Clinical Trials Register

Summary
EudraCT Number:	2012-005313-39
Sponsor's Protocol Code Number:	LAN-HD-ACRO
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:	2013-03-20
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

2012-005313-39

A.3

Full title of the trial

Scheme of treatment with high-dose lanreotide in acromegalic patients poorly responsive to treatment with standard doses."

“Schema di trattamento con lanreotide ad alte dosi in pazienti acromegalici scarsamente responsivi al trattamento con dosi standard”.

A.3.1

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

"High-dose lanreotide in patients with acromegaly"

“Lanreotide ad alte dosi in pazienti con acromegalia”

A.3.2

Name or abbreviated title of the trial where available

LAN-HD-ACRO

A.4.1

Sponsor's protocol code number

LAN-HD-ACRO

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	AZIENDA OSPEDALIERA Spedali Civili di Brescia
B.1.3.4	Country	Italy
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	IPSEN SPA
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	GB Pharma Services & Consulting
B.5.2	Functional name of contact point	Reparto Ricerca Clinica
B.5.3	Address:
B.5.3.1	Street Address	Via Ferreri, 11
B.5.3.2	Town/ city	PAVIA
B.5.3.3	Post code	27100
B.5.3.4	Country	Italy
B.5.4	Telephone number	00390382530676
B.5.5	Fax number	00390382302619
B.5.6	E-mail	info@gbpharmaservices.it

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Comparator
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	Ipstyl 90 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Ipsen SpA
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	Ipstyl 90 mg
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	LANREOTIDE ACETATE
D.3.9.1	CAS number	127984-74-1
D.3.9.3	Other descriptive name	LANREOTIDE ACETATE
D.3.9.4	EV Substance Code	SUB14326MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
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)	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.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	Ipstyl 120 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Ipsen SpA
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	Ipstyl 120 mg
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	LANREOTIDE ACETATE
D.3.9.1	CAS number	127984-74-1
D.3.9.3	Other descriptive name	LANREOTIDE ACETATE
D.3.9.4	EV Substance Code	SUB14326MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	120
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	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

acromegaly

acromegalia

E.1.1.1

Medical condition in easily understood language

excessive production of growth hormone which causes a progressive deformation of the face, hands and feet

esagerata produzione dell’ormone della crescita che provoca una deformazione progressiva del volto, delle mani e dei piedi

E.1.1.2

Therapeutic area

Body processes [G] - Metabolic Phenomena [G03]

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	10000599
E.1.2	Term	Acromegaly
E.1.2	System Organ Class	10014698 - Endocrine disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

confirm efficacy and safety of treatment with lanreoride at doses increased and reduced time intervals between doses in patients with acromegaly poorly responsive to standard treatment

confermare efficacia sicurezza del trattamento con lanreoride a dosi incrementati e ridotti intervalli di tempo tra le somministrazioni in pazienti affetti da acromegalia scarsamente responsivi al trattamento standard

E.2.2

Secondary objectives of the trial

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Age> = 18 years
Basal GH> = 1 microg / l,
IGF1> 1.2 x ULN (age and sex)
Ongoing treatment with lanreotide 120 mg every 4 weeks or octreotide 30 mg every 4 weeks for at least 6 months prior to randomization
Reduction of GH> = 50% in the course of therapy with LLSSA to standard doses compared to pretreatment values
Written informed consent

Età >=18 anni
GH basale >= 1 microg/l,
IGF1 > 1,2 x ULN (per età e sesso)
Trattamento in corso con lanreotide 120 mg ogni 4 settimane o octreotide 30 mg ogni 4 settimane da almeno 6 mesi prima della randomizzazione
Riduzione di GH >= 50% in corso di terapia con LLSSA a dosi standard rispetto ai valori di pretrattamento
Consenso informato scritto

E.4

Principal exclusion criteria

Symptomatic cholelithiasis
Unstable angina, sustained ventricular tachycardia, ventricular fibrillation, or a history of acute myocardial infarction in the 3 months prior to enrollment.
Liver disorders such as cirrhosis, chronic hepatitis, persistent rise in transaminase levels (AST, ALT, alkaline phosphatase 2 x ULN, total bilirubin 1.5 x ULN) or renal dysfunction (creatinine 1.5 x ULN) evaluated at screening;
Radiotherapy performed in the 5 years prior to enrollment and surgery for acromegaly performed in the 6 months prior to enrollment
Pregnant or breast-feeding women and women of childbearing age who do not adopt contraceptive methods. For women enrolled in the study, will require a negative urine pregnancy test at enrollment
Concomitant treatment with drugs able to modify the secretion of GH or IGF-1, as eg. dopamine agonists and pegvisomant
History of hypersensitivity to treatment with lanreotide
At the time of screening, and / or enrollment, adverse events being considered related to treatment with SSA of severity greater than grade 1.

Colelitiasi sintomatica
Angina instabile, tachicardia ventricolare sostenuta, fibrillazione ventricolare o una storia di infarto miocardico acuto nei 3 mesi precedenti l’arruolamento.
Disfunzioni epatiche quali cirrosi, epatite cronica, persistente rialzo dei livelli di transaminasi (AST, ALT, fosfatasi alcalina 2 x ULN, bilirubina totale 1.5 x ULN); o disfunzioni renali (creatinina 1.5 x ULN) valutati allo screening;
Radioterapia effettuata nei 5 anni precedenti l’arruolamento e chirurgia per acromegalia effettuata nei 6 mesi precedenti l’arruolamento
Stato di gravidanza o allattamento; donne e uomini in età fertile che non adottano metodi contraccettivi. Per le donne arruolate nello studio, sarà richiesto un test di gravidanza sulle urine negativo all’arruolamento
Trattamento concomitante con farmaci in grado di modificare la secrezione di GH o IGF1, come ad es. agonisti della dopamina e pegvisomant
Storia di ipersensibilità al trattamento con lanreotide
Al momento dello screening, e/o dell’arruolamento, eventi avversi in corso considerati legati al trattamento con SSA di severità superiore al grado 1.

E.5 End points

E.5.1

Primary end point(s)

Biochemical control of acromegaly (IGF-I ≤ 1.2 x ULN and basal GH <1 mg / L)

Controllo biochimico dell’acromegalia (IGF-I ≤ 1.2 x ULN e GH basale < 1 µg/L)

E.5.1.1

Timepoint(s) of evaluation of this end point

After 24 weeks of treatment

Dopo trattamento di 24 settimane

E.5.2

Secondary end point(s)

Number of serious and not serious adverse events

Numero di eventi avversi seri e non seri

E.5.2.1

Timepoint(s) of evaluation of this end point

For the entire duration of the study

Per tutta la durata dello studio

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)

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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)

Yes

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

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

STUDY DURATION 19 MONTHS

DURATA DELLO STUDIO 19 MESI

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

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)

NONE

NESSUNO

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

2013-05-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-03-05

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-03-09

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