Clinical Trials Register

Summary
EudraCT Number:	2021-000001-25
Sponsor's Protocol Code Number:	OXO-001-201
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:	2021-07-27
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

2021-000001-25

A.3

Full title of the trial

A phase II, randomised, double-blind, parallel-group, placebo-controlled trial to assess the ongoing pregnancy rate with OXO-001 (200 mg, 300 mg) or placebo at 10 weeks following fresh single blastocyst transfer resulting from donor oocyte IVF/ICSI

Un ensayo de fase II, aleatorizado, doble ciego, de grupos paralelos, controlado con placebo para evaluar la tasa de embarazo en curso con OXO-001 (200 mg, 300 mg) o placebo a las 10 semanas después de la transferencia de un único blastocisto fresco resultante de la FIV/ICSI de ovocitos de una donante

A.3.1

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

A clinical study assess the ongoing pregnancy rate with an Investigational Medicinal Product in woman undergoing a donor oocyte IVF/ICSI.

Ensayo clínico para evaluar la tasa de embarazo en curso con un Producto Médico en fase de Investigación en mujeres sometidas a FIV/ICSI con ovocitos de una donante.

A.3.2

Name or abbreviated title of the trial where available

OXOART 2 (OXO-001 in Assisted Reproductive Technology, phase 2 trial)

OXOART 2 (OXO-001 en Técnica de Reproducción Asistida (TRA), ensayo de fase 2)

A.4.1

Sponsor's protocol code number

OXO-001-201

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	Oxolife S.L.
B.1.3.4	Country	Spain
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	Oxolife S.L.
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	Oxolife S.L.
B.5.2	Functional name of contact point	CEO
B.5.3	Address:
B.5.3.1	Street Address	C/Nou no. 46
B.5.3.2	Town/ city	Sant Quirze del Vallès
B.5.3.3	Post code	08192
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34609771937
B.5.6	E-mail	info@oxolife.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	Sodium tungstate
D.3.2	Product code	OXO-001 (100 mg)
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	Sodium Tungstate
D.3.9.1	CAS number	13472-45-2
D.3.9.2	Current sponsor code	OXO-001
D.3.9.3	Other descriptive name	Sodium tungstate(VI); Sodium tungstate(VI) Dihydrate ; Sodium tungstate(VI), 181W-labeled
D.3.9.4	EV Substance Code	SUB181898
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	100
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	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	Sodium Tungstate
D.3.2	Product code	OXO-001 (150 mg)
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	Sodium Tungstate
D.3.9.1	CAS number	13472-45-2
D.3.9.2	Current sponsor code	OXO-001
D.3.9.3	Other descriptive name	Sodium tungstate(VI); Sodium tungstate(VI) Dihydrate ; Sodium tungstate(VI), 181W-labeled
D.3.9.4	EV Substance Code	SUB181898
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	150
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	Film-coated tablet
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

Infertility treatment and fertility enhancer in women undergoing assisted reproductive techniques or natural reproduction

Tratamiento de la infertilidad y potenciador de la fertilidad en mujeres sometidas a técnicas de reproducción asistida o reproducción natural.

E.1.1.1

Medical condition in easily understood language

Female Infertility and Improvemet of fertility

Infertilidad femenina y mejora de la fertilidad

E.1.1.2

Therapeutic area

Body processes [G] - Reproductive physiologi cal processes [G08]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective of this trial is to assess the efficacy of oral OXO-001 (200 mg and 300 mg) versus placebo taken once-daily to increase the ongoing pregnancy rate (defined as the rate of intrauterine pregnancy with foetal heartbeat) at 10 weeks post embryo transfer (ET)

El objetivo principal de este ensayo es evaluar la eficacia de OXO-001 oral 200 mg y 300 mg) versus placebo administrado una vez al día para aumentar la tasa de embarazo en curso (definida como la tasa de embarazo intrauterino con latidos cardíacos fetales) a las 10 semanas después de la transferencia de embriones (TE)

E.2.2

Secondary objectives of the trial

The secondary objective of this trial is to assess the efficacy of OXO-001 (200 mg and 300 mg) versus placebo in terms of biochemical pregnancy rate and pregnancy loss rate until 10 weeks post ET and to assess the safety and tolerability of OXO-001 (200 mg and 300 mg) from the first administration until 10 weeks post ET.

El objetivo secundario de este ensayo es evaluar la eficacia de OXO-001 (200 mg y 300 mg) versus placebo en términos de tasa de embarazo bioquímico y tasa de pérdida de embarazo hasta 10 semanas después de la TE y evaluar la seguridad y tolerabilidad de OXO-001 (200 mg y 300 mg) desde la primera administración hasta 10 semanas después de la TE.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Voluntary written informed consent before initiation of any trial-related procedures, including the agreement to participate in the pregnancy and infant follow-up if becoming pregnant.
2. Infertile female subjects indicated for egg donor programme in the context of ART. Infertility is defined as the failure to achieve a clinical pregnancy after:
a. at least 12 months of regular unprotected sexual intercourse, if < 35 years of age,
b. at least 6 months of regular unprotected sexual intercourse, if ≥ 35 years of age.
3. Subjects aged ≥ 18 to ≤ 45 years at screening.
4. Body mass index (BMI) ≥ 18.0 and < 30.0 kg/m2.
5. Normal results of a 2-dimensional (2D) or 3-dimensional (3D) transvaginal US (TVUS) at screening (no presence of gynaecological abnormality suspected to affect the ART procedure and outcome). The TVUS should have been performed in the mid of the second part of a menstrual cycle. .
6. Planned transfer of a fresh single blastocyst from a donated egg.
7. Good quality sperm (fresh or frozen) available from partner or donor.
NOTE: The partner’s consent on the review of his medical source data to assess sperm quality and for the potential use of donor sperms, as applicable, is required.
8. Planned endometrial preparation (not natural) and luteal support.

1.Consentimiento informado voluntario por escrito antes del inicio de cualquier procedimiento relacionado con el ensayo, incluido el acuerdo para participar en el seguimiento del embarazo y del lactante si la participante queda embarazada.
2.Mujeres infértiles indicadas para el programa de donación de óvulos en el contexto de la ART. La infertilidad se define como la imposibilidad de lograr un embarazo clínico después de:
a. al menos 12 meses de relaciones sexuales regulares sin protección, si se es < 35 años,
b. al menos 6 meses de relaciones sexuales regulares sin protección, si ≥ 35 años.
3.Pacientes de ≥ 18 a ≤ 45 años en el momento de la selección.
4.Índice de masa corporal (IMC) ≥ 18,0 y <30,0 kg / m2.
5.Resultados normales de una ecografía transvaginal (TVUS) bidimensional (2D) o tridimensional (3D) en la selección (sin presencia de anomalía ginecológica que se sospeche que afecte al procedimiento y al resultado de la ART). La TVUS debe haberse realizado a mediados de la segunda parte de un ciclo menstrual.
6.Transferencia planificada de un solo blastocisto en fresco de un óvulo donado.
7.Esperma de buena calidad (fresco o congelado) disponible de la pareja o donante.
NOTA: Se requiere el consentimiento de la pareja sobre la revisión de los datos médicos fuente para evaluar la calidad del esperma y para el uso potencial de espermatozoides como donante, según corresponda.
8.Preparación endometrial planificada (no natural) y soporte lúteo.

E.4

Principal exclusion criteria

1. History of two or more failed (no clinical pregnancy) in-vitro fertilisation (IVF) / intra-cytoplasmic sperm injection (ICSI) cycles after embryo transfer of donor oocyte during the last attempts prior to the trial.
2. Gynaecological abnormality relevant to the ART procedure and outcome, which in the opinion of the investigator could interfere with the trial objectives (e.g. significant uterine anomaly, communicating hydrosalpinx or submucosal/intramural fibroid(s) that deform the uterine cavity, congenital malformations) documented during transvaginal sonography.
3. Abnormal haemorrhage of the reproductive tract of undetermined origin.
4. Endometrial biopsy or endometrial local injury within one month prior to screening.
5. Diagnosis of severe endometriosis (stage III or IV) and/or adenomyosis.
6. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results.
7. Relevant clinically significant abnormality in the results of safety laboratory tests at screening.
8. Systemic disease (e.g. diabetes, epilepsy, severe migraine, hepatic, renal or cardiovascular disease, severe oral corticosteroid-dependent asthma, autoimmune disease, thrombophilia disease) which might interfere with the purpose of the trial.
9. Any malignant neoplasm.
10. Known history of venous thrombosis or thromboembolism, including any coagulation abnormality leading to an increased risk of clotting.
11. History of uncontrolled hypertension.
12. Known hypersensitivity to any component of the IP used in this trial.
13. Known allergy, hypersensitivity or any other contraindications to preparations used in the context of endometrial preparation and fresh ET with a donated egg.
14. History (within 12 months) of or known current problems with alcohol or substance abuse.
15. Any condition or treatment that, in the opinion of the investigator, may jeopardise the trial conduct according to the protocol.
16. Previous treatment with the IP of this trial at any time or participation in another clinical trial within the past 3 months prior to screening.
17. Employees of the investigator or trial centre, with direct involvement in the proposed trial or other studies under the direction of that investigator or trial centre, as well as family members of the employees or the principal investigator.
18. Persons committed to an institution by virtue of an order issued either by the judicial or other authorities.

1.Antecedentes de dos o más ciclos de fertilización in vitro (FIV)/inyección intracitoplasmática de espermatozoides (ICSI) fallidos (sin embarazo clínico) después de la transferencia de embriones de ovocitos de donantes durante los últimos intentos antes del ensayo.
2.Anomalía ginecológica relevante para el procedimiento y el resultado de la ART, que en opinión del investigador podría interferir con los objetivos del ensayo (p. ej., anomalía uterina significativa, hidrosálpinx comunicante o fibroma submucoso/intramural que deforma la cavidad uterina, malformaciones congénitas) documentado mediante ecografía transvaginal.
3.Hemorragia anormal del aparato reproductor de origen indeterminado.
4.Biopsia endometrial o lesión local endometrial dentro de un mes antes de la selección.
5.Diagnóstico de endometriosis grave (estadio III o IV) y/o adenomiosis.
6.Resultados positivos para el antígeno de superficie de la hepatitis B (HBsAg), anticuerpos contra el virus de la hepatitis C (HCV Ab) o virus de inmunodeficiencia humana (VIH).
7.Anormalidad relevante clínicamente significativa en los resultados de las pruebas de laboratorio de seguridad en la selección.
8.Enfermedad sistémica (por ejemplo, diabetes, epilepsia, migraña grave, enfermedad hepática, renal o cardiovascular, asma grave dependiente de corticosteroides orales, enfermedad autoinmune, enfermedad de trombofilia) que podría interferir con el propósito del ensayo.
9.Cualquier neoplasia maligna.
10.Antecedentes conocidos de trombosis venosa o tromboembolismo, incluida cualquier anomalía de la coagulación que conduzca a un mayor riesgo de formación de coágulos.
11.Antecedentes de hipertensión no controlada.
12.Hipersensibilidad conocida a cualquier componente del PI utilizado en este ensayo.
13.Alergia conocida, hipersensibilidad o cualquier otra contraindicación a las preparaciones utilizadas en el contexto de la preparación endometrial y TE reciente con un óvulo donado.
14.Antecedentes (dentro de los 12 meses) de problemas actuales conocidos con el abuso de alcohol o de sustancias.
15.Cualquier condición o tratamiento que, a juicio del investigador, pueda poner en peligro la realización del ensayo según el protocolo.
16.Tratamiento previo con el PI de este ensayo en cualquier momento o participación en otro ensayo clínico dentro de los últimos 3 meses antes de la selección.
17.Empleados del centro del ensayo clínico o del investigador, con participación directa en el ensayo propuesto u otros estudios bajo la dirección de ese mismo centro del ensayo clínico o del investigador, así como familiares de los empleados o del investigador principal.
18.Personas internadas en una institución en virtud de una orden emitida por autoridades judiciales u otras.

E.5 End points

E.5.1

Primary end point(s)

Efficacy will be assessed using the ongoing pregnancy rate, defined as the rate of subjects with uterine pregnancy and a foetal heartbeat, confirmed by ultrasound (US) at 10 weeks post embryo transfer.

La eficacia se evaluará utilizando la tasa de embarazo en curso, definida como la tasa de pacientes con embarazo uterino y latidos cardíacos fetales, confirmada por ecografía (US) a las 10 semanas después de la TE.

E.5.1.1

Timepoint(s) of evaluation of this end point

At the end of the main part of the trial.

Al final de la parte principal del ensayo.

E.5.2

Secondary end point(s)

1. Percentage of women with positive blood pregnancy test 10 to 15 days post ET.
2. Percentage of women with vital pregnancy (defined as intra-uterine pregnancy with foetal heartbeat) at 6 weeks post ET.
3. Early pregnancy loss rate within 10 weeks of gestation (i.e. after positive blood pregnancy test 10 - 15 days post ET).
4. Incidence and severity of AEs/ SAEs, reported during the period from the first intake of the IP until 10 weeks post ET.
5. Changes from baseline in haematology and biochemistry values 6 weeks post ET.
6. Changes from baseline in vital signs (heart rate, blood pressure).
7. Changes in endometrial thickness.
8. Proportion of subjects achieving the endometrial criteria to undergo ET.

1. Porcentaje de mujeres con prueba de embarazo en sangre positiva entre 10 y 15 días después de la TE.
2. Porcentaje de mujeres con embarazo vital (definido como embarazo intrauterino con latidos cardíacos fetales) a las 6 semanas después de la TE.
3. Tasa de pérdida temprana del embarazo dentro de las 10 semanas de gestación (es decir, después de una prueba de embarazo en sangre positiva 10 15 días después de la TE).
4. Incidencia y gravedad de los eventos adversos (EA)/eventos adversos graves (EAG) informados durante el período desde la primera ingesta del producto en investigación (PI) hasta las 10 semanas posteriores a la TE.
5. Cambios desde los valores de referencia en hematología y bioquímica.
6. Cambios con respecto al valor de referencia en los signos vitales (frecuencia cardíaca, presión arterial).
7. Cambios en el grosor del endometrio.
8. Proporción de sujetos que lograron los criterios de endometrio para someterse a la TE.

E.5.2.1

Timepoint(s) of evaluation of this end point

At the end of the main part of the trial.

Al final de la parte principal del ensayo.

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)

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)

E.8.2.2

Placebo

Yes

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

E.8.6.2

Trial being conducted completely outside of the EEA

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 (main part of the trial)

Última visita del último paciente (parte principal del ensayo)

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:

351

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

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

Yes

F.3.3.2

Women of child-bearing potential using contraception

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

220

F.4.2

For a multinational trial

F.4.2.1

In the EEA

351

F.4.2.2

In the whole clinical trial

351

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
G.4 Investigator Network to be involved in the Trial: 1

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2021-07-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-05-14

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

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