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Molecular and Cellular Mechanism in Rhinitis Allergic Patients Treated With GRAZAX® (GT-20)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02437786
Recruitment Status : Completed
First Posted : May 8, 2015
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
ALK-Abelló A/S

Brief Summary:
The specific clinical trial is a part in which ALK- Abelló will directly work to explore human immunological mechanisms of SIT (observed after GRAZAX treatment).

Condition or disease Intervention/treatment Phase
Allergic Rhinoconjunctivitis Drug: GRAZAX Phase 4

Detailed Description:
The main idea of the project was to address the study of some of the most important inflammatory diseases (psoriasis, rheumatoid arthritis, lupus, rhinitis/asthma… ) with the aim of identifying novel inflammatory markers.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Molecular and Cellular Mechanism in Rhinitis Allergic Patients Treated With GRAZAX®
Study Start Date : September 2009
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Experimental: GRAZAX
GRAZAX
Drug: GRAZAX
GRAZAX




Primary Outcome Measures :
  1. Changes in immunological markers (composite) measured in grass allergic subjects during treatment with Grazax® [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Number of participants with IMP related adverse events [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent obtained before entering the trial.
  • Male and female 18-65 years of age.
  • A clinical history of relevant rhinitis or rhinoconjunctivitis (with/without concurrent asthma) to grass pollen of at least one year prior to trial entry.
  • Documented positive specific IgE against grass pollen (IgE ≥ Class 2) into the 5 previous years.
  • Positive Skin Prick Test response (wheal diameter ≥ 3 mm) to Phleum pratense.
  • Negative pregnancy test for childbearing potential females.
  • Willing and able to comply with the trial protocol regimen.

Exclusion Criteria:

  • Previous treatment by immunotherapy with grass allergen extracts.
  • A clinical history of symptomatic perennial allergic rhinitis or asthma.
  • Patients with contraindications for immunotherapy as established by the IT subcommittee of the EAACI or in the Summary of Products Characteristics of GRAZAX®.
  • Positive pregnancy test (in fertile females).
  • Being immediate family of the investigator or trial staff.
  • A mental condition rendering the subject unable to understand the nature, scope and possible consequences of the trial, and/or evidence of an uncooperative attitude.
  • Unlikely to be able to complete the trial, for any reason, or likely to move, or travel for extended periods of time during the trial period.
  • Use of an investigational drug within 30 days or 5 half-lives, whichever is longest, prior to screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02437786


Locations
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Spain
Hospital Universitario de La Princesa
Madrid, Spain, 28006
Sponsors and Collaborators
ALK-Abelló A/S
Investigators
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Principal Investigator: CARLOS BLANCO, PhD HOSPITAL UNIVERSITARIO DE LA PRINCESA MADRID

Publications of Results:
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Responsible Party: ALK-Abelló A/S
ClinicalTrials.gov Identifier: NCT02437786    
Other Study ID Numbers: GT-20
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases