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An Open Trial to Assess the Tolerability of AVANZ® Salsola Immunotherapy (AV-X-02)
This trial is an open, national, multi-centre trial. The trial will be initiated in December 2013 and subjects will receive treatment for 6 weeks. Safety monitoring will be performed in an ongoing basis through a Clinical Safety Group with immediate access to Adverse Events registered in the clinical database. The composition, procedures and deliverables of the Clinical Safety Group will be detailed in a Safety Agreement prior to trial start.
Details
| Lead sponsor | ALK-Abelló A/S |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 51 |
| Start date | 2013-12 |
| Completion | 2014-12 |
Conditions
- Allergic Rhinoconjunctivitis Due to Salsola Kali Pollen
Interventions
- AVANZ Salsola
Primary outcomes
- Frequency of patients with adverse reactions — Participants will be followed for an expected average of 6 weeks
Countries
Spain