Clinical Trials Register

Summary
EudraCT Number:	2011-005399-40
Sponsor's Protocol Code Number:	20110233
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:	2013-04-23
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

2011-005399-40

A.3

Full title of the trial

A two part, Phase 2/3 Study to Assess the Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia
Part A - Open-label, Single-arm, Multicenter Pilot Study to Evaluate Safety, Tolerability, and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia
Part B - Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia

Studio di fase 2/3 in 2 parti per valutare sicurezza, tollerabilità ed efficacia di AMG 145 in soggetti con ipercolesterolemia familiare omozigote. Parte A – Studio pilota multicentrico in aperto, a braccio singolo, per valutare sicurezza, tollerabilità ed efficacia di AMG 145 nei soggetti con ipercolesterolemia familiare omozigote. Parte B – Studio multicentrico in doppio cieco, randomizzato, controllato verso placebo, per valutare sicurezza, tollerabilità ed efficacia di AMG 145 in soggetti con ipercolesterolemia familiare omozigote

A.3.1

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

A clinical study to assess the safety, tolerability and efficacy of AMG 145 in subjects with homozygous familial hypercholesterolemia

Studio Clinico per valutare la sicurezza, la tollerabilità e l’efficacia di AMG 145 in soggetti con ipercolesterolemia familiare omozigote

A.4.1

Sponsor's protocol code number

20110233

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Amgen 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	Amgen 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	Amgen (EUROPE) GmbH
B.5.2	Functional name of contact point	IHQ Medical Info - Clinical Trials
B.5.3	Address:
B.5.3.1	Street Address	Dammstrasse 23, P.O. Box 1557
B.5.3.2	Town/ city	Zug
B.5.3.3	Post code	(CH-)6300
B.5.3.4	Country	Switzerland
B.5.4	Telephone number	N/A
B.5.5	Fax number	N/A
B.5.6	E-mail	MedinfoInternational@amgen.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	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	AMG 145
D.3.2	Product code	AMG 145
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NA
D.3.9.1	CAS number	NA
D.3.9.2	Current sponsor code	AMG 145
D.3.9.3	Other descriptive name	AMG 145
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	70
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	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.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 injection
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Homozygous familial hypercholesterolaemia

Ipercolesterolemia familiare monozigote

E.1.1.1

Medical condition in easily understood language

Hypercholesterolemia (high cholesterol), familial

Ipercolesterolemia (elevato livello di colesterolo) familiare

E.1.1.2

Therapeutic area

Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10057100
E.1.2	Term	Homozygous familial hypercholesterolaemia
E.1.2	System Organ Class	100000004850

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

Part A: To characterize the effect of 12 weeks of subcutaneous (SC) AMG 145 on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in subjects with homozygous familial hypercholesterolemia (HoFH)
Part B: To evaluate the effect of 12 weeks of subcutaneous (SC) AMG 145 compared with placebo on percent change from baseline in LDL-C in subjects with HoFH

Parte A: Valutare l’effetto di 12 settimane di trattamento con AMG 145 per via sottocutanea (SC) sulla variazione percentuale rispetto al basale del colesterolo LDL (lipoproteina a bassa densità, LDL-C) in soggetti con ipercolesterolemia familiare omozigote
Parte B: Valutare l’effetto di 12 settimane di trattamento con AMG 145 per via sottocutanea (SC) rispetto al placebo sulla variazione percentuale rispetto al basale dell’LDL-C in soggetti con ipercolesterolemia familiare omozigote

E.2.2

Secondary objectives of the trial

Part A:
- To evaluate the safety and tolerability of AMG 145 SC in subjects with HoFH
- To assess the effects of 12 weeks of AMG 145 SC on absolute change in LDL-C, and percent change in non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B
(ApoB), total cholesterol/HDL-C ratio, and ApoB/Apolipoprotein A-1 (ApoA1) ratio in subjects with HoFH
Part B:
-To evaluate the safety and tolerability of AMG 145 SC compared with placebo in subjects with HoFH
- To assess the effects of 12 weeks of AMG 145 SC, compared with placebo, on absolute change in LDL-C, and percent change in non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), total cholesterol/HDL-C ratio, and ApoB/Apolipoprotein A-1 (ApoA1) ratio in subjects with HoFH

Parte A:Valutare sicurezza e tollerabilità di AMG 145 per via SC in soggetti con ipercolesterolemia familiare omozigote
Valutare gli effetti di 12 settimane di AMG 145 per via SC sulla variazione assoluta di LDL-C e sulla variazione percentuale delle lipoproteine non ad alta densità (non-HDL-C), dell’apolipoproteina B (ApoB), del rapporto colesterolo totale/HDL-C e del rapporto ApoB/Apolipoproteina A-1 (ApoA1) in soggetti con ipercolesterolemia familiare omozigote
Parte B:Valutare sicurezza e tollerabilità di AMG 145 per via SC rispetto al placebo in soggetti con ipercolesterolemia familiare omozigote, valutare gli effetti di 12 settimane di trattamento con AMG 145 per via SC, rispetto al placebo, sulla variazione assoluta di LDL-C e sulla variazione percentuale delle lipoproteine non ad alta densità (non-HDL-C), dell’apolipoproteina B (ApoB), del rapporto colesterolo totale/HDL-C e del rapporto ApoB/Apolipoproteina A-1 (ApoA1) in soggetti con ipercolesterolemia familiare omozigote

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Pharmacogenetic sub-study.
This sub-study will investigate potential correlations of study data including the subject response to AMG 145 with genetic variation in markers of proprotein convertase subtilisin/kexin type 9 (PCSK9) signaling, low-density lipoprotein receptor (LDLR) turnover, cholesterol metabolism, inflammation, and plaque stability.

Sottostudio di farmacogenetica
Questo sottostudio valuterà le potenziali correlazioni dei dati dello studio inclusa la risposta dei soggetti a AMG 145 con una variazione genetica dei markers della PCSK9, del turnover del recettore LDL, del metabolismo del colesterolo, dell’infiammazione e della stabilità della placca

E.3

Principal inclusion criteria

• Subject has provided informed consent.
• Male or female ≥ 12 to ≤ 65 years of age
• Diagnosis of homozygous familial hypercholesterolemia by genetic confirmation or a clinical diagnosis based on a history of an untreated LDL cholesterol concentration greater than 500 mg/dl (13 mmol/L) together with either xanthoma before 10 years of age or evidence of heterozygous familial hypercholesterolemia in both parents.
• On a stable on a low-fat diet and taking pre-existing lipid-lowering therapies (such as statins, cholesterol-absorption inhibitors, bile-acid sequestrants or nicotinic acid, or combinations thereof) for at least 4 weeks, with fasting central lab LDL cholesterol concentration > 130 (3.4 mmol/L)
• Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L) by central laboratory at screening
• Bodyweight of 40 kg or greater at screening

Soggetto che abbia fornito il consenso informato
Soggetti di entrambi i sessi, di età compresa tra ≥ 12 e ≤ 65 anni con diagnosi di ipercolesterolemia familiare omozigote confermata geneticamente o diagnosticata clinicamente in base a un’anamnesi di concentrazione di colesterolo LDL non trattato superiore a 500 mg/dL (13 mmol/L) associata a xantoma prima dei 10 anni di età o evidenza di ipercolesterolemia familiare eterozigote in entrambi i genitori.
Per l’arruolamento i soggetti devono essere da almeno 4 settimane in una situazione di stabilità con una dieta ipolipidica e una terapia ipolipemizzante preesistenti (con statine, inibitori dell’assorbimento del colesterolo, sequestranti degli acidi biliari, acido nicotinico o con combinazioni dei farmaci citati). Al momento dello screening devono inoltre presentare concentrazioni determinate dal laboratorio centrale di colesterolo LDL a digiuno >130 mg/dL (3,4 mmol/L), di trigliceridi < 400 mg/dL (4,5 mmol/L), e un peso pari o superiore a 40 kg. Durante lo studio i pazienti non dovranno modificare la terapia ipolipemizzante di base. Per via della difficoltà di mantenere concentrazioni stabili di colesterolo LDL durante l’aferesi, nelle 8 settimane che precedono la visita di screening e durante lo studio, i pazienti non dovranno essere sottoposti a LDL aferesi.

E.4

Principal exclusion criteria

• LDL or plasma apheresis within 8 weeks prior to enrollment
• Use of Mipomersen within 5 months of screening
• NYHA III or IV heart failure, or last known left ventricular ejection fraction < 30%
• Uncontrolled serious cardiac arrhythmia defined as recurrent and highly symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response, or supraventricular tachycardia that are not controlled by medications, in the past 3 months prior to enrollment
• Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to enrollment
• Planned cardiac surgery or revascularization within 20 weeks of screening
• Uncontrolled hypertension defined as sitting systolic blood pressure (SBP) > 180 mmHg or diastolic BP (DBP) > 110 mmHg, confirmed with repeat measurement
• Subject requires uptitration of their current statin dose within 4 weeks of screening (these subjects can be uptitrated and rescreened 1 month later)
• Moderate to severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2 at screening
• Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the ULN as determined by central laboratory analysis at screening
• Unexplained CK > 5 times the ULN at screening, confirmed by a repeat measurement at least 1 week apart
• Known active infection or major hematologic, renal, metabolic, gastrointestinal or endocrine dysfunction in the judgment of the investigator
• Diagnosis of deep vein thrombosis or pulmonary embolism within 3 months prior to enrollment
• Unreliability as a study participant based on the investigator's (or designee’s) knowledge of the subject (eg, alcohol or other drug abuse, inability or unwillingness to adhere to the protocol, or psychosis)
• Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s)
• Female subject who is not willing to use at least 1 highly effective method of birth control during treatment and for an additional 15 weeks after the end of treatment unless subject is sterilized or postmenopausal;
• Subject is pregnant or breast feeding, or planning to become pregnant during treatment and/or within 15 weeks after the end of treatment
• Malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma) within the last 5 years
• Subject has previously received AMG 145 or any other investigational therapy to inhibit inhibiting PCSK9
• Known sensitivity to any of the products to be administered during dosing
• Subject will not be available for protocol-required study visits or procedures, to the best of the subject and investigator’s knowledge.
• Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures.

I principali criteri di esclusione sono: plasmaferesi o LDL aferesi nelle 8 settimane precedenti l’arruolamento; utilizzo di Mipomersen nei 5 mesi precedenti lo screening; classe III o IV secondo la New York Heart Failure Association (NYHA) o ultimo valore noto della frazione di eiezione ventricolare sinistra < 30%; negli ultimi 3 mesi aritmia cardiaca non controllata farmacologicamente; infarto miocardico, angina instabile, intervento coronarico percutaneo (PCI), innesto di bypass coronarico (CABG) o ictus negli ultimi 3 mesi prima dell’arruolamento; intervento programmato di cardiochirurgia o rivascolarizzazione; pressione arteriosa sistolica (SBP) > 180 mmHg o diastolica (DBP) > 110 mmHg; necessità di aumento della dose di statine nelle 4 settimane che precedono lo screening; tasso di filtrazione glomerulare stimato (eGFR) < 30 ml/min/1,73m2; valori persistenti di aspartato aminotransferasi (AST) o alanina aminotransferasi (ALT) > 3x ULN, di creatinchinasi (CK) > 5x ULN senza una causa nota; infezione maggiore attiva o disfunzioni ematologiche, renali, metaboliche, gastrointestinali o endocrine maggiori; trombosi venosa profonda o embolia polmonare nei 3 mesi precedenti l’arruolamento.
Le donne non devono essere in gravidanza o in allattamento, e le donne in età premenopausale devono essere disposte ad utilizzare almeno 1 metodo contraccettivo altamente efficace durante il trattamento e per le 15 settimane che seguono la fine del trattamento.

E.5 End points

E.5.1

Primary end point(s)

Part A & Part B: The percent change LDL-C from baseline to week 12.

Parte A e parte B dello studio: percentuale di cambiamento dei livelli di colesterolo LDL-C dal basale alla settimana 12

E.5.1.1

Timepoint(s) of evaluation of this end point

From baseline to week 12

dal basale alla settimana 12

E.5.2

Secondary end point(s)

• Change in LDL-C at week 12 (Part A and Part B)
• Percent change in non-HDL-C at week 12 (Part A and Part B)
• Percent change in ApoB at week 12 (Part A and Part B)
• Percent change in the total cholesterol/HDL-C ratio at week 12 (Part A and Part B)
• Percent change in ApoB/ApoA1 ratio at week 12 (Part A and Part B)
• Response rate of subjects with 15% or greater reduction in LDL-C from baseline to Week 12 (Part A only)
• Change in PCSK9 at week 12 (Part A and Part B)Subject incidence of treatment emergent adverse events

• -variazione rispetto al basale dei valori di LDL-C alla settimana 12 (Parte A e B)
• -variazione percentuale rispetto al basale dei valori di non-HDL-C alla settimana 12 (Parte A e B)
• -variazione percentuale rispetto al basale dei valori di ApoB alla settimana 12 (Parte A e B)
• -variazione percentuale rispetto al basale del rapporto colesterolo totale/HDL-C alla settimana 12 (Parte A e B)
• -variazione percentuale rispetto al basale del rapporto ApoB/ApoA1 alla settimana 12 (Parte A e B)
• -tasso di risposta dei soggetti con riduzione pari o superiore al 15% dei valori di LDL-C rispetto al basale alla settimana 12 (solo parte A)
• -variazione rispetto al basale dei valori di PCSK9 alla settimana 12 (Parte A e B)
• -incidenza per soggetto di eventi avversi emersi durante il trattamento

E.5.2.1

Timepoint(s) of evaluation of this end point

- Percent change from baseline in non-HDL-C at week 12: from baseline to week 12
- Percent change from baseline in ApoB at week 12: from baseline to week 12
- Percent change from baseline in the total cholesterol/HDL-C ratio at week 12: from baseline to week 12
- Percent change from baseline in ApoB/ApoA1 ratio at week 12: from baseline to week 12
- Response rate of subjects with 15% or greater reduction in LDL-C from baseline to Week 12 (Part A only): from baseline to week 12
- Change in PCSK9 at week 12 (Part A and Part B)Subject incidence of treatment emergent adverse events: from baseline to week 12

- variazione percentuale rispetto al basale non-HDL-C alla settimana 12: dal basale alla settimana 12,
- variazione percentuale rispetto al basale alla settimana 12 dell’ApoB: dal basale alla
settimana 12 - variazione percentuale rispetto al basale del colesterolo totale / HDL-C alla
settimana 12: dal basale alla settimana 12 - variazione percentuale rispetto al basale ApoB/ApoA1 alla settimana 12: dal
basale alla settimana 12, percentuale di risposta dei soggetti con il 15% o maggiore riduzione di LDL-C dal
basale alla settimana 12 (Parte A solo : dal basale alla settimana 12)
- variazione della PCSK9 alla settimana 12 (Parte A e Parte B incidenza di eventi avversi emergenti dal trattamento, per soggetto: dal basale alla settimana 12

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

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Tolerability

Tollerabilità

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)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

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

Parte A in aperto, singolo cieco; Parte B dello studio - doppio cieco, gruppi paralleli

Part A - Open label, single blind; Part B - double blind, parallel group

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

Yes

E.8.4

The trial involves multiple sites in the 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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

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

Austria

Belgium

Brazil

Canada

Czech Republic

France

Hong Kong

Malaysia

New Zealand

South Africa

Spain

Turkey

United States

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

ultima visita dell'ultimo paziente

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

Yes

F.1.1

Number of subjects for this age range:

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)

Yes

F.1.1.6.1

Number of subjects for this age range:

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)

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

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)

The plans for treatment or care after the subject has ended participation in the trial are not different from the expected normal treatment of this condition.

I piani terapeutici o le cure forniti al soggetto una volta terminata la sua partecipazione allo studio, non differiscono dal trattamento di routine della patologia.

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

2013-06-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-06-06

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-01-31

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