Clinical Trials Register

Summary
EudraCT Number:	2008-000072-25
Sponsor's Protocol Code Number:	IG402
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2008-02-29
Trial results	View 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

Spain - AEMPS

A.2

EudraCT number

2008-000072-25

A.3

Full title of the trial

Estudio prospectivo, simple ciego, de Fase II/III para evaluar la Seguridad y Eficacia del Adhesivo de Fibrina Grifols (FS Grifols) como un Adyuvante a la Hemostasia durante Cirugía Vascular Periférica.
A Prospective, Single-blind, Randomized, Phase II/III Study to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Hemostasis during Peripheral Vascular Surgery

A.4.1

Sponsor's protocol code number

IG402

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Instituto Grifols S.A.
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	No
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	Human plasma-derived fibrin sealant Grifols; fibrin sealant Grifols; FS Grifols; adhesivo de fibrina
D.3.4	Pharmaceutical form	Sterile concentrate*
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Local use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Fibrinógeno
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	80
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Trombina
D.3.10	Strength
D.3.10.1	Concentration unit	IU/ml international unit(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	500
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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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

Adyuvante a la hemostasia en cirugía vascular periférica.
Adjunct to hemostasis during peripheral vascular surgery.

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

Evaluar la seguridad y eficacia hemostática de FS Grifols en cirugía vascular periférica.

E.2.2

Secondary objectives of the trial

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Obtención del Consentimiento Informado del sujeto
2) Sean hombres o mujeres.
3) Tengan al menos 18 años de edad sin límite superior de edad
4) Tengan disposición y habilidad para completar todos los requerimientos del protocolo.
5) .Tengan un valor de hemoglobina (Hgb) ≥ 9.0 g/dL
6) Tengan un recuento de plaquetas por encima de 70x103/mm3
7) Requieran un procedimiento de cirugía vascular periférica abierta (no laparoscópica, no endovascular) electiva (no urgente)
8) Requieran uno de los siguientes procedimientos de cirugía vascular periférica, que impliquen angioplastia arterial con parche o anastomosis arterial utilizando prótesis de Dacron o PTFE según la selección del Investigador:
Endarterectomía de carótida que requiere angioplastia con parche
Trasposición carótida-subclavia
Trasposición axilo-femoral
Resección de aneurisma abdominal aórtico
Trasposición aorto-mesentérica
Trasposición aorto-celiaca
Trasposición aorto-uniiliaca
Trasposición aorto-biiliaca
Trasposición aorto-unifemoral
Trasposición aorto-bifemoral
Resección de aneurisma iliaco
Resección de aneurisma femoral
Trasposición femoral-femoral
Trasposición femoral-poplítea
Revascularización arterial renal (mediante trasposición)
Revascularización arterial renal (mediante endarterectomía con angioplastia con parche)
Revascularización de la arteria poplítea (mediante trasposición)
Revascularización de la arteria poplítea (mediante endarterectomía con angioplastia con parche)
9) Criterios de inclusión intraoperatorios::
- Se pueda identificar un área sangrante objeto de tratamiento (TBS), y
- El TBS tenga una hemorragia arterial leve o moderada de acuerdo con el criterio del Investigador.

E.4

Principal exclusion criteria

1) Tengan un Índice Normalizado Internacional (INR) ≥ 2 en el preoperatorio
2) Tengan un ratio de tiempo de tromboplastina parcial activada (aPTT) ≥ 1.5 en el preoperatorio
3) Tengan una creatinina sérica> 2 veces el límite superior normal (LSN) del rango de laboratorio.
4) Tengan un valor de aspartato aminotranferasa (AST) o de alanino tranferasa (ALT) > 2.5 veces LSN del rango de laboratorio
5) Sean sometidos a un procedimiento reoperatorio: se define como un segundo, o sucesivos, procedimiento quirúrgico en la misma angioplastia con parche o anastomosis arterial.
6) Tengan una infección en el área anatómica quirúrgica.
7) Tengan una historia de reacciones intensas (e.g anafilácticas) a la sangre o a cualquier derivado sanguíneo.
8) No deseen recibir productos sanguíneos.
9) Sea improbable que se cumpla con los requerimientos del protocolo o que coopere durante la realización del estudio.
10) Tenga una historia positiva de hemorragia. La valoración de la historia de hemorragia incluye una historia médica detallada acerca de cirugías previas y episodios traumáticos previos, historia familiar, y acerca de la utilización de medicaciones antitrombóticas.
11) Se conoce que abusan de alcohol, opiáceos, psicotrópicos u otros compuestos químicos o fármacos, o lo hayan hecho durante los últimos 12 meses previos a la visita de selección.
12) Sean mujeres embarazadas o estén en periodo de lactancia.
13) Estén participando en otro ensayo clínico con un fármaco en investigación o un producto sanitario o hayan participado en uno en los 3 meses anteriores a la visita de selección.
14) Hayan sido previamente incluidos en este ensayo clínico.
15) Criterios de exclusión intraoperatorios:
-No se pueda identificar un TBS, o
-El TBS presente una hemorragia arterial intensa de acuerdo con el criterio del Investigador

E.5 End points

E.5.1

Primary end point(s)

La variable principal de eficacia es el tiempo para la hemostasia (TTH). Éste se mide desde el inicio de la aplicación del tratamiento en el TBS hasta alcanzar la hemostasia en ese punto o al final de un periodo observacional de 10 minutos en el caso de no haberse alcanzado la hemostasia. La variable principal de eficacia se cuantificará en minutos.

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

Information not present in EudraCT

E.7.1.2

Bioequivalence study

Information not present in EudraCT

E.7.1.3

Other

Information not present in EudraCT

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

Yes

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)

Information not present in EudraCT

E.8.2.2

Placebo

Information not present in EudraCT

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Compresión Manual

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

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

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

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

Information not present in EudraCT

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

Information not present in EudraCT

F.1.1.3

Newborns (0-27 days)

Information not present in EudraCT

F.1.1.4

Infants and toddlers (28 days-23 months)

Information not present in EudraCT

F.1.1.5

Children (2-11years)

Information not present in EudraCT

F.1.1.6

Adolescents (12-17 years)

Information not present in EudraCT

F.1.2

Adults (18-64 years)

Yes

F.1.3

Elderly (>=65 years)

Yes

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 2008-02-29.

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

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

140

F.4.2.2

In the whole clinical trial

312

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)

Los sujetos se someterán a un periodo de seguimiento de 6 meses tras la cirugía durante el que se controlarán aspectos de seguridad viral e inmunogenicidad

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

2008-01-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2008-08-04

P. End of Trial
P.	End of Trial Status	Completed

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