Clinical Trials Register

Summary
EudraCT Number:	2014-004386-24
Sponsor's Protocol Code Number:	PEGACRO
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2020-12-18
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

2014-004386-24

A.3

Full title of the trial

Effect of GH receptor antagonist on insulin resistance associated with acromegaly

Effetto dell¿antagonista del recettore del GH (pegvisomant) sul metabolismo glucidico in pazienti affetti da acromegalia

A.3.1

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

Effect of pegvisomant , GH receptor competitor, using glucose in patients with acromegaly

Effetto del pegvisomant, un competitore del recettore dell'ormone GH, sull'utilizzo del glucosio in pazienti con acromegalia

A.3.2

Name or abbreviated title of the trial where available

PEGACRO

A.4.1

Sponsor's protocol code number

PEGACRO

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	DIPARTIMENTO DI MEDICINA CLINICA E CHIRURGIA - UNIVERSITÀ DEGLI STUDI DI NAPOLI FEDERICO II
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	Pfizer srl
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Dipartimento di Medicina Clinica e Chirurgia
B.5.2	Functional name of contact point	Sezione di Endocrinologia
B.5.3	Address:
B.5.3.1	Street Address	VIa S: Pansini 5
B.5.3.2	Town/ city	Napoli
B.5.3.3	Post code	80131
B.5.3.4	Country	Italy
B.5.4	Telephone number	0817464983
B.5.5	Fax number	0815465443
B.5.6	E-mail	giovanna.muscogiuri@gmail.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	Yes
D.2.1.1.1	Trade name	SOMAVERT - 10 MG POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 30 FLACONCINI + 30 FLACONCINI 8 ML SOLVENTE USO SOTTOCUTANEO
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER LIMITED
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	somavert
D.3.4	Pharmaceutical form	Powder and solvent for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
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	Yes
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 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

acromegaly

acromegalia

E.1.1.1

Medical condition in easily understood language

Growth Hormone (GH) excess disease

malattia dovuta all' eccesso di ormone della crescita (GH)

E.1.1.2

Therapeutic area

Diseases [C] - Hormonal diseases [C19]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
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

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

to investigate glucose abnormalities in acromegalic patients before and after treatment with Pegvisomant;
to investigate ISen, ISec and incretin response in acromegalic patients before and after treatment with pegvisomant

valutare la prevalenza di anomalie della tolleranza glucidica nei pazienti affetti da acromegalia prima e dopo trattamento con Pegvisomant;
valutare gli effetti del trattamento con pegvisomant sull¿insulino-sensibilit¿, la secrezione insulinica e la risposta dell¿ asse entero- insulare a breve e lungo termine

E.2.2

Secondary objectives of the trial

to evaluate the effects of pegvisomant on plasma glucose in fasting conditions and after glucose load;
to evaluate the effects of pegvisomant on insulin sensitivity

valutare gli effetti del trattamento con Pegvisomant sui livelli di glicemia a digiuno e dopo carico orale di glucosio;
- valutare gli effetti del pegvisomant sull¿insulino-sensibilit¿.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Age > 18 yr;
- Diagnosis of active acromegaly, defined as: 1. GH levels > 2.5 µg/L as mean of five samples collected at 30 min-intervals during a 2 hr-time course; 2. lack of GH suppression <1.0 µg/L during oral glucose tolerance test (oGTT); IGF-1 at least 1.2 x ULN.
- Previous unsuccessful pituitary surgery and/or radiotherapy
- Proven resistance/intolerance/contraindication to SA

1. Maschi o femmine di età >18 anni;
2. Diagnosi di acromegalia in fase attiva definita come: livelli di GH > 2.5 µg/L come media di 5 campioni prelevati ad intervalli di 30 minuti durante un time-course di 2 ore; mancata soppressione del GH (> 1.0 µg/L durante curva da carico di glucosio); IGF-1 superiore di almeno 1.2 volte rispetto al valore massimo del range di normalità;
3. Precedente intervento neurochirurgico di adenomectomia e/o radioterapia non curativi ;
4. Provata resistenza/intolleranza al trattamento con analoghi della somatostatina convenzionali o controindicazione al trattamento con analoghi della somatostatina convenzionali;

E.4

Principal exclusion criteria

- Previous diagnosis of impaired glucose tolerance (IGT) or diabetes mellitus (DM) requiring antidiabetic agents (both oral or insulin)
- Known liver or renal failure
- Known concomitant malignancies
- Known chronic hematological, liver, renal or rheumatologic disease
- Alcohol and drug abuse
- Pregnancy and lactation
- Intolerance to the study drug

1. Pazienti diabetici od in trattamento con farmaci antidiabetici e/o insulina
2. Insufficienza epatica e/o renale nota
3. Neoplasie maligne endocrine e non endocrine note
4. Patologie acute e croniche ematologiche, renali, epatiche e reumatologiche note
5. Abuso di alcool e droghe
6. Pazienti che si trovano o si sono trovati in particolari condizioni mediche che possono interferire con l’esecuzione dello studio o con la valutazione dei suoi risultati da parte degli sperimentatori;
7. Pazienti in gravidanza/allattamento. Le donne dovranno fare ricorso a metodi di contraccezione accettabili, che comprendono: contraccettivi orali, a doppia barriera (profilattico con crema spermicida, ovuli con schiuma spermicida, diaframma con crema spermicida o profilattico e diaframma con crema spermicida), sistema intrauterino o iniettabile. Non dovrà essere usato alcun metodo contraccettivo nel caso di menopausa da almeno 1 anno o, almeno 3 mesi prima dell’inizio dello studio, interventi chirurgici di sterilizzazione o di isterectomia. Gli uomini dovranno utilizzare condoms durante l’intera durata dello studio fino ad 1 mese dopo l’assunzione dell’ultima dose del farmaco;
8. Intolleranza al farmaco in studio.

E.5 End points

E.5.1

Primary end point(s)

valutare gli effetti del trattamento con Pegvisomant sui livelli di glicemia a digiuno e dopo carico orale di glucosio;
valutare gli effetti del pegvisomant sull’insulino-sensibilità

valutare la prevalenza di anomalie della tolleranza glucidica nei pazienti affetti da acromegalia prima e dopo trattamento con Pegvisomant;
valutare gli effetti del trattamento con pegvisomant sull’insulino-sensibilità, la secrezione insulinica e la risposta dell’ asse entero- insulare a breve e lungo termine

E.5.1.1

Timepoint(s) of evaluation of this end point

3 and 6 months

3 e 6 mesi

E.5.2

Secondary end point(s)

to evaluate the effects of pegvisomant on plasma glucose in fasting conditions and after glucose load (75gr)
to evaluate the effects of pegvisomant on insulin sensitivity.

valutare gli effetti del trattamento con Pegvisomant sui livelli di glicemia a digiuno e dopo carico orale di glucosio;
valutare gli effetti del pegvisomant sull¿insulino-sensibilit¿.

E.5.2.1

Timepoint(s) of evaluation of this end point

3 and 6 months

3 e 6 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

Yes

E.6.4

Safety

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

loading dose: pegvisomat versus soluzione salina

Loading dose: pegvisomat versus saline solution

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.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

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

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)

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)

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

2015-12-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-10-14

P. End of Trial
P.	End of Trial Status	Ongoing

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