Clinical Trials Register

Summary
EudraCT Number:	2014-003320-51
Sponsor's Protocol Code Number:	2013/24
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-06-17
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

2014-003320-51

A.3

Full title of the trial

A phase 1/2 clinical trial to assess safety and efficacy of a new treatment for Hodgkin lymphoma's disease combining Adcetris¿ and Levact¿ in Old patients

Studio di fase I/II di valutazione della sicurezza e dell¿efficacia di un nuovo trattamento di prima linea del Linfoma di Hodgkin nel paziente anziano che prevede l¿associazione di Adcetris¿ e Levact¿

A.3.1

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

A phase 1/2 clinical trial to assess safety and efficacy of a new treatment for Hodgkin lymphoma's disease combining Adcetris¿ and Levact¿ in Old patients

A.3.2

Name or abbreviated title of the trial where available

HALO

A.4.1

Sponsor's protocol code number

2013/24

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	CENTRE ANTOINE LACASSAGNE
B.1.3.4	Country	France
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	TAKEDA Millenium
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	CENTRE ANTOINE LACASSAGNE
B.5.2	Functional name of contact point	Christine LOVERA
B.5.3	Address:
B.5.3.1	Street Address	33 Avenue de Valombrose
B.5.3.2	Town/ city	Nice
B.5.3.3	Post code	06189
B.5.3.4	Country	France
B.5.4	Telephone number	+33492031618
B.5.5	Fax number	+33492031030
B.5.6	E-mail	christine.lovera@nice.unicancer.fr

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	ADCETRIS - 50 MG - POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) - 1 FLACONCINO
D.2.1.1.2	Name of the Marketing Authorisation holder	TAKEDA GLOBAL RESEARCH AND DEVELOPMENT CENTRE (EUROPE) LTD
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	ADCETRIS
D.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	Powder for 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	NA
D.3.10	Strength
D.3.10.1	Concentration unit	µg/kg microgram(s)/kilogram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1200
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)	Yes
	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	LEVACT - 2.5 MG/ML POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE 5 FLACONCINI IN VETRO DA 25 MG
D.2.1.1.2	Name of the Marketing Authorisation holder	ASTELLAS PHARMA GMBH
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	LEVACT
D.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	Powder for 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	NA
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	90
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

Hodgkin Lymphoma

Linfoma di Hodgkin

E.1.1.1

Medical condition in easily understood language

Hodgkin Lymphoma

Linfoma di Hodgkin

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	10020328
E.1.2	Term	Hodgkin's lymphoma
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

Phase 1:
To evaluate the tolerability and toxicity of Be-BV association.
Phase 2:
To evaluate the efficacy in terms of Response Rate after treatment completion of Be-BV association.

Fase 1:
Valutazione della tollerabilit¿ e della tossicit¿ dell¿associazione BV-Be.
¿Fase 2:
Valutazione dell¿efficacia della associazione Be-BV, in termini di tasso di Remissioni Complete al termine del trattamento

E.2.2

Secondary objectives of the trial

¿ To evaluate the efficacy in terms of:
Progression Free Survival at 3 years
Event Free Survival at 3 years
Overall Survival at 3 years
¿ To evaluate the efficacy in terms of Complete Response Rate after
two Be-BV cycles of Be-BV association
¿ To evaluate the feasibility of the treatment

¿Valutare l¿efficacia in termini di:
¿Sopravvivenza libera da progressione (PFS) a 3 anni
¿Sopravvivenza libera da eventi (EFS) a 3 anni
¿Sopravvivenza globale a 3 anni
¿Valutare l¿efficacia in termini di tasso di risposte complete dopo 2 cicli di trattamento con l¿associazione Be-BV
¿Valutare la fattibilit¿ del trattamento.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Patients with advanced classical Hodgkin Lymphoma according to the World Health Organization classification. All Hasenclever
IPS prognostic groups accepted
2.Stages IIB to IV B
3.Age 60-80 years included
4.Patient not previously treated
5.ECOG = 2
6.Patient with adequate organ function:
•Absolute neutrophil count (ANC) = 1.5 x 109/L
•Haemoglobin = 9 g/dL
•Platelets (PTL) = 100 x 109/L
•AST - ALAT = 2.5x ULN
•Bilirubin = 1.5 x ULN
•Creatinine < 150 µmol/l (or 1.7 mg/dl)
7.Male patients, even if surgically sterilized, (i.e., status post vasectomy) and women of childbearing potential agree to practice
effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to
completely abstain from heterosexual intercourse.
•Contraception as described above is not a requirement if the female patient’s postmenopausal status is documented (has had no
menstrual period for at least 12 consecutive months)
8.Information delivered to patient and voluntary written informed consent must be given before performance of any study-related
procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time
without prejudice to future medical care.
9.Patient affiliated with a health insurance system.

1.Diagnosi di Linfoma di Hodgkin avanzato classico secondo la classificazione WHO. Sono ammessi tutti i gruppi prognostici
secondo classificazione Hasenclever IPS
2.Stadio IIB-IVB
3.Età compresa tra 60 e 80 anni inclusi
4.Paziente non pretrattato.
5.ECOG = 2
6.Paziente con parametri biologici adeguati come di seguito:
• Neutrofili = 1.5 x 109/L
• Emoglobina = 9 g/dl
• Piastrine = 100 x 109/L
• SGOT-SGPT = 2.5x LSN
• Bilirubina = 1.5 x LSN
• Creatinina < 150 µmol/L (o 1.7 mg/dl)
7.I pazienti in età fertile (anche se sterili o vasectomizzati) devono accettare di utilizzare un metodo contraccettivo efficace
(metodi di barriera) durante tutta la durata dello studio e per i sei mesi successivi alla fine del trattamento o di accettare
un’astinenza completa nei rapporti eterosessuali.
•La contraccezione di cui sopra non è richiesta in caso di paziente di sesso femminile in menopausa documentata (assenza di ciclo
mestruale per almeno 12 mesi consecutivi)
8.Avvenuta consegna al paziente del foglio informativo completo e dettagliato sullo studio, ed ottenimento del consenso informato
firmato dal paziente stesso, o da un suo rappresentante legale, prima che venga effettuata qualsiasi procedura correlata allo
studio, consapevoli del fatto che il paziente può ritirare il consenso in qualsiasi momento senza con ciò pregiudicare le cure future.
9.Paziente iscritto al Servizio Sanitario Nazionale

E.4

Principal exclusion criteria

1.Patients aged less than 60 years.
2.Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another
malignancy and have evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are
not excluded if they have undergone complete resection.
3.Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of PML.
4.Symptomatic neurologic disease compromising instrumental activities of daily living or requiring medication.
5.Symptomatic sensory or motor peripheral neuropathy.
6.Concurrent use of other investigational agents. In case of previous participation to a Clinical trial, a period of 30 days will be
observed after the end of the previous Clinical Trial and before the inclusion in HALO study
7.Chemotherapy, biologics, and/or other treatment with immunotherapy not completed at least 4 weeks prior to first dose of study
drug.
8.Patient who had major surgery less than 30 days before start of treatment
9.Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to first study drug
dose.
10.Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of BV.
11.Patient presenting an uncontrolled infectious disease, including active HBV infection defined by either detection of HBs Antigen
or presence of anti HBc antibody without detectable anti HBs antibody or HIV or HCV serology positivity. In case of HBc positive
serology, a PCR could be performed in order to determine viral load. Patients with viral load defined as negative could be
included.
oA prophylactic treatment will be strongly recommended (see HALO Study protocol, paragraph 6.2.3, page 36)
12.Patient with history of poor compliance or current or past psychiatric conditions or severe acute or chronic medical conditions,
or laboratory abnormalities that would interfere, in the judgment of the investigator and/or sponsor, with the ability to comply with
the study protocol.
13.Patients with uncompensated diabetes mellitus and fasting glucose levels over 180 mg/dl.
14.Known history of any of the following cardiovascular conditions
•Myocardial infarction within 2 years of enrollment
•New York Heart Association (NYHA) Class III or IV heart failure (see Appendix 12)
•Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina,
or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
15.Recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction <50%
16.People particularly vulnerable including:
•Person deprived of liberty
•Adult patient entitled to protection of law

1.Età inferiore ai 60 anni.
2.Paziente con diagnosi o trattamento per altra neoplasia nei 3 anni immediatamente precedenti la somministrazione della prima
dose della terapia in studio, o con altra neoplasia diagnosticata in precedenza, trattata senza raggiungimento di una remissione
completa. I pazienti con neoplasia cutanea non melanomatosa o con carcinoma in situ di qualsiasi tipo non sono esclusi se è stata
realizzata un’asportazione chirurgica completa della lesione.
3.Nota malattia cerebrale o meningite, caratterizzate dalla presenza dei segni o dei sintomi compatibili con leuco-encefalopatia
multifocale progressiva (LEMP).
4.Malattia neurologica sintomatica che interferisce con le normali attività della vita quotidiana, o che necessita di trattamento.
5.Polineuropatia motoria o sensitiva sintomatica.
6.Trattamento concomitante con un altro farmaco sperimentale. In caso di partecipazione precedente ad uno studio clinico, dovrà
essere trascorso un periodo di 30 giorni tra la conclusione di tale studio e l’inclusione nello studio HALO.
7.Chemioterapia, terapia con farmaci biologici e/o altro trattamento di immunoterapia non conclusi almeno 4 settimane prima
della prima somministrazione della associazione terapeutica in studio.
8.Paziente reduce da intervento chirurgico esteso, eseguito meno di 30 giorni prima dell’inizio del trattamento.
9.Qualsiasi infezione virale, batterica o fungina con necessità di trattamento antibiotico sistemico nelle 2 settimane precedenti la
prima somministrazione del trattamento sperimentale oggetto dello studio.
10.Ipersensibilità conosciuta alle proteine ricombinanti, murine o agli eccipienti del Brentuximab-Vedotin.
11.Paziente con malattia infettiva non controllata, compresa infezione attiva da HBV definita sia tramite determinazione di
antigene HBs che tramite determinazione di anticorpi anti-HBc in assenza di anticorpi anti-HBs, oppure sierologia positica per HIV o
HCV. In caso di sierologia positiva per HBc, deve essere eseguito il dosaggio della PCR per determinare la carica virale. I pazienti
con carica virale definita come negativa possono essere inclusi .
•è fortemente raccomandato un trattamento profilattico (si veda il protocollo, paragrafo 6.2.3 pagina 37)
12.Pazienti con storia pregressa di scarsa compliance alla terapia o di turbe psichiche (in atto o pregresse) o affetto da problemi
gravi di salute acuti o cronici, o con parametri biologici alterati che potrebbero interferire, a giudizio dello sperimentatore o del
promotore, con la loro capacità di accettare le condizioni del protocollo.
13.Paziente affetto da diabete mellito scompensato, con valori glicemici a digiuno superiori a 180 mg/dl.
14.Storia nota di una qualunque tra le seguenti patologie cardiovascolari:
Infarto miocardico nei 2 anni precedenti l’arruolamento
Insufficienza cardiaca di Classe III o IV secondo la classificazione NYHA (New York Heart Association)
Evidenza di condizioni cardiovascolari non controllate, comprese le aritmie cardiache, insufficienza cardiaca congestizia, infarto, o
evidenza elettrocardiografica di ischemia acuta o anomalie nel sistema di conduzione
15.Evidenza recente (nei 6 mesi precedenti la somministrazione della prima dose della terapia in studio) di LVEF < 50%
16.Soggetti particolarmente vulnerabili come:
•Persone private della libertà personale
•Adulti sotto protezione per legge

E.5 End points

E.5.1

Primary end point(s)

Phase 1:
Evaluation of frequency and grades of toxicity using the NCI CTCAE v4.03 classification
Phase 2:
Response Rate after treatment completion using modified IHP criteria with the five-point scale Deauville criteria as interpretation
Key for end of treatment PET scan.

Fase 1:
Valutazione della frequenza e dei gradi di tossicità secondo la classificazione NCI CTCAE v4.02.
Fase 2:
Percentuale di risposta, alla fine del trattamento, che sarà valutata con esame PET/CT, interpretato secondo i criteri IHP, adattati
alla scala di valutazione visuale a 5 punti di Deauville.

E.5.1.1

Timepoint(s) of evaluation of this end point

2 years and six months

2 anni e sei mesi

E.5.2

Secondary end point(s)

¿Rate at 3 years and median of
Progression Free Survival
¿Rate at 3 years and median of Event Free Survival
¿Rate at 3 years and median of Overall Survival
¿Control disease rate after two Be-BV cycles by using percentage of PET negative after two Be-BV cycles.
¿Prevalence of patient receiving the whole treatment courses (6 cycles)

¿Sopravvivenza libera da progressione, mediana e a 3 anni.
¿Sopravvivenza libera da eventi, mediana e a 3 anni.
¿Percentuale di sopravvivenza globale, mediana e a 3 anni.
¿Percentuale di risposta al trattamento dopo 2 cicli di Be-BV valutata come percentuale di pazienti con interim PET negativa.
¿Prevalenza di pazienti che ricevono il trattamento completo con 6 cicli di Be-BV.

E.5.2.1

Timepoint(s) of evaluation of this end point

3 years

3 anni

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

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)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

Association of medications

Associazione di farmaci

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

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

Yes

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

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

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

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

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)

according to the choice of the Investigator

a giudizio dello Sperimentatore

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

2015-04-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-04-29

P. End of Trial
P.	End of Trial Status	Completed

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Orphan Designation Number:
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