CTRI/2021/10/037406进行中（未招募）4 期
Phase 4, Multicenter, Prospective, Interventional, Post-Marketing Study in Hemophilia A Patients in India Receiving ADVATE as On-Demand or Prophylaxis Under Standard Clinical Practice
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 5
- 主要终点
- Incidence of SAEs (including FVIII inhibitor formation) that are at least possibly related to ADVATE
研究概览
简要总结
This is a single-country,multi-centre, prospective, interventional, open-label, post-marketing,non-randomised trial with a single treatment arm in previously treated haemophiliaA patients (PTPs) in India receiving ADVATE under standard clinical practice.
50 PTPs with congenital haemophilia A will receive aprophylactic or on demand regimen with ADVATE (Recombinant Coagulation FactorVIII -rFVIII; Octocog Alfa) for a period of 6 months ± 1 week
All enrolled subjects who havemet the inclusion and exclusion criteria will be treated with ADVATE accordingto a regimen determined by the treating physician.The individual subjectsduration of participation is expected to be approximately 7-8 months. Theperiod of observation for each subject will be 6 months; another 10 to 15 daysare anticipated for the study completion visit (“End-of-Treatment Visitâ€).
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 0.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •The subject or legally authorized representative (in case of study participants <18 years of age) gave written informed consent to participate in the study.
- •Subject of any age with hemophilia A.
- •Subject is defined as previously treated patient (PTP): • Subject aged ≥ 6 years that has been previously treated with plasma-derived and/or recombinant FVIII concentrate(s) for a minimum of 150 exposure days (EDs).
- •â€¢ Subject aged < 6 years that has been previously treated with plasma-derived and/or recombinant FVIII concentrate(s) for a minimum of 50 EDs.
- •Subject has negative history of FVIII inhibitors and negative inhibitor at screening defined as less than 0.6 Bethesda units (BU)/mL (Nijmegen-modified Bethesda assay).
- •Subject is human immunodeficiency virus negative (HIV-); or HIV+ with stable disease and CD4+ count ≥ 200 cells/mm3, as confirmed by central laboratory at screening.
- •Subject is hepatitis C virus negative (HCV-) by antibody or polymerase chain reaction (PCR) testing (if positive, antibody titer will be confirmed by PCR), as confirmed by central laboratory at screening; or HCV+ with chronic stable hepatitis.
- •The subject is willing and able to comply with the requirements of the protocol.
排除标准
- •Subject has known hypersensitivity to mouse or hamster proteins or to any of the excipients of FVIII concentrates.
- •Subject has been diagnosed with bleeding disorder(s) other than congenital hemophilia A, such as acquired hemophilia A, von Willebrand´s disease or thrombocytopenia (platelet count<100,000/mL).
- •Subject has received treatment for hemophilia A with non-FVIII products/concentrates (eg, emicizumab [Hemlibra®]) in the 6 months prior to screening.
- •Subject has severe chronic hepatic dysfunction [eg, ≥ 5 times upper limit of normal alanine aminotransferase (ALT), aspartate aminotransferase (AST) or INR > 1.5 as confirmed by central laboratory at screening].
- •Subject has planned, or is likely to have, surgery during the study period.
- •Subject has a clinically significant medical, psychiatric, or cognitive illness, or recreational drug/alcohol use that, in the opinion of the investigator, would affect subject’s safety or compliance.
- •Subject is currently receiving or is scheduled to receive during the course of the study, an immunomodulating drug (eg, corticosteroid agents at a dose equivalent to hydrocortisone greater than mg/day, or α-interferon) other than antiretroviral chemotherapy.
- •Subject has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study.
- •Subject is a family member or employee of the investigator.
结局指标
主要结局
Incidence of SAEs (including FVIII inhibitor formation) that are at least possibly related to ADVATE
时间窗: 6 months ± 1 week
次要结局
- Safety:(1. Incidence of non-serious AEs that are at least possibly related to ADVATE.)
- Efficacy:(1. Annualized bleeding rate (ABR) with prophylactic use of ADVATE.)
研究者
研究点 (5)
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