Clinical Trials Register

Summary
EudraCT Number:	2015-000866-72
Sponsor's Protocol Code Number:	015-IRCCS-27F-1
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:	2020-12-18
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

2015-000866-72

A.3

Full title of the trial

Feasibility, efficacy and safety of Pressurized IntraPeritoneal Air-flow Chemotherapy (PIPAC) with Oxaliplatin, Cisplatin and Doxorubicin in patients with peritoneal carcinomatosis from colorectal, ovarian, gastric cancers and primary tumors of the peritoneum: an open-label, two-arm, phase I-II clinical trial. PI-CaP study

Fattibilit¿, efficacia e sicurezza della Chemioterapia IntraPeritoneale a flusso d¿Aria Pressurizzata (PIPAC) in pazienti affetti da carcinosi peritoneale di origine intestinale, ovarica, gastrica e nei tumori primitivi del peritoneo: studio di fase I-II, open-label, a due braccia.

A.3.1

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

Study of efficacy and safety of laparoscopic intra -abdominal chemotherapy performed in patients with peritoneal carcinomatosis from colorectal , ovarian, gastric cancer and primary peritoneal tumors.

Studio di efficacia e sicurezza della chemioterapia intra -addominale effettuata con tecnica laparoscopica in pazienti affetti da carcinosi peritoneale da tumore del colonretto, dell'ovaio, dello stomaco e primitivo del peritoneo.

A.3.2

Name or abbreviated title of the trial where available

PI-CaP study

Studio PI-CaP

A.4.1

Sponsor's protocol code number

015-IRCCS-27F-1

A.5.4

Other Identifiers

Name:

n.a.

Number:

015-IRCCS-27F-1

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 DEL PIEMONTE PER L'ONCOLOGIA 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	Fondazione Piemontese per la Ricerca sul Cancro
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	Fondazione del Piemonte per l'Oncologia
B.5.2	Functional name of contact point	Direzione di Chirurgia Oncologica
B.5.3	Address:
B.5.3.1	Street Address	Strada Provinciale 142 Km 3.95
B.5.3.2	Town/ city	Candiolo (TO)
B.5.3.3	Post code	10060
B.5.3.4	Country	Italy
B.5.4	Telephone number	+39 0119933673
B.5.5	Fax number	+39 0119933440
B.5.6	E-mail	michele.desimone@ircc.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	Yes
D.2.1.1.1	Trade name	CISPLATINO TEVA ITALIA - 1MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO IN VETRO DA 100 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	TEVA 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	cisplatino
D.3.2	Product code	n.a.
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CISPLATINO
D.3.9.1	CAS number	15663-27-1
D.3.9.2	Current sponsor code	n.a.
D.3.9.3	Other descriptive name	cisplatin
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
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.2.1.1.1	Trade name	OXALIPLATINO KABI - 5 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO DI VETRO DA 200 MG/40 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	FRESENIUS KABI ONCOLOGY PLC
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	oxaliplatino
D.3.2	Product code	n.a.
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
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	Yes
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.2.1.1.1	Trade name	DOXORUBICINA TEVA - 2 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO IN VETRO DA 200MG/100 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	TEVA 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	doxorubicina
D.3.2	Product code	n.a.
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DOXORUBICINA CLORIDRATO
D.3.9.1	CAS number	23214-92-8
D.3.9.2	Current sponsor code	n.a.
D.3.9.3	Other descriptive name	doxorubicin
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2
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

patients with peritoneal carcinomatosis from ovarian, gastric and colorectal cancers and in primary cancers of peritoneum.

pazienti affetti da carcinosi peritoneale di origine colorettale, ovarica, gastrica e da tumori primitivi del peritoneo.

E.1.1.1

Medical condition in easily understood language

Presence of disease in the abdomen originated from colon rectum, ovary, stomach and peritoneum.

Presenza di malattia a livello addominale a partenza dal colon retto, dall'ovaio, dallo stomaco e dal peritoneo.

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	PT
E.1.2	Classification code	10028980
E.1.2	Term	Neoplasm
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

Cohort A:
- To evaluate the efficacy of PIPAC according to the Overall Response Rate (ORR) in peritoneal carcinomatosis (CP) from colorectal, ovarian, gastric cancers and primary peritoneal tumors.
Cohort B
- To determine the maximum tolerated dose of oxaliplatin o cisplatin and doxorubicin by PIPAC
- To evaluate safety and tolerability of oxaliplatin o cisplatin and doxorubicin by PIPAC

Coorte A
- Valutare l¿efficacia in termini di Objective Response Rate (ORR) secondo i criteri RECIST (versione 1.1) del trattamento PIPAC con oxaliplatino o cisplatino e doxorubicina (a seconda della patologia) nella carcinosi peritoneale (CP) di origine intestinale, ovarica, gastrica e nei tumori primitivi del peritoneo.

Coorte B
- Determinare la dose massima tollerata e/o raccomandata dei farmaci oxaliplatino o cisplatino e doxorubicina (a seconda della patologia) somministrati per via intraperitoneale sotto forma di flusso d¿aria pressurizzato (PIPAC) in pazienti selezionati affetti da carcinosi peritoneale.
- Valutare la sicurezza e la tollerabilit¿ della somministrazione intraperitoneale di oxaliplatino o cisplatino e doxorubicina (a seconda della patologia) sotto forma di flusso d¿aria pressurizzato (PIPAC) in pazienti affetti da carcinosi peritoneale.

E.2.2

Secondary objectives of the trial

To evaluate the efficacy in terms of overall survival and time to progression and the safety according to the criteria of the CTCAE v. 4.0

Valutare l¿efficacia in termini di sopravvivenza globale e di tempo alla progressione e la sicurezza secondo i criteri del CTCAE v. 4.0

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Clinical and pathological confirmation of peritoneal carcinomatosis from gastric, colorectal and ovarian cancers or primary peritoneal tumors.
- Patients aged between 18 and 78 years.
- Performance status sec. ECOG = 2
- Disease progression/relapse after at least one line of previous i.v. standard chemotherapy in gastric cancer and primary peritoneal tumors and two lines in colorectal and ovarian cancers.
- Patients with peritoneal carcinomatosis from ovarian, gastric and colorectal cancers and primary peritoneal cancers not eligible to cytoreductive surgery +/- HIPEC.
- Blood and electrolyte counts, liver, renal and cardiopulmonary function parameters within 10% of the normal range.
- Written informed consent.
- Tumor mass present on CT-scan in order to allow tumor response assessment with RECIST-criteria.

- Consenso informato firmato prima della procedura
- Esame istologico/citologico diagnostico di tumore solido in stadio avanzato con carcinosi peritoneale documentata a partenza dalle seguenti neoplasie:
• Mesotelioma peritoneale o tumore maligno primitivo del peritoneo
• Tumore dell’ovaio
• Tumore dello stomaco
• Tumore di origine intestinale
- Età compresa tra i 18 e gli 80 anni
- Performance status sec. ECOG = 2
- Funzionalità epatica, renale e cardiaca conservate
• Conta assoluta neutrofili (ANC) = 1,5 x 10^9 / L
• Emoglobina (Hb) = 9 g / dl
• Piastrine (PLT) = 100 x 10^9 / L
• AST/SGOT e/o ALT/SGPT = 2,5 x ULN (limite superiore del range di normalità) o = 5 x ULN se presenti metastasi epatiche
• Bilirubina sierica = 1,5 x ULN
• Creatinina sierica = 1,5 x ULN o CrCl < 50 ml/min
- Recupero totale o a CTCAE Grado = 1 da tutti gli eventi clinici avversi di precedenti chemioterapie, compresi interventi chirurgici e radioterapia, fatta eccezione per l’alopecia

Esclusivamente i pazienti arruolati nella Coorte B devono presentare il seguente criterio di inclusione:

- No chemioterapia/interventi di chirurgia maggiore nelle ultime quattro settimane prima della procedura PIPAC

E.4

Principal exclusion criteria

- Extra-abdominal metastatic disease, with the exception of isolated pleural carcinomatosis.
- Bowel obstruction.
- Chemotherapy or surgery within the last TWO weeks prior to enrollment.
- Severe renal impairment, myelosuppression, severe hepatic impairment, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias.
- Immunocompromised patients such as those with an immunosuppressive medication or a known disease of the immune system.
- Creatinine clearance < 60 ml /min.
- Pregnancy.
- Prior treatment that reached the maximum cumulative dose of doxorubicin, daunorubicin, epirubicin, idarubicin and / or other anthracyclines and anthracenediones.
- Known allergy to cisplatin or other platinum-containing compounds or to doxorubicin.
- Patients of both sexes who do not conduct complete abstinence from heterosexual intercourse or agree to use an effective clinically acceptable method (with failure rate <1%) during the study and during 6 months after the last treatment.

- Malattia metastatica extra addominale, ad eccezione di isolata carcinosi pleurica.
- Occlusione intestinale.
- Storia di reazioni allergiche a Cisplatino/Doxorubicina/Oxaliplatino o a loro derivati.
- Insufficienza renale severa, mielosoppressione, grave insufficienza epatica, grave insufficienza cardiaca, recente infarto miocardico, severa aritmia.
- Pazienti immunodepressi, sottoposti a terapia immunosoppressive o malattie del sistema immunitario
- Clearance della creatinina < 50 ml/min
- Trattamento precedente con raggiungimento della dose cumulativa massima di doxorubicina, daunorubicina, epirubicina, idarubicina e/o altre antracicline ed antracenedioni.
- Gravidanza
- Pazienti di entrambi i sessi che non pratichino la completa astinenza da rapporti eterosessuali o accettino di adottare un metodo contraccettivo clinicamente accettabile (con percentuale di fallimento < 1%) durante lo studio e per i 6 mesi successivi l’ultimo trattamento.
Esclusivamente per i pazienti arruolati nella Coorte B vale il seguente criterio di esclusione:
- Interventi chirurgici maggiori o chemioterapia eseguiti da meno di quattro settimane

E.5 End points

E.5.1

Primary end point(s)

Overall Response Rate (ORR) according to RECIST criteria (version 1.1)

Overall Response Rate (ORR) secondo i criteri RECIST (versione 1.1)

E.5.1.1

Timepoint(s) of evaluation of this end point

week 10 and 17

settimana 10 e 17

E.5.2

Secondary end point(s)

The overall survival (OS); The degree of histological regression assessed by pathological review; - Measurement of clinical tumor response to therapy using FDG- Positron Emission Tomography (PET) according to PERCIST criteria (versione 1.0).; The median time to progression (TTP) according to RECIST criteria (version 1.1) after two or three cycles of PIPAC

Sopravvivenza globale (OS).; Grado di regressione istologica valutato con esame istopatologico; - Valutazione della risposta clinica della malattia con FDG-PET secondo i criteri PERCIST (versione 1.0).; Time To Progression (TTP) secondo i criteri RECIST (versione 1.1)

E.5.2.1

Timepoint(s) of evaluation of this end point

18 months; week 0, 6 and 12; week 11; weeks 10,17 and follow up

18 mesi; settimana 0, 6 e 12; settimana 11; settimana 10, 17 e follow up

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

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

Yes

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 a due braccia parallele

two parallel arms

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

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

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

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:

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

105

F.4.2

For a multinational trial

F.4.2.1

In the EEA

105

F.4.2.2

In the whole clinical trial

105

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 will continue regular follow up with the revaluation of the following diagnostic-therapeutic procedures.

Proseguiranno regolare follow up con rivalutazione del successivo iter diagnostico-terapeutico.

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

2015-09-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-04-21

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

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