Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00118612
Status:
COMPLETED
Last Update Posted:
2021-02-09
First Post:
2005-07-01
Brief Title:
Different Doses of Tyrosine Adsorbed Tree Pollen Allergoid With Monophosphoryl Lipid A MPL in Patients Sensitized to Tree Pollen
Sponsor:
Allergy Therapeutics
Organization:
Allergy Therapeutics
Study Overview
Official Title:
A DoubleBlind Phase 2b Study to Evaluate Safety Efficacy of Different Doses of Tyrosine Adsorbed BirchHazelAlder Pollen Allergoid With MPL in Patients Sensitized to Birch Hazel Alder Pollen
Status:
COMPLETED
Status Verified Date:
2021-02
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:
Allergen-specific immunotherapy SIT the administration of gradually increasing quantities of an allergen extract to an allergic patient is a curative approach which directly treats the underlying allergic disease Tree MATA MPL has been developed to provide pre-seasonal specific immunotherapy for patients with an allergy to tree pollen hay fever
The purpose of this double-blind Phase IIb study is to assess the tolerability and immunogenicity of different doses of Tree MATA MPL in volunteers allergic to birch hazel and alder pollen
The purpose of this double-blind Phase IIb study is to assess the tolerability and immunogenicity of different doses of Tree MATA MPL in volunteers allergic to birch hazel and alder pollen
Detailed Description:
Tree MATAMPL tyrosine adsorbed tree pollen allergoid with monophosphoryl lipid A MPL has been developed to provide pre-seasonal specific immunotherapy for patients with proven type I hypersensitivity to cross-reacting tree pollens that cause rhinitis andor conjunctivitis with or without mild to moderate asthma
This was a phase IIb double-blind placebo-controlled study to assess the tolerability and immunogenicity of different doses of Tree MATA MPL in volunteers allergic to birch hazel and alder pollen
Sixty eight 68 volunteers were randomly assigned to one of three active treatments or placebo to receive up to 4 subcutaneous injections of either increasing doses of Tree MATAMPL or Placebo over 7 day 1 day interval
The duration of the study from screening Visit 1 to end of study Visit 6 Post-Treatment Visit was approximately 50 days
This was a phase IIb double-blind placebo-controlled study to assess the tolerability and immunogenicity of different doses of Tree MATA MPL in volunteers allergic to birch hazel and alder pollen
Sixty eight 68 volunteers were randomly assigned to one of three active treatments or placebo to receive up to 4 subcutaneous injections of either increasing doses of Tree MATAMPL or Placebo over 7 day 1 day interval
The duration of the study from screening Visit 1 to end of study Visit 6 Post-Treatment Visit was approximately 50 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P2DP05003 | None | None | None |