NCT01454531
Completed
Phase 2
An Open Trial to Assess the Tolerability of AVANZ Phleum Pratense Immunotherapy
Overview
- Phase
- Phase 2
- Intervention
- AVANZ Phleum pratense
- Conditions
- Allergic Rhinoconjunctivitis
- Sponsor
- ALK-Abelló A/S
- Enrollment
- 199
- Locations
- 20
- Primary Endpoint
- Frequency of Subjects With Adverse Drug Reactions
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The purpose of this study is to assess the tolerability of AVANZ.
Detailed Description
To assess the tolerability of the up-dosing phase of AVANZ Phleum pratense. The frequency of patients with adverse reactions will be the study primary endpoint.
Investigators
Eligibility Criteria
Inclusion Criteria
- •History of grass pollen rhinoconjunctivitis
- •Positive SPT to Phleum pratense
- •Positive specific IgE against Phleum pratense
Exclusion Criteria
- •Uncontrolled severe asthma
Arms & Interventions
AVANZ Phleum pratense
AVANZ Phleum pratense up-dosing phase (300, 600, 3000, 6000 and 15,000 SQ+) + one 15,000 SQ+ maintenance injection
Intervention: AVANZ Phleum pratense
Outcomes
Primary Outcomes
Frequency of Subjects With Adverse Drug Reactions
Time Frame: 6 weeks
Frequency of patients with adverse reactions, local or systemic
Secondary Outcomes
- Change in Phleum Pratense Specific IgE-blocking Factor(baseline (visit 1) and at 6 weeks (visit 6))
- Frequency of Subjects With Systemic Reactions(6 weeks)
- Frequency of Subjects With Local Adverse Reaction(6 weeks)
- Change in Phleum Pratense Specific IgG4(baseline (visit 1) and at 6 weeks (visit 6))
- Change in Immediate Cutaneous Response to Phleum Pratense(baseline (visit 1) and at 6 weeks (visit 6))
Study Sites (20)
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