Clinical Trials Register

Summary
EudraCT Number:	2021-000354-25
Sponsor's Protocol Code Number:	2.1
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:	2021-08-25
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

2021-000354-25

A.3

Full title of the trial

A multicenter randomized trial of fosfomycin versus ciprofloxacin for febrile neutropenia in hematologic patients: efficacy and microbiologic safety.

Un ensayo aleatorizado multicéntrico de fosfomicina frente a ciprofloxacino para la neutropenia febril en pacientes hematológicos: eficacia y seguridad microbiológica.

A.3.1

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

Clinical trial for the treatment of febrile neutropenia in hematologic patients with antibiotics: fosfomycin versus ciprofloxacin.

Ensayo clínico para el tratamiento de la neutropenia febril en pacientes hematológicos con antibióticos: fosfomicina frente a ciprofloxacino.

A.3.2

Name or abbreviated title of the trial where available

FOVOCIP

A.4.1

Sponsor's protocol code number

2.1

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	FINBA
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	FINBA
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Agencia de ensayos clínicos-SCREN-IDIVAL
B.5.2	Functional name of contact point	Mar García
B.5.3	Address:
B.5.3.1	Street Address	AVDA. VALDECILLA S/N
B.5.3.2	Town/ city	SANTANDER
B.5.3.3	Post code	39008
B.5.3.4	Country	Spain
B.5.6	E-mail	mmar.garcia@scsalud.es

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	FOSFOMICINA CALCICA SOLUFOS
D.2.1.1.2	Name of the Marketing Authorisation holder	Q pharma labs
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	Capsule
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	FOSFOMYCIN CALCIUM
D.3.9.1	CAS number	26016-98-8
D.3.9.4	EV Substance Code	SUB02261MIG
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	500
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	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.3.1	Product name	CIPROFLOXACIN
D.3.4	Pharmaceutical form	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	CIPROFLOXACIN
D.3.9.3	Other descriptive name	CIPROFLOXACIN
D.3.9.4	EV Substance Code	SUB07470MIG
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	500
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Post-chemotherapy neutropenia with high risk of developing infection in patients with acute leukemia undergoing induction, autologous or allogeneic hematopoietic stem cell transplantation.

Neutropenia postquimioterapia con alto riesgo de desarrollar infección en pacientes con leucemia aguda en inducción, trasplante autólogo o alogénico de progenitores hematopoyéticos (TPH)

E.1.1.1

Medical condition in easily understood language

Neutropenia after chemotherapy in patients with acute leukemia in induction, autologous or allogeneic transplantation of hematopoietic progenitors.

Neutropenica tras quimioterapia en pacientes con leucemia aguda en inducción, trasplante autólogo o alogénico de progenitores hematopoyéticos.

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	21.0
E.1.2	Level	LLT
E.1.2	Classification code	10000835
E.1.2	Term	Acute leukemia
E.1.2	System Organ Class	100000004864

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	10076734
E.1.2	Term	Chemotherapy induced neutropenia
E.1.2	System Organ Class	100000004851

E.1.2 Medical condition or disease under investigation

E.1.2	Version	22.0
E.1.2	Level	LLT
E.1.2	Classification code	10067862
E.1.2	Term	Allogeneic stem cell transplantation
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 demonstrate non-inferiority in efficacy of oral fosfomycin versus oral ciprofloxacin in preventing febrile neutropenia in patients with acute leukemia treated with intensive chemotherapy and/or recipients of hematopoietic stem cell transplantation hematopoietic stem cell transplantation.

Demostrar la no inferioridad en cuanto a eficacia de fosfomicina oral frente a la ciprofloxacino oral para prevenir la neutropenia febril en pacientes con leucemia aguda tratados con quimioterapia intensiva y/o receptores de un trasplante de células madre hematopoyéticas trasplante de células madre hematopoyéticas

E.2.2

Secondary objectives of the trial

1. To compare the rates and types of infections documented between the two treatment arms.
2. Compare overall survival from baseline to resolution of neutropenia in both treatment arms.
3. To evaluate the safety and tolerability of both prophylactic strategies.
4. Perform surveillance cultures to determine the rate of Gram-negative multiresistant colonization (GNMRB), analyze the time course of colonization, and identify clinical factors associated with the clearance or persistence of GNMRB bacteria in the gut of previously colonized patients.
5. To evaluate the utility of a metagenomic approach in the identification of underdetected colonization, as compared to traditional surveillance cultures.
6. To analyze changes in the fecal microbiome of patients from initiation of chemotherapy to resolution of neutropenia and compare these changes between both treatment arms.

1. Comparar las tasas y los tipos de infecciones documentadas entre los dos brazos.
2. Comparar la supervivencia global desde el inicio del estudio hasta la resolución de la neutropenia entre los brazos de tratamiento.
3. Evaluar la seguridad y la tolerancia de ambas estrategias profilácticas.
4. Realizar cultivos de vigilancia para determinar la tasa de colonización de la bacteria Gram Negativas multirresistente (GNMR), analizar el tiempo en el que se produce la colonización, e identificar los factores clínicos asociados a la eliminación o persistencia de bacterias GNMRB en el intestino de pacientes previamente colonizados.
5. Evaluar la utilidad de un enfoque metagenómico en la identificación de colonizaciones infradetectadas, en comparación con los cultivos de vigilancia tradicionales.
6. Analizar los cambios en el microbioma fecal de los pacientes desde el inicio de la quimioterapia hasta la resolución de la neutropenia y comparar entre ambos brazos de tratamiento.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Subjects must meet all of the following inclusion criteria:
1. Subjects must be able to understand the study procedures, comply with them, and give written informed consent prior to any specific study procedure.
2. Adult subjects ≥ 18 years of age with a diagnosis of acute leukemia who are to receive their first course of chemotherapy or adult subjects ≥ 18 years of age who are candidates for a first stem cell transplant.
3. Expected neutropenia of 100x109/L lasting at least seven days. In the case of an expected range of 100-500x109/L neutropenia lasting seven days or longer, at least one of the following risk factors for infection must be present:
a. Performance status (Eastern Cooperative Oncology Group, ECOG) ≥2.
b. Expected grade 3-4 mucositis.
c. Age ≥65 years.
d. Comorbidity index (HCTI) ≥3.
e. Serum albumin< 35 g/L.
f. Total dose of etoposide > 500 mg/m2.
g. Total dose of cytarabine > 1 g/m2.
h. Active or refractory neoplasia at the time of stem cell transplantation.
4. Performance status (Eastern Cooperative Oncology Group, ECOG) of 0 to 3.
5. Adequate organ function defined as:
- Liver : bilirubin, alkaline phosphatase or SGOT < 3 times the upper limit of normal (unless attributable to tumor activity).
- Renal : creatinine ≤ 250 μmol/l (2.5 mg/dL) (unless attributable to AML activity).
6. Life expectancy greater than 3 months.
7. Women of childbearing age should not be pregnant or breastfeeding and should have a negative pregnancy test at the time of screening. Women of childbearing age and men with female partners of childbearing age must agree to practice 2 highly effective contraceptive measures and must agree not to become pregnant or father a child while receiving any study therapy and for at least 3 months after completion of treatment.

Los sujetos deben cumplir todos los siguientes criterios de inclusión:
1. Los sujetos deben ser capaces de comprender los procedimientos del estudio, cumplirlos y dar su consentimiento informado por escrito antes de cualquier procedimiento específico del estudio.
2. Sujetos adultos ≥ 18 años de edad con diagnóstico de leucemia aguda que vayan a recibir su primer ciclo de quimioterapia o sujetos adultos ≥ 18 años de edad que sean candidatos a recibir un primer trasplante de células madre.
3. Neutropenia esperada de 100x109/L que dure al menos siete días. En caso de que se espere un rango de neutropenia 100-500x109/L que dure siete días o más, al menos uno de los siguientes factores de riesgo de infección debe estar presente:
a. Estado de rendimiento (Eastern Cooperative Oncology Group, ECOG) ≥2.
b. Mucositis prevista de grado 3-4.
c. Edad ≥65 años.
d. Índice de comorbilidad (HCTI) ≥3.
e. Albúmina sérica< 35 g/L.
f. Dosis total de etopósido > 500 mg/m2.
g. Dosis total de citarabina > 1 g/m2
h. Neoplasia activa o refractaria en el momento del trasplante de células madre.
4. Estado de rendimiento (Eastern Cooperative Oncology Group, ECOG) de 0 a 3.
5. Función orgánica adecuada definida como:
- Hígado: bilirrubina, fosfatasa alcalina o SGOT < 3 veces el límite superior normal (a menos que sea atribuible a la actividad tumoral).
- Renal : creatinina ≤ 250 μmol/l (2,5 mg/dL) (salvo que sea atribuible a la actividad de la LMA).
6. Esperanza de vida superior a 3 meses.
7. Las mujeres en edad fértil no deben estar embarazadas ni en periodo de lactancia y deben tener una prueba de embarazo negativa en el momento del cribado. Las mujeres en edad fértil y los hombres con parejas femeninas en edad fértil deben comprometerse a practicar 2 medidas anticonceptivas de alta eficacia y deben aceptar no quedarse embarazadas ni engendrar un hijo mientras reciban cualquier terapia del estudio y durante al menos 3 meses después de completar el tratamiento.

E.4

Principal exclusion criteria

Patients who meet any of the following exclusion criteria cannot be included in this study:
1. Hypersensitivity to fluoroquinolones or fosfomycin.
2. Treatment with broad-spectrum antimicrobial therapy within 4 weeks of the first study treatment.
3. Prior intensive chemotherapy or stem cell transplantation. Treatment with hydroxyurea or corticosteroids used to control white blood cell count is allowed.
4. Fever of infectious origin or documented infection within 4 weeks of first study treatment.
5. Presence of any serious psychiatric illness or physical condition that, in the judgment of the physicians, contraindicates the patient's inclusion in the clinical trial.

Los pacientes que cumplan alguno de los siguientes criterios de exclusión no podrán ser incluidos en este estudio:
1. Hipersensibilidad a las fluoroquinolonas o a la fosfomicina.
2. Tratamiento con terapia antimicrobiana de amplio espectro dentro de las 4 semanas del primer tratamiento del estudio.
3. Quimioterapia intensiva previa o trasplante de células madre. Se permite el tratamiento con hidroxiurea o corticosteroides utilizados para controlar el recuento de glóbulos blancos.
4. Fiebre de origen infeccioso o infección documentada dentro de las 4 semanas del primer tratamiento del estudio.
5. Presencia de cualquier enfermedad psiquiátrica grave o condición física que, según el criterio de los médicos contraindique la inclusión del paciente en el ensayo clínico.

E.5 End points

E.5.1

Primary end point(s)

Treatment will be discontinued upon the occurrence of any of the following events:
1) febrile neutropenia requiring antibacterial treatment (study endpoint).
2) Absolute Neutrophil Count (ANR) >0.5x109/L;
3) If the subject fails to achieve more than 0.5x109/L neutrophils the study will end when more than 60 days have elapsed since the onset of neutropenia, or on the first day of the next chemotherapy cycle (whichever is earlier).
4) death.

El tratamiento se interrumpirá cuando se produzca alguno de los siguientes acontecimientos:
1) neutropenia febril que requiera tratamiento antibacteriano (punto final del estudio).
2) Recuento Absoluto de Neutrófilos (RAN) >0,5x109/L;
3) Si el sujeto no llega a alcanzar más de 0.5x109/L neutrófilos el estudio finalizará cuando hayan transcurrido más 60 días desde el inicio de neutropenia, o bien el primer día del siguiente ciclo de quimioterapia (lo que ocurra antes).
4) la muerte.

E.5.1.1

Timepoint(s) of evaluation of this end point

On day 60 or the next chemotherapy cycle or after recovery of neutrophil count to 0.5X109/L.

En el día 60 o en el siguiente ciclo de quimioterapia o tras las recuperacion del número de neutrofilos a 0.5X109/L

E.5.2

Secondary end point(s)

1. To compare the rates and types of infections documented between the two treatment arms.
2. Compare overall survival from baseline to resolution of neutropenia in both treatment arms.
3. To evaluate the safety and tolerability of both prophylactic strategies.
4. Perform surveillance cultures to determine the rate of colonization of MRGN bacteria, analyze the time course of colonization, and identify clinical factors associated with clearance or persistence of MRGN bacteria in the gut of previously colonized patients.
5. To evaluate the utility of a metagenomic approach in the identification of underdetected colonization, as compared to traditional surveillance cultures.
6. To analyze changes in the fecal microbiome of patients from initiation of chemotherapy to resolution of neutropenia and compare these changes between both treatment arms.

1. Comparar las tasas y los tipos de infecciones documentadas entre los dos brazos de tratamiento.
2. Comparar la supervivencia global desde el inicio del estudio hasta la resolución de la neutropenia en ambos brazos de tratamiento.
3. Evaluar la seguridad y la tolerancia de ambas estrategias profilácticas.
4. Realizar cultivos de vigilancia para determinar la tasa de colonización de la bacteria GNMR, analizar el tiempo en el que se produce la colonización, e identificar los factores clínicos asociados a la eliminación o persistencia de bacterias GNMR en el intestino de pacientes previamente colonizados.
5. Evaluar la utilidad de un enfoque metagenómico en la identificación de colonizaciones infradetectadas, en comparación con los cultivos de vigilancia tradicionales.
6. Analizar los cambios en el microbioma fecal de los pacientes desde el inicio de la quimioterapia hasta la resolución de la neutropenia y comparar estos cambios entre ambos brazos de tratamiento.

E.5.2.1

Timepoint(s) of evaluation of this end point

On day 60 or the next chemotherapy cycle or after recovery of neutrophil count to 0.5X109/L.

En el día 60 o en el siguiente ciclo de quimioterapia o tras las recuperacion del número de neutrofilos a 0.5X109/L

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

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

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

Yes

E.8.2.3.1

Comparator description

ciprofloxacin

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

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

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

Safety and efficacy data will be evaluated during the study.
Efficacy and safety data are unblinded and will be reviewed at least three times. The first safety review will occur when 25% of the sample has been included in the trial. The second review will occur when half of the sample has been reached and the third review will occur after 75% of the sample has been reached.

Los datos de seguridad y eficacia se evaluarán durante el estudio.
Los datos de eficacia y seguridad no están cegados y se revisarán al menos tres veces. La primera revisión de seguridad tendrá lugar cuando el 25% de la muestra haya sido incluida en el ensayo. La segunda revisión tendrá lugar cuando se haya alcanzado la mitad de la muestra y la tercera revisión tendrá lugar cuando se haya alcanzado el 75% de la muestra.

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

156

F.4.2

For a multinational trial

F.4.2.1

In the EEA

156

F.4.2.2

In the whole clinical trial

156

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)

According to routine clinical practice

De acuerdo a la práctica clínica habitual

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2021-11-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-08-26

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

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