EUCTR2013-002812-28-GR进行中（未招募）1 期
A single arm, multicenter, phase IIa study to explore the efficacy and safety of ruxolitinib (INC424) in regularly transfused patients with thalassemia
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients 18 years of age or older
- •2. Patients with thalassemia on a regular and stable transfusion regimen (at least 2 RBC units within every 4-week interval for 24 weeks prior to Screening) and anticipated to receive the same transfusion regimen during the study.
- •3. Patients with spleen enlargement at Screening, defined as
- •a. Spleen palpable below the costal margin, AND
- •b. Spleen volume of = 450 cm3 as confirmed by MRI (or CT scan in applicable patients)
- •4. Patients need to be on iron chelation treatment (deferoxamine or deferasirox) for at least four weeks prior to Screening.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Splenectomy prior to or planned during the study
- •2. Active serious bacterial, mycobacterial, fungal, parasitic or viral infection which requires therapy (e.g., pneumonia, tuberculosis, systemic mycosis, herpes zoster)
- •3. Hemoglobin <65 g/L (<4.0 mmol/L) at Screening
- •4. Platelet count < 75 109/L, absolute neutrophils count < 1.5 109/L at Screening
- •5. Estimated MDRD < 30 mL/min/1.73 m2 at Screening
- •6. ALT (SGPT) levels >5 times ULN at Screening
- •7. Hepatocellular disease such as hepatitis B (presence of HBs antigen), hepatitis C (presence of HCV RNA), liver cirrhosis
- •8. HIV positivity
研究者
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