NCT07680413招募中不适用
Real-world Evaluation of the Effectiveness of Immunoglobulin-Histamine Complex; IHC (Histoglob) in the Management of Chronic Urticaria: A Prospective, Multicenter, Observational Study.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 40
- 主要终点
- Change in clinical improvement as assessed by Urticaria Activity Score (UAS7)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in clinical improvement as assessed by Urticaria Activity Score (UAS7)
时间窗: End of study, approximately 1 year
Proportion of patients achieving UAS7 \<7
次要结局
- Requirement of Antihistamine ± other non-biologic anti-allergic medications (Pill Burden):(baseline to 2 months)
- 3. Change in Quality of Life:(Baseline to 2 months)
- 4. Safety and Tolerability:(Throughout the study period, an average of 1 year)
研究者
研究点 (40)
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