Clinical Trials Register

Summary
EudraCT Number:	2015-004068-13
Sponsor's Protocol Code Number:	HALO-109-301
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2021-02-10
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2015-004068-13

A.3

Full title of the trial

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination With nab-Paclitaxel Plus Gemcitabine Compared With Placebo
Plus nab-Paclitaxel and Gemcitabine in Subjects with Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma

Studio multicentrico di fase 3, randomizzato, in doppio cieco, controllato con placebo sulla terapia con ialuronidasi umana ricombinante PEGilata (PEGPH20) in associazione a nab-paclitaxel più gemcitabina rispetto a placebo più nab-paclitaxel e gemcitabina in soggetti con adenocarcinoma duttale pancreatico in stadio IV con alta espressione di acido ialuronico non precedentemente trattato

A.3.1

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

Study investigating PEGylated Recombinant Human Hyaluronidase (PEGPH20) in previously untreated patients with pancreatic cancer that have high levels of hyaluronan. The study has two groups: all patients will be treated with nab-Paclitaxel plus Gemcitabine. In addition, one group will receive PEGPH20 and the other group will receive an inactive substance. Neither the patient nor the doctor will know the treatment group in which the patient has been randomly assigned to.

Studio che valuta ialuronidasi umana ricombinante PEGilata (PEGPH20) in pazienti con tumore pancreatico non precedentemente trattati che mostrano alti livelli di acido ialuronico. Lo studio ha due gruppi: tutti i pazienti saranno trattati con nab-Paclitaxel più Gemcitabina. In aggiunta, un gruppo riceverà PEGPH20 e l’altro gruppo riceverà una sostanza inattiva. Né il paziente né il medico conoscerà il gruppo di trattamento in cui il paziente è stato assegnato in modo randomico.

A.3.2

Name or abbreviated title of the trial where available

nap

A.4.1

Sponsor's protocol code number

HALO-109-301

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02715804

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	HALOZYME, INC.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Halozyme, Inc.
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	Halozyme Inc.
B.5.2	Functional name of contact point	Halozyme Study Information
B.5.3	Address:
B.5.3.1	Street Address	11388 Sorrento Valley Road
B.5.3.2	Town/ city	San Diego
B.5.3.3	Post code	92121
B.5.3.4	Country	United States
B.5.4	Telephone number	0018448554256
B.5.5	Fax number	0018449880800
B.5.6	E-mail	medinfo@halozyme.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	EU/3/14/1394
D.3 Description of the IMP
D.3.1	Product name	ialuronidasi umana ricombinante PEGilata
D.3.2	Product code	[PEGPH20]
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	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	pegvorhyaluronidase alfa
D.3.9.1	CAS number	1620390-06-8
D.3.9.2	Current sponsor code	PEGPH20
D.3.9.4	EV Substance Code	SUB33062
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	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	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	Yes
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	ABRAXANE
D.2.1.1.2	Name of the Marketing Authorisation holder	Celgene Europe Limited
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	nap
D.3.2	Product code	[nap]
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.3.8	INN - Proposed INN	PACLITAXEL ALBUMINA
D.3.9.1	CAS number	33069-62-4
D.3.9.2	Current sponsor code	nap
D.3.9.4	EV Substance Code	SUB09583MIG
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	5
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: 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	Gemcitabina 38 mg/ml Concentrato per Soluzione per Infusione
D.2.1.1.2	Name of the Marketing Authorisation holder	Hospira UK Ltd
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	nap
D.3.2	Product code	[nap]
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	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	GEMCITABINA CLORIDRATO
D.3.9.1	CAS number	122111-03-9
D.3.9.2	Current sponsor code	nap
D.3.9.4	EV Substance Code	SUB02324MIG
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	38
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma

Adenocarcinoma duttale pancreatico in stadio IV con alta espressione di acido ialuronico non precedentemente trattato

E.1.1.1

Medical condition in easily understood language

Previously Untreated Pancreatic Cancer with High Levels of Hyaluronan

Tumore pancreatico con alta espressione di acido ialuronico non precedentemente trattato

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	10007050
E.1.2	Term	Cancer
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

To determine the OS benefit of PEGPH20 combined with NAB plus GEM (PAG treatment), compared with placebo plus NAB/GEM (AG treatment), in subjects with HA-high Stage IV previously untreated PDA.

Determinare il beneficio in termini di sopravvivenza generale (OS) del trattamento con PEGPH20 combinata con NAB + GEM (trattamento PAG) vs. AG in soggetti con placebo + NAB/GEM (trattamento AG) in stadio IV con alta espressione di HA non recedentemente trattato.

E.2.2

Secondary objectives of the trial

• To determine the PFS benefit of PAG treatment, compared with AG treatment, in subjects with HA-high Stage IV previously untreated PDA
• To determine the objective response rate (ORR) and duration of response (DOR) of PAG treatment, compared with AG treatment, in subjects with HA-high Stage IV previously untreated PDA
• To assess the safety and tolerability of PAG treatment in subjects with HA-high Stage IV previously untreated PDA

• Determinare il beneficio PFS del trattamento con PAG, confrontato con il trattamento con AG, in soggetti con PDA in stadio IV ad alto livello precedentemente non trattati
• Determinare il tasso di risposta obiettiva (ORR) e la durata della risposta (DOR) del trattamento PAG vs. AG in soggetti con PDA in stadio IV con alta espressione di HA non precedentemente trattato
• Valutare la sicurezza e la tollerabilità del trattamento PAG in soggetti con PDA in stadio IV con alta espressione di HA non precedentemente trattato

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Signed, written Institutional Review Board/Ethics Committee approved Informed Consent Form (ICF).
2. Stage IV pancreatic ductal adenocarcinoma (PDA) with histological confirmation of PDA via archived or fresh core biopsy of either the primary tumor or 1 metastatic in minimum of 5-10 unstained core biopsy slides that meet specific tissue sample requirements are required.
3. Subjects must be determined to be HA-high based on tumor biopsy that meets the requirements noted in inclusion criteria #2.
4. At least 1 tumor metastasis measurable on computed tomography (CT) scan or MRI per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, excluding the primary pancreatic lesion.
5. If a subject has had adjuvant/neoadjuvant therapyand/or therapy for locally advanced disease chemotherapy for non-metastatic pancreatic cancer in combination with or without radiation therapy), tumor recurrence or disease progression must have occurred no sooner than 6 months after completing the last dose of the aforementioned therapies, provided all toxicities have returned to baseline or = Grade 1.
6. Eastern Cooperative Oncology Group Performance Status of 0 or 1.

1. Firma del modulo di consenso informato scritto approvato dal Comitato di revisione istituzionale/Comitato etico
2. È richiesta una diagnosi di adenocarcinoma duttale pancreatico (PDA) in stadio IV con conferma istologica tramite biopsia conservata o fresca del tumore primario o di 1 sito metastatico con minimo 5-10 biopsie non marcate che soddisfino specifici requisiti di campionamento di tessuto
3. I soggetti devono presentare un’ alta espressione di HA sulla base della biopsia tumorale che soddisfa i requisiti indicati al criterio di inclusione #2
4. Almeno 1 tumore in metastasi misurabile con tomografia computerizzata (CT) o MRI secondo i criteri di valutazione della risposta nei tumori solidi (RECIST) versione 1.1, escludendo la lesione pancreatica primaria.
5. Se un soggetto è stato sottoposto a terapia adiuvante/neoadiuvante e/o a terapia per la malattia localmente avanzata (chemioterapia per il carcinoma pancreatico non metastatico con o senza radioterapia), la recidiva del tumore o la regressione della malattia deve essersi manifestata non prima di 6 mesi dall’ultima dose delle sopra
citate terapie, posto che tutte le tossicità devono essere tornate ai valori basali o a un grado =1.
6. Eastern Cooperative Oncology Group Performance Status pari a 0 o 1.

E.4

Principal exclusion criteria

1. Clinical evidence of DVT, PE or other known TE event present during the screening period.
2. Previous radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of metastatic disease.
a. Palliative radiotherapy for pain control of metastatic bone lesions is allowed.
3. Known central nervous system involvement or brain metastases.
4. New York Heart Association Class III or IV cardiac disease or myocardial infarction within the past 12 months.
5. History of cerebrovascular accident or transient ischemic attack.
6. Clinically significant pre-existing carotid artery disease.

1. Evidenze cliniche di trombosi venosa profonda (TVP), embolia polmonare (EP) o altro evento TE noto presente durante il periodo di screening
2. Precedente radioterapia, chirurgia, chemioterapia o terapia sperimentale per il trattamento della malattia metastatica
a. È consentita la radioterapia palliativa per il controllo del dolore provocato dalle lesioni ossee metastatiche
3. Interessamento noto del sistema nervoso centrale o metastasi cerebrali note 4. Presenza di malattia cardiaca o infarto del miocardio di classe III o IV secondo la classificazione NYHA (New York Heart Association) nei 12 mesi precedenti
5. Storia di accidente cerebrovascolare o attacco ischemico transitorio
6. Arteriopatia carotidea preesistente clinicamente significativa.

E.5 End points

E.5.1

Primary end point(s)

• Overall survival

• Sopravvivenza generale

E.5.1.1

Timepoint(s) of evaluation of this end point

Refer to protocol for information.

Si prega di fare riferimento al protocollo per ulteriori informazioni.

E.5.2

Secondary end point(s)

Progression-free survival
• Objective response rate
• Duration of response
• Incidence of AEs, changes in clinical safety laboratory values, and changes in cardiovascular parameters (electrocardiogram [ECG] and vital signs)

• Sopravvivenza libera da progressione;
• Tasso di risposta obiettiva;
• Durata della risposta;
• Incidenza di eventi avversi (AE), variazioni nei parametri clinici di laboratorio di sicurezza e nei parametri cardiovascolari (ECG e segni vitali)

E.5.2.1

Timepoint(s) of evaluation of this end point

Refer to protocol for information

Si prega di fare riferimento al protocollo per tutte le informazioni

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

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

Yes

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

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

Yes

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

103

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Australia

Brazil

Canada

China

Israel

Korea, Republic of

Mexico

Taiwan

United States

Belgium

Croatia

Denmark

Estonia

France

Germany

Hungary

Italy

Latvia

Lithuania

Netherlands

Poland

Spain

United Kingdom

Czechia

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

The end of the study is defined by the time of the last subject last visit (final data point collection).

La fine dello studio è definita dal momento dell'ultima visita dell'ultimo soggetto (raccolta dati finale).

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:

253

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

247

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.4.2

For a multinational trial

F.4.2.1

In the EEA

224

F.4.2.2

In the whole clinical trial

500

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)

Within 7 days of trial discontinuation, the subject will undergo End of Treatment evaluations and proceed to the long-term follow-up phase which does not require a clinical visit. Enoxaparin treatment will also be stopped at the time of trial discontinuation. The investigator will ensure that consideration has been given to the post-trial medical care of the trial subject's medical condition.

Entro 7 giorni dall'interruzione dello studio, il soggetto sarà sottoposto agli esami di fine trattamento e procederà con la fase di follow-up a lungo termine che non richiede ulteriori visite cliniche. il trattamento con Enoxaparina sarà interrotto al momento dell'interruzione dello studio. Lo sperimentatore è responsabile di assicurare che vengano fatte adeguate considerazioni per le cure successive allo studio in base alla condizione medica del soggetto

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

2016-02-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-04-05

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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