Back to resultsFAST-Fish -Food Allergy Specific Treatment for Fish Allergy.
Primary Purpose
Fish Allergy
Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
mCyp c 1
Sponsored by
About this trial
This is an interventional treatment trial for Fish Allergy focused on measuring Fish allergy, immunotherapy, hypoallergen
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.
Sites / Locations
- Allergy Clinic, Gentofte Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
group 1
Group 2
Arm Description
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
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.
Outcomes
Primary Outcome Measures
Safety in the form of number and severity of adverse events
Safety is evaluated by number and severity of adverse events
Secondary Outcome Measures
Specific IgE
To study the pharmaco-dynamics of the hypo-allergen administered to human subjects i.e. Specific IgE.
IgG4
Immunologic parameter.
Skin Prick Test
Pharmaco-dynamics of the hypo-allergen administered to human subjects.
Full Information
NCT ID
NCT02017626
First Posted
August 21, 2013
Last Updated
June 18, 2015
Sponsor
Rigshospitalet, Denmark
Collaborators
University Hospital, Gentofte, Copenhagen, Odense University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02017626
Brief Title
FAST-Fish -Food Allergy Specific Treatment for Fish Allergy.
Official Title
FAST-Fish -Food Allergy Specific Treatment for Fish Allergy.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
University Hospital, Gentofte, Copenhagen, Odense University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fish Allergy
Keywords
Fish allergy, immunotherapy, hypoallergen
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group 1
Arm Type
Experimental
Arm Description
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
Arm Title
Group 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
mCyp c 1
Other Intervention Name(s)
A modified hypo-allergenic Parvalbumin
Intervention Description
2 patient groups with different doses of allergen.
Primary Outcome Measure Information:
Title
Safety in the form of number and severity of adverse events
Description
Safety is evaluated by number and severity of adverse events
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Specific IgE
Description
To study the pharmaco-dynamics of the hypo-allergen administered to human subjects i.e. Specific IgE.
Time Frame
1 year
Title
IgG4
Description
Immunologic parameter.
Time Frame
1 year
Title
Skin Prick Test
Description
Pharmaco-dynamics of the hypo-allergen administered to human subjects.
Time Frame
1 Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans-Joergen Malling, MD
Organizational Affiliation
Allergy Clinic, Gentofte University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allergy Clinic, Gentofte Hospital
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
12. IPD Sharing Statement
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/?term=FAST%3A+towards+safe+and+effective+subcutaneous+immunotherapy+of+persistent+food+allergies
Description
FAST: Towards safe and effective subcutaneous immunotherapy of persistent life-threatening food allergies.
Learn more about this trial
FAST-Fish -Food Allergy Specific Treatment for Fish Allergy.
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