Clinical Trials Nct-pagina

Summary
EudraCT Number:2021-004890-29
Sponsor's Protocol Code Number:FIT-PIV
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:2022-08-29
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
A. Protocol Information
A.1Member State ConcernedSpain - AEMPS
A.2EudraCT number2021-004890-29
A.3Full title of the trial
A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants
Estudio multicéntrico, aleatorizado, doble ciego, de dos grupos paralelos y controlado con placebo para evaluar la eficacia y la seguridad de ELGN-2112 en la malabsorción intestinal de los recién nacidos prematuros.
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
Study that will be conduced in different clinical sites, in which nor the patient neither the doctors will know the treatment given to patient, with 2 different group in which the patients will be assigned randomly, controlled with respect to placebo, that has the aim to estabilish the efficacy and the safety of ELGN2112 on the incapability of preterm baby to absorb sufficient nutrients, a condition known as intestinal malabsorption
Estudio que se llevará a cabo en diferentes centros clínicos, en los que ni el paciente ni los médicos conocerán el tratamiento administrado al paciente, con 2 grupos diferentes en los que los pacientes serán asignados aleatoriamente, controlados respecto al placebo, que tiene el objetivo de establecer la eficacia y la seguridad de ELGN2112 sobre la incapacidad del bebé prematuro de absorber suficientes nutrientes, una condición conocida como malabsorción intestinal.
A.3.2Name or abbreviated title of the trial where available
FIT-PIV
FIT-PIV
A.4.1Sponsor's protocol code numberFIT-PIV
A.7Trial is part of a Paediatric Investigation Plan Yes
A.8EMA Decision number of Paediatric Investigation PlanP/079/2018
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorELGAN Pharma
B.1.3.4CountryIsrael
B.3.1 and B.3.2Status of the sponsorCommercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing supportELGAN Pharma
B.4.2CountrySpain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisationSAIL SL
B.5.2Functional name of contact pointSilvia Martinez Rabasa
B.5.3 Address:
B.5.3.1Street AddressAvenida Meridiana 350, 9D
B.5.3.2Town/ cityBarcelona
B.5.3.3Post code08027
B.5.3.4CountrySpain
B.5.4Telephone number0034935042736101
B.5.6E-mailsilvia.martinez@sail-biometria.com
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation No
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameELGN-2112
D.3.2Product code ELGN-2112
D.3.4Pharmaceutical form Powder and solvent for oral solution
D.3.4.1Specific paediatric formulation Yes
D.3.7Routes of administration for this IMPEnteral use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNInsulin human
D.3.9.1CAS number 11061-68-0
D.3.9.2Current sponsor codeELGN-2112
D.3.9.4EV Substance CodeSUB08197MIG
D.3.10 Strength
D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number0.5
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin No
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product Yes
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.8 Information on Placebo
D.8 Placebo: 1
D.8.1Is a Placebo used in this Trial?Yes
D.8.3Pharmaceutical form of the placeboPowder for oral solution
D.8.4Route of administration of the placeboEnteral use (Noncurrent)
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Intestinal Malabsorption in Preterm Infants.
Malabsorción intestinal en recién nacidos prematuros.
E.1.1.1Medical condition in easily understood language
Digestive tract (oesophagus, stomach and intestines)in preterm infants is not fully developed. These infants are unable to absorb sufficient nutrients, which is described as intestinal malabsorption.
El tracto digestivo (esófago, estómago e intestinos) de los bebés prematuros no está completamente desarrollado y no pueden absorber suficientes nutrientes, lo que se llama malabsorción intestinal.
E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 20.0
E.1.2Level LLT
E.1.2Classification code 10032413
E.1.2Term Other preterm infants, 750-999 grams
E.1.2System Organ Class 100000004868
E.1.2 Medical condition or disease under investigation
E.1.2Version 20.0
E.1.2Level LLT
E.1.2Classification code 10032407
E.1.2Term Other preterm infants, 1,250-1,499 grams
E.1.2System Organ Class 100000004868
E.1.2 Medical condition or disease under investigation
E.1.2Version 20.0
E.1.2Level LLT
E.1.2Classification code 10032409
E.1.2Term Other preterm infants, 1,750-1,999 grams
E.1.2System Organ Class 100000004868
E.1.2 Medical condition or disease under investigation
E.1.2Version 20.0
E.1.2Level LLT
E.1.2Classification code 10032411
E.1.2Term Other preterm infants, 2,500+ grams
E.1.2System Organ Class 100000004868
E.1.2 Medical condition or disease under investigation
E.1.2Version 20.0
E.1.2Level LLT
E.1.2Classification code 10032415
E.1.2Term Other preterm infants, unspecified {weight}
E.1.2System Organ Class 100000004868
E.1.2 Medical condition or disease under investigation
E.1.2Version 20.0
E.1.2Level LLT
E.1.2Classification code 10032412
E.1.2Term Other preterm infants, 500-749 grams
E.1.2System Organ Class 100000004868
E.1.2 Medical condition or disease under investigation
E.1.2Version 20.0
E.1.2Level LLT
E.1.2Classification code 10032406
E.1.2Term Other preterm infants, 1,000-1,249 grams
E.1.2System Organ Class 100000004868
E.1.2 Medical condition or disease under investigation
E.1.2Version 20.0
E.1.2Level LLT
E.1.2Classification code 10032408
E.1.2Term Other preterm infants, 1,500-1,749 grams
E.1.2System Organ Class 100000004868
E.1.2 Medical condition or disease under investigation
E.1.2Version 20.0
E.1.2Level LLT
E.1.2Classification code 10032410
E.1.2Term Other preterm infants, 2,000-2,499 grams
E.1.2System Organ Class 100000004868
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
To assess the efficacy of ELGN-2112 as compared to placebo on intestinal malabsorption in preterm infants as measured by the time to full enteral feeding.
Evaluar la eficacia del tratamiento con ELGN-2112 en comparación con placebo sobre la malabsorción intestinal en lactantes prematuros, medida por el tiempo hasta la nutrición enteral completa.
E.2.2Secondary objectives of the trial
1To assess effect of ELGN-2112 compared to placebo on number of days until full wean off PN, 2To assess the effect of ELGN-2112 compared to placebo on nº of days to discharge to home, 3Incidence and severity of Necrotizing Enterocolitis (NEC) in infants born at 26-28 weeks GA, 4Percentage of infants reaching full enteral feeding within 6, 8, and 10 days from initiation of treatment, 5Number of days to 120 ml/kg/day for three consecutive days, 6Number of days until PN wean off (time to amino acids and lipids withdrawal), 7Percentage of infants weaned off PN within 4, 6, and 8 days from initiation of treatment, 8Percent enteral/ parenteral feedings from total nutrition over time, 9Number of days to discharge from primary hospital, 10Anthropometrics, 11Percent of infants with culture proven nosocomial sepsis, 12Percent of infants experiencing one of the adverse events of relevance (NEC, Infections, Death), 13Retinopathy of prematurity (ROP) activity score at 30-36 weeks PMA.
1Evaluar el efecto de ELGN-2112 en comparación con placebo en el nº de días hasta el abandono completo de la NP, 2Efecto de ELGN-2112 en comparación con placebo sobre el nºde días hasta el alta hospitalaria, 3Incidencia y gravedad de la enterocolitis necrosante en lactantes nacidos a las 26-28 semanas de EG, 4% de lactantes que alcanzaran la nutrición enteral completa en los 6, 8 y 10 días siguientes al inicio del tratamiento, 5Nº de días hasta 120 ml/kg/día durante 3 días consecutivos, 6Nº de días hasta el abandono de la NP, 7% de lactantes que dejaron de recibir NP en los 4, 6 y 8 días siguientes al inicio del tratamiento, 8Porcentaje de tomas respecto a la nutrición total a lo largo del tiempo, 9Número de días hasta el alta, 10Antropometría, 11Porcentaje de lactantes con sepsis nosocomial confirmada por cultivo, 12Porcentaje de lactantes que sufrieron uno de los acontecimientos adversos de interés, 13Puntuación de actividad de la retinopatía del prematuro a las 30-36 semanas de EPM.
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
1. Male or female pre-term infants 26 and up to 32 weeks gestation (32 weeks + 0 day maximum). Gestational age matching (±2 weeks) between maternal dates and/or early antenatal ultrasound*.
2. Birth weight ≥ 500g.
3. Singleton, or twin birth.
4. Postnatal age up through and including Day 5 (up to 120 hours post birth).
5. Fraction of inspired oxygen ≤ 0.60 at enrolment.
6. Infants must demonstrate cardiovascular stability at time of enrolment and would be considered unstable if they require blood pressure support via a central line.
7. Infant is able to tolerate enteral feed.
8. Infant is expected to wean off PN at the primary hospital.
9. Informed consent form (ICF) signed by parents or legal guardian.
10. In the Investigator’s opinion, the infant is able to comply with the study procedures and sufficiently stable to partake in the trial to completion.
* If both exist and difference > 2 weeks, based on early antenatal ultrasound
1.Lactantes prematuros de ambos sexos de 26 a 32 semanas de gestación (32 semanas + 0 días como máximo). Emparejamiento de la edad de gestación (±2 semanas) entre las fechas maternas y la ecografía prenatal precoz*.
2.Peso al nacer ≥500 g.
3.Parto único o gemelar.
4.Edad posnatal hasta el día 5 inclusive (hasta 120 horas después del parto).
5.Fracción de oxígeno inspirado ≤0,60 en la inclusión.
6.Los lactantes deben mostrar estabilidad cardiovascular en el momento del reclutamiento en el estudio y se les considerará inestables si precisan apoyo de la presión arterial a través de una vía central.
7.El lactante tolera la alimentación enteral.
8.Se espera que el lactante deje de recibir la nutrición parenteral (NP) en el hospital principal.
9.Documento de consentimiento informado firmado por los padres o el tutor legal.
10.En opinión del investigador, el lactante es capaz de cumplir los procedimientos del estudio y se encuentra suficientemente estable para continuar en el ensayo hasta su finalización.
* Si existen ambas y la diferencia es >2 semanas, conforme a la ecografía prenatal precoz.
E.4Principal exclusion criteria
1. Infant is consuming more than 100 ml/kg/day enterally at study entry
2. Infant is not dependent on any parenteral amino acids/lipids as nutrition
3. Major congenital malformation (e.g., Infants with genetic, metabolic, and/or endocrine disorder diagnosed before enrolment).
4. Intra-uterine growth restriction (IUGR) defined as weight for gestational age less than the third percentile according to Fenton preterm growth chart (see Appendix D).
5. Confirmed necrotizing enterocolitis (NEC).1
6. Maternal diabetes (Type I/II or gestational) requiring insulin during pregnancy or in mothers past medical history.
7. suspected or confirmed Hyperinsulinemia requiring glucose administration of more than 12 mg/kg/min at randomization.
8. Any systemic insulin administration at randomization.
9. Never anything per os (NPO) until 120 hrs post-birth for any reason.
10. Heart and chest compression or any resuscitation drugs given to the infant during delivery.
11. Subjects at risk for significant GI complications such as twin-to-twin transfusion syndrome (TTTS) or monochorionic monoamniotic twins.
12. Participation in another interventional clinical study that may interfere with the primary and secondary outcomes of this trial.
1.El lactante consume más de 100 ml/kg/día por vía enteral al incorporarse al estudio.
2.El lactante no depende de aminoácidos/lípidos parenterales como nutrición.
3.Malformación congénita importante (p. ej., lactantes con trastorno genético, metabólico o endocrino diagnosticado antes de la inclusión).
4.Restricción del crecimiento intrauterino (RCIU) definida como un peso para una edad gestacional inferior al tercer percentil según la gráfica de crecimiento prematuro de Fenton (véase el apéndice D).
5.Enterocolitis necrosante (ECN) confirmada.
6.Diabetes materna (de tipo 1/2 o gravídica) con necesidad de insulina durante el embarazo o en madres con antecedentes médicos.
7.Sospecha de hiperinsulinemia o hiperinsulinemia confirmada con necesidad de administración de más de 12 mg/kg/min de glucosa en el momento de la aleatorización.
8.Administración de cualquier insulina sistémica en la aleatorización.
9.Nunca nada por vía oral hasta 120 horas después del parto por cualquier motivo.
10.Se han administrado compresión coronaria o torácica o fármacos de reanimación al recién nacido durante el parto.
11.Sujetos con riesgo de complicaciones GI importantes, como síndrome de transfusión fetofetal (STFF) o gemelos monoamnióticos monocoriónicos.
12.Participación en otro estudio clínico intervencionista que pueda interferir en los criterios de valoración principal y secundarios de este ensayo.
E.5 End points
E.5.1Primary end point(s)
Numbers of days to achieve full enteral feeding, defined as the first day of ability of the preterm infant to achieve enteral feeding of at least 150 ml/kg/day for three consecutive days.
Número de días hasta alcanzar la nutrición enteral completa, definido como el primer día de capacidad del lactante prematuro para alcanzar una alimentación enteral mínima de 150 ml/kg al día durante tres días consecutivos.
E.5.1.1Timepoint(s) of evaluation of this end point
During the study (first day of ability of the preterm infant to achieve enteral feeding of at least 150 ml/kg/day for three consecutive days)
Durante el estudio (primer día de la capacidad del bebé prematuro para lograr una alimentación enteral de al menos 150 ml/kg/día durante tres días consecutivos).
E.5.2Secondary end point(s)
1. Number of days until wean off PN (total cessation)
2. Number of days from randomization to discharge home
3. Incidence and severity of Necrotizing Enterocolitis (NEC)
o Incidence of modified Bell’s stage grade >=2 of Necrotizing Enterocolitis (NEC) in infants born at 26-28 weeks GA.
o Distribution of severity of Necrotizing Enterocolitis (NEC) according to modified Bell’s staging in infants born at 26-28 weeks GA who experienced NEC.
o Incidence of modified Bell’s stage grade >=2 of Necrotizing Enterocolitis (NEC) in the entire study population.
o Distribution of severity of Necrotizing Enterocolitis (NEC) according to modified Bell’s staging in infants who experienced NEC in the entire study population.
4. Percentage of infants reaching full enteral feeding within 6, 8, and 10 days from initiation of treatment.
5. Number of days to 120 ml/kg/day for three consecutive days
6. Number of days until PN wean off (time to amino acids and lipids withdrawal)
7. Percentage of infants weaned off PN within 4, 6, and 8 days from initiation of treatment
8. Percent enteral/ parenteral feedings from total nutrition over time
9. Number of days to discharge from primary hospital.
10. Anthropometrics
11. Number of events of culture proven nosocomial Sepsis
12. Percentage of subjects experiencing one of the adverse events of relevance (NEC, Infections, Death)
13. Retinopathy of prematurity (ROP) activity score (Appendix ) at 30-36 weeks PMA
1.Número de días hasta la suspensión de la NP (interrupción total).
2.Número de días desde la aleatorización hasta el alta.
3.Incidencia y gravedad de la enterocolitis necrosante (ECN).
oIncidencia de enterocolitis necrosante (ECN) en estadio de Bell modificado ≥2 en lactantes nacidos con una EG de 26-28 semanas.
oDistribución de la gravedad de la enterocolitis necrosante (ECN) según la estadificación de Bell modificada en lactantes nacidos con EG de 26-28 semanas que presentaron ECN.
oIncidencia de enterocolitis necrosante (ECN) en estadio de Bell modificado ≥2 en toda la población del estudio.
oDistribución de la gravedad de la enterocolitis necrosante (ECN) según la estadificación de Bell modificada en los lactantes que presentaron ECN en toda la población del estudio.
4.Número y porcentaje de lactantes que alcanzaran la nutrición enteral completa en los 6, 8 y 10 días siguientes al inicio del tratamiento.
5.Número de días hasta 120 ml/kg/día durante tres días consecutivos.
6.Número de días hasta el abandono de la NP (tiempo hasta la retirada de aminoácidos y lípidos).
7.Porcentaje de lactantes que dejaron de recibir NP en los 4, 6 y 8 días siguientes al inicio del tratamiento.
8.Porcentaje de tomas enterales/parenterales respecto a la nutrición total a lo largo del tiempo.
9.Número de días hasta el alta del hospital principal.
10.Antropometría.
11.Número de episodios de sepsis nosocomial confirmada por cultivo.
12.Porcentaje de sujetos que sufrieron uno de los acontecimientos adversos de interés (ECN, infecciones, muerte).
13.Puntuación de actividad de la retinopatía del prematuro (RP) (apéndice ) a las 30-36 semanas de EPM.
E.5.2.1Timepoint(s) of evaluation of this end point
During the study.
Durante el estudio.
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy No
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic No
E.6.7Pharmacodynamic No
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic No
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) No
E.7.3Therapeutic confirmatory (Phase III) Yes
E.7.4Therapeutic use (Phase IV) No
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised Yes
E.8.1.2Open No
E.8.1.3Single blind No
E.8.1.4Double blind Yes
E.8.1.5Parallel group Yes
E.8.1.6Cross over No
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) No
E.8.2.2Placebo Yes
E.8.2.3Other No
E.8.2.4Number of treatment arms in the trial2
E.8.3 The trial involves single site in the Member State concerned No
E.8.4 The trial involves multiple sites in the Member State concerned Yes
E.8.4.1Number of sites anticipated in Member State concerned6
E.8.5The trial involves multiple Member States Yes
E.8.5.1Number of sites anticipated in the EEA20
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA Yes
E.8.6.2Trial being conducted completely outside of the EEA No
E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
Israel
United States
France
Sweden
Netherlands
Spain
Italy
E.8.7Trial 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
LVLS
Última visita del último paciente.
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years3
E.8.9.1In the Member State concerned months0
E.8.9.1In the Member State concerned days0
E.8.9.2In all countries concerned by the trial years3
E.8.9.2In all countries concerned by the trial months0
E.8.9.2In all countries concerned by the trial days0
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 Yes
F.1.1Number of subjects for this age range: 360
F.1.1.1In Utero No
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
F.1.1.2.1Number of subjects for this age range: 360
F.1.1.3Newborns (0-27 days) No
F.1.1.4Infants and toddlers (28 days-23 months) No
F.1.1.5Children (2-11years) No
F.1.1.6Adolescents (12-17 years) No
F.1.2Adults (18-64 years) No
F.1.2.1Number of subjects for this age range: 0
F.1.3Elderly (>=65 years) No
F.1.3.1Number of subjects for this age range: 0
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Yes
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception No
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally Yes
F.3.3.6.1Details of subjects incapable of giving consent
Newborn infants.
Neonatos.
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state60
F.4.2 For a multinational trial
F.4.2.1In the EEA 280
F.4.2.2In the whole clinical trial 360
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)
Follow up period
The infants will return to the clinical site for a follow-up visit at 3 -6 months, 12 months, and 24 months corrected age.
Período de seguimiento
Los niños volverán al centro clínico para una visita de seguimiento a los 3-6 meses, 12 meses y 24 meses de edad corregida.
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2023-01-13
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2022-10-04
P. End of Trial
P.End of Trial StatusOngoing

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