Clinical Trials Register

Summary
EudraCT Number:	2012-001939-31
Sponsor's Protocol Code Number:	101-PR-PRI-196
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:	2012-11-29
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2012-001939-31

A.3

Full title of the trial

Biological standardization of Dermatophagoides pteronyssinus allergen extract to determine the biological activity in histamine equivalent units (HEP).

Estandarización biológica del extracto alergénico de Dermatophagoides pteronyssinus para determinar la actividad biológica en unidades equivalentes de Histamina (HEP).

A.3.1

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

To determine the minimum amount of Dermatophagoides pteronyssinus allergen extract producing a positive skin reaction.

Determinar la cantidad mínima de extracto alergénico de Dermatophagoides pteronyssinus que produce una reacción cutánea positiva.

A.4.1

Sponsor's protocol code number

101-PR-PRI-196

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	LABORATORIOS LETI S.L.U
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	LABORATORIOS LETI S.L.U.
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Laboratorios Leti, S.L.U.
B.5.2	Functional name of contact point	Departamento Médico
B.5.3	Address:
B.5.3.1	Street Address	C/ del Sol, 5
B.5.3.2	Town/ city	Tres Cantos, Madrid
B.5.3.3	Post code	28760
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034917711738
B.5.5	Fax number	0034918037472
B.5.6	E-mail	mjgomez@leti.com

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	PRICK TEST Dermatophagoides pteronyssinus LETI (100 HEP/ml)
D.2.1.1.2	Name of the Marketing Authorisation holder	LETI 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	Extracto alergénico nativo de Dermatophagoides pteronyssinus
D.3.4	Pharmaceutical form	Solution for skin-prick test
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Extracto alergénico nativo de Dermatophagoides pteronyssinus
D.3.9.2	Current sponsor code	101
D.3.9.3	Other descriptive name	DERMATOPHAGOIDES PTERONYSSINUS EXTRACT
D.3.9.4	EV Substance Code	SUB84531
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	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Extracto alergénico nativo de Dermatophagoides pteronyssinus
D.3.9.2	Current sponsor code	101
D.3.9.3	Other descriptive name	DERMATOPHAGOIDES PTERONYSSINUS EXTRACT
D.3.9.4	EV Substance Code	SUB84531
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	1
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Extracto alergénico nativo de Dermatophagoides pteronyssinus
D.3.9.2	Current sponsor code	101
D.3.9.3	Other descriptive name	DERMATOPHAGOIDES PTERONYSSINUS EXTRACT
D.3.9.4	EV Substance Code	SUB84531
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	0.1
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	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	Yes
D.3.11.13.1	Other medicinal product type	Producto para pruebas cutáneas de diagnóstico in vivo.
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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	Diclorhidrato de histamina 10 mg/ml
D.3.2	Product code	Control positivo
D.3.4	Pharmaceutical form	Solution for skin-prick test
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Diclorhidrato de histamina 10 mg/ml
D.3.9.1	CAS number	56-92-8
D.3.9.3	Other descriptive name	HISTAMINE DIHYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB12022MIG
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	10
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	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	Yes
D.3.11.13.1	Other medicinal product type	Se trata de un control positivo para pruebas cutáneas de diagnóstico in vivo.
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Comparator
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	Diluyente. Solución Salina Fenolada Glicerinada.
D.3.4	Pharmaceutical form	Solution for skin-prick test
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Diluyente. Solución Salina Fenolada Glicerinada
D.3.9.2	Current sponsor code	Control Negativo
D.3.10	Strength
D.3.10.1	Concentration unit	Gtt drop(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2
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	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	Yes
D.3.11.13.1	Other medicinal product type	Se trata de un control negativo para pruebas cutáneas de diagnóstico in vivo.

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

Allergy to Dermatophagoides pteronyssinus

Alergia frente a Dermatophagoides pteronyssinus

E.1.1.1

Medical condition in easily understood language

Allergy to house dust mites (Dermatophagoides pteronyssinus)

Alergia a ácaros del polvo (Dermatophagoides pteronyssinus)

E.1.1.2

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10020419
E.1.2	Term	House dust mite allergy
E.1.2	System Organ Class	100000004870

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective is to assess the concentration of Dermatophagoides pteronyssinus allergen extract that elicits a wheal size equivalent to that of a 10 mg/ml histamine dyhidrochloride solution.

.El objetivo principal consiste en evaluar la concentración de extracto alergénico de Dermatophagoides pteronyssinus que provoca una pápula de un tamaño equivalente a la producida por una solución de diclorhidrato de histaminadiclorhidrato de histamina a 10 mg/ml.

E.2.2

Secondary objectives of the trial

The secondary objective is to perform the in vitro characterization of the internal reference preparation from patients' serum, to determine their in vitro biological potency and to guarantee the consistency of the biological potency of the product batch by batch.

El objetivo secundario es realizar la caracterización in vitro de la preparación de referencia interna a partir de la obtención de sueros, para determinar su potencia biológica in vitro y poder garantizar la consistencia de la potencia biológica del producto lote a lote.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Positive clinical history of allergy with respiratory symptoms
(rhinitis and / or rhinoconjunctivitis and / or asthma) against Dermatophagoides pteronyssinus.
-Subject has provided written informed consent, appropriately signed and dated by the subject (or legal representative, if applicable).
-Subject can be male or female of any race and ethnic group.
-Age ?18 years and ? 60 years at the study inclusion day.
-Positive skin prick test with a standardized commercially available
preparation of Dermatophagoides pteronyssinus allergen extract. The skin prick test will be considered positive if the test results in a wheal major diameter of at least 3 mm or an area at least 7 mm2. Positive skin prick test results are valid if performed within one year prior to the inclusion of the subject in the study
-A positive test for specific IgE to Dermatophagoides pteronyssinus (CAP-RAST major or equal to 2). IgE results are valid if performed within one year prior to the inclusion of the subject in the study.

- Historia clínica positiva de alergia con síntomas respiratorios (rinitis y/o rinoconjuntivitis y/o asma) frente a Dermatophagoides pteronyssinus .
- El sujeto (y/o su representante legal, si procede) ha otorgado su consentimiento informado por escrito, y lo ha firmado y fechado debidamente.
- Sujetos de ambos sexos, de cualquier raza y grupo étnico.
- Edad ? 18 años y ? 60 años en el día de la inclusión en el ensayo.
- Un prick test positivo (diámetro medio de la pápula ? 3mm o área de la pápula ? 7 mm2) con un extracto alergénico estandarizado comercial de Dermatophagoides pteronyssinus. Los resultados de la prueba prick-test serán válidos si se realizaron en el año previo a la inclusión del sujeto en el ensayo.
- Una prueba positiva de IgE específica de Dermatophagoides pteronyssinus (CAP-RAST ? 2). Los resultados de la prueba de IgE serán válidos si se realizaron en el año previo a la inclusión del sujeto en el ensayo.

E.4

Principal exclusion criteria

-Immunotherapy in the last 5 years with a allergen extract of Dermatophagoides pteronyssinus or other allergenic extracts of mites that may interfere with the allergen to test due to a high degree of cross-reactivity
-Use of drugs that may interfere with the skin reactions (e.g.,
antihistamines). See Appendix 1 of the protocol
-Treatment with any of the following medications: oral tricyclic or
tetracyclic antidepressants or IMAOs, beta-blockers, chronic use of
corticosteroids or use of oral or parenteral corticosteroids in repeated and intermittent patterns (10 mg/daily of prednisone or equivalent).
-Women who are pregnant or period of breastfeeding and women with a pregnancy test positive during the visit 2, prior to the prick test.
-Dermographism affecting the skin area at the test site at either study visit.
-Atopic dermatitis affecting the skin area at the test site at either study visit.
-Urticaria affecting the skin area at the test site at either study visit.
- Diseases of the immune system relevant clinically, both autoimmune and immunodeficiencies.
-Serious diseases not controlled that may increase the risk for the safety of the subjects involved in this study, including, but not limited to the following: heart failure, uncontrolled or severe respiratory diseases, endocrine diseases, clinically relevant kidney or liver diseases or hematological diseases.
-Participation in any other clinical trial within 30 days (or 5 times the biological half-life of the research of the study product, whichever is longer) prior to the inclusion of the subject in this clinical trial.
-Patients with diseases or conditions that limit the use of adrenaline (heart disease, severe hypertension, ..)
-Severe psychiatric, psychological or neurological disorders
-Abuse of alcohol, drugs or medicines in the previous year.

- Inmunoterapia en los últimos 5 años con un extracto alergénico de Dermatophagoides pteronyssinus u otros extractos alergénicos de ácaros que puedan interferir con el alérgeno a testar por presentar un alto grado de reactividad cruzada
- Uso de fármacos que puedan interferir con la respuesta cutánea antes y durante el estudio (por ejemplo: antihistamínicos) dentro de los plazos establecidos en el apéndice 1.
- Tratamiento con cualquiera de los siguientes medicamentos: antidepresivos tricíclicos, tetracíclicos o IMAOs, betabloqueantes, uso crónico de corticoides orales o uso de corticoides vía oral o parenteral en pautas repetidas e intermitentes (> 10 mg/día de prednisona o equivalente).
- Mujeres que estén embarazadas o en periodo de lactancia y mujeres con una prueba de embarazo positivo en la visita 2, antes de la realización del prick test.
- Dermografismo que afecte a la zona de la piel en la que se realiza la prueba, en cualquiera de las dos visitas del ensayo.
- Dermatitis atópica que afecte a la zona de la piel en la que se realiz la prueba, en cualquiera de las dos visitas del ensayo.
- Urticaria que afecte a la zona de la piel en la que se realiza la prueba, en cualquiera de las dos visitas del ensayo.
- Enfermedades del sistema inmunitario relevantes clínicamente, tanto autoinmunes como inmunodeficiencias (una tiroiditis de Hashimoto con hipotiroidismo bien controlada con tratamiento con hormona tiroidea no supone necesariamente una contraindicación. Una enfermedad de Graves con hipertiroidismo sería criterio de exclusión por el riesgo que habría en caso de tener que utilizar adrenalina).
- Enfermedades graves no controladas que puedan aumentar el riesgo para la seguridad de los sujetos que participen en este estudio, incluyendo, pero no limitando, las siguientes: insuficiencia cardiaca, enfermedades respiratorias graves o no controladas, enfermedades endocrinas, enfermedades hepáticas o renales clínicamente relevantes o enfermedades hematológicas.
- Participación en cualquier otro ensayo clínico en los 30 días (o 5 veces la semivida biológica del producto en investigación del estudio, lo que sea más largo) previos a la inclusión del sujeto en este ensayo clínico.
- Pacientes con enfermedades o trastornos que limiten el uso de adrenalina (enfermedades coronarias, HTA grave,?).
- Trastornos psiquiátricos, psicológicos o neurológicos graves.
- Abuso de alcohol, drogas o medicamentos en el año anterior.

E.5 End points

E.5.1

Primary end point(s)

Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase.

El área de la pápula(mm2) que se produce en la piel después de la
aplicación del extracto.

E.5.1.1

Timepoint(s) of evaluation of this end point

The primary endpoint will be determined after the last patient last
visit (end of study).

La variable principal se determinará tras la UVUP (fin de estudio).

E.5.2

Secondary end point(s)

The power of the PRI in vitro must be determined through the implementation of immunoassays, such as competitive inhibition from specific IgE, and shall be expressed in units of biological activity. In particular, the in vitro to be used in the assay technique is that of REINA competition.

La potencia del PRI "in vitro" se debe determinar mediante la realización de inmunoensayos, como la inhibición competitiva de IgE específica, y se expresará en unidades de actividad biológica. En concreto, la técnica "in vitro" a utilizar en el ensayo es la de REINA competición.

E.5.2.1

Timepoint(s) of evaluation of this end point

The secondary endpoint will be determined after the last patient last visit (end of study).

La variable secundaria se determinará tras la UVUP (fin de estudio).

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

Yes

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

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

Yes

E.8.1.7.1

Other trial design description

Los parámetros de control estarán siempre incluidos en cada uno de los sujetos

Control parameters are always included in each of the subjects

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

Yes

E.8.2.3.1

Comparator description

Control +:diclorhidrato de histamina; control-:diluyente (solución salina fenolada glicerinada)

Control +: histamine dihydrochloride;Control -: diluent (phenolated glycerinated saline solution)

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

LVLS

Última visita último paciente

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)

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 2012-11-29.

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.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 clinical trial is on the diagnosis of Dermatophagoides pteronyssinus prick test.
This section does not apply because of the characteristics of the study (patients do not
receive treatment).

El ensayo clínico es sobre el prick diagnostico de Dermatophagoides pteronyssinus. Esta sección no
aplica debido a las características del estudio(los pacientes no reciben tratamiento).

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

2013-02-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-12-19

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials