Clinical Trials Register

Summary
EudraCT Number:	2020-002613-17
Sponsor's Protocol Code Number:	SONIBEC
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2020-10-22
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

2020-002613-17

A.3

Full title of the trial

A phase II, open-label study improving compliance and time of treatment after obtaining complete response through a tailored schedule of sonidegib in locally advanced basal cell carcinomas (BCC) – the SONIBEC trial

Studio di fase II, in aperto, volto al miglioramento della compliance e del tempo di trattamento in seguito a risposta completa attraverso un programma di trattamento personalizzato con sonidegib in carcinomi localmente avanzati a cellule basali (BCC) – lo studio SONIBEC

A.3.1

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

A.3.2

Name or abbreviated title of the trial where available

SONIBEC

A.4.1

Sponsor's protocol code number

SONIBEC

A.5.4

Other Identifiers

Name:

Number:

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	G.O.N.O. - GRUPPO ONCOLOGICO DEL NORD OVEST
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	Sun Pharmaceutical Industries Europe B.V.
B.4.2	Country	Netherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Clinical Research Technology
B.5.2	Functional name of contact point	CRO
B.5.3	Address:
B.5.3.1	Street Address	via S. Leonardo, trav. Migliaro
B.5.3.2	Town/ city	Salerno
B.5.3.3	Post code	84131
B.5.3.4	Country	Italy
B.5.4	Telephone number	089301545
B.5.5	Fax number	0897724155
B.5.6	E-mail	sonibec@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	odomzo
D.2.1.1.2	Name of the Marketing Authorisation holder	Sun Pharmaceutical Indistries Europe B.V.
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	sonidegib
D.3.2	Product code	[sonidegib]
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	sonidegib
D.3.9.1	CAS number	956697-53-3
D.3.9.2	Current sponsor code	sonidegib
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	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

Adult patients with locally advanced BCC, not amenable to surgical treatment and who obtained a complete response (CR) to Hedgehog inhibitors as defined by RECIST 1.1 and dermoscopic exam regardless of the tumor’s subtype and burden.

Pazienti adulti affetti da BCC localmente avanzato, indipendentemente dal sottotipo e dalla massa tumorale, non suscettibili di chirurgia radicale o con controindicazioni cliniche alla chirurgia, in trattamento con inibitori del pathway Hedgehog e in risposta completa (CR) clinica o radiologica come definito dai criteri RECIST 1.1 e esame visuale e demoscopico.

E.1.1.1

Medical condition in easily understood language

Adult patients with locally advanced BCC, not amenable to surgery, who obtained a complete response to Hedgehog inhibitors regardless of the tumor’s subtype and burden.

Pazienti affetti da BCC localmente avanzato per i quali non è possibile rimuovere le lesioni in modo chirurgico e in risposta completa ad un inibitore del pathway di Hedgehog.

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10064679
E.1.2	Term	Basal cell carcinoma of skin in situ
E.1.2	System Organ Class	100000004864

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 evaluate the compliance to a tailored regimen of sonidegib in patients who have previously obtained CR assuming any inhibitor of the Hedgehog pathway.

Valutare la compliance al regime personalizzato di sonidegib in pazienti che mostrano CR dopo aver assunto un inibitore del pathway di Hedgehog.

E.2.2

Secondary objectives of the trial

1. To assess the compliance with the study treatment.
2. To evaluate the proportion of patients maintaining sonidegib treatment 2 years after achieving CR.
3. To evaluate the proportion of patients who experimented relapse free survival (RFS) after sonidegib interruption for causes other than disease progression.
4. To evaluate the safety of sonidegib tailored regimens (measured by CTCAE v 5.0 scale).
5. To assess the quality of life (ESAS scale).
6. To assess the use of concomitant medication and use of medical resources to manage toxicities caused by the study drug.
7. Dermoscopic Evaluation: to collect the most common characteristics of BCC at baseline and during treatment period.
8. Translational research: to evaluate the changes in molecular pattern of BCC after achieving complete response and in microenvironment in naive and pre-treated BCC.

1. Valutare la compliance al trattamento
2. Valutare la proporzione di pazienti che continuano il trattamento con sonidegib 2 anni dopo aver ottenuto CR.
3. Valutare la proporzione di pazienti in cui si è osservata relapse free survival (RFS) in seguito all’interruzione di sonidegib per cause diverse da progressione di malattia.
4. Valutare la sicurezza del regime mirato di sonidegib (misurato con classificazione CTCAE v 5.0).
5. Valutare la qualità della vita (classificazione ESAS).
6. Valutare l’uso di farmaci concomitanti e risorse mediche per gestire le tossicità causate dal farmaco in studio.
7. Valutazione dermoscopica: raccogliere le caratteristiche più comuni del BCC al baseline e durante il periodo di trattamento.
8. Ricerca traslazionale: valutare i cambi nel pattern molecolare e nel microambiente del BCC in seguito a RC e in BCC naive al trattamento e pre-trattamento.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Written, signed informed consent, including consent to photographs of lesions.
2. Age = 18 years.
3. Histologic confirmation of locally advanced BCC lesion.
4. Patients with BCCs already in treatment with Hedgehog inhibitor for:
• BCC that has recurred in the same location after three or more surgical procedures and/or curative resection is deemed unlikely
• multifocal BCC or extensive tumours with bleeding or infected areas
• anticipated substantial morbidity and/or deformity from surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation)
• multiple BCCs not amenable to surgical treatment because of oncologic or clinical reasons
5. Patient having shown a complete response (CR) to Hedgehog inhibitor within the 3 months prior to the screening. In BCC every effort should be made to obtain histologic confirmation of CR mainly in case of doubt, performing several biopsies in the sites where disease was present. CR must have been confirmed by 2 consecutive radiologic exams and by visual and dermoscopic examinations.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
7. Adequate hematopoietic capacity, defined as the following:
• Haemoglobin > 8.5 g/dl
• Absolute neutrophil count (ANC) = 1000/mmc
• Platelet count = 75,000/mmc
8. Adequate hepatic and renal function, defined as the following:
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3 times the upper limit of normal (ULN), Total bilirubin = 1.5 × ULN or within 3 × ULN for patients with documented Gilbert syndrome
• Calculated serum creatinine clearance (CrCl) = 30 mL/min
9. For women of childbearing potential, a negative pregnancy test within 7 days prior to commencement of dosing is required
10. Women of child-bearing potential must use two methods of acceptable contraception including one highly effective method and a barrier method, as directed by their physician, during treatment and for at least 20 months after completion of study treatment. Highly effective methods of contraception are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (e.g., implants, injectables, combined oral contraception, or intra-uterine devices). Check Appendix B for details.
11. Participant must agree to not breastfeed during the study and for 20 months after the last dose of study treatment.
12. For male patients with female partners of childbearing potential, agreement to use a condom, even after a vasectomy, during sexual intercourse with female partners while being treated with sonidegib, and for 6 months after the last dose was received.
13. Agreement not to donate blood or blood products during the study and for at least 20 months after the last dose was received.
14. For male patients, agreement not to donate sperm during treatment and for 6 months after the last dose was received.

1. Consenso Informato scritto e firmato che includa il consenso a fotografare le lesioni
2. Età = 18
3. Conferma istopatologica che la lesione sia un BBC
4. Pazienti con BCC già in trattamento con un inibitore di Hedgehog per:
• BCC ripresentatosi nella stessa area in seguito a 3 o più interventi chirurgici e/o escissione curativa è ritenuta improbabile.
• BCC multifocale o tumore estensivo con sanguinamento e area infetta.
• Morbilità sostanziale anticipata e/o deformità a causa della chirurgia (es. rimozione di tutta o di parte della struttura facciale come naso, orecchio, palpebra, occhio o amputazione).
• BCC multiple non suscettibile di trattamento chirurgico per motivi clinici o oncologici.
5. Pazienti che hanno mostrato CR in seguito a trattamento con inibitore di Hedgehog. In caso di BCC localmente avanzato dovrebbe essere fatto di tutto per ottenere una conferma istologica di CR se in dubbio, eseguendo diverse biopsie nelle aree dove la malattia era presente. La CR deve essere confermata da 2 esami radiologici consecutivi e da un esame dermoscopico e visivo.
6. Eastern Cooperative Oncology Group (ECOG) performance status da 0 a 2.
7. Capacità ematopoietica adeguata, definite come segue:
• Emoglobina > 8.5 g/dl
• Conta dei neutrofili assoluta (ANC) = 1000/mmc
• Conta piastrinica = 75,000/mmc
8. Funzione epatica e renale adeguata, definita come segue:
• Aspartato amminotrasferasi (AST) e alanina amminotrasferasi (ALT) = 3 il limite superiore del valore normale (ULN), bilirubina totale = 1.5 ILN o entro 3 x ULN per pazienti con Sindrome di Gilbert documentata.
• Clearance calcolata della creatina (CrCl) = 30 mL/min
9. Per donne in età fertile, test di gravidanza negativo entro 7 giorni dall’inizio della terapia.
10. Donne in età fertile devono utilizzare due metodi contraccettivi che includano un metodo molto efficacie e un metodo barriera, come indicato dal medico, durante il trattamento e per almeno 20 mesi dopo il completamento del trattamento. Un metodo contraccettivo molto efficacie risulta in una percentuale bassa di fallimento (meno dell’1% all’anno) quando usato in modo consistente e correttamente (es. impianti, iniettabili, contraccettivi orali combinati o dispositivi intra-uterini).
11. Le partecipanti devono accettare di non allattare durante il trattamento e fino a 20 mesi dopo la somministrazione dell’ultima dose.
12. I pazienti di sesso maschile con partner di sesso femminile e in età fertile devono accettare di utilizzare condom anche in seguito a vasectomia durante il trattamento e fino a 6 mesi dopo aver ricevuto l’ultima dose.
13. I partecipanti devono accettare di non donare sangue e derivanti per almeno 20 mesi dopo aver ricevuto l’ultima dose.
14. I pazienti di sesso maschile devono accettare di non donare liquido seminale durante il trattamento e fino a 6 mesi dopo aver ricevuto l’ultima dose.

E.4

Principal exclusion criteria

1. Metastatic BCC.
2. Inability or unwillingness to swallow capsules.
3. Inability or unwillingness to comply with study procedures.
4. Pregnancy or lactation.
5. Concurrent non–protocol-specified anti-tumour therapy (e.g., chemotherapy, other targeted therapy, radiation therapy, or photodynamic therapy, including participation in an experimental drug study).
6. Uncontrolled medical illness, including advanced malignancies, at the discretion of the Investigator.
7. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or renders the patient at high risk for treatment complications.

1. BBC metastatico.
2. Incapacità/non volontà di ingoiare capsule.
3. Incapacità/non volontà di aderire alle procedure dello studio.
4. In gravidanza o allattamento.
5. In trattamento con altra terapia antitumorale non specifica nel protocollo (es. chemioterapia, altro tipo di terapia target, radioterapia, terapia fotodinamica, terapia sperimentale di altro studio clinico)
6. Condizione medica di malattia non controllata, incluse neoplasie maligne avanzate, a discrezione dello sperimentatore.
7. All’anamnesi assenti malattie, disfunzioni metaboliche, condizioni riscontrate durante le visite e/o gli esami di laboratorio che fanno sospettare che l’uso del prodotto sperimentale sia controindicato o ponga il paziente a rischio elevato di complicazioni.

E.5 End points

E.5.1

Primary end point(s)

Proportion of patients maintaining the tailored treatment with sonidegib 12 months after enrolment into the study.

Proporzione di pazienti che mantengono il trattamento con sonidegib 12 mesi dopo l’arruolamento nello studio.

E.5.1.1

Timepoint(s) of evaluation of this end point

every 28 months

ogni 28 giorni

E.5.2

Secondary end point(s)

1. Compliance with the study treatment (number of sonidegib cps assumed/number of sonidegib cps foreseen during the study period).
2. Proportion of patients maintaining treatment 2 years after achieving CR.
3. Proportion of patients who experimented relapses after sonidegib interruption for causes other than disease progression at 1 year after achieving CR.
4. Proportion of patients who experimented relapse after sonidegib interruption for causes other than disease progression at 2 years after achieving CR.
5. Safety of the tailored sonidegib schedules (schedule 1: 14 days on - 14 days off; schedule 2: 7 days on – 21 days off) measured by CTCAE scale. AEs and SAEs will be described as number of events and percentages, stratified for grade.
6. Quality of life measured by monthly ESAS (Edmonton Symptom Assessment System scales. The QoL scores for each domain and the overall QoL will be described and possible significant predictors of the QoL scores will be analysed using the Chi-square test or the Wilcoxon t test, when appropriate.
7. Use of concomitant medication and use of medical resources to manage toxicities caused by the study drug (e.g., general practitioner’s consultation, other medical visits, etc). Number of drugs and access to medical visits will be registered for descriptive purposes.
8. Dermoscopic Evaluation: Dermoscopic images of the lesion area will be obtained using a videodermatoscope. Changes during treatment period will be described and correlate with drug response.
9. Translational analysis: characteristics of mutation in Hh pathway genes of BCC pre and post-treatment and evaluation of microenvironment in naive and pre-treated BCC.

1. Compliance al trattamento in studio (numero di capsule di sonidegib assunte/numero di capsule di sonidegib attese durante il periodo di studio)
2. Proporzione di pazienti che hanno mantenuto il trattamento due anni dopo aver ottenuto CR.
3. Proporzione di pazienti in cui si è osservata una recidiva dopo l'interruzione di sonidegib per cause diverse dalla progressione della malattia a 1 anno dopo il raggiungimento della CR.
4. Proporzione di pazienti in cui si è osservata la RFS dopo l'interruzione di sonidegib per cause diverse dalla progressione della malattia a 2 anni dopo il raggiungimento della CR.
5. Sicurezza del programma di trattamento mirato di sonidegib (schedule 1: 14 giorni on – 14 giorni off; schedule 2: 7 giorni on – 21 giorni off) valutato attraverso la classificazione CTCAE. AEs e SAEs saranno descritti come numero di eventi e percentuali stratificati per grado.
6. Qualità della vita: misurata mensilmente con classificazione ESAS (Edmonton Quality of Life). I punteggi del QoL verrano descritti per ogni ambito e per la QoL totale, potenziali predittori del punteggio QoL saranno analizzati usando il test del Chi-quadro o Wilcoxon t-test, se appropriato.
7. L’uso di farmaci concomitanti e di risorse mediche per gestire tossicità causate dal farmaco in studio (es. visita presso il medico curante, altro tipo di visita medica ecc.). Numero di farmaci e accesso alle visite mediche saranno registrati a scopo descrittivo.
8. Valutazione dermoscopica: le immagini dermoscopiche dell’area della lesione saranno attenute con un videodermatoscopio. Cambiamenti dell’area durante il periodo di trattamento saranno descritti e correlati alla risposta al trattamento.
9. Analisi traslazionale: caratteristiche delle mutazioni nei geni del pathway di Hh in BCC pre e post trattamento e valutazione del microambiente in BCC ingenuo e pretrattato

E.5.2.1

Timepoint(s) of evaluation of this end point

1. every 28 days
2. every 28 days
3. every 28 days
4. every 28 days
5. continuously
6. every 28 days
7. continuously
8. every 28 days
9. at baseline and a disease progression / end of study due to toxicity

1. ogni 28 giorni
2. ogni 28 giorni
3. ogni 28 giorni
4. ogni 28 giorni
5. continuamente
6. ogni 28 giorni
7. continuamente
8. ogni 28 giorni
9. al baseline e a progressione di malattia / uscita dallo studio per tossicità

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

To evaluate the compliance to a tailored regimen of sonidegib in patients who have previously obtained CR assuming any inhibitor of the Hedgehog pathway.

Valutare la compliance al regime personalizzato di sonidegib in pazienti che mostrano CR dopo aver assunto un inibitore del pathway di Hedgehog.

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

E.8.1.1

Randomised

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

fase II a braccio singolo su sonidegib in pazienti con BCC localmente avanzato e in risposta complet

single arm, phase II study of sonidegib in adult patients with locally advanced BCC, who obtained a

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

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

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

36 months since last patient first visit

36 mesi dalla prima visitda dell'ultimo paziente

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Subject incapable of giving consent for physical reasons or reason linked to their medical condition

Soggetto incapace di dare il consenso per motivi fisici o motivi legati alla loro condizione medica

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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)

At the end of the study patients will be followed as per clinical practice. A phone call follow up will be done every 3 months for 24 months.

Al termine dello studio i pazienti verranno seguiti per la patologia come da pratica clinica. Un follow up telefonico verrà effettuato ogni 3 mesi per 24 mesi.

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

2020-09-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-10-13

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

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Clinical trials