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Molecular and Cellular Mechanism in Rhinitis Allergic Patients Treated With GRAZAX®

Sponsored by ALK-Abelló A/S

About this trial

Last updated 7 years ago

Study ID

GT-20

Status

Completed

Type

Interventional

Phase

Phase 4

Placebo

No

Accepting

18-75 Years
18 to 65 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 11 years ago

What is this trial about?

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).

What are the participation requirements?

Yes

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.

No

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.

Locations

Location

Status