Health Condition 1: L508- Other urticaria
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Bharat Serums and Vaccines Limited
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1. Male or female patients aged 13 years and above. 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 care.
Exclusion criteria
Exclusion criteria: 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 |
|---|---|
| 1. Change in clinical improvement as assessed by Urticaria Activity Score (UAS7): Proportion of patients achieving UAS7 less than 7 at the end of the study period and time taken to achieve UAS7 less than 7 Mean reduction of UAS7 score (from the baseline score) at the end of the study Proportion of patients achieving and maintaining a Urticaria Control Test (UCT) score of greater than or equal to 12 at the end of the study Timepoint: Baseline, 4 weeks & 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 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. 2. 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. 3. Safety & Tolerability: Incidence, severity, & relationship of adverse events (AEs) treatment-emergent adverse events (TEAEs) & adverse drug reactions (ADRs) during the study period. Proportion of patients discontinuing treatment due to adverse events or intolerance. Timepoint: Baseline, 4 weeks & 8 weeks | — |
Countries
India
Contacts
Public ContactDr Manish Rajak
Bharat Serums and Vaccines Limited
Outcome results
None listed