ICH GCP - EU Clinical trials Registry - 2015-002882-41 (AT)

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Summary
EudraCT Number:	2015-002882-41
Sponsor's Protocol Code Number:	AIBDSG_002
National Competent Authority:	Austria - BASG
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2015-11-05
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

Austria - BASG

A.2

EudraCT number

2015-002882-41

A.3

Full title of the trial

Sono-Response-Study
A Pilot Study on the use of contrast enhanced ultrasound in Crohn’s disease

Sono-Response-Studie
Die Verwendung von Kontrastmittel-verstärktem Ultraschall bei Morbus Crohn

A.3.1

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

A Pilot Study on the use of contrast enhanced ultrasound in Crohn’s disease

Die Verwendung von Kontrastmittel-verstärktem Ultraschall bei Morbus Crohn

A.4.1

Sponsor's protocol code number

AIBDSG_002

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 of Vienna (MUW)
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	Universitätsklinik für Innere Medizin III, Klinische Abteilung für Gastroenterologie und Hepatologie
B.4.2	Country	Austria
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Universitätsklinik für Innere Medizin III, Klinische Abteilung für Gastroenterologie und Hepatologie
B.5.2	Functional name of contact point	Working Party IBD
B.5.3	Address:
B.5.3.1	Street Address	Währinger Gürtel 18-20
B.5.3.2	Town/ city	Vienna
B.5.3.3	Post code	1090
B.5.3.4	Country	Austria
B.5.4	Telephone number	+431404006245
B.5.5	Fax number	+431404004735
B.5.6	E-mail	christian.primas@meduniwien.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	SonoVue
D.2.1.1.2	Name of the Marketing Authorisation holder	Bracco International B.V. Strawinskylaan 3051 NL - 1077 ZX Amsterdam Niederlande
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	SonoVue
D.3.4	Pharmaceutical form	Gas and solvent for dispersion for injection/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	sulphur hexafluoride
D.3.9.1	CAS number	2551-62-4
D.3.9.3	Other descriptive name	SULFUR HEXAFLUORIDE
D.3.9.4	EV Substance Code	SUB15925MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µl/ml microlitre(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	8
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

Inflammatory bowel disease (Crohn's disease)

Chronisch entzündliche Darmerkrankungen (Morbus Crohn)

E.1.1.1

Medical condition in easily understood language

chronic inflammatory bowel disease

Chronisch entzündliche Darmerkrankungen

E.1.1.2

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.1
E.1.2	Level	PT
E.1.2	Classification code	10011401
E.1.2	Term	Crohn's disease
E.1.2	System Organ Class	10017947 - Gastrointestinal disorders

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 the predicitve capacity of contrast enhanced ultrasound for response assessment in Crohn’s disease patients under newly established therapy with antiTNFalpha treatment (stratified by the Harvey Bradshaw Index in responders and non responders).

Es soll die Vorhersagekraft von Kontrastmittel-verstärktem Ultraschall am Dünndarm zur Beurteilung des Ansprechens auf eine neu begonnen Therapie mit einem TNF-alpha-Blocker gezeigt werden (stratifiziert durch den Harvey Bradshaw Index in Responder und Non Responder).

E.2.2

Secondary objectives of the trial

Assess the predictive capacity of CEUS for response assessment in Crohn’s disease patients under newly established therapy with antiTNFalpha treatment with biometrical parameters as stratifiers for response (fCP).
Correlate results from CEUS with
- MRI
- Change of fecal calprotectin (Visit 1 versus Visit 2, 3 and 4)
Correlate results form MRI with
- Change in disease activity scores
- Change of fecal calprotectin (Visit 1 versus Visit 2, 3 and 4)

Bewertung der Vorhersagekraft von Kontrastmittel-verstärktem Ultraschall bei Patienten mit Morbus Crohn und neu begonnener Therapie mit einem TNF-alpha-Blocker durch biometrische Parameter.
Korrelation der Ergebnisse des Kontrastmittel-verstärkten Ultraschalles mit
- MRT
- Veränderungen beim fäkalen Calprotectin (Visite 1 versus Visite 2, 3 und 4)
Korrelation der Ergebnisse des MRT mit
- Veränderungen im Aktivitätsscore
- Veränderungen beim fäkalen Calprotectin (Visite 1 versus Visite 2, 3 und 4)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Men and women above the age of 18 with an established diagnosis of Crohn’s disease for at least 3
months (according to a histology from an ileocolonoscopy evidentiary
for Crohn’s disease)
2) Able and willing to provide written informed consent
3) Crohn’s disease with evidence
of ileal or ileocolonic disease
4) Clinically active disease as evidenced by a Harvey Bradshaw index of 8 or above
5) Planned step-‐up in immunosuppressive therapy with an antiTNFalpha agent

1) Männer und Frauen mit einer seit mindestens drei Monaten etablierten Diagnose von Morbus Crohn (gemäß einer bei einer Ileocolonoskopie gewonnenen Histologie)
2) Imstande und bereit einen Einvertsändnisbogen (Patienteninformation) zu unterschreiben.
3) Vorliegen von ilealen oder ileocolonischen M. Crohn (abgesichert durch Bildgebung oder
Histologie)
4) Klinische Aktivität der Erkrankung gemessen an einem Werte von 8 oder mehr im Harvey Bradshaw Index
5) Geplante Eskalation der Therapie zu einem TNF-alpha-Blocker.

E.4

Principal exclusion criteria

1) Ulcerative colitis or indeterminate colitis
2) Isolated colonic Crohn’s disease
3) Contraindications for undergoing magnetic resonance imaging with computed tomography or other methods planned to be applied for disease/response assessment as substitute for MRI
4) Contraindications to undergo contrast enhanced ultrasound examinations
5) Contraindications against therapy with an antiTNFalpha agent
6) Inability to adhere to follow up schedule and/or provide information necessary to assess response parameters
7) Unwilling or unable to undergo blood sampling
8) Female subjects pregnant or planning pregnancy within the timeframe of the study participation
9) Significant coronary heart disease, right-to-left, bidirectional, or transient right-to-left cardiac shunt

1) Colitis ulceroca oder IBDU
2) Rein colonischer M. Crohn
3) Vorliegen von Kontraindikationen für die Durchführung einer MRT
4) Vorliegen von Kontraindikationen für die Durchführung einer kontrastmittel-verstärkten Ultraschalluntersuchung
5) Kontraindikationen gegen eine Therapie mit einem TNF-alpha-Blocker
6) Unvermögen die vorgegebenen Abläufe einzuhalten und/oder Informationen zur Verfügung zu stellen, die zur Beurteilung des Ansprechens zu erheben sind
7) Unwillig oder außerstandefür eine Blutabnahme
8) Schwangere sowie Frauen, die eine Schwangerschaft im Zeitraum der klinischen Studie planen
9) Relevante KHK, Rechts-zu-Links, bidirektionaler oder vorübergehender Shunt am Herzen

E.5 End points

E.5.1

Primary end point(s)

To assess the predicitve capacity of contrast enhanced ultrasound for response assessment in Crohn’s disease patients under newly established therapy with antiTNFalpha treatment, measured at week 12 (stratified by the Harvey Bradshaw Index in responders and non responders).

Vorhersagekraft von Kontrastmittel-verstärktem Ultraschall am Dünndarm zur Beurteilung des Ansprechens auf eine neu begonnen Therapie mit einem TNF-alpha-Blocker, gemessen zu Woche 12 (stratifiziert durch den Harvey Bradshaw Index in Responder und Non Responder).

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 12

Woche 12

E.5.2

Secondary end point(s)

Correlate results from CEUS with
-MRI
-Change of fecal calprotectin
Correlate results form MRI with
-Change in disease activity scores
-Change of fecal calprotectin

Korrelation der Ergebnisse des CEUS mit
- MRT
- Veränderungen im fäkalen Calprotectin
Korrelation der Ergebnisse des MRT mit
- Veränderungen der Krankheitsaktivität
- Veränderungen im fäkalen Calprotectin

E.5.2.1

Timepoint(s) of evaluation of this end point

Visit 1 versus Visit 2 (week 4), 3 (week 12) and 4 (week 24)

Visite 1 verglichen mit Visite 2 (Woche 4), 3 (Woche 12) und 4 (Woche 24)

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

E.6.5

Efficacy

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

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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

E.8.2.3

Other

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

Letzter Besuch des letzten Patienten

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.1.1.1

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

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.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

Keine

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

2015-12-15

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

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

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