ICH GCP - EU Clinical trials Registry - 2010-022923-31 (CZ)

임상 시험 Nct 페이지

Summary
EudraCT Number:	2010-022923-31
Sponsor's Protocol Code Number:	FIinTIC
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2013-06-27
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

A. Protocol Information

A.1

Member State Concerned

Czechia - SUKL

A.2

EudraCT number

2010-022923-31

A.3

Full title of the trial

A multicenter double-blind, placebo controlled, randomized, pilot trial to assess the efficacy of pre-hospital administration of Fibrinogen Concentrate (FGTW) in trauma patients, presumed to bleed (FI in TIC)

Multicenterická, dvojitě zaslepená, placebem kontrolovaná, randomizovaná, pilotní studie ke zjištění účinnosti přednemocničního podání koncentrátu fibrinogenu (FGTW) u traumatizovaných pacientů s předpokladem krvácení

A.3.1

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

A multicenter (several study centers) double-blind (neither the physician nor the patient knows if the FGTW or the placebo is given), placebo controlled (a comparator without an active substance), randomized (random distribution) pilot trial to assess the efficacy of pre-hospital administration of Fibrinogen Concentrate (administration of Fibrinogen – a substance to stop or reduce the bleeding - immediately at the accident location) in trauma patients, presumed to bleed (FI in TIC)

Zjištění účinnosti přednemocničního podání koncentrátu fibrinogenu (FGTW) u traumatizovaných pacientů s předpokladem krvácení

A.3.2

Name or abbreviated title of the trial where available

FI in TIC

A.4.1

Sponsor's protocol code number

FIinTIC

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	Medical University Innsbruck / Department for General and Surgical Intensive Care Medicine
B.1.3.4	Country	Austria
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	LFB Biomedicaments
B.4.2	Country	France
B.4.1	Name of organisation providing support	US Army
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Medical University Innsbruck / Department for General and Surgical Intensive Care Medicine
B.5.2	Functional name of contact point	Research Office - Dr. Fries
B.5.3	Address:
B.5.3.1	Street Address	Anichstraße 35
B.5.3.2	Town/ city	Innsbruck
B.5.3.3	Post code	6020
B.5.3.4	Country	Austria
B.5.4	Telephone number	00430512504 80450
B.5.5	Fax number	00430512504 6780450
B.5.6	E-mail	pamela.schech@i-med.ac.at

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	CLOTTAFACT
D.2.1.1.2	Name of the Marketing Authorisation holder	LFB - BIOMEDICAMENTS
D.2.1.2	Country which granted the Marketing Authorisation	France
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	CLOTTAFACT
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	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Human Fibrinogen
D.3.9.1	CAS number	9001-32-5
D.3.9.2	Current sponsor code	FGTW
D.3.9.3	Other descriptive name	HUMAN FIBRINOGEN
D.3.10	Strength
D.3.10.1	Concentration unit	g/ml gram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.015
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	Yes
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Powder and solvent for solution for injection
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

Trauma patients with major bleeding or occult bleeding with the need of volume replacement therapy

E.1.1.1

Medical condition in easily understood language

Trauma patients with massive blood loss or internal bleeding who need volume replacement

E.1.1.2

Therapeutic area

Diseases [C] - Injuries, poisonings, and occupational diseases [C21]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.1
E.1.2	Level	LLT
E.1.2	Classification code	10018988
E.1.2	Term	Haemorrhage NOS
E.1.2	System Organ Class	100000004866

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 assess whether the ultra-early pro-coagulatory treatment with fibrinogen concentrate on the scene would improve plasmatic coagulation capacity in multiple trauma patients with bleeding and/or major blood loss.

E.2.2

Secondary objectives of the trial

- to assess biological and clinical safety

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

I.1) Trauma patient
I.2) Patient at the obvious age of ≥ 18 years of either sex
I.3) Major bleeding or occult bleeding
I.4) Need for volume replacement therapy
I.5) Patient, who will be admitted to one of the participating hospitals

E.4

Principal exclusion criteria

E.1) Solely penetrating trauma
E.2) Solely head injury
E.3) In case of ongoing severe hemodynamic instability refractory to therapy (vasopressor, volume)
E.4) Patient with inevitable lethal course as evaluated by emergency physician
E.5) Need for CPR on the scene
E.6) Deep hypothermia (<30°C)
E.7) Obviously pregnant women
E.8) Patient with known recent history of thromboembolic events within the last 6 months
E.9) Patient known to be on anticoagulant therapy
E.10) Patient with known refusal of a participation in this clinical trial

E.5 End points

E.5.1

Primary end point(s)

Change from baseline (before FGTW administration) to hospital admission (T2) in MCF FibtEM® (Maximum Clot Firmness) – as the measure of fibrinogen polymerisation capacity.

E.5.1.1

Timepoint(s) of evaluation of this end point

T1 and T2

E.5.2

Secondary end point(s)

- Other ROTEM® parameters and coagulation tests
- Number of thrombosis after 7 days assessed by duplex sonography

E.5.2.1

Timepoint(s) of evaluation of this end point

- T1 - T8
- T7

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

Yes

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

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

Yes

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

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2013-06-27.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

Yes

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

Trauma Patients with major bleeding treated by emergency physicians of certain emergency helicopter teams or ground teams, who will be admitted to certain Hospitals (IMP administration on scene).

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)

The post-treatment is not different from the expected normal treatment of that condition.

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

2014-08-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-04-22

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

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