Real-world Evaluation of the Effectiveness of Immunoglobulin-Histamine Complex ; IHC (Histoglob) in the Management of Chronic Urticaria: A Prospective, Multicenter, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 600
- 试验地点
- 41
研究概览
简要总结
This is a prospective, multicenter, non-interventional, observational, real-world evidence (RWE) study designed to evaluate the effectiveness and safety of Histoglob (Immunoglobulin-Histamine Complex; IHC) in patients with Chronic Urticaria in India. Histoglob is a sterile preparation of Histamine dihydrochloride coupled to active protein fraction extracted from human blood (Gamma-globulin) in strictly defined proportions...
Approximately 50 centers across representative geographies in India will participate, with an anticipated enrolment of around 600 patients receiving Histoglob as part of routine clinical practice.
Patients will be followed for up to 2 months (/+ 1 week) for primary effectiveness assessment, with additional follow-up as per usual clinical care to capture safety and treatment outcomes. Data will be collected through routine clinical records and patient-reported outcome measures without any intervention beyond standard management.
The study will be initiated after obtaining written approval of Independent Ethics Committee (IEC) /Institutional Review Board (IRB).
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 13.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion Criteria
- •Male or female patients aged 13 years and above.
- •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 care.
排除标准
- •Exclusion Criteria
- •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.
- •Participation in any other clinical study.
- •Any other condition or circumstance that, in the opinion of the study physician, makes the patient unsuitable for study participation.
研究者
Dr Saswata Banerjee
Bharat Serums and Vaccines Limited (BSV)