This is a prospective, multicentre, non-interventional, observational, real-world evidence (RWE) study designed to evaluate the effectiveness and safety of Immunoglobulin/Histamine Complex (IHC) in patients with Chronic Urticaria in India.
Study Type
OBSERVATIONAL
Enrollment
600
Histaglobulin prefilled syringe is administered subcutaneously as a single 1mL dose.
Change in clinical improvement as assessed by Urticaria Activity Score (UAS7)
Proportion of patients achieving UAS7 \<7
Time frame: End of study, approximately 1 year
Requirement of Antihistamine ± other non-biologic anti-allergic medications (Pill Burden):
\- Change in the requirement of regular anti-allergic medications (including dose increase/ decrease/or complete discontinuation) from baseline to 2 months.
Time frame: baseline to 2 months
3. Change in Quality of Life:
• Proportion of patients showing improvement in Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) score from baseline to 2 months.
Time frame: Baseline to 2 months
4. Safety and Tolerability:
Incidence, severity, and relationship of adverse events (AEs) treatment-emergent adverse events (TEAEs) and adverse drug reactions (ADRs) during the study period.
Time frame: Throughout the study period, an average of 1 year
Dr.Saswata Banerjee, Vice President Medical Affairs
CONTACT
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