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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ALK-Abelló A/S
ClinicalTrials.gov Identifier:
NCT01454531
First received: October 13, 2011
Last updated: April 24, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention Phase
Allergic Rhinoconjunctivitis
Drug: AVANZ Phleum pratense
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Trial to Assess the Tolerability of AVANZ Phleum Pratense Immunotherapy

Resource links provided by NLM:


Further study details as provided by ALK-Abelló A/S:

Primary Outcome Measures:
  • To assess the tolerability of AVANZ [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    The frequency of patients with adverse reactions will be the study primary endpoint.


Secondary Outcome Measures:
  • Frequency of systemic reactions and Change in immunological parameters [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Frequency of systemic reactions, based on EAACI classification, increase in IgG4 and in IgE-blocking factor; reduction in immediate skin reactivity.


Enrollment: 198
Study Start Date: June 2011
Study Completion Date: April 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AVANZ Phleum pratense Drug: AVANZ Phleum pratense
Up-dosing phase of AVANZ Phleum pratense
Other Name: AVANZ

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of grass pollen rhinoconjunctivitis
  • Positive SPT to Phleum pratense
  • Positive specific Ig E against Phleum pratense

Exclusion Criteria:

  • Uncontrolled severe asthma
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01454531

Locations
Spain
Hospital Nuestra Señora de Sonsoles
Avila, Spain, 05071
Hospital Universitario Infanta Cristina
Badajoz, Spain, 06007
Hospital de Basurto
Bilbao, Spain, 48013
Complejo Hospitalario de Burgos
Burgos, Spain, 09001
H. Campo Arañuelo
Cáceres, Spain, 10300
Hospital Nuestra Señora de La Montaña
Cáceres, Spain, 10004
Hospital Universitario de La Princesa
Madrid, Spain, 28006
Fundación Jiménez Diaz
Madrid, Spain, 28025
Hospital Infanta Leonor
Madrid, Spain, 28031
Hospital Univesitario Fundación Hospital de Alcorcón
Madrid, Spain, 28922
Hospital Infanta Elena
Madrid, Spain, 28342
Hospital Gregorio Marañón
Madrid, Spain, 28007
Hospital Carlos Haya
Malaga, Spain, 29009
Hospital Rio Carrion
Palencia, Spain, 34005
Hospital Santa Bárbara
Puertollano, Spain, 13500
Hospital Universitario de Salamanca
Salamanca, Spain, 37007
Hosptial Univeritario Marques de Valdeilla
Santander, Spain, 39008
Hospital Universitari Politecnic La Fe
Valencia, Spain, 46026
Hospital Santiago Apostol
Vitoria, Spain, 01004
Hospital Virgen de La Concha
Zamora, Spain, 49022
Sponsors and Collaborators
ALK-Abelló A/S
  More Information

No publications provided

Responsible Party: ALK-Abelló A/S
ClinicalTrials.gov Identifier: NCT01454531     History of Changes
Other Study ID Numbers: AV-G-01
Study First Received: October 13, 2011
Last Updated: April 24, 2012
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on October 19, 2014