Clinical Trials Register

Summary
EudraCT Number:	2016-001216-37
Sponsor's Protocol Code Number:	6371
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2016-11-22
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

France - ANSM

A.2

EudraCT number

2016-001216-37

A.3

Full title of the trial

Comparaison de deux stratégies d’administration de l’albumine humaine chez des malades agressés de réanimation présentant une hypoalbuminémie ≤ 20g/L.

A.3.1

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

Comparaison de deux stratégies d’administration de l’albumine humaine chez des malades agressés de réanimation présentant une hypoalbuminémie ≤ 20g/L.

A.3.2

Name or abbreviated title of the trial where available

ALBALSACE

A.4.1

Sponsor's protocol code number

6371

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	Hôpitaux Universitaires de Strasbourg
B.1.3.4	Country	France
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	Hôpitaux Universitraires de Strasbourg
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Hôpitaux Universitaires de Strasbourg
B.5.2	Functional name of contact point	Clinical Research Direction
B.5.3	Address:
B.5.3.1	Street Address	1, place de l’hôpital
B.5.3.2	Town/ city	Strasbourg
B.5.3.3	Post code	67091
B.5.3.4	Country	France
B.5.4	Telephone number	0033388115266
B.5.5	Fax number	0033388115494
B.5.6	E-mail	drci@chru-strasbourg.fr

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	VIALEBEX
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.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous 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	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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Patients admis en réanimation avec un Syndrome de Réponse Inflammatoire Systémique (SIRS) sévère avec une hypoalbuminémie ≤ à 20g/L :

E.1.1.2

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

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

Baisse de mortalité de 10% au cours du choc quelle qu’en soit l’étiologie, mortalité estimée à J28 post-inclusion

E.2.2

Secondary objectives of the trial

Comparer la durée du choc entre les groupes

Diminuer le nombre et de la durée des déchéances viscérales aigues lors de l’administration intraveineuse de noradrénaline

Diminuer du nombre d’infections associées aux soins en réanimation

Analyser le rapport coût-efficacité du traitement par albumine

Etudier l’effet de la perfusion d’albumine sur les concentrations plasmatiques de la vasostatine (VS-1) pendant la durée du choc. (objectif réalisé uniquement dans le service de réanimation de Hautepierre du Pr Schneider)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Age > 18 ans
Homme ou femme
Sujet hospitalisé en réanimation pour une agression aigüe avec défaillances viscérales risquant d’engager le pronostic vital et présentant simultanément :
une insuffisance circulatoire aigüe (hypotension artérielle systolique < 100 mm Hg ou pression artérielle moyenne (PAM) ≤ 65mm Hg, avec signes périphériques d’hypoperfusion et ou lactatémie > 2 mmol/L) nécessitant l’administration de noradrénaline après administration d’au moins 1000 mL de sérum physiologique,
une réaction immuno-inflammatoire systémique typique (tachycardie, fièvre ou hypothermie, hyperleucocytose ou neutropénie, oligurie, hyperlactatémie > 2 mmol/L) et,
un épisode inaugural d’hypo-albuminémie < 20 g/L avant toute perfusion thérapeutique d’albumine.

E.4

Principal exclusion criteria

Hypersensibilité à l'albumine ou à l'un des excipients
Sujet en période d’exclusion ou en cours de suivi pour une autre étude thérapeutique,
Formes cliniques particulières de la maladie :
SIRS sans hypoalbuminémie sévère (ie : albuminémie reste spontanément > 25g/L).
Hypoalbuminémie chronique par dénutrition chronique, type Kwashiorkor, anorexie mentale….
Impossibilité de donner au sujet des informations éclairées (sujet en situation d’urgence, difficultés de compréhension du sujet, …) : si consentement d’urgence donné est refusé secondairement, le malade sera retiré de l’étude
Sujet mineur
Sujet sous sauvegarde de justice
Sujet majeur sous tutelle ou sous curatelle
Grossesse avérée (dosage sanguin des β-HCG
Allaitement
Cachexie terminale quelle que soit sa cause,
Refus de soins

E.5 End points

E.5.1

Primary end point(s)

Mortalité à J28 (ou à la sortie d’hospitalisation si sortie avant J28)

E.5.1.1

Timepoint(s) of evaluation of this end point

28 jours après l'inclusion

E.5.2

Secondary end point(s)

Durée de temps entre première administration de Comparaison de la durée du choc entre les groupes. Cette durée commence au moment de la première administration d’albumine et se termine à la première administration de noradrénaline dont la posologie a diminué de 30%.

Diminution des variations temporelles du score SOFA journalier, entre le début d’administration d’albumine et l’arrêt de la noradrénaline

Diminution du nombre d’épisode infectieux associés aux soins après la 48ème heure d’admission en réanimation

Coût-efficacité de la posologie d’albumine utilisée

Variations des concentrations plasmatiques de VS-1

E.5.2.1

Timepoint(s) of evaluation of this end point

Durée de temps entre première administration de l’albumine et première baisse de 30 % de l’administration du traitement par noradrénaline

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)

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

Yes

E.8.1.7.1

Other trial design description

two arms with different concentration of albumin

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.8.2.3.1

Comparator description

Vialebex 40mg/ml

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

Please enter information in English and add any other language that is applicableLVLS

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 months

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.1.3

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

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

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

550

F.4.2

For a multinational trial

F.4.2.2

In the whole clinical trial

550

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

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

2016-06-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-05-10

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2019-08-10

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