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Grass MATA MPL in Grass/Rye Pollen Allergy
NCT00133146Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2005
- Primary completion
- Nov 2005
- Countries
- 1
- Sponsor
- Allergy Therapeutics PLC
- Modality
- Vaccines & Immunotherapeutics
- Drugs
- Grass MATA MPL
- Conditions
- seasonal allergic rhinitis (SAR)
01
Overview
Phase 2, randomised, double-blind trial of Grass MATA MPL in seasonal allergic rhinitis (SAR) (2 arms), sponsored by Allergy Therapeutics PLC. Primary endpoint: Immunological response to Grass MATA MPL versus Grass MATA (grass specific) at 14 days. Started Sep 2005; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Grass MATA MPL
Grass MATA MPL injections (300, 800, 2000 SU)
Grass MATA
Grass MATA injections (300, 800, 2000 SU)
03
Who it enrols
Adults with moderate to severe seasonal allergic rhinitis due to grass/rye pollen, positive skin prick test, and specific IgE class >= 2. Excludes moderate/severe asthma and other significant allergies.
04
Endpoints
Primary
Immunological response to Grass MATA MPL versus Grass MATA (grass specific)
Secondary
Immunological response to Grass MATA MPL versus Grass MATA in volunteers allergic to grass and rye pollen
Tolerability of native allergen, modified allergen and tyrosine adsorbents with and without MPL® in the skin prick tests
Tolerability of the cumulative subcutaneous doses compared between Grass MATA MPL and Grass MATA
Tolerability of the different dose steps compared between GrassMATAMPL and GrassMATA treatment groups
Measure of concentration of Albumin
Measure of concentration of Alkaline Phospatase, ALT, AST and LDH
Measure of concentration of Bilirubin Total and Creatinine
Measure of concentration of Calcium, Glucose, Phosphorus, Potassium, Sodium and Urea
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