Clinical Trials Register

Summary
EudraCT Number:	2011-001995-20
Sponsor's Protocol Code Number:	2205p
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:	2012-04-10
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2011-001995-20

A.3

Full title of the trial

A pilot study on educational aproach to improve compliance to medical precriptions in transplantation recipients.

Progetto Pilota d'Intervento Educativo per Migliorare l'Aderenza alle Prescrizioni Mediche in Pazienti sottoposti a Trapianto d'Organo

A.3.1

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

evaluation of the compliance to immunosoppressive therapy in transplatation recipient.

Valutazione dell'aderenza alla terapia immunosopressiva in pazienti sottoposti a trapianto d'organo.

A.3.2

Name or abbreviated title of the trial where available

Single

A.4.1

Sponsor's protocol code number

2205p

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 DI PADOVA
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	Azienda Ospedaliera di Padova
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	Hippocrates Research
B.5.2	Functional name of contact point	CRO
B.5.3	Address:
B.5.3.1	Street Address	Via XX Settembre 30/12
B.5.3.2	Town/ city	Genova
B.5.3.3	Post code	16121
B.5.3.4	Country	Italy
B.5.4	Telephone number	010 545481
B.5.5	Fax number	010 5454830
B.5.6	E-mail	REGULATORY.AIFA@HIPPOCRATES-RESEARCH.IT

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.2.1.2	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.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TACROLIMUS
D.3.9.1	CAS number	104987-11-3
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	1
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	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.2.1.2	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.3.4	Pharmaceutical form	Prolonged-release tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TACROLIMUS
D.3.9.1	CAS number	104987-11-3
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	1
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	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

Patients who underwent liver or renal transplantation

pazienti sottoposti a trapianto di fegato o di rene

E.1.1.1

Medical condition in easily understood language

Patients who underwent liver or renal transplantation

pazienti sottoposti a trapianto di fegato o di rene

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The main objecive is splitted in evaluated by the connection between two parts: - Efficacy of the switch from double to single daily administration of the immunosuppressant drug (from Progrf to Advagraf)to reduce the non compliant patient's population. - Efficacy of Self Learning anc Patient's education to reduce the non compliant patient's population

L’obiettivo primario si articola su due componenti tra loro collegate • Verifica dell’efficacia della conversione da duplice a singola somministrazione giornaliera del farmaco immunosoppressore (conversione da Prograf ad Advagraf) nel ridurre la frazione di soggetti non aderenti alle indicazioni. • Verifica dell’efficacia di due interventi psicoeducativi (Self Learning e Patient Education) nel ridurre la frazione di soggetti non aderenti alle indicazioni.

E.2.2

Secondary objectives of the trial

The secondary objective is the evaluation of the patient's perception, measured by objective and subjective paramethers, of his quality of life.

Lo studio ha l’obiettivo secondario di misurare le variazioni della percezione, secondo valori oggettivi e soggettivi da parte del paziente,della qualita' di vita.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Aging more than 18 2.Liver or renal transplantation from at least 8 months 3. immunosuppressive regimen with tacrolimus bid (Prograf) which hasn`t been changed in the last 2 months before the enrolment and without counterindications for switch to monotherapy (Advagraf). 4. Clinically stable patients 5. Childbearing potential female patients with negative serum pregnancy test who agree in using medical acceptable contraception for the whole duration of the study. 6. Patients who are able to give their consent 7. AST and ALT < 2 UNV (for liver transpantation) 8. Tacrolimus blood levels between 3-10 ng/ml and stable Prograf dosage in the 4-week period berfore enrolment.

1.Eta' superiore ai 18 anni. 2. Trapianto di fegato o di rene da almeno 8 mesi. 3. Regime immunosoppressivo con tacrolimus a duplice somministrazione giornaliera (Prograf) invariato negli ultimi 2 mesi prima dell’arruolamento e che non presenti controindicazioni per l’eventuale conversione alla monoterapia (Advagraf). 4. Pazienti clinicamente stabili. 5. Donne in eta' fertile con test di gravidanza (eseguito su campione sierico) negativo che accettino di utilizzare metodi contraccettivi ritenuti scientificamente validi per tutta la durata dello studio. 6. Soggetti capaci di intendere e volere che siano in grado di capire i propositi e i rischi della sperimentazione e che abbiano firmato il consenso informato alla partecipazione allo studio. 7. Transaminasi (AST e ALT) < 2 volte la norma (per i pazienti sottoposti a trapianto di fegato). 8. Livelli ematici di tacrolimus nel range 3-10 ng/mL e dosaggio di Prograf stabili nelle 4 settimane precedenti la visita di arruolament

E.4

Principal exclusion criteria

1. Acute rejection episodes in the 6-month period before enrolment. 2. Known allergy or hypersensibility to one or more investigational drugs components. 3. Any substances abuse, psychiatric disorders or any condition that, in investigator`s opinion, might affect the comunication with investigators or might affect the compliance to the study. 4. Newly diagnosed neoplasy after transplantation (excepted skin neoplasy)- 5. Patient participating in other clinical trial or who ended another clinical trial in the last 3 monts. 6. patients who took any other experimental drug in the month before the enrolment. 7. HIV positive patients 8. pregnant women 9. creatinine<30ml/min calculated by the Cockcroft and Gault`s formula (renal transpantation) 10. Increase of creatinine level over 20% in the last 6 months before enrolment (renal transplantation) 11. ASL/ALT > 2 UNV and/or total bilirubine >= 2 UNV (liver transplantation)

1. Episodi di rigetto acuto nei 6 mesi precedenti l’arruolamento. 2. Allergia nota o ipersensibilita' ad uno o piu' dei componenti dei farmaci utilizzati per lo studio. 3. Qualsiasi forma di abuso di sostanze, disordini psichiatrici o qualsiasi condizione che, secondo lo sperimentatore potrebbe rendere difficile la comunicazione col medico o che a giudizio dello sperimentatore possano non rispettare scadenze e procedure previste dal protocollo. 4. Diagnosi di neoplasia maligna di nuova insorgenza dopo il trapianto, ad eccezione di neoplasie cutanee. 5. Pazienti arruolati in altro studio clinico o che hanno concluso altro studio clinico da meno di 3 mesi. 6. Pazienti che hanno assunto farmaco sperimentale nell’ultimo mese prima dell’arruolamento. 7. Pazienti risultati positivi al test HIV. 8. Donne in gravidanza. 9. Paziente trapiantato di rene con clearance della creatinina calcolata con formula di Cockcroft and Gault <30 mL/min. 10. Paziente trapiantato di rene con aumento di creatinina superiore al 20% negli ultimi 6 mesi prima dell’arruolamento. 11. Transaminasi (AST e ALT) >2 volte la norma e/o livelli di Bilirubina totale ≥2 volte il limite superiore di normalita' del centro (solo per pazienti trapiantati di fegato).

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is the compliance to medical prescriptions, defined as the complete cocperation of the patient in the therapy, attend to the scheduled visits, perform blood exams and comply with the healthy way of life as indicated by the investigator.

La variabile esito primaria dello studio e' l’aderenza alle prescrizioni mediche, definita come la completa cooperazione del paziente nell`assumere la terapia, presentarsi alle visite mediche programmate, eseguire i controlli ematici e nel seguire un corretto stile di vita indicato dal medico.

E.5.1.1

Timepoint(s) of evaluation of this end point

12 months

12 mesi

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

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)

E.7.4

Therapeutic use (Phase IV)

Yes

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

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

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

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

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)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

304

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

104

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

408

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)

Subjects will be followed up by investigators according to the usual clinical practice.

I soggetti continueranno ad essere seguiti dal medico sperimentatore presso il centro secondo la consueta pratica clinica

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

2011-03-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-12-13

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials