NCT07660172尚未招募2 期
A Phase 2, Open-label, Single-arm Study of Ianalumab in Addition to Eltrombopag in Pediatric Patients With Primary Immune Thrombocytopenia Who Had an Insufficient Response to or Relapsed After First-line Corticosteroid Treatment (VAYHIT-P).
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 36
研究概览
简要总结
The purpose of this study is to assess the efficacy, safety and pharmacokinetics (PK) of ianalumab (VAY736) in addition to eltrombopag treatment; and to inform the dose of ianalumab in pediatric patients (5 to <18 years of age) with primary ITP who have had an insufficient response to or relapsed after first-line treatment with corticosteroids.
详细描述
The study will consist of 3 phases:
- Screening phase
- Treatment phase
- Follow-up phase consisting of Efficacy follow-up phase and Safety follow-up phase
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent and/or assent must be obtained from the participant and/or their parent(s)/legal guardian(s) before any study-related activity or assessment is performed. Informed consent must be obtained from participants once they reach the local legal age of adulthood during the study.
- •Male or female patients aged 5 to <18 years on the day of signing informed assent/consent (as appropriate for age).
- •A confirmed diagnosis of primary ITP, with insufficient response to, or relapse after a firstline corticosteroid therapy with or without IVIG.
- •Patients with platelet count <30 G/L for whom eltrombopag is clinically indicated (per physician's discretion) and with no contraindications to receive eltrombopag.
- •Patients who are up-to-date on childhood vaccinations as per the local recommended vaccination schedule.
排除标准
- •Patients with ITP who received previous second-line ITP treatments (other than corticosteroid therapy with or without IVIG) including splenectomy. However, patients exposed to thrombopoietin receptor agonists (TPO-RAs) for a limited time (maximum one week) before or during screening are eligible.
- •Patients with key renal or hepatic laboratory abnormalities.
- •Patients with other hematologic diagnosis associated with cytopenias, including Evans Syndrome.
- •Patients with current or history of life-threatening bleeding due to thrombocytopenia.
- •Patients who are Human Immunodeficiency Virus (HIV), hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) positive.
- •Patients with known active or uncontrolled infections requiring systemic treatment during the screening period or history of recurrent clinically significant infection.
- •Patients with hepatic impairment (Child-Pugh score >5, or equivalent).
- •Patients with concurrent bleeding disorders or coagulation disorders and/or receiving antiplatelet or anticoagulant medication.
- •Female patients who are nursing or pregnant.
- •Other protocol-defined inclusion/exclusion may apply.
研究组 & 干预措施
Ianalumab + eltrombopag
Experimental
Participants will receive ianalumab in addition to eltrombopag.
干预措施: Ianalumab (Biological)
Ianalumab + eltrombopag
Experimental
Participants will receive ianalumab in addition to eltrombopag.
干预措施: Eltrombopag (Drug)
研究者
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