Clinical Trials Register

Summary
EudraCT Number:	2023-000086-14
Sponsor's Protocol Code Number:	IRST100.60
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:	2023-01-23
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

2023-000086-14

A.3

Full title of the trial

Receptor radionuclide therapy with 177Lu-DOTATOC (177Lu-edotreotide or 177Lu-octreotide) in SSTR positive patients: a multicenter, prospective, phase II trial

Terapia radionuclidica recettoriale con 177Lu-DOTATOC (177Lu-edotreotide o 177Lu-octreotide) in pazienti con tumore positivi per i recettori SSTR: uno studio clinico multicentrico, prospettico, di
fase II

A.3.1

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

Therapy with radiopharmaceutical 177Lu-DOTATOC (177Lu-edotreotide or 177Lu-octreotide) in patients with diagnosis of somatostatin receptor positive tumor: a multicenter, prospective phase 2 study

Studio Clinico di fase II finalizzato a valutare l’efficacia della terapia radiorecettoriale con il farmaco Lutezio 177 DOTATOC nei tumori positivi ai recettori della somatostatina

A.3.2

Name or abbreviated title of the trial where available

LUFOR

A.4.1

Sponsor's protocol code number

IRST100.60

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	ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	IRCCS IRST
B.5.2	Functional name of contact point	Centro di Coordinamento
B.5.3	Address:
B.5.3.1	Street Address	Via P. Maroncelli 40
B.5.3.2	Town/ city	Meldola (FC)
B.5.3.3	Post code	47014
B.5.3.4	Country	Italy
B.5.4	Telephone number	0544287167
B.5.6	E-mail	cc.ubsc@irst.emr.it

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	177Lu-edotreotide or 177Lu-octreotide
D.3.2	Product code	[177Lu-DOTATOC_IRSTIRCCS]
D.3.4	Pharmaceutical form	Solution for infusion
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.3.9.2	Current sponsor code	177Lu-DOTATOC_IRSTIRCCS
D.3.9.3	Other descriptive name	177Lu–DOTA-Tyr3-Octreotide
D.3.9.4	EV Substance Code	PRD10011056
D.3.10	Strength
D.3.10.1	Concentration unit	GBq gigabecquerel(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	5.5 to 7.4
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	Yes
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

Patients must have histologically or cytologically confirmation of neuroendocrine tumors or any other tumor histotype documented as sst-positive

I pazienti devono avere conferma istologica o citologica di tumori neuroendocrini o qualsiasi altro istotipo tumorale documentato come sst-positivo

E.1.1.1

Medical condition in easily understood language

Patients must have histologically or cytologically confirmation of neuroendocrine tumors or any other tumor histotype documented as somatostatin receptor positive

I pazienti devono avere conferma istologica o citologica di tumori neuroendocrini o qualsiasi altro istotipo tumorale documentato come positivi al recettore della somatostatina

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	20.0
E.1.2	Level	SOC
E.1.2	Classification code	10029104
E.1.2	Term	Neoplasms benign, malignant and unspecified (incl cysts and polyps)
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

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 main objective of this phase II basket study is to evaluate the efficacy of 177Lu-DOTATOC in five different cohorts of SSTR-positive tumors (Ga-dotatoc positive PET/TC) defined as follow:
1) NETs retreated with PRRT
2) Bronchopulmonary NETs
3) Meningiomas
4) Pheochromocytomas and paragangliomas
5) Other SSTR-positive tumors.

L'obiettivo principale di questo studio basket di fase II è valutare l'efficacia di 177Lu-DOTATOC in cinque diverse coorti di tumori SSTR-positivi (Ga-dotatoc positivi PET/TC) definiti come segue:
1) I NET si sono ritrattati con PRRT
2) NET broncopolmonari
3) Meningiomi
4) Feocromocitomi e paragangliomi
5) Altri tumori SSTR-positivi.

E.2.2

Secondary objectives of the trial

The secondary objectives are the assessment of safety, efficacy in terms of PFS (for cohorts 2,3,4,5) or DCR (for cohort 1) and OS, and evaluation of quality of life (QoL)

Gli obiettivi secondari sono la valutazione della sicurezza, dell'efficacia in termini di PFS (per le coorti 2,3,4,5) o DCR (per la coorte 1) e OS, e la valutazione della qualità della vita (QoL)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Age =18 years.
2) Patients must have histologically or cytologically confirmation of neuroendocrine tumors or any other tumor histology type documented as sst2-positive, that may benefit from receptor radionuclide therapy and for which there aren’t any other effective treatments. For cerebral and PPGLs sst2-positive tumors, if biopsy is no feasible for technical reason or risk benefit balance, patients may be enrolled if CT or MRI strongly suggest oncological lesion confirming the 68Ga PET-CT dota-peptide SSTr2 positivity.
3) Measurable disease according to RECIST 1.1 criteria also patients without measurable but with evaluable disease can be enrolled.
4) Any disease stage is allowed. Patients with documented disease will be admitted to the therapeutic phase only if the diagnostic PET/CT 68Ga-peptide images demonstrate a significant uptake in the tumour.
5) Patients with progressive disease in pre-study period (PD within the last 12 months), refractory to conventional standard treatments; clinical progression is allowed.
6) Patients with or without concurrent therapy with somatostatin analogs.
7) Life expectancy of greater than 6 months.
8) ECOG performance status =2.
9) Adequate haematological, liver and renal function: haemoglobin >= 9 g/dL, absolute neutrophil count (ANC) >= 1.5 x 109 /L, platelets >= 100 x 109 /L, bilirubin =1.5 X UNL (upper normal limit), ALT and AST <2.5 X UNL (< 5 X UNL in presence of liver metastases), creatinine < 2 mg/dL.
10) If female of childbearing potential highly effective birth control methods, according to guideline “Recommendation related to contraception and pregnancy testing in clinical trials”, (2014_09_15 section 4.1) are mandatory (see Appendix F). Highly effective birth control methods are required beginning at the screening visit and continuing until 6 months following last treatment with study drug. Negative serum pregnancy test for females of childbearing potential within 14 days of starting treatment.
11) Male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 6 months after final study drug administration. Two acceptable methods of birth control thus include Condom (barrier method of contraception) and one of the following is required ( established use of oral, or injected or implanted hormonal method of contraception by the female partner; placement of an intrauterine device (IUD) or intrauterine system (IUS) by the female partner; additional barrier method like occlusive cap with spermicidal foam/gel/film/cream/suppository in the female partner; tubal ligation in the female partner; vasectomy or other procedure resulting in infertility (eg, bilateral orchiectomy), for more than 6 months (see Appendix F).
12) Participant is willing and able to give informed consent for participation in the study.

1) Età =18 anni.
2) I pazienti devono avere conferma istologica o citologica di tumori neuroendocrini o di qualsiasi altro tipo istologico di tumore documentato come sst2-positivo, che può beneficiare della terapia con radionuclidi del recettore e per il quale non esistono altri trattamenti efficaci. Per i tumori cerebrali e PPGLs sst2-positivi, se la biopsia non è fattibile per motivi tecnici o rapporto rischio-beneficio, i pazienti possono essere arruolati se la TC o la RM suggeriscono fortemente una lesione oncologica che conferma la positività del 68Ga PET-CT dota-peptide SSTr2.
3) Malattia misurabile secondo i criteri RECIST 1.1 possono essere arruolati anche pazienti senza malattia misurabile ma con malattia valutabile.
4) È consentito qualsiasi stadio della malattia. I pazienti con malattia documentata saranno ammessi alla fase terapeutica solo se le immagini diagnostiche PET/TC del 68Ga-peptide dimostrano un assorbimento significativo nel tumore.
5) Pazienti con malattia progressiva nel periodo pre-studio (PD negli ultimi 12 mesi), refrattari ai trattamenti standard convenzionali; la progressione clinica è consentita.
6) Pazienti con o senza terapia concomitante con analoghi della somatostatina.
7) Aspettativa di vita superiore a 6 mesi.
8) Performance status ECOG =2.
9) Funzionalità ematologica, epatica e renale adeguata: emoglobina >= 9 g/dL, conta assoluta dei neutrofili (ANC) >= 1,5 x 109 /L, piastrine >= 100 x 109 /L, bilirubina =1,5 X UNL (limite normale superiore ), ALT e AST <2,5 X UNL (< 5 X UNL in presenza di metastasi epatiche), creatinina < 2 mg/dL.
10) Se donne in età fertile, sono obbligatori metodi di controllo delle nascite altamente efficaci, secondo la linea guida "Raccomandazione relativa alla contraccezione e al test di gravidanza negli studi clinici" (2014_09_15 sezione 4.1) (vedere Appendice F). Sono richiesti metodi contraccettivi altamente efficaci a partire dalla visita di screening e fino a 6 mesi dopo l'ultimo trattamento con il farmaco in studio. Test di gravidanza su siero negativo per le donne in età fertile entro 14 giorni dall'inizio del trattamento.
11) Il paziente maschio e la sua compagna in età fertile devono utilizzare 2 metodi contraccettivi accettabili (uno dei quali deve includere un preservativo come metodo contraccettivo di barriera) a partire dallo screening e continuando per tutto il periodo di studio e per 6 mesi dopo somministrazione finale del farmaco in studio. Due metodi accettabili di controllo delle nascite includono quindi il preservativo (metodo contraccettivo di barriera) ed è richiesto uno dei seguenti (uso stabilito di un metodo contraccettivo ormonale orale o iniettato o impiantato da parte della partner femminile; posizionamento di un dispositivo intrauterino (IUD) o sistema intrauterino (IUS) da parte della partner femminile; metodo di barriera aggiuntivo come tappo occlusivo con schiuma/gel/pellicola/crema/supposta spermicida nella partner femminile; legatura delle tube nella partner femminile; vasectomia o altra procedura con conseguente infertilità (p. es., bilaterale orchiectomia), per più di 6 mesi (vedi Appendice F).
12) Il partecipante è disposto e in grado di fornire il consenso informato per la partecipazione allo studio.

E.4

Principal exclusion criteria

1) Patients treated with chemotherapy and therapeutic radiotherapy within 4 weeks and treated within 2 weeks with palliative radiotherapy, hormonal or biological therapy.
2) Patients treated with previous PRRT with an absorbed dose to the kidney more than 23 Gy and more than 1.8 Gy for the bone marrow or as surrogate of dosimetry.
3) Patients which are included in the indication of LUTATHERA®
4) All acute toxic effects of any prior therapy (including surgery radiation therapy, chemotherapy) must have resolved to a grade = 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE).
5) ECOG performance status >2.
6) Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
7) Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
8) Assessed bone marrow invasion > 50% (with Bone Marrow biopsy or instrumental exams i.e bone scan or CT or MRI).
9) Pregnant or breastfeeding women are excluded from the present study.

1) Pazienti trattati con chemioterapia e radioterapia terapeutica entro 4 settimane e trattati entro 2 settimane con radioterapia palliativa, terapia ormonale o biologica.
2) Pazienti trattati con precedente PRRT con una dose assorbita al rene superiore a 23 Gy e superiore a 1,8 Gy per il midollo osseo o come surrogato della dosimetria.
3) Pazienti inclusi nell'indicazione di LUTATHERA®
4) Tutti gli effetti tossici acuti di qualsiasi terapia precedente (inclusa la radioterapia chirurgica, la chemioterapia) devono essersi risolti a un grado = 1 secondo i Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE) del National Cancer Institute.
5) Performance status ECOG >2.
6) Partecipazione a un'altra sperimentazione clinica con qualsiasi agente sperimentale entro 30 giorni prima dello screening dello studio.
7) Malattia intercorrente incontrollata inclusa, ma non limitata a, infezione in corso o attiva, insufficienza cardiaca congestizia sintomatica, angina pectoris instabile, aritmia cardiaca o malattia psichiatrica/situazioni sociali che limiterebbero la conformità ai requisiti dello studio.
8) Invasione del midollo osseo valutata > 50% (con biopsia del midollo osseo o esami strumentali, ad esempio scintigrafia ossea o TC o RM).
9) Le donne in gravidanza o in allattamento sono escluse dal presente studio.

E.5 End points

E.5.1

Primary end point(s)

For the cohorts 2,3,4 and 5 the primary endpoint is DCR, defined as the percentage of patients who have achieved complete response, partial response, stable disease (according to RECIST 1.1) at the 1st planned evaluation. For the first cohort a time to event outcome was chosen (PFS), according to a higher level of evidence from literature data.

Valutazione della DCR (tasso di controllo della malattia) per le coorti di tumori SSTR-positive (coorti 2,3,4 e 5), inteso come la percentuale di pazienti che raggiungono la risposta completa, parziale o malattia stabile (secondo i criteri RECIST 1.1) e PFS (progressione libera da malattia) per la coorte 1 di pazienti NET ritrattati con PRRT.

E.5.1.1

Timepoint(s) of evaluation of this end point

2 years since last therapy cycle

2 anni dall'ultimo ciclo di terapia

E.5.2

Secondary end point(s)

Quality of life evaluated through validated standardized data collection forms from the EORTC QLQ-C30 questionnaire.; Safety, evaluated according to version 5.0 CTC-AE, defined as the percentage of patients who experience acute toxicity from the 1st treatment until 30 days after the last treatment cycle or late toxicity that occurred after 30 days from the last treatment administration up to 6 months.; PFS (progression free survival) for cohorts 2, 3, 4 and 5 defined as the time from the start treatment date to the date of first observation of documented disease progression or death due to any cause. Patients without tumor progression at the time of analysis will be censored at their last date of tumor evaluation.; Overall survival defined as the time from the therapy start to the date of death due to any cause or the date of last contact (censored observation) at the date of data cut-off.; DCR (disease control rate) for cohort 1 defined as the percentage of patients who have achieved complete response, partial response, stable disease (according to RECIST 1.1)

Qualità della vita valutata attraverso moduli di raccolta dati standardizzati convalidati attraverso il questionario EORTC QLQ-C30.; Sicurezza, valutata secondo la versione 5.0 CTC-AE, definita come la percentuale di pazienti che manifestano tossicità acuta dal 1° trattamento fino a 30 giorni dopo l'ultimo ciclo di trattamento o tossicità tardiva che si verifica dopo 30 giorni dall'ultima somministrazione del trattamento fino a 6 mesi .; PFS (sopravvivenza libera da progressione) per le coorti 2,3 4, 5 definita come il tempo dalla data di inizio del trattamento alla data della prima osservazione di progressione documentata della malattia o del decesso dovuto a qualsiasi causa. I pazienti senza progressione del tumore al momento dell'analisi saranno censurati alla loro ultima data di valutazione del tumore.; Sopravvivenza globale definita come il tempo dall'inizio della terapia alla data del decesso per qualsiasi causa o la data dell'ultimo contatto (osservazione censurata) alla data di cut-off dei dati.; DCR (tasso di controllo della malattia) per la coorte 1 definita come la percentuale di pazienti che raggiungono risposta completa, risposta parziale o malattia stabile (secondo i criteri RECIST 1.1)

E.5.2.1

Timepoint(s) of evaluation of this end point

5 years and 6 months; Acute toxicity from the 1st treatment until 30 days after the last treatment cycle or late toxicity that occurred after 30 days from the last treatment administration up to 6 months.; 2 years since last therapy cycle; 2 years; 2 years

5 anni e 6 mesi; tossicità acuta dal 1° trattamento fino a 30 giorni dopo l'ultimo ciclo di trattamento o tossicità tardiva che si verifica dopo 30 giorni dall'ultima somministrazione del trattamento fino a 6 mesi .; 2 anni dall'ultimo ciclo di terapia; 2 anni; 2 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

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

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

Studio basket a braccio singolo, in aperto, multicentrico, prospettico che include 5 coorti

This is a single-arm, open-label, multi-center, prospective, basket study that includes 5 cohorts

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

The end of trial will be 12 months after the last data capture (LPLV), i.e. all patients completed/discontinued the study protocol.

La fine dello studio avverrà 12 mesi dopo l'ultima acquisizione dei dati (LPLV), ovvero tutti i pazienti hanno completato/interrotto il protocollo dello studio.

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:

134

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

134

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

F.3.3.1

Women of childbearing potential not using contraception

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

268

F.4.2

For a multinational trial

F.4.2.1

In the EEA

268

F.4.2.2

In the whole clinical trial

268

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)

Patients who discontinue treatment will enter the follow-up phase (clinical, laboratory and instrumental checks will be performed every 4 months until 24 months). Patients who discontinue treatment for an adverse event will be monitored during the follow-up phase and/or through the telephone contacts in which the patient's health status will be assessed.

I pazienti che discontinuano il trattamento saranno seguiti in follow-up (controlli clinici, laboratoristici e strumentali ogni 4 mesi per 24 mesi totali). I pazienti che discontinuano il trattamento per un evento avverso, saranno seguiti in follow up e/o mediante telefonate in cui sarà valutato lo stato di salute del paziente.

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

2023-03-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2023-04-14

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

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