is longer) or within 3 months if the investigational medical product was for CDI.
11. Have received an investigational vaccine against C. difficile.
12. Patients that the Investigator feels are inappropriate for the study this would include those;
a. with any other condition that, in the Investigator's judgment, would make the patient unsuitable for inclusion in the study.
b. who, in the opinion of the Investigator, are not likely to complete the study for whatever reason. E.g. short life expectancy.
c. with known hypersensitivity or intolerance to ridinilazole, vancomycin, and/or their excipients
d. who are unwilling or unable to comply with protocol requirements, e.g. complete the full course of study treatment per schedule, attend study visits, complete an electronic diary (or have a caregiver able to complete this on the patient’s behalf), provide stool samples, ingest capsules, blood draws.

Los pacientes se excluyen del estudio si se aplica alguno de los
siguientes criterios:
1. Haber tenido más de un episodio previo de CDI en los últimos 3 meses o más de 3 episodios en los últimos 12 meses
2. Tiene antecedentes de enfermedad diarreica crónica, incluida la enfermedad inflamatoria intestinal (enfermedad de Crohn o colitis ulcerosa).
3. Haber tenido una prueba diagnóstica positiva para otros patógenos GI considerados clínicamente relevantes, dentro de las 2 semanas posteriores a la aleatorización.
4. Ha tenido una cirugía gastrointestinal (GI) mayor (por ejemplo, resección intestinal significativa) dentro de los 3 meses posteriores a la aleatorización (esto no incluye la apendicectomía) La presencia de una colostomía o ileostomía o un posible requisito de una ostomía durante el estudio.
5. Tener un CDI potencialmente mortal o fulminante con evidencia de hipotensión, shock séptico, signos peritoneales o ausencia de ruidos intestinales o megacolon tóxico.
6. Tener un historial actual de sistemas inmunológicos
significativamente comprometidos, p. Ej.
a. VIH positivo con un CD4 <200 células / mm3 dentro de los 6 meses posteriores a la aleatorización.
segundo. Neutropenia grave con recuento de neutrófilos <500 células / ml.
Se encuentra en terapia inmunosupresora concurrente para un
trasplante de órgano sólido o trasplante de médula ósea reciente (dentro
de los 6 meses anteriores) o anticipado.
re. Reciben quimioterapia, radioterapia o tratamiento biológico
concurrente para la enfermedad maligna activa. O malignidad activa con
quimioterapia ablativa en los últimos 3 meses o prevista durante el
estudio.
7. Haber recibido más de 24 horas de dosificación o equivalente (es decir, cuatro dosis de vancomicina oral, dos dosis de fidaxomicina o tres dosis de metronidazol) de tratamiento antimicrobiano activo contra el episodio actual de CDI antes de la aleatorización.
8. Uso anterior o actual de anticuerpos anti-toxina, incluyendo
bezlotoxumab.
9. No puede descontinuar los productos utilizados para afectar el movimiento intestinal o la progresión de la enfermedad (consulte la sección 6.5.1 para obtener una lista de medicamentos potencialmente confusos).
10. Ha participado en un ensayo clínico y ha recibido un medicamento en investigación para indicaciones que no son CDI dentro de 1 mes o cinco vidas medias (lo que sea más largo) o dentro de 3 meses si el product médico en investigación era para CDI.
11. Haber recibido una vacuna en investigación contra C. difficile.
12. Los pacientes que el investigador considere inapropiados para el estudio, esto incluiría a aquellos;
a. con cualquier otra condición que, a juicio del investigador, haga que el paciente no sea adecuado para su inclusión en el estudio.
b. quién, en opinión del investigador, no es probable que complete el estudio por cualquier motivo. P.ej. corta esperanza de vida.
c. Conocido con hipersensibilidad o intolerancia conocida al ridinilazol, vancomicina y / o sus excipientes
d. que no están dispuestos o no pueden cumplir con los requisitos del protocolo, por ejemplo, complete el curso completo de tratamiento del estudio según el horario, asista a las visitas del estudio, complete un diario electrónico (o haga que un cuidador pueda completar esto en nombre del paciente), proporcione muestras de heces, ingiera cápsulas,
extraiga sangre.
E

E.5 End points

E.5.1

Primary end point(s)

Sustained clinical response defined as clinical cure at the Assessment Of Cure (AOC) visit and no recurrence of CDI within 30 days post End Of Treatment (EOT).

Respuesta clínica sostenida definida como cura clínica en la visita de Evaluación de la curación (AOC) y sin recurrencia de CDI dentro de los 30 días posteriores al final del tratamiento (EOT).

E.5.1.1

Timepoint(s) of evaluation of this end point

Day 40

Día 40

E.5.2

Secondary end point(s)

Clinical cure at the AOC visit.

Sustained clinical response over 60 days – defined as clinical cure at the AOC visit and no recurrence of CDI within 60 days post EOT

Sustained clinical response over 90 days – defined as clinical cure at the AOC visit and no recurrence of CDI within 90 days post EOT

Curación clínica en la visita de AOC.
Respuesta clínica sostenida durante 60 días: definida como cura clínica en la visita de AOC y sin recurrencia de CDI dentro de los 60 días posteriores a la EOT
Respuesta clínica sostenida durante 90 días, definida como cura clínica en la visita de AOC y sin recurrencia de CDI dentro de los 90 días posteriores a la EOT).

E.5.2.1

Timepoint(s) of evaluation of this end point

• Clinical cure at the AOC visit: Day 12 (AOC)

• Sustained clinical response over 60 days – defined as clinical cure at the AOC visit and no recurrence of CDI within 60 days post EOT: Day 70

• Sustained clinical response over 90 days – defined as clinical cure at the AOC visit and no recurrence of CDI within 90 days post EOT: day 100

• Curación clínica en la visita AOC: día 12 (AOC)
• Respuesta clínica sostenida durante 60 días: definida como cura clínica en la visita de AOC y sin recurrencia de CDI dentro de los 60 días posteriores al EOT: día 70
• Respuesta clínica sostenida durante 90 días: definida como cura clínica en la visita de AOC y sin recurrencia de CDI dentro de los 90 días posteriores al EOT: día 100

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

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

Yes

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)

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

Argentina

Belarus

Belgium

Brazil

Canada

Chile

Czech Republic

Estonia

France

Georgia

Germany

Israel

Italy

Latvia

Lithuania

Mexico

Peru

Romania

Spain

United States

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

The end of the study is defined as the date of the last study assessment of the last patient in the study.

El final del estudio se define como la fecha de la última evaluación del
estudio del último paciente en el studio.

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:

340

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

340

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

Yes

F.3.3.7.1

Details of other specific vulnerable populations

persons in nursing homes

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

162

F.4.2.2

In the whole clinical trial

680

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

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

2019-09-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-09-06

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials