Clinical Trials Register

Summary
EudraCT Number:	2016-001454-18
Sponsor's Protocol Code Number:	UG1617
National Competent Authority:	Denmark - DHMA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2016-07-19
Trial results	View 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

Denmark - DHMA

A.2

EudraCT number

2016-001454-18

A.3

Full title of the trial

T cell therapy for patients with advanced Renal Cell Carcinoma

T celle terapi til patienter med metastisk renalcelle karcinom

A.3.1

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

T Cell based treatment for patients with Renal Cell Carcinoma

Videnskabeligt forsøg med behandling af nyrekræft med spredning med T-celle terapi

A.4.1

Sponsor's protocol code number

UG1617

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	Center for Cancer Immune Therapy
B.1.3.4	Country	Denmark
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	Center for Cancer Immune Therapy
B.4.2	Country	Denmark
B.4.1	Name of organisation providing support	Herlev Hospital
B.4.2	Country	Denmark
B.4.1	Name of organisation providing support	The Danish Cancer Society / Kræftens Bekæmpelse
B.4.2	Country	Denmark
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Center for Cancer Immune Therapy
B.5.2	Functional name of contact point	Center for Cancer Immune Therapy
B.5.3	Address:
B.5.3.1	Street Address	Herlev Ringvej 75
B.5.3.2	Town/ city	Herlev
B.5.3.3	Post code	2730
B.5.3.4	Country	Denmark
B.5.6	E-mail	magnus.pedersen@regionh.dk

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	Tumor infiltrating Lymphocytes
D.3.2	Product code	TIL
D.3.4	Pharmaceutical form	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.3.8	INN - Proposed INN	TIL
D.3.9.3	Other descriptive name	AUTOLOGOUS T-LYMPHOCYTES
D.3.9.4	EV Substance Code	SUB96123
D.3.10	Strength
D.3.10.1	Concentration unit	Other
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	5000000000 to 200000000000
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
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)	Yes
D.3.11.3.1	Somatic cell therapy medicinal product	Yes
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	Sendoxan (cyclophosphamide)
D.2.1.1.2	Name of the Marketing Authorisation holder	Baxter
D.2.1.2	Country which granted the Marketing Authorisation	Denmark
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	Sendoxan
D.3.4	Pharmaceutical form	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.3.8	INN - Proposed INN	CYCLOPHOSPHAMIDE
D.3.9.1	CAS number	50-18-0
D.3.9.4	EV Substance Code	SUB06859MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/kg milligram(s)/kilogram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	60
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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.2.1.1.1	Trade name	Fludara (fludarabin phosphate)
D.2.1.1.2	Name of the Marketing Authorisation holder	Actavis
D.2.1.2	Country which granted the Marketing Authorisation	Denmark
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	Fludara
D.3.4	Pharmaceutical form	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.3.8	INN - Proposed INN	FLUDARABINE PHOSPHATE
D.3.9.1	CAS number	75607-67-9
D.3.9.4	EV Substance Code	SUB13897MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/m2 milligram(s)/square meter
D.3.10.2	Concentration type	up to
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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: 4
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	Proleukin (aldesleukin)
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis
D.2.1.2	Country which granted the Marketing Authorisation	Denmark
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	Proleukin
D.3.4	Pharmaceutical form	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.3.8	INN - Proposed INN	INTERLEUKIN-2
D.3.9.1	CAS number	8000048-25-1
D.3.9.4	EV Substance Code	SUB14225MIG
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	675000000
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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

Advanced Renal Cell Carcinoma

Metastatisk Nyrecancer

E.1.1.1

Medical condition in easily understood language

Renal Cell Carcinoma

Nyrekræft

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	LLT
E.1.2	Classification code	10038409
E.1.2	Term	Renal cell carcinoma NOS
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 toxicity (according to CTCAE version 4.0) and feasibility.

At evaluere bivirkninger (ifølge CTCAE version 4.0) og gennemførlighed.

E.2.2

Secondary objectives of the trial

To evaluate treatment related immune responses
To evaluate clinical response (according to RECIST 1.1 - response rate,
progressionfree survival and overall survival)

At evaluere behandlingsrelateret immunresponser
At evaluere klinisk respons (ifølge RECIST 1.1 - responsrate,
progressionsfri overlevelse og samlet overlevelse)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Histological proven mRCC with the possibility of surgical removal of tumor tissue of > 1 cm3. Histology must include a clear cell component with or without a sarcomatoid dedifferentiation.
2. Metastatic disease irrespective of number of previous treatment lines. Treatment naïve pt’s can be included.
3. Age: 18 – 70 years.
4. ECOG performance status of ≤1.
5. IMDC prognostic group ‘Favorable’ or ‘Intermediary’
6. Life expectancy of > 6 months.
7. At least one measurable parameter after surgery in accordance with RECIST 1.1 –criteria’s.
8. No significant toxicities or side effects (CTC ≤ 1) from previous treatments.
9. Normal ejection fraction (EF) measured by a multigated acquisition (MUGA) scan.
10. Crom EDTA clearance >40 ml/min
11. Sufficient organ function.
12. LDH ≤ 5 times upper normal limit as a measure of tumor burden
13. Women in the fertile age must use effective contraception. Likewise, men included in the study, as well as their partners, must use effective contraception. This applies from inclusion and until 6 months after treatment. Birth control pills, spiral, depot injection with gestagen, subdermal implantation, hormonal vaginal ring and transdermal depot patch are all considered safe contraceptives.
14. Signed statement of consent after receiving oral and written study information. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research
15. Willingness to participate in the planned controls.

1. Histologisk verificeret metastatisk RCC med mulighed for kirurgisk fjernelse af tumorvæv på > 1 cm3. Histologien skal indeholde en clear celle komponent med eller uden sarkomatoid dedifferentiering.
2. Metastatisk sygdom uanset antallet af tidligere behandlinger. Behandlingsnaive patienter kan inkluderes.
3. Alder 18-70 år.
4. ECOG performance status < 1.
5. IMDC prognostisk gruppe 'Favorabel' eller 'Intermediær'.
6. Forventet levetid > 6 måneder.
7. Mindst et målbart parameter efter kirurgi i henhold til RECIST 1.1 kriterierne.
8. Ingen signifikant toxicitet eller bivirkninger (CTC ≤ 1) fra tidligere behandlinger.
9. Normal uddrivelsesfraktion (EF) målt ved MUGA
10. Crom EDTA clearance >40 ml/min
11. Sufficient organ funktion.
12. LDH ≤ 5 gange over øvre normalgrænse som mål for tumorbyrde.
13. Kvinder i den fertile alder skal benytte sikker antikonception. Det samme skal mænd og deres partnere. Dette gælder fra inklusion til 6 måneder efter behandlingen.
14. Underskrevet samtykke efter mundtlig og skriftlig forsøgsinformation.
15. Patienten skal være villig til at deltage i de planlagte kontroller og i stand til at håndtere toxicitet.

E.4

Principal exclusion criteria

1. A history of prior malignancies, exept curatively treated non-melanoma skin cancer and CIS of the cervix uteri. Patients treated for another malignancy can participate if they are without signs of disease for a minimum of 3 years after treatment.
2. Patients with cerebral metastases.
3. Patients with widespread bone or bone only metastases.
4. Known hypersensitivity to one of the active drugs or one or more of the excipients.
5. Severe medical conditions, such as severe asthma/COLD, ischemic hearth disease/significant cardiac disease (e.g. NYHA class ≥2), poorly regulated insulin dependent diabetes mellitus among others, which can interfere with patient compliance and/or significantly increase the risk of side effects upon investigators clinical judgement.
6. Acutte/chronic infection with HIV, hepatitis, tuberculosis among others.
7. Severe allergies or previous anaphylactic reactions.
8. Active autoimmune disease, such as autoimmune neutropenia/thrombocytopenia or hemolytic anemia, systemic lupus erythematosis, Sjögren’s syndrome, sclerodermia, myasthenia gravis, Goodpasteur’s disease, Addison’s disease, Hashimotos thyroiditis, active Graves disease.
9. Pregnant women and women breastfeeding.
10. Simultaneous treatment with systemic immunosuppressive drugs (including prednisolone, methotrexate among others).
11. Simultaneous treatment with other experimental drugs.
12. Simultaneous treatment with other systemic anti-cancer treatments.
13. Patients with active and uncontrollable hypercalcaemia.

1. Tidligere cancer undtagen kurativt behandlet ikke-melanom hudkræft og CIS i cervix uteri.
2. Patienter med cerebrale metastaser.
3. Patienter med udbredte knoglemetastaser eller kun knoglemetastaser.
4. Kendt hypersensitivitet til et af de aktive stoffer eller en/flere af hjælpestofferne.
5. Alvorlig komorbiditet, som eksempelvis svær astma/KOLD, iskæmisk hjertesygdom/signifikant hjertesygdom, dårligt reguleret insulin-afhængig sukkersyge, som kan påvirke patient compliance og/eller signifikant øge risikoen for bivirkninger efter investigators kliniske vurdering.
6. Akut/kronisk infektion med HIV, hepatitis, tuberkulose blandt andre.
7. Alvorlige allergier eller tidligere anafylaktiske reaktioner.
8. Aktiv autoimmun sygdom, eksempelvis autoimmun neutropeni/trombocytopeni eller hæmolytisk anæmi, lupus erythematosis, sjögrens syndrom, sclerodermi, myasthenia gravis, Goodpasteur’s sygdom, Addison’s sygdom, Hashimotos thyroiditis, aktiv Graves sygdom.
9. Gravide kvinder og kvinder der ammer.
10. Samtidig behandling med systemiske immunsupprimerende stoffer
(herunder prednisolon, methotrexat blandt andre).
11. Samtidig behandling med andre eksperimentelle stoffer.
12. Samtidig behandling med andre systemiske anti-cancer
behandlinger.
13. Patienter med aktiv og ukontrollerbar hypercalcæmi.

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is toxicity (according to CTCAE 4.0).

Det primære endepunkt er bivirkninger (ifølge CTCAE 4.0).

E.5.1.1

Timepoint(s) of evaluation of this end point

The primary endpoint will be evaluated before treatment, during
treatment and at follow-up visits untill 6 months after treatment.

Det primære endepunkt vil blive evalueret før behandling, under
behandling og ved opfølgende besøg op til 6 måneder efter behandling.

E.5.2

Secondary end point(s)

Secondary endpoints are treatment related immune response and clinical response (according to RECIST 1.1 - response rate, progressionfree
survival and overall survival).

Sekundære endepunkter er behandlingsrelateret immunrespons og
klinisk respons (ifølge RECIST 1.1 - responsrate, progressionsfri
overlevelse og samlet overlevelse).

E.5.2.1

Timepoint(s) of evaluation of this end point

The secondary endpoints will be evaluated after all patients have
received treatment and clinical response is evaluated. Estimated 1 year
after treatment of last patient.

De sekundære endepunkter vil blive evalueret efter at alle patienter har
modtaget behandling og klinisk respons er vurderet. Estimeret 1 år efter
sidste patients behandling.

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

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

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.8.3

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.8.5

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

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

Sidste patients sidste besøg

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

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

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)

That depends on the condition of the patient at the time.

Det afhænger af patientens tilstand på det givne tidspunkt.

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

2016-10-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-09-05

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-10-31

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