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A randomized, double-blind, placebo-controlled (DBPC), parallel group study to assess the clinical efficacy and safety of SUBLIVAC FIX Birch immunotherapy in patients suffering from allergic rhinitis/rhinoconjunctivitis caused by birch pollen followed by an optional open label, one group safety-extension period. SB/0042 study

Trial Profile

A randomized, double-blind, placebo-controlled (DBPC), parallel group study to assess the clinical efficacy and safety of SUBLIVAC FIX Birch immunotherapy in patients suffering from allergic rhinitis/rhinoconjunctivitis caused by birch pollen followed by an optional open label, one group safety-extension period. SB/0042 study

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Birch pollen allergy immunotherapy (Primary)
  • Indications Allergic rhinitis; Allergic rhinoconjunctivitis; Tree pollen hypersensitivity
  • Focus Registrational; Therapeutic Use
  • Sponsors HAL Allergy
  • Most Recent Events

    • 30 Nov 2018 Primary endpoint has been met as per the results published in the Journal of Allergy and Clinical Immunology.
    • 30 Nov 2018 Results published in the Journal of Allergy and Clinical Immunology.
    • 21 Jun 2016 Status changed from active, no longer recruiting to completed.

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