Clinical Trials Register

Summary
EudraCT Number:	2021-006854-29
Sponsor's Protocol Code Number:	CLIgAN
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Trial now transitioned
Date on which this record was first entered in the EudraCT database:	2022-03-24
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2021-006854-29

A.3

Full title of the trial

A multicentre, prospective, open-label, randomized CLinical study to evaluate the effect of personalized therapy on patients with Immunoglobulin A Nephropathy (CLIgAN)

Studio CLinico prospettico, multicentrico, randomizzato, in aperto, per valutare l’effetto della terapia personalizzata nei pazienti con Nefropatia da Immunoglobulina A (CLIgAN)

A.3.1

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

A clinical study to evaluate the effect of personalized therapy on patients with Immunoglobulin A Nephropathy, a kidney disease characterized by the accumulation of a particular type of antibodies in the kidney.

Studio clinico volto a valutare l’effetto della terapia personalizzata nei pazienti con Nefropatia da Immunoglobulina A, malattia renale caratterizzata da accumulo di un particolare tipo di anticorpi nel rene.

A.3.2

Name or abbreviated title of the trial where available

A multicentre, prospective, open-label, randomized clinical study to evaluate the effect of personal

Studio clinico prospettico, multicentrico, randomizzato, in aperto, per valutare l’effetto della ter

A.4.1

Sponsor's protocol code number

CLIgAN

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT04662723

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	Fondazione Schena - Centro Europeo della Ricerca sulle Malattie Renali
B.1.3.4	Country	Italy
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	MUR (Ministero dell’Università e della Ricerca)
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Clinical Research Technology S.r.l.
B.5.2	Functional name of contact point	Clinical Operations
B.5.3	Address:
B.5.3.1	Street Address	Piazza Nicola Amore, 10
B.5.3.2	Town/ city	Napoli
B.5.3.3	Post code	80138
B.5.3.4	Country	Italy
B.5.4	Telephone number	08119572570
B.5.5	Fax number	0897724155
B.5.6	E-mail	cligan@cr-technology.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	Yes
D.2.1.1.1	Trade name	SOLU MEDROL - 1000 MG/16 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE DI POLVERE DA 1000 MG+ 1 FLACONE SOLVENTE DA 16 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER ITALIA S.R.L.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	SOLU MEDROL
D.3.2	Product code	[Metilprednisolone sodio succinato]
D.3.4	Pharmaceutical form	Powder and solvent for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	METILPREDNISOLONE SODIO SUCCINATO
D.3.9.1	CAS number	2921-57-5
D.3.9.2	Current sponsor code	Metilprednisolone
D.3.9.3	Other descriptive name	Methylprednisolone succinate
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	1000
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	Yes
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Dapagliflozin
D.3.2	Product code	[Dapagliflozin]
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	DAPAGLIFLOZIN
D.3.9.2	Current sponsor code	Dapagliflozin
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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: 3
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.2.5	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	Prednisone
D.3.2	Product code	[Prednisone]
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	PREDNISONE
D.3.9.1	CAS number	53-03-2
D.3.9.2	Current sponsor code	Prednisone
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	25
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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

Idiopathic IgA nephropathy (IgAN)

Nefropatia da IgA (IgAN) idiopatica

E.1.1.1

Medical condition in easily understood language

A kidney disease characterized by the accumulation of a particular type of antibodies in the kidney

Malattia renale caratterizzata da accumulo di un particolare tipo di anticorpi nel rene

E.1.1.2

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

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	10021263
E.1.2	Term	IgA nephropathy
E.1.2	System Organ Class	10038359 - Renal and urinary disorders

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	10021263
E.1.2	Term	IgA nephropathy
E.1.2	System Organ Class	10038359 - Renal and urinary disorders

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

• To evaluate the effect of corticosteroids combined with RASBs in IgAN patients with active renal lesions (ACIgAN) versus RASBs alone to determine whether the renal damage is reversed by corticosteroids;
• To evaluate the effect of SGLT2i (Dapagliflozin) combined with RASBs versus RASBs alone in patients with chronic renal lesions (CHRONIgAN) and in patients with moderate renal lesions at high or very high risk of CKD to determine whether a delay of the ESKD onset is achieved.

• Valutare l’effetto dei corticosteroidi associati con RASB rispetto alla terapia con soli RASB, in pazienti IgAN con lesioni renali attive (ACIgAN), per valutare se il paziente ha un effetto benefico con i corticosteroidi.
• Valutare l’effetto dell’inibitore del co-trasportatore renale del sodio-glucosio di tipo 2 (SGLT2i), Dapagliflozina, associato con RASB rispetto alla terapia con soli RASB, in pazienti con lesioni renali croniche (CHRONIgAN) ed in pazienti con lesioni renali moderate con rischio alto o molto alto di malattia renale cronica (CKD), per valutare se si ottiene un ritardo nell’insorgenza della insufficienza renale cronica (ESKD).

E.2.2

Secondary objectives of the trial

• after the prediction of ESKD through our IgAN CDSS tool (DialCheck), to determine whether personalized therapy delays the impairment of the renal function;
• a cutting edge-molecular study will be conducted on a small cohort of enrolled IgAN patients with active or chronic/moderate renal lesions to evaluate the effect of precision therapy (BIO-D).

• Valutare se la terapia personalizzata ritarda il danno renale e monitorare il decorso della malattia, mediante l’utilizzo del tool CDSS (Sistema di supporto alla decisione clinica) DialCheck.
• Sarà condotto uno studio molecolare all’avanguardia su una piccola coorte di pazienti IgAN arruolati con lesioni renali attive o croniche/moderate per valutare l’effetto della terapia di precisione (BIO-D).

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Pharmacogenomics
Version: 1.0
Date: 08/02/2022
Title: Cutting-edge bio-molecular analysis for precision therapy in IgAN (BIO-D)
Objectives: • to integrate transcriptomic results obtained from all three compartments (blood, kidney and urine) in the same patient, at the time of the kidney biopsy and then during the follow-up, to evaluate the benefit of corticosteroids and the benefit of Dapagliflozin combined with RASBs vs RASBs in patients with active renal lesions and in patients with chronic or moderate renal lesions. • to identify specific biomarkers that could be exploited for the identification of novel therapeutic targets and the benefit of personalized therapy.

Farmacogenomica
Versione: 1.0
Data: 08/02/2022
Titolo: Analisi molecolari su campioni biologici per la terapia di precisione in IgAN (BIO-D)
Obiettivi: • integrare i risultati trascrittomici ottenuti da tutti e tre i compartimenti (sangue, rene e urina) nello stesso paziente, al momento della biopsia renale e poi durante il follow-up, per valutare il beneficio dei corticosteroidi e il beneficio di Dapagliflozin in combinazione con RASB vs RASB nei pazienti con lesioni renali attive e in pazienti con lesioni renali croniche o moderate. • identificare biomarcatori specifici che potrebbero essere sfruttati per l'identificazione di nuovi bersagli terapeutici e il beneficio di una terapia personalizzata.

E.3

Principal inclusion criteria

1. Males and females aged 18 to 75 years.
2. Written informed consent form.
3. Biopsy-proven idiopathic IgAN within 2 weeks (for patients with active renal lesions) or 4 weeks (for patients with chronic or moderate renal lesions).
4. Patients with active (E1 and/or C1) or chronic (T1,2) or moderate (M1, S1, E0, T0, C0) renal lesions at high or very high CKD risk.
5. eGFR = 30 ml/min/1.73 m2.
6. 24 hour proteinuria = 0.5 g.
7. Patients on treatment or candidate for the treatment with RASBs (either an ACEi or ARB), as per clinical practice, according to the current KDIGO guidelines.

1. Pazienti adulti con età tra 18 e 75 anni,
2. Consenso informato scritto;
3. Diagnosi di nefropatia idiopatica da IgA (IgAN), effettuata mediante biopsia renale entro 2 settimane (per i pazienti con lesioni renali attive) o entro 4 settimane (per i pazienti con lesioni renali croniche o moderate);
4. Pazienti con lesioni renali attive (E1 e/o C1) o croniche (T1,2) o moderate (M1, S1, E0, T0, C0) con alto o molto alto rischio di malattia renale cronica.
5. eGFR = 30 ml/min/1.73 m2.
6. proteinuria = 0.5 g/24 ore
7. pazienti già in trattamento o candidati al trattamento con RASB (sia inibitori dell’enzima di conversione dell’angiotensina, ACEi, sia antagonisti del recettore dell’angiotensina II, sartani), secondo pratica clinica, in accordo alle attuali linee guida KDIGO.

E.4

Principal exclusion criteria

1. IgAN patients with minimal change disease at kidney biopsy and nephrotic syndrome.
2. IgAN patients with macrohematuria and acute renal failure.
3. IgAN patients with rapidly progressive glomerulonephritis (extracapillary lesions in more than 25 % of glomeruli in the kidney biopsy).
4. Patients with secondary IgAN (lupus nephritis, Schoenlein-Henoch purpura, liver cirrhosis).
5. Superimposed IgAN in a kidney transplant.
6. Patients with myocardial infarction or cerebrovascular stroke in the previous six months.
7. Severe liver diseases, infections, malignancies.
8. Uncontrolled diabetes.
9. Aseptic necrosis of any bone.
10. Any prior immunosuppressive therapy.
11. Other conditions that can be exacerbated by corticosteroids.
12. Previous adverse side effects to RASBs and SGLT2is.
13. Pregnancy and breastfeeding.
14. If women of childbearing potential (WOCBP): patients not available to use highly effective contraceptive measures during the study treatment period and up to one month after the last dose of study drugs.

1. Pazienti IgAN con lesioni renali minime e sindrome nefrosica.
2. Pazienti IgAN con macroematuria ed insufficienza renale acuta.
3. Pazienti IgAN con glomerulonefrite rapidamente progressiva (presenza di lesioni extracapillari in più del 25% dei glomeruli evidenziate alla biopsia renale).
4. Pazienti con IgAN secondaria (nefrite lupica, porpora di Schoenlein-Henoch, cirrosi epatica).
5. Pazienti con IgAN sovrapposta in trapianto renale.
6. Pazienti con infarto del miocardio o ictus cerebrale nei precedenti sei mesi.
7. Malattie epatiche severe, infezioni in atto, neoplasie
8. Diabete scompensato.
9. Necrosi asettica di un qualunque osso.
10. Trattamenti precedenti con una qualsiasi terapia immunosoppressiva.
11. Altre condizioni morbose che possono essere esacerbate dalla terapia corticosteroidea.
12. Precedenti effetti avversi ai RASB e ai SGLT2i.
13. Gravidanza e allattamento.
14. Se donne in età fertile: pazienti non disponibili a utilizzare misure contraccettive altamente efficaci durante il periodo di trattamento di studio e fino a un mese dopo l'ultima dose di farmaci in studio.

E.5 End points

E.5.1

Primary end point(s)

Between-arms difference in proteinuria reduction within 6 months in ACIgAN and within 12 months in CHRONIgAN study.

Differenza tra i bracci, in termini di riduzione della proteinuria, entro 6 mesi nello studio ACIgAN ed entro 12 mesi nello studio CHRONIgAN.

E.5.1.1

Timepoint(s) of evaluation of this end point

6 months in ACIgAN study and 12 months in CHRONIgAN study.

6 mesi nel trial ACIgAN e 12 mesi nel trial CHRONIgAN.

E.5.2

Secondary end point(s)

• eGFR slope calculated as mean of individual slope obtained from individual linear regression of eGFR overtime (3 years);
• eGFR decline > 40 % from the baseline value;
• composite end point: GFR decline > 40%, ESKD (defined as long-term GFR = 15 ml/min/1.73m2 for more than three months or need for maintenance dialysis or kidney transplantation) or death due to kidney disease;
• absolute difference between last GFR value and baseline GFR;
• stable renal function defined as a decline in GFR = 5 ml/min/1.73m2 at the end of three years follow- up;
• mean annual change in the slope of the reciprocal of serum creatinine concentration;
• time-averaged proteinuria (TA-P) calculated as the weighted mean of all post- randomisation measurement, with weights representing the time elapsed since the previous measurement;
• proteinuria slope, calculated as a mean of individual slope, obtained from individual linear regression of daily proteinuria overtime (3 years);
• complete remission of proteinuria defined as achievement of urinary protein level = 0.2 g/day or a urinary protein-to-creatinine ratio = 0.2 g/g;
• partial remission of proteinuria defined as achievement of a urinary protein level = 50% or greater compared with the baseline value.

• Declino dell’eGFR nell’arco di 3 anni, calcolato come media del declino individuale, ottenuto da una analisi di regressione lineare di eGFR;
• Diminuzione dell’eGFR > 40 % dal valore basale;
• Evento composito: diminuzione dell’eGFR > 40%, insufficienza renale terminale (definita come eGFR a lungo termine = 15 ml/min/1.73m2 per più di tre mesi o necessità di iniziare dialisi o trapianto renale) oppure decesso dovuto a malattia renale;
• differenza assoluta tra l’ultimo valore di eGFR e quello basale;
• funzione renale stabile definita come diminuzione dell’eGFR = 5 ml/min/1.73 m2 al termine dei tre anni di follow-up;
• cambiamento annuale medio nella riduzione del reciproco della creatininemia sierica;
• proteinuria media nel tempo (TA-P) calcolata come media ponderata di tutte le proteinurie dosate dopo la randomizzazione e pesate in base all’intervallo di tempo trascorso tra una misurazione e l’altra;
• declino della proteinuria nell’arco di 3 anni, calcolato come media del declino individuale, ottenuto tramite una analisi di regressione lineare della proteinuria giornaliera;
• remissione completa della proteinuria, definita come il raggiungimento di un valore della proteinuria = 0.2 g/24 ore o di un rapporto proteinuria/creatinuria = 0.2 g/g;
• remissione parziale della proteinuria definita come il raggiungimento di un valore della proteinuria = 50% o superiore rispetto al valore basale.

E.5.2.1

Timepoint(s) of evaluation of this end point

3 years

3 anni

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

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

Yes

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

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

Information not present in EudraCT

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

LVLS

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:

380

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

426

F.4.2

For a multinational trial

F.4.2.1

In the EEA

426

F.4.2.2

In the whole clinical trial

426

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)

No specific treatment plans. Subjetcs will be treated according to current clinical practice of each site.

Nessun programma terapeutico specifico. I soggetti saranno trattati in accordo alla pratica clinica del centro sperimentale.

G. Investigator Networks to be involved in the Trial

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2022-09-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-09-08

P. End of Trial
P.	End of Trial Status	Trial now transitioned

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IMP with orphan designation in the indication
Orphan Designation Number:
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