Fish Allergy
Conditions
Interventions
Product Name: FAST-mCyp c 1
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Rm Cyp C 1
CAS Number: not relevant
Current Sponsor code: FF-1
Other descriptive name: FISH
Concentration
Sponsors
FAST-consortium
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Allergy towards fish, 18-65 years, Case history of alleryg 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 at screening, Positive DBPCFC with fish within the last two years, FEV1 at least 80 % of predited values at screening, Subject accepting to comply fully with the protocol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Food anaphylactic shock due to fish intake, Specific IgE to fish parvalbumin below 0.35 kUA/L, ongoing pollen IT, Any clinical conition that contraindicates IT, Any significant clinical condition that might hamper the patients safety or the study outcome. Ongoing treatment with betablockers or ACE-inhibitors, Pregnancy or ursing.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Immunological parameters;Timepoint(s) of evaluation of this end point: after study | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the safety of treatment with mCyp c 1;Secondary Objective: To study the efficacy of treatment with mCyp c 1;Primary end point(s): Safety in the form of lack of serious allergic reactions;Timepoint(s) of evaluation of this end point: During and after study | — |
Countries
Denmark
Contacts
Public ContactAllergy CLinic
Allergy Clinic
Outcome results
None listed