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Age: 13Years +
All Genders
ID07680413

Observing the Safety and Effectiveness of Immunoglobulin-Histamine Complex Injections for Chronic Urticaria in Patients Aged 13 and Older

Led by Bharat Serums and Vaccines Limited · Updated on 2026-07-02

600

Participants Needed

40

Research Sites

8 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are observing the use of ImmunoglobulinHistamine Complex IHC, also known as Histoglob, in patients aged 13 years and older who have Chronic Urticaria in India. This real-world evidence study aims to assess how effective and safe Histoglob is for managing this condition, particularly in patients who are not controlled by first-line treatments like antihistamines. Participants in this observational study receive Histoglob injections, administered as a single 1 mL subcutaneous dose via prefilled syringe. The study focuses on patients who have been prescribed Histoglob for the first time as part of their routine care, without altering their usual treatment plans. There is no placebo or comparison group, as this is a non-interventional study following patients in real-world settings. During the approximately one-year study period, participants will be monitored for clinical improvement using the Urticaria Activity Score UAS7. Researchers will also track changes in antihistamine and other medication use, quality of life measures, and safety and tolerability throughout the study. Participants will continue their regular care while providing data through this observation to help evaluate Histoglobs role in managing Chronic Urticaria.

CONDITIONS

Brief Title

Real-world Evaluation of the Effectiveness of Immunoglobulin-Histamine Complex, IHC (Histoglob) in Chronic Urticaria

Research Team

D

Dr.Saswata Banerjee, Vice President Medical Affairs

D

Dr.Falgun Vyas, MBBS, MD

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