Clinical Trials Register

Summary
EudraCT Number:	2012-001931-30
Sponsor's Protocol Code Number:	206-PG-PRI-190
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2012-07-09
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

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2012-001931-30

A.3

Full title of the trial

Ensayo Clínico multicéntrico, abierto, para la comparación de la potencia biológica entre los extractos alergénicos nativo, despigmentado y despigmentado-polimerizado de epitelio de gato.

A.3.1

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

Ensayo clínico para comparar el tamaño de las pápulas producidas por los distintos extractos de epitelio de gato

A.3.2

Name or abbreviated title of the trial where available

190

A.4.1

Sponsor's protocol code number

206-PG-PRI-190

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	Área de Investigación Clínica
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	+34607285953
B.5.5	Fax number	+34918037472
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	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	Extracto alergénico despigmentado de epitelio de gato
D.3.2	Product code	206DP
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 despigmentado de epitelio de gato 5 mg/ml
D.3.9.2	Current sponsor code	206DP 5 mg/ml
D.3.9.3	Other descriptive name	Extracto alergénico despigmentado de epitelio de gato 5 mg/ml
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	5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Extracto alergénico despigmentado de epitelio de gato 1 mg/ml
D.3.9.2	Current sponsor code	206DP 1 mg/ml
D.3.9.3	Other descriptive name	Extracto alergénico despigmentado de epitelio de gato 1 mg/ml
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 despigmentado de epitelio de gato 0,1 mg/ml
D.3.9.2	Current sponsor code	206DP 0,1 mg/ml
D.3.9.3	Other descriptive name	Extracto alergénico despigmentado de epitelio de gato 0,1 mg/ml
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	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	Extracto alergénico despigmentado-polimerizado de epitelio de gato
D.3.2	Product code	206DPP
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 despigmentado-polimerizado de epitelio de gato 5 mg/ml
D.3.9.2	Current sponsor code	206DPP 5 mg/ml
D.3.9.3	Other descriptive name	Extracto alergénico despigmentado-polimerizado de epitelio de gato 5 mg/ml
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	5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Extracto alergénico despigmentado-polimerizado de epitelio de gato 1 mg/ml
D.3.9.2	Current sponsor code	206DPP 1 mg/ml
D.3.9.3	Other descriptive name	Extracto alergénico despigmentado-polimerizado de epitelio de gato 1 mg/ml
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 despigmentado-polimerizado de epitelio de gato 0,1 mg/ml
D.3.9.2	Current sponsor code	206DPP 0,1 mg/ml
D.3.9.3	Other descriptive name	Extracto alergénico despigmentado-polimerizado de epitelio de gato 0,1 mg/ml
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: 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	Yes
D.2.1.1.1	Trade name	PRICK TEST Katzenepithel LETI (Cat)
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 epitelio de gato
D.3.2	Product code	206N
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 epitelio de gato 5 mg/ml
D.3.9.2	Current sponsor code	206N 5 mg/ml
D.3.9.3	Other descriptive name	Extracto alergénico nativo de epitelio de gato 5 mg/ml
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	5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Extracto alergénico nativo de epitelio de gato 1 mg/ml
D.3.9.2	Current sponsor code	206N 1 mg/ml
D.3.9.3	Other descriptive name	Extracto alergénico nativo de epitelio de gato 1 mg/ml
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 epitelio de gato 0,1 mg/ml
D.3.9.2	Current sponsor code	206N 0,1 mg/ml
D.3.9.3	Other descriptive name	Extracto alergénico nativo de epitelio de gato 0,1 mg/ml
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: 4
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 HYDROCHLORIDE
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	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	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: 5
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.3.2	Product code	Control negativo
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.3.9.3	Other descriptive name	Solución salina fenolada glicerinada
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	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	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

Alergia frente al epitelio de gato

E.1.1.1

Medical condition in easily understood language

Alergia al gato

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	10001731
E.1.2	Term	Allergic to cats
E.1.2	System Organ Class	10021428 - Immune system 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

El objetivo principal del ensayo clínico es cuantificar la pérdida de potencia biológica in vivo de un extracto alergénico despigmentado-polimerizado (DPP) de epitelio de gato respecto al extracto alergénico nativo (N).

E.2.2

Secondary objectives of the trial

? Comparar la potencia biológica in vivo del extracto alergénico despigmentado (DP) de epitelio de gato respecto al extracto alergénico nativo (N).
? Comparar la potencia biológica in vivo del extracto alergénico despigmentado (DP) de epitelio de gato respecto al extracto alergénico despigmentado-polimerazado (DPP). despigmentado-polimerizado (DPP) de epitelio de gato.
? Cuantificar la pérdida de potencia in vitro del extracto despigmentado-polimerizado (DPP) de epitelio de gato respecto al extracto nativo (N) y al extracto despigmentado (DP) mediante estudios de inhibición de IgE e IgG específicos.
? Calcular la dosis 10 HEP del extracto alergénico nativo de epitelio de gato (N).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

.- El sujeto (y/o su representante legal, si procede) ha otorgado su consentimiento informado por escrito y lo ha firmado y fechado debidamente.
.- Sujeto de ambos sexos, de cualquier raza y grupo étnico.
.- Edad > 18 años y < 60 años el día de la inclusión en el estudio
.- Historia clínica positiva de alergia a epitelio de gato (es decir, rinitis, conjuntivitis, rinoconjuntivitis, asma, urticaria,?. ).
.- Un prick-test positivo (diámetro medio de la pápula ? 3 mm o área de la pápula ? 7 mm2) con un extracto comercial de epitelio gato. Los resultados de la prueba prick-test serán válidos si se realizaron en el año previo a la inclusión del sujeto en el estudio.
.- Una prueba positiva de IgE específica (> 0,70 KU/l) frente a epitelio de gato. Los resultados de la prueba de IgE serán válidos si se realizaron en el año previo a la inclusión del sujeto en el estudio.

E.4

Principal exclusion criteria

.- Inmunoterapia en los últimos 5 años con preparaciones alergénicas conocidas que puedan interferir con el alérgeno a testar (p. ejemplo: extracto a gato).
.- Uso de fármacos que pueden interferir con la respuesta cutánea antes y durante el estudio (por ejemplo: antihistamínicos) dentro de los plazos establecidos en la sección 9.1 y apéndice 1.
.- Tratamiento con cualquiera de los siguientes medicamentos: antidepresivos tricíclicos o tetracíclicos o IMAOs, betabloqueantes o uso crónico de corticoides orales o uso de corticoides, ambos 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.
.- Dermografismo que afecte a la zona de la piel en la que se realiza la prueba, en cualquiera de las dos visitas al centro del estudio.
.- Dermatitis atópica que afecte a la zona de la piel en la que se realiza la prueba, en cualquiera de las dos visitas al centro del estudio.
.- Urticaria que afecte a la zona de la piel en la que se realiza la prueba, en cualquiera de las dos visitas al centro del estudio.
.- 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 (hipertidoidismo) sería criterio de exclusión por el posible riesgo 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.
.- 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.
.- 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.

E.5 End points

E.5.1

Primary end point(s)

Se medirá el tamaño de la pápula, calculado como el área de la pápula (mm2) que se produce en la piel tras la aplicación del prick test dosis-respuesta, por duplicado, con cada una de las tres concentraciones (5, 1 y 0,1 mg/m) de los extractos alergénicos nativo (N) y despigmentado-polimerizado (DPP) de epitelio de gato, junto con el área de las pápulas inducidas por el control positivo y el negativo.

E.5.1.1

Timepoint(s) of evaluation of this end point

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

E.5.2

Secondary end point(s)

? Se medirá el tamaño de la pápula, calculado como el área de la pápula (mm2) que se produce en la piel tras la aplicación del prick test dosis-respuesta, por duplicado, con cada una de las tres concentraciones (5, 1 y 0,1 mg/m) de los extractos alergénicos nativo (N) y despigmentado (DP) de epitelio de gato, junto con el área de las pápulas inducidas por el control positivo y el negativo.
? Se medirá el tamaño de la pápula, calculado como el área de la pápula (mm2) que se produce en la piel tras la aplicación del prick test dosis-respuesta,por duplicado, con cada una de las tres concentraciones (5, 1 y 0,1 mg/m) de los extractos alergénicos despigmentado (DP) y despigmentado-polimerizado (DPP) de epitelio de gato, junto con el área de las pápulas inducidas por el control positivo y el negativo.
? Cuantificar la pérdida de potencia in vitro del extracto despigmentado-polimerizado (DPP) de epitelio de gato respecto al extracto nativo (N) y al extracto despigmentado (DP) mediante estudios de inhibición de IgE e IgG específicos.
? Calcular la dosis 10 HEP del extracto alergénico nativo de epitelio de gato (N).

E.5.2.1

Timepoint(s) of evaluation of this end point

La UVUP (última visita del último sujeto) será considerada como el final del ensayo.

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

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 de reactividad cutánea estarán siempre incluidos en cada uno de los sujeto

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 positivo (diclorhidrato de histamina) y Control negativo (sol. salina fenolada glicerinada)

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

La UVUP (última visita del último sujeto) será considerada como el final del ensayo.

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 2012-07-09.

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

Yes

F.3.3.7.1

Details of other specific vulnerable populations

Podrán participar mujeres que den negativo al test embarazo dentro de las 24h previas al Prick Test

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)

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

2012-10-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-08-06

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

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