Chronic Urticaria
Conditions
Keywords
Histoglob, urticaria, histaglobulin, Chronic urticaria, RWE study, antihistaminics
Brief summary
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.
Interventions
DRUGAntihistaminics, H2 blockers, Leukotriene antagonists, Immunoglobulin/Histamine Complex (IHC) Injection
Histaglobulin prefilled syringe is administered subcutaneously as a single 1mL dose.
Sponsors
Bharat Serums and Vaccines Limited
Innvocept Global Solutions Private Limited
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female patients aged ≥13 years. 2. Able and willing to provide written informed consent (or assent where applicable). 3. Diagnosed with chronic urticaria with UAS7 prior to enrollment already on first line of treatment for Chronic Urticaria 4. Prescribed Histoglob injections for the first time at the discretion of treating physician as part of routine car
Exclusion criteria
1. Known allergy or hypersensitivity to Histoglob or human immunoglobulin product. 2. Patients with acute allergic attack 3. Pregnant or lactating women. 4. History of malignancy or any condition requiring immunosuppressive therapy other than study indication. 5. Participation in any other clinical study. 6. Any other condition or circumstance that, in the opinion of the study physician, makes the patient unsuitable for study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in clinical improvement as assessed by Urticaria Activity Score (UAS7) | End of study, approximately 1 year | Proportion of patients achieving UAS7 \<7 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Requirement of Antihistamine ± other non-biologic anti-allergic medications (Pill Burden): | baseline to 2 months | \- 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: | Baseline to 2 months | • Proportion of patients showing improvement in Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) score from baseline to 2 months. |
| 4. Safety and Tolerability: | Throughout the study period, an average of 1 year | Incidence, severity, and relationship of adverse events (AEs) treatment-emergent adverse events (TEAEs) and adverse drug reactions (ADRs) during the study period. |
Countries
India
Contacts
CONTACTDr.Saswata Banerjee, Vice President Medical Affairs
CONTACTDr.Falgun Vyas, MBBS, MD
STUDY_DIRECTORDr Saswata Banerjee
Bharat serums and Vaccines LTd
Outcome results
None listed