Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-25 @ 4:50 AM
NCT ID:
NCT02382718
Eligibility Criteria:
Inclusion Criteria:
* Subject having given a written informed consent before completing any study related procedure.
* Male or female subject from 18 to 65 years old and in general good health as determined by past medical history and physical examination.
* For woman of child bearing potential:
* a negative urine pregnancy test at screening visit,
* the subject must receive/ use a medically effective contraceptive method during the study.
* Convincing case history of allergy (immediate allergic reaction ≤ 2 hours) to fish ingestion.
* Specific IgE to fish by both a positive (3mm mean wheal diameter over negative control) SPT to cod extract and an ImmunoCAP ≥ class 2 (0.70 kUA/L) for cod (f3) and rCyp c 1 at screening.
* Positive DBPCFC with cod at screening visits.
* FEV1 ≥ 80% of predicted values at screening.
* Subject accepting to comply fully with the protocol.
Exclusion Criteria:
* Placebo-reaction in DBPCFC.
* Food anaphylaxis: anaphylactic shock (a score of 2 or 3 on cardiovascular/ neurologic symptoms according to PRACTALL (1): score 2 = drop in blood pressure and/or \>20% from baseline, or significant change in mental status- score 3 = cardiovascular collapse, signs of impaired circulation/ unconscious) due to fish intake, both during the past and at screening DBPCFC.
* Ongoing immunotherapy (IT) with any kind of allergen.
* Ongoing or previous treatment with omalizumab.
* Any clinical condition that contraindicates IT (EAACI guidelines) (8): serious immunological diseases, major cardiovascular disease, cancer, chronic infections, lack of compliance and severe psychological disorders.
* Any significant clinical condition that the investigators judged might hamper the patient's safety or the study outcomes. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, mental disease, immunological and endocrine disease.
* Chronic urticaria.
* Severe atopic dermatitis or non-controlled atopic dermatitis.
* Ongoing treatment with betablockers, angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor II antagonists (ARA II).
* Pregnancy or nursing.
* Uncontrolled asthma (asthma, if present, should be well controlled according to GINA guidelines using any kind of drugs except oral corticosteroids and omalizumab).
* An FEV1\<80% of predicted value during screening spirometry.
* Subject who has participated in a clinical trial within 3 months prior to this one.
* Subject with a history of drug or alcohol abuse.
* Investigators, co-investigators, as well as their children or spouses and all the study collaborators should not be enrolled in the study.
* Patients with concurrent allergy symptoms can be included if patients can manage without antihistamines and/or leukotriene receptor antagonists five days prior each screening and treatment visit.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02382718
Study Brief:
Protocol Section:
NCT02382718