CTRI/2023/01/049204尚未招募未知
A Global, Non-interventional Study to Prospectively Evaluate Bleeding Episodes and Treatment Use in Patients With Hemophilia
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- ApcinteX Ltd
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1. Male patients >=12 and <=65 years of age
- •2. Capable of providing written informed consent (adolescent assent and parental/guardian consent when appropriate) for participation after reading the information and consent form and having the opportunity to discuss the study with the Investigator or their designee
- •3. Historically documented severe HemA (defined as FVIII <0.01 IU/mL [ <1%]), with or without inhibitors, or moderately severe to severe HemB (defined as FIX <=0.02 IU/mL [<=2%]) without inhibitors. Patients must be currently included in a prophylactic treatment program or if undergoing an on-demand treatment regimen must have had >=6 documented acute bleeding episodes (spontaneous or traumatic) that required coagulation factor infusion during the 6 months before enrollment
- •OR: Historically documented HemB (defined as FIX <=0.05 IU/mL [<=5%]) with inhibitors with a historical or ongoing high-titer inhibitor [>=5 Bethesda Units/mL] based on medical records or laboratory reports) and an ABR of >=6 in the 6 months before enrollment
- •4. Able to use a diary to document bleeding events and treatment
排除标准
- •1. Known thrombophilia
- •2. Body weight >150 kg or body mass index >40
- •3. Known current inadequate hematologic function (eg, platelet count <100,000/uL and/or hemoglobin level <10 g/dL, <100 g/L), hepatic function (ie, total bilirubin >1.5 x upper limit of normal [ULN] [excluding Gilbert syndrome], aspartate transferase and/or alanine aminotransferase levels >3 x ULN; clinical signs or known laboratory or radiographic evidence consistent with cirrhosis of the liver) or renal function (ie, serum creatinine >2 x ULN; based on medical records or available laboratory reports)
- •4. Previous deep vein thrombosis and pulmonary embolism, myocardial infarction, or stroke
- •5. History of intolerance to subcutaneous injections
- •6. Known current uncontrolled hypertension (systolic blood pressure >160 mm Hg; diastolic blood pressure >100 mm Hg; based on medical records)
- •7. Active cancer or requires therapy for cancer, except for basal cell carcinoma
- •8. Concurrent participation in an interventional clinical trial
- •9. Current or planned use of emicizumab
- •10. Prior, ongoing, or planned treatment with gene therapy for hemophilia
- •11. History of or other evidence of recent alcohol or drug abuse as determined by the Investigator or their designee (in the 12 months before enrollment)
- •12. Known HIV infection with CD4 count (or T-cell count) of <200 cells/μL within 24 weeks before enrollment
- •13. Current or planned treatment with anticoagulant or antiplatelet drugs
- •14. Any other significant conditions or comorbidities that, in the opinion of the Investigator
研究者
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