Clinical Trials Register

Summary
EudraCT Number:	2010-021775-80
Sponsor's Protocol Code Number:	ProGIT
National Competent Authority:	Germany - PEI
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2010-09-14
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

Germany - PEI

A.2

EudraCT number

2010-021775-80

A.3

Full title of the trial

Explorative Untersuchung zum Einfluss der Vitamin D-vermitteltenr Modulation der initialen subkutanen Gräserpollen-spezifischen Immuntherapie bei Allergikern mit Gräserpollen-induzierter Rhinokonjunktivitis mit/ohne allergischem Asthma

A.4.1

Sponsor's protocol code number

ProGIT

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	Charité - Universitätsmedizin Berlin
B.1.3.4	Country	Germany
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
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	Yes
D.2.1.1.1	Trade name	Vigantol® Öl
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck Pharma GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	entfällt
D.3.2	Product code	entfällt
D.3.4	Pharmaceutical form	Oral solution
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	8050-67-7
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	20.000
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)	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	No
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	Yes
D.3.11.13.1	Other medicinal product type	Vitamin D
D.IMP: 2
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	Allergovit® Gräser
D.2.1.1.2	Name of the Marketing Authorisation holder	Allergopharma Joachim Ganzer KG
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	entfällt
D.3.2	Product code	entfällt
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	nein
D.3.9.1	CAS number	nein
D.3.9.2	Current sponsor code	Allergovit® Gräser
D.3.9.3	Other descriptive name	nein
D.3.10	Strength
D.3.10.1	Concentration unit	U/ml unit(s)/millilitre
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	100 to 6000
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)	Yes
D.3.11.7	Plasma derived medicinal product	No
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Oral solution
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Allergische Rhinokonjunktivitis mit oder ohne allergischem Asthma verursacht durch Gräserpollen

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	12.1
E.1.2	Level	LLT
E.1.2	Classification code	10001728
E.1.2	Term	Allergic rhinoconjunctivitis

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Das Hauptziel der klinisch wissenschaftlichen Untersuchung ist zu prüfen, ob eine gleichzeitige Vitamin D Supplementation nach Einleitung der Allergen-spezifischen Immuntherapie zu einem schnelleren Wirkungseintritt und zu einer länger anhaltenden Wirkung der Behandlung führt.

E.2.2

Secondary objectives of the trial

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• schriftliche Einwilligungserklärung (laut AMG §40 (1) 3b)
• Männer und Frauen im Alter von 18 - 55 Jahren
• 25-Hydroxyvitamin D Konzentration im Serum <50 nM
• klinisch-relevante Gräserpollenallergie seit ≥2 Jahren
• positiver Gräserpollen-spezifischer SPT mit Quaddelgröße ≥3 mm (bei negativer Negativkontrolle)
• Quaddeldurchmesser von ≥10 mm bei der höchsten Konzentration (500 SBU/ml) im titrierten IKT
• Gräserpollen-sIgE (sIgE) im Serum CAP-Klasse ≥2
• Lungenfunktion: FEV1 >70%
• rSS ≥12 Punkte
• Frauen im gebärfähigen Alter: Anwendung einer effektiven Kontrazeption

E.4

Principal exclusion criteria

• 25-Hydroxyvitamin D Konzentration im Serum ≥50 nM
• regelmäßige oder geplante UV-Exposition, z.B. Sonnen-studio >1x pro Woche, Reise an einen anderen Ort mit verstärkter UV-Exposition (UV-Index/Tag >5)
• Einnahme von Medikamenten zur symptomatischen Behandlung von Rhinokonjunktivitis- oder Asthma-Beschwerden, außer kurz wirksame Beta-2-Agonisten und topische oder orale Antihistaminika
• Behandlung mit Vitamin A-Derivaten
• Behandlung mit Immunsuppressiva / Immunmodulatoren
• Einnahme / topische Anwendung von Glukokortikoide
• Behandlung mit Phenytoin, Barbiturate, Thiazid-Diuretika, Herzglykoside
• Einnahme trizyklischen Psychopharmaka / Neuroleptika (bis 2 Wochen vor Screening)
• Einnahme / topische Anwendung von Betablockern
• Impfung innerhalb 7 Tage vor Gräser-SIT (Visite 1)
• Anamnestisch: Hyperkalziämie/-urie, Neigung zu Nierensteine, Niereninsuffizienz, Sakroidose, Pseudoparahyperthyreodismus
• jede schwere chronisch-entzündliche, gastrointestinale, kardiovaskuläre oder autoimmune Erkrankung
• Kalzium, Phosphat oder Kreatinin im Serum außerhalb des entsprechenden Referenzbereiches (Anlage 6), klinisch relevante Abweichungen der hämatologischen Werte (Differenzialblutbild) nach Beurteilung durch einen unabhängigen Arzt
• bestehende schwere Grund- oder Begleiterkrankungen
• bestehende Unverträglichkeiten gegenüber den Inhaltsstoffen von Vigantol® Öl oder Allergovit® Gräser
• Kontraindikation einer spezifischen Immuntherapie
• bereits begonnene oder innerhalb der letzen 2 Jahre abgeschlossene Gräser-SIT
• bestehende Behandlung in Form einer spezifische Immuntherapie
• instabiles allergisches Asthma Grad GINA III – IV
• Unterbringung in einer Anstalt auf gerichtliche oder behördliche Anordnung
• (geplante) Schwangerschaft und Stillzeit
• bestehende Abhängigkeit zum bevollmächtigten Sponsor, z.B. Verwandtschaft, Arbeitsverhältnis)
• gleichzeitige Teilnahme an einer anderen Studie nach dem AMG 1 Monat vor und während der Teilnahme
• sonstige Gründe, wie Drogen- und Alkoholabusus, zu erwartende fehlende Compliance

E.5 End points

E.5.1

Primary end point(s)

Quaddeldurchmesser (Hautreaktion) im Intrakutantest (IKT) bei 500 SBU/ml nach Gräser-SIT (Visite 10) im Vergleich Verum (Vitamin D) zu Placebo.

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

Yes

E.6.4

Safety

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)

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.8.3

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.8.5

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

Information not present in EudraCT

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

Die klinisch wissenschaftliche Untersuchung ist beendet mit dem letzten Besuch des letzten Patienten, voraussichtlich im Oktober 2011.

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.1.1.1

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)

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)

Ist zu finden im Protokoll Kapitel 9.3.

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

2010-11-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Patient Information Sheet and consent form and procedure

Date of Ethics Committee Opinion

2010-12-06

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-01-13

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