FAST-Fish -Food Allergy Specific Treatment for Fish Allergy.

Fish Allergy Clinical Trial

Official title:

FAST-Fish -Food Allergy Specific Treatment for Fish Allergy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02017626
• Other study ID #: K-489 DK
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 21, 2013
• Last updated: June 18, 2015
• Start date: August 2013
• Est. completion date: October 2014

Study information

• Verified date: June 2015
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines AuthorityDenmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Description:

The aim of the FAST project in general is to develop novel recombinant allergen-based therapeutics for the treatment of food allergy. The chosen approach is to modify recombinant allergens into hypo-allergenic molecules to decrease the risk of anaphylactic side-effects and to allow administration of higher doses leading to better efficacy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 asthma.

• Subject who have 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 during screening and treatments.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fish Allergy
• Food Hypersensitivity
• Hypersensitivity

Intervention

Biological:
• mCyp c 1
2 patient groups with different doses of allergen.

Locations

Country	Name	City	State
Denmark	Allergy Clinic, Gentofte Hospital	Hellerup

Sponsors (3)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Odense University Hospital, University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety in the form of number and severity of adverse events	Safety is evaluated by number and severity of adverse events	1 year	Yes
Secondary	Specific IgE	To study the pharmaco-dynamics of the hypo-allergen administered to human subjects i.e. Specific IgE.	1 year	No
Secondary	IgG4	Immunologic parameter.	1 year	No
Secondary	Skin Prick Test	Pharmaco-dynamics of the hypo-allergen administered to human subjects.	1 Year	No

External Links

•   FAST: Towards safe and effective subcutaneous immunotherapy of persistent life-threatening food allergies.