Clinical Trials Register

Summary
EudraCT Number:	2011-004834-32
Sponsor's Protocol Code Number:	PROTEINA-C
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:	2012-03-08
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

2011-004834-32

A.3

Full title of the trial

Administration of concentrated Protein C in patients with severe sepsis and contraindications to activated protein C. A monocentric, randomised placebo-controlled study.

Somministrazione di concentrato di Proteina C in pazienti con sepsi severa e controindicazioni alla Proteina C attivata. Uno studio monocentrico, randomizzato controllato con placebo.

A.3.1

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

administration of protein C in patients with severe sepsis.

somministrazione di Proteina C in pazienti affetti da sepsi grave .

A.4.1

Sponsor's protocol code number

PROTEINA-C

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	FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR
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	Ministero della Salute Bando Giovani Ricercatori 2009
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	Fondazione San Raffaele del Monte Tabor
B.5.2	Functional name of contact point	Anest. e Rianim. Cardiotoracovasc.
B.5.3	Address:
B.5.3.1	Street Address	via Olgettina, 60
B.5.3.2	Town/ city	Milano
B.5.3.3	Post code	20132
B.5.3.4	Country	Italy
B.5.4	Telephone number	022643.7154
B.5.5	Fax number	022643.7158
B.5.6	E-mail	federico.pappalardo@hsr.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.2.1.1.1	Trade name	CEPROTIN
D.2.1.1.2	Name of the Marketing Authorisation holder	BAXTER
D.2.1.2	Country which granted the Marketing Authorisation	Austria
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	Powder and solvent 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	proteina C
D.3.9.1	CAS number	NA
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	U/ml unit(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
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	Yes
D.3.11.13.1	Other medicinal product type	natura biologica

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 infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

patients affected by severe sepsis admitted to intensive care

pazienti affetti da sepsi severa ricoverati in terapia intensiva

E.1.1.1

Medical condition in easily understood language

severe sepsis and sepsis requiring admission to intensive care with a contraindication to administration of activated protein C

sepsi grave e setticemia che richiedano ricovero in terapia intensiva con controindicazione alla somministrazione di proteina C attivata

E.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

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	10040047
E.1.2	Term	Sepsis
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

to confirm the beneficial effects of the use of protein C concentrate

confermare gli effetti benefici dell'uso concentrato di proteina C

E.2.2

Secondary objectives of the trial

to confirm that any possible bleeding is not related to the use of protein C

confermare che un eventuale sanguinamento non e' correlato all'uso di proteina C

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

age > 18 years; extracorporeal membrane oxygenation (ECMO) veno-venous; acute respiratory distress syndrome (ARDS)with sepsis; disseminated intravascular coagulation (DIC) sepsis based; organ dysfunction induced by sepsis associated with a clinical assessment of high risk of death

eta' > 18 anni; ossigenatore extracorporeo a membrana (ECMO) veno-venoso;sindrome da insufficienza respiratoria acuta (ARDS) con sepsi; coagulazione intravascolare disseminata (DIC) su base settica; disfunzione d'organo indotta dalla sepsi associata a un giudizio clinico di elevato rischio di morte

E.4

Principal exclusion criteria

previous abnormal reactions to any component or PC; PC administration or inclusion in other randomized protocols in the previous 30 days; 24 hours expectation of death; cardiogenic shock refractory; pregnant women

precedenti reazioni anomale alla PC o a qualche componente; somministrazione di PC o inclusione in altri protocolli randomizzati nei precedenti 30 giorni; aspettativa di morte nelle 24 ore; shock cardiogenico refrattario; donne gravide

E.5 End points

E.5.1

Primary end point(s)

mortality to 30 days and / or prolonged stay in intensive care (more than 30 days after randomization) in patients with severe sepsis from 75% to 50%

mortalita' a 30 gg e/o permanenza prolungata in terapia intensiva (oltre 30 gg dalla randomizzazione)in pazienti con sepsi severe dal 75% al 50%

E.5.1.1

Timepoint(s) of evaluation of this end point

30 days and 1 year follow-up by telephone call

a 30 gg ed a 1 anno mediante follow up telefonico

E.5.2

Secondary end point(s)

time of mechanical ventilation, time of hospital stay, thrombo embolic events (ie: microvascular dysfunction, organ, amputation, stroke, proved thrombosis, inflammatory and coagulation values such as IL6, IL10, IL18, ATIII, TAT, F1 + F2, FG, APC, D-dimer and platelets count)

tempo di ventilazione meccanica, durata della degenza ospedaliera, eventi trombo embolici (i.e. disfunzione micro vascolare d'organo, amputazione, infarto, trombosi conclamata, valori infiammatori e coagulativi come IL6,IL10,IL18,ATIII,TAT,F1+F2,FG,APC,D-dimero e conta piastrinica)

E.5.2.1

Timepoint(s) of evaluation of this end point

30 days and 1 year follow-up by telephone call

a 30 gg ed a 1 anno mediante follow up telefonico

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

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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

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.8.4.1

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:

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

Yes

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

for uncoscious patients the infornmed obtained from a relative or a legal representative and subsequently from the patient him/herself if possible .

per pazienti in condizioni di incoscienza il consenso verra' ottenuto da un parente o da un rappresentante legale e successivamente dal/dalla paziente stesso/a.

F.3.3.7

Others

Yes

F.3.3.7.1

Details of other specific vulnerable populations

intubated critically ill patients

pazienti critici intubati

F.4 Planned number of subjects to be included

F.4.1

In the member state

120

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)

All patients at the end of the study will follow the treatment programs for their specific disease as clinical routine.

Tutti i pazienti al termine dello studio seguiranno i programmi di cura specifici per la loro patologia come da routine 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

2012-06-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-02-09

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

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