Ignite Creation Date:
2024-05-06 @ 2:20 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02017626
Status:
COMPLETED
Last Update Posted:
2015-06-19
First Post:
2013-08-21
Brief Title:
FAST-Fish -Food Allergy Specific Treatment for Fish Allergy
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
FAST-Fish -Food Allergy Specific Treatment for Fish Allergy
Status:
COMPLETED
Status Verified Date:
2015-06
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:
None
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
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
Study Oversight
Has Oversight DMC:
None
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?:
None