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

NCT02017626 | Completed Phase 1 DMC

• 1 other identifier: K-489 DK
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Fish Allergy

Keywords

Fish allergy; immunotherapy; hypoallergen

Outcome Measures

Primary Outcomes (1)

• Safety in the form of number and severity of adverse events

  Safety is evaluated by number and severity of adverse events

  1 year

Secondary Outcomes (3)

• Specific IgE

  1 year

• IgG4

  1 year

• Skin Prick Test

  1 Year

Study Arms (2)

group 1

EXPERIMENTAL

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

Biological: mCyp c 1

Group 2

EXPERIMENTAL

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.

Biological: mCyp c 1

Interventions

mCyp c 1 BIOLOGICAL

2 patient groups with different doses of allergen.

Also known as: A modified hypo-allergenic Parvalbumin

Group 2; group 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• University Hospital, Gentofte, Copenhagen: collaborator
• Odense University Hospital: collaborator

Study Sites (1)

Allergy Clinic, Gentofte Hospital

Hellerup, 2900, Denmark

Location

Related Links

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

Study Officials

• Hans-Joergen Malling, MD

  Allergy Clinic, Gentofte University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 21, 2013
• First Posted: December 23, 2013
• Study Start: August 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: June 19, 2015

Record last verified: 2015-06

Locations

DK (1)