NL-OMON43447已完成不适用
A Phase 1, Prospective, Open Label, Two Period, Fixed Sequence, Dose-Escalation Study of the PK and Safety of BAX 826 (PSA-rFVIII) in Previously Treated Patients with Severe (FVIII <1%) Hemophilia A: Protocol number: 291501 - BAX 826 Dose Escalation Safety Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Baxter
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Previously treated male subjects aged 18 to 65 years (inclusive) at the time of screening.
- •2. Prior diagnosis of severe hemophilia A (FVIII level <1%) or as confirmed by the central laboratory at screening.
- •3. Previously treated with FVIII concentrates for *150 documented EDs.
- •4. Karnofsky performance score of *60
- •5. Human immunodeficiency virus negative (HIV-); or HIV+ with stable disease and cluster of differentiation 4 (CD4+) count *200 cells/mm3, as confirmed by the central laboratory at screening
- •6. Hepatitis C virus negative (HCV-) by antibody or polymerase chain reaction (PCR) testing as confirmed by the central laboratory at screening; or HCV+ with chronic stable hepatitis as assessed by the investigator
- •7. Able to understand and have provided written informed consent including signature on an informed consent form (ICF) approved by an ethics committee (EC)
- •8. Have provided written authorization for use and disclosure of protected health information
- •9. Agree to abide by the study schedule and to return for the required assessments
- •10. Willing and able to comply with the requirements of the protocol
排除标准
- •1. Detectable FVIII inhibitor at screening, with a titer *0.6 BU (Nijmegen modification of the Bethesda assay) as determined at the central laboratory
- •2. Documented history of FVIII inhibitors with a titer *0.4 BU (using the Nijmegen modification of the Bethesda assay or *0.6 with Bethesda assay) at any time prior to screening
- •3. Known clinical hypersensitivity towards mouse or hamster proteins or to PSA
- •4. Scheduled elective surgery during study participation
- •5. Severe chronic hepatic dysfunction (defined as *5 x upper limit of normal [ULN] alanine aminotransferase [ALT] or an international normalized ratio [INR] >1.5).
- •6. Severe renal impairment (serum creatinine >2.0 mg/dL)
- •7. Currently receiving, or has recently received (less than 3 months prior to study participation), or is scheduled to receive during the course of the study, other PSA-ylated drugs
- •8. Have received another investigational drug within 30 days prior to study entry and/or is scheduled to receive additional investigational drug during the course of the study in the context of another investigational drug study
- •9. Diagnosis of an inherited or acquired hemostatic defect other than hemophilia A
- •10. Currently receiving, or scheduled to receive during the course of the study, an immune-modulating drug (eg, systemic corticosteroid agent at a dose equivalent to hydrocortisone greater than 10 mg/day, or alpha interferon) other than anti-retroviral chemotherapy
- •11. Has a clinically significant medical, psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the investigator, would affect the safety or compliance of the subject during the study
- •12. Is a family member or employee of the investigator
研究者
相似试验
招募中
2 期
A Phase II, Open-Label, Single Arm, prospective, multicenter study of niraparib plus dostarlimab in patients with advanced non-small cell lung cancer and/or malignant pleural mesothelioma, and positive for PD-L1 expression and germline or somatic mutations in the HRR genesPLEURAL MESOTHELIOMA2024-515555-38-01Universita' Degli Studi Di Torino48
已完成
不适用
A phase I, open-label, randomized, two period, two-way cross over study to assess the influence of a high-calorie, high fat meal on the bioavailability of a 40 mg extended release PHA 022121 oral formulatioangioedemaNL-OMON53489Pharvaris Netherlands BV10
进行中（未招募）
不适用
A Phase II, single center open label, prospective trial to evaluate the efficacy and safety of mepolizumab for patients with refractory or relapsing Churg Strauss Syndrome - MEPOCHUSSChurg-Strauss-SyndromeMedDRA version: 9.1Level: LLTClassification code 10009164Term: Churg Strauss syndromeEUCTR2006-001791-20-DEniversity Hospital of Schleswig-Holstein (UKSH), Campus Lübeck
已完成
2 期
A clinical study to evaluate safety andEffectiveness of the Elure advanced skin whitening products (Advanced whitening lotion andAdvanced whitening night cream) in imparting skin fairness on healthy human volunteers.CTRI/2012/01/002363Syneron P Ltd40
已完成
1 期
A Phase 1, Open Label, Randomized, Two-Period, Crossover Study to Evaluate the Relative Bioavailability of Two Paltusotine Tablet Strengths in Healthy VolunteersAcromegalyACTRN12622000491763Crinetics Australia Pty Ltd14