ICH GCP - EU Clinical trials Registry - 2004-000930-35 (IT)

Página de ensayos clínicos Nct

Summary
EudraCT Number:	2004-000930-35
Sponsor's Protocol Code Number:	MHE100901
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:	2007-03-05
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

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2004-000930-35

A.3

Full title of the trial

An open-label extension study to study 100185, to evaluate long-term safety, efficacy and optimal dosing frequency of 750mg intravenous mepolizumab in subjects with hypereosinophilic syndrome.

Studio in aperto, estensione dello studio MHE100185, mirato a valutare la tollerabilita`, efficacia a lungo termine e frequenza della dose ottimale di mepolizumab 750mg endovena in soggetti con sindrome ipereosinofila.

A.4.1

Sponsor's protocol code number

MHE100901

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	GLAXO SMITHKLINE
B.1.3.4	Country	Italy
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	EMEA/OD/027/04
D.3 Description of the IMP
D.3.1	Product name	Mepolizumab
D.3.2	Product code	SB-240563
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	Mepolizumab
D.3.9.2	Current sponsor code	SB-240563
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.3	Concentration number	250
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

HES

Trattamento della sindrome ipereosinofila

E.1.1.2

Therapeutic area

Diseases [C] - Blood and lymphatic diseases [C15]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10048643
E.1.2	Term	Hypereosinophilic syndrome
E.1.2	System Organ Class	10005329 - Blood and lymphatic system disorders

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

Valutare la sicurezza a lungotermine di 750 mg di mepolizumab somministrato per via endovenosa, in soggetti con HES con una frequenza massima di dosaggio di una volta al mese.

E.2.2

Secondary objectives of the trial

1.Descrivere gli effetti duraturi di 750 mg ev di mepolizumab nel mantenimento della livello di dose del prednisone in questi soggetti che hanno completato 9 mesi di dosaggio del MHE100185 e che hanno raggiunto una dose di prednisone ≤ 10 mg.2.Descrivere gli effetti duraturi di 750 mg ev di mepolizumab nel ridurre la conta degli eosinofili sanguigni 3.Ottenere ulteriori informazioni sulla possibile frequenza di dosaggio ottimale di 750 mg ev di mepolizumab nei soggetti con HES basandosi sulla conta degli eosinofili sanguigni come marker del dosaggio.4.Descrivere l?efficacia clinica di 750 mg ev di mepolizumab,per una durata superiore ai 9 mesi,in soggetti con varie manifestazioni cliniche della sindrome ipereosinofila.5.Ottenere ulteriori informazioni sulla qualita' della vita misurata nel soggetti con sindrome ipereosinofila trattati con 750 mg di mepolizumab.

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

LIFE QUALITY:
Vers:
Date:
Title:
Objectives:

QUALITA DELLA VITA:
Vers:
Data:
Titolo:
Obiettivi:

E.3

Principal inclusion criteria

E.4

Principal exclusion criteria

E.5 End points

E.5.1

Primary end point(s)

Primario ?Frequenza degli eventi avversi. Secondari ?Numero di soggetti che raggiungono un livello di prednisone ≤10 mg (come unica terapia di background) alla fine dello studio MHE100901. ?Numero di soggetti che raggiungono un livello degli eosinifili <600 cell/ul (in aggiunta alla terapia di backgound con dosaggio inferiore per l?HES) alla fine dello studio MHE100901. ?Numero di soggetti che raggiungono un livello di prednisone ≤10 mg (come unica terapia di background) per un periodo ≥ a 3 mesi, tra i pazienti che hanno completato 9 mesi di dosaggio nello studio MHE100185 e che hanno raggiunto un livello di prednisone ≤10 mg. ?Numero di soggetti che raggiungono un livello di prednisone ≤10 mg (come unica terapia di background) per un periodo ≥ a 8 settimane, tra i pazienti che hanno completato 9 mesi di dosaggio nello studio MHE100185 e che hanno raggiunto un livello di prednisone >10 mg. ?Numero di soggetti che raggiungono un livello di prednisone ≤10 mg (come unica terapia di background) per un periodo ≥ a 3 mesi, tra i pazienti che sono entrati nello stage 2 dallo studio MHE100185 con un livello di prednisone ≤10 mg ?Nuemro di soggetti che raggiungono un livello di prednisone ≤10 mg (come unica terapia di background) per un periodo ≥ a 3 mesi, tra i pazienti che sono entrati nello stage 1 dallo studio MHE100185 con un livello di prednisone >10 mg ?Conta degli eosinofili sanguigni (tenendo in considerazione la terapia per l?HES di background) durante gli Stages 1-3. ?Numero di soggetti per gruppo di frequenza del dosaggio alla fine dello Stage 2. ?Scala analogica visuale del prurito (pVAS) a 3 mesi dall?inizio dello studio MHE100901 e successivamente ogni sei mesi. ?Punteggio dell?eritema/edema a 3 mesi dall?inizio dello studio MHE100901 e successivamente ogni sei mesi ? Analisi della QoL e dello stato di salute: punteggio riassuntivo fisico e mentale dell?SF-12TM a 3 mesi dall?inizio dello studio MHE100901 e successivamente ogni sei mesi

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

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

E.8.1.1

Randomised

Yes

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)

Information not present in EudraCT

E.8.2.2

Placebo

Information not present in EudraCT

E.8.2.3

Other

Information not present in EudraCT

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

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

Information not present in EudraCT

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

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

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1	Number of subjects for this age range:	0
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	Yes
F.3.3.2	Women of child-bearing potential using contraception	No
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	4
F.4.2	For a multinational trial
F.4.2.1	In the EEA	27
F.4.2.2	In the whole clinical trial	84

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

2005-05-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2005-03-22

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

Página de ensayos clínicos Nct

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas