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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Rigshospitalet, Denmark
Sponsor:
Collaborators:
University Hospital, Gentofte, Copenhagen
Odense University Hospital
Information provided by (Responsible Party):
Professor, Dr. Med Hans-Joergen Malling, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT02017626
First received: August 21, 2013
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Fish Allergy
Biological: mCyp c 1
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: FAST-Fish -Food Allergy Specific Treatment for Fish Allergy.

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Safety in the form of number and severity of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Safety is evaluated by number and severity of adverse events


Secondary Outcome Measures:
  • Specific IgE [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To study the pharmaco-dynamics of the hypo-allergen administered to human subjects i.e. Specific IgE.

  • IgG4 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Immunologic parameter.

  • Skin Prick Test [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Pharmaco-dynamics of the hypo-allergen administered to human subjects.


Estimated Enrollment: 24
Study Start Date: August 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: group 1
6 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
3 patient groups with different doses of allergen.
Other Name: A modified hypo-allergenic Parvalbumin
Experimental: 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.
Biological: mCyp c 1
3 patient groups with different doses of allergen.
Other Name: A modified hypo-allergenic Parvalbumin
Experimental: Group 3
6 Patients with active treatment and 2 patients treated with placebo 6 patients will receive 10 single rising doses of mCyp c 1 from 40 ng to 375 ug and two maintenance doses, and two patients will receive placebo.
Biological: mCyp c 1
3 patient groups with different doses of allergen.
Other Name: A modified hypo-allergenic Parvalbumin

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02017626

Contacts
Contact: Hans-Joernge Malling, MD 0045 39772489 hans-joergen.Malling@regionh.dk

Locations
Denmark
Allergy Clinic, Gentofte Hospital Recruiting
Hellerup, Denmark, 2900
Contact: Marianne Witten, MD, PhD    +45 39772340    marianne.witten@regionh.dk   
Sub-Investigator: Marianne Witten, MD, PhD         
Sponsors and Collaborators
Rigshospitalet, Denmark
University Hospital, Gentofte, Copenhagen
Odense University Hospital
Investigators
Principal Investigator: Hans-Joergen Malling, MD Allergy Clinic, Gentofte University Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Professor, Dr. Med Hans-Joergen Malling, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02017626     History of Changes
Other Study ID Numbers: K-489 DK
Study First Received: August 21, 2013
Last Updated: December 16, 2013
Health Authority: Denmark: Danish Health and Medicines Authority
Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by Rigshospitalet, Denmark:
Fish allergy
immunotherapy
hypoallergen

Additional relevant MeSH terms:
Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on August 28, 2014