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

NCT ID: NCT02017626

Last Updated: 2015-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-10-31

Brief 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.

Detailed 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.

Conditions

Fish Allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

group 1

5 patients will receive 10 single rising doses of mCyp c 1 (modified allergen)from 0.6 ng to 6 ug and two maintenance doses, and 2 patients will receive placebo

Group Type: EXPERIMENTAL

mCyp c 1

Intervention Type: BIOLOGICAL

2 patient groups with different doses of allergen.

Group 2

6 patients will receive 10 single rising doses of mCyp c 1 from 6 ng to 60 ug and two maintenance doses, and two patients will receive placebo.

Group Type: EXPERIMENTAL

mCyp c 1

Intervention Type: BIOLOGICAL

2 patient groups with different doses of allergen.

Interventions

mCyp c 1

2 patient groups with different doses of allergen.

Intervention Type: BIOLOGICAL

Other Intervention Names

A modified hypo-allergenic Parvalbumin

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role: collaborator

Odense University Hospital

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Professor, Dr. Med Hans-Joergen Malling

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hans-Joergen Malling, MD

Role: PRINCIPAL_INVESTIGATOR

Allergy Clinic, Gentofte University Hospital

Locations

Allergy Clinic, Gentofte Hospital

Hellerup, , Denmark

Countries

Denmark

Related Links

http://www.ncbi.nlm.nih.gov/pubmed/?term=FAST%3A+towards+safe+and+effective+subcutaneous+immunotherapy+of+persistent+food+allergies

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

Other Identifiers

K-489 DK

Identifier Type: -

Identifier Source: org_study_id