An Open Trial to Assess the Tolerability of AVANZ Phleum Pratense Immunotherapy

NCT ID: NCT01454531

Last Updated: 2015-03-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

199 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-04-30

Brief Summary

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The purpose of this study is to assess the tolerability of AVANZ.

Detailed Description

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To assess the tolerability of the up-dosing phase of AVANZ Phleum pratense. The frequency of patients with adverse reactions will be the study primary endpoint.

Conditions

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Allergic Rhinoconjunctivitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AVANZ Phleum pratense

AVANZ Phleum pratense up-dosing phase (300, 600, 3000, 6000 and 15,000 SQ+) + one 15,000 SQ+ maintenance injection

Group Type EXPERIMENTAL

AVANZ Phleum pratense

Intervention Type DRUG

AVANZ Phleum pratense up-dosing phase (300, 600, 3000, 6000 and 15,000 SQ+) + one 15,000 SQ+ maintenance injection

Interventions

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AVANZ Phleum pratense

AVANZ Phleum pratense up-dosing phase (300, 600, 3000, 6000 and 15,000 SQ+) + one 15,000 SQ+ maintenance injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* History of grass pollen rhinoconjunctivitis
* Positive SPT to Phleum pratense
* Positive specific IgE against Phleum pratense

Exclusion Criteria

* Uncontrolled severe asthma
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ALK-Abelló A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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JOAQUIN SASTRE, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

FUNDACIÓN JIMÉNEZ DIAZ

Locations

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Hospital de Basurto

Bilbao, Bilbao, Spain

Site Status

Fundación Jiménez Diaz

Madrid, Madrid, Spain

Site Status

Hospital Infanta Elena

Madrid, Madrid, Spain

Site Status

Hospital Universitari Politecnic La Fe

Valencia, Valencia, Spain

Site Status

Hospital Nuestra Señora de Sonsoles

Ávila, , Spain

Site Status

Hospital Universitario Infanta Cristina

Badajoz, , Spain

Site Status

Complejo Hospitalario de Burgos

Burgos, , Spain

Site Status

Hospital Nuestra Señora de La Montaña

Cáceres, , Spain

Site Status

H. Campo Arañuelo

Cáceres, , Spain

Site Status

Hospital Universitario de La Princesa

Madrid, , Spain

Site Status

Hospital Gregorio Marañón

Madrid, , Spain

Site Status

Hospital Infanta Leonor

Madrid, , Spain

Site Status

Hospital Univesitario Fundación Hospital de Alcorcón

Madrid, , Spain

Site Status

Hospital Carlos Haya

Málaga, , Spain

Site Status

Hospital Rio Carrion

Palencia, , Spain

Site Status

Hospital Santa Bárbara

Puertollano, , Spain

Site Status

Hospital Universitario de Salamanca

Salamanca, , Spain

Site Status

Hospital Univeritario Marques de Valdeilla

Santander, , Spain

Site Status

Hospital Santiago Apostol

Vitoria-Gasteiz, , Spain

Site Status

Hospital Virgen de La Concha

Zamora, , Spain

Site Status

Countries

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Spain

Other Identifiers

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AV-G-01

Identifier Type: -

Identifier Source: org_study_id

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