Evaluation of Safety and Efficacy of Specific Immunotherapy With Recombinant Major Allergens of Timothy Grass Pollen Adsorbed Onto Aluminium-hydroxide in Patients With IgE-mediated Allergic Rhinoconjunctivitis +/- Controlled Asthma
AMETHYST
Multicentre, Multinational Randomised DBPC Clinical Trial for Evaluation of Safety and Efficacy of Specific Immunotherapy With Recombinant Major Allergens of Timothy Grass Pollen Adsorbed Onto Aluminium-hydroxide in Patients With IgE-mediated Allergic Rhinoconjunctivitis +/- Controlled Asthma
2 other identifiers
interventional
256
1 country
1
Brief Summary
Efficacy and Safety from a high-dosed subcutaneous recombinant preparation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2008
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 23, 2008
CompletedFirst Posted
Study publicly available on registry
May 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedNovember 8, 2013
November 1, 2013
4 years
April 23, 2008
November 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of Symptom and Medication score
during the baseline and the following two pollen seasons
Study Arms (2)
1
EXPERIMENTALstrict subcutaneous
2
PLACEBO COMPARATORstrict subcutaneous
Interventions
Eligibility Criteria
You may qualify if:
- Allergic rhinoconjunctivitis attributable to grass pollen
- Positive SPT
- Positive EAST
- Positive provocation test
You may not qualify if:
- serious disease
- other perennial allergies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Allergopharma GmbH & Co. KG
Reinbek, Germany
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Margitta Worm, Professor
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2008
First Posted
May 5, 2008
Study Start
March 1, 2008
Primary Completion
March 1, 2012
Study Completion
March 1, 2013
Last Updated
November 8, 2013
Record last verified: 2013-11