Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2026-03-16 @ 1:07 AM
Study NCT ID:
NCT02382718
Status:
COMPLETED
Last Update Posted:
2017-06-12
First Post:
2015-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FAST Fish Phase IIb Clinical Trial for the Treatment of Fish Allergy by Subcutaneous Immunotherapy
Sponsor:
George Stavroulakis
Organization:
Study Overview
Official Title:
A Multinational Phase IIb Study to Investigate the Efficacy and Safety of Subcutaneous Immunotherapy With a Modified Fish- Parvalbumin Given in Single Rising and Maintenance Doses to Subjects Allergic to Fish
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FASTIIb
Brief Summary:
This is a phase IIb clinical trial to investigate the efficacy and safety of subcutaneous immunotherapy with a modified parvalbumin called mCyp c 1 for the treatment of fish allergy to subjects allergic to fish.
Detailed Description:
Fish allergy is a persistent food allergy (usually lifelong) which can be life threatening due to the danger for anaphylaxis (severe allergic reaction) upon accidental exposure to fish. Until today there is no curative treatment for fish allergy. The only treatment is avoidance. Patients with fish allergy have to avoid fish of all types and carry an adrenaline autoinjector and rescue medication, in case of accidental exposure to fish. That way patients with fish allergy have to continuously control what they are eating and this causes a great deal of stress and impacts their quality of life.
The major allergen responsible for fish allergy is the protein parvalbumin. It is recognized by the vast majority (96-100%) of fish allergic patients.
During the past, treatment of food allergy with immunotherapy was successful but dangerous, due to serious side effects (anaphylaxis).
A novel biotechnological product, a recombinant hypoallergenic parvalbumin, called mCyp c 1, is used for the first time in a phase IIb clinical trial, to test the efficacy of subcutaneous immunotherapy for the treatment of fish allergy. The investigational medicinal product mCyp c1, is based on the recombinant wild type carp parvalbumin (rCyp c 1) and is the result of site directed mutagenesis, by which the disruption of the two calcium binding sites of carp parvalbumin is performed. The modified parvalbumin mCyp c 1, is both hypoallergenic and immunogenic. That way it is a promising molecule for the safe and effective treatment of fish allergy.
This molecule has proven to be safe in a phase I/IIa study that has been performed, during which mCyp c 1 was administered with subcutaneous injections. During this study only local reactions at the injection site were observed. There were no observed systemic reactions. Even more, there were clear indications that mCyp c 1 was recognized by the immune system. The results of this phase I/IIa study guarantee the necessity of a phase IIb clinical trial with mCyp c 1, in order to study the efficacy of this modified parvalbumin in the treatment of fish allergy.
The major allergen responsible for fish allergy is the protein parvalbumin. It is recognized by the vast majority (96-100%) of fish allergic patients.
During the past, treatment of food allergy with immunotherapy was successful but dangerous, due to serious side effects (anaphylaxis).
A novel biotechnological product, a recombinant hypoallergenic parvalbumin, called mCyp c 1, is used for the first time in a phase IIb clinical trial, to test the efficacy of subcutaneous immunotherapy for the treatment of fish allergy. The investigational medicinal product mCyp c1, is based on the recombinant wild type carp parvalbumin (rCyp c 1) and is the result of site directed mutagenesis, by which the disruption of the two calcium binding sites of carp parvalbumin is performed. The modified parvalbumin mCyp c 1, is both hypoallergenic and immunogenic. That way it is a promising molecule for the safe and effective treatment of fish allergy.
This molecule has proven to be safe in a phase I/IIa study that has been performed, during which mCyp c 1 was administered with subcutaneous injections. During this study only local reactions at the injection site were observed. There were no observed systemic reactions. Even more, there were clear indications that mCyp c 1 was recognized by the immune system. The results of this phase I/IIa study guarantee the necessity of a phase IIb clinical trial with mCyp c 1, in order to study the efficacy of this modified parvalbumin in the treatment of fish allergy.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: