FAST-Fish -Food Allergy Specific Treatment for Fish Allergy. (NCT02017626) | Clinical Trial Compass
CompletedPhase 1/2
FAST-Fish -Food Allergy Specific Treatment for Fish Allergy.
Denmark15 participantsStarted 2013-08
Plain-language summary
The aim of this study is to investigate the safety and tolerability of Subcutaneous Immunotherapy treatment (SCIT) with incremental doses of a modified recombinant fish parvalbumin (mCyp c 1) quantified in mass units:
To establish a safe dose of the candidate hypo-allergen in human subjects and To study the pharmaco-dynamics of the hypo-allergen administered to human subjects.
The study is performed as a placebo-controlled double-blinded randomized trial with 24 fish allergic patients allocated into three different groups of eight.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Male or female subject from 18 to 65 years old and in general good health as determined by past medical history and physical examination.
* Case history of allergy to fish ingestion.
* Specific IgE to fish by either a positive SPT to cod fish extract or an ImmunoCAP to cod fish above 0.70 kUA/L,(Class 2) at screening.
* Positive Double blind placebo-controlled Food challenge (DBPCFC) with fish within the last two years.
* FEV1 at least 80% of predicted values at screening.
* Subject accepting to comply fully with the protocol.
* For woman of child bearing potential:
* a negative urine pregnancy test at screening visit,
* subject must receive a medically effective contraceptive method during the study
Exclusion Criteria:
* Food Anaphylactic Reaction: anaphylactic shock due to fish intake.
* Specific IgE (ImmunoCAP) to fish parvalbumin (rCyp c 1) below 0.35 kUA/L
* Ongoing pollen Immunotherapy (SIT).
* Any clinical condition that contraindicates SIT (EAACI-guidelines).
* 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, immunological and endocrine disease.
* Ongoing treatment with betablockers or ACE-inhibitors.
* Impossibility for the patient to comply with the scheduled visits.
* Pregnancy or nursing.
* Uncontrolled …
What they're measuring
1
Safety in the form of number and severity of adverse events