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.
Male or female patients aged ≥13 years.
Able and willing to provide written informed consent (or assent where applicable).
Diagnosed with chronic urticaria with UAS7 prior to enrollment already on first line of treatment for Chronic Urticaria
Prescribed Histoglob injections for the first time at the discretion of treating physician as part of routine car
Known allergy or hypersensitivity to Histoglob or human immunoglobulin product.
Patients with acute allergic attack
Pregnant or lactating women.
History of malignancy or any condition requiring immunosuppressive therapy other than study indication.
Male or female patients aged above 13 years diagnosed with chronic urticaria with UAS7
Case-only
Prospective
Antihistaminics, H2 blockers, Leukotriene antagonists, Immunoglobulin/Histamine Complex (IHC) Injection
DrugHistaglobulin 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
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.
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.
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.
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Bharat Serums and Vaccines Limited
Lead sponsor
Innvocept Global Solutions Private Limited
Collaborator
