NCT03565237已完成4 期
Phase IV Multi-Center, Prospective, Interventional, Post-Marketing Study in Hemophilia B Patients in India Receiving RIXUBIS as On-demand or Prophylaxis Under Standard Clinical Practice
Baxalta now part of Shire2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2018年12月7日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Number of Participants With Serious Treatment-emergent Adverse Events (TEAEs) Related to RIXUBIS
研究概览
简要总结
The purpose of this study is to characterize the safety and describe the effectiveness of RIXUBIS in routine clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant or legally authorized representative (in case of study participants <18 years of age) gave written informed consent to participate in the study.
- •Participant has hemophilia B.
- •Participant is defined as previously-treated patient (PTP):
- •Participant aged ≥ 6 years that has been previously treated with plasma-derived and/or recombinant factor IX (FIX) concentrate(s) for a minimum of 150 exposure days (EDs).
- •Participant aged < 6 years that has been previously treated with plasma-derived and/or recombinant FIX concentrate(s) for a minimum of 50 EDs.
- •Participant has no evidence of a history of FIX inhibitors.
- •Participant is human immunodeficiency virus negative (HIV-); or HIV+ with stable disease and CD4+ count ≥ 200 cells/mm^3, as confirmed by central laboratory at screening.
- •Participant is hepatitis C virus negative (HCV-) by antibody or PCR testing (if positive, antibody titer will be confirmed by polymerase chain reaction (PCR)), as confirmed by central laboratory at screening; or HCV+ with chronic stable hepatitis.
- •The participant is willing and able to comply with the requirements of the protocol.
排除标准
- •Participant has known hypersensitivity or presence of any contraindication to RIXUBIS or its excipients including hamster protein.
- •Participant has evidence of an ongoing or recent thrombotic disease, fibrinolysis or disseminated intravascular coagulation (DIC).
- •Participant has a history of FIX inhibitors with a titer ≥ 0.6 Bethesda Units (BU) (as determined by the Nijmegen modification of the Bethesda assay or the assay, employed in the respective local laboratory) at any time prior to screening.
- •Participant has a detectable FIX inhibitor at screening, with a titer ≥ 0.6 BU as determined by the Nijmegen modification of the Bethesda assay in the central laboratory.
- •Participant has severe chronic liver disease as evidenced by, but not limited to, any of the following: International Normalized Ratio (INR) > 1.4 hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices.
- •Participant has severe chronic hepatic dysfunction [eg, ≥ 5 times upper limit of normal alanine aminotransferase (ALT), as confirmed by central laboratory at screening, or a documented INR > 1.5].
- •Participant has severe renal impairment (serum creatinine > 2.0 mg/dL), as confirmed by central laboratory at screening.
- •Participant has been diagnosed with an inherited or acquired hemostatic defect other than hemophilia B.
- •Participant's platelet count is < 100,000/mL.
- •Participant has a clinically significant medical, psychiatric, or cognitive illness, or recreational drug/alcohol use that, in the opinion of the investigator, would affect participant's safety or compliance.
- •Participant 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 10 mg/day, or α-interferon) other than antiretroviral chemotherapy.
- •Participant 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.
- •Participant is a family member or employee of the investigator.
结局指标
主要结局
Number of Participants With Serious Treatment-emergent Adverse Events (TEAEs) Related to RIXUBIS
时间窗: From start of study drug administration up to End of treatment (EOT) (up to 6 months)
TEAE was defined as any event not presented prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments. A SAE was defined as any untoward medical occurrence that at any dose met one or more of the following criteria: outcome was fatal/resulted in death, life-threatening, required in-patient hospitalization or resulted in prolongation of an existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event that was not immediately life-threatening or resulted in death or required hospitalization but jeopardize the participant or required medical or surgical intervention to prevent any of the above outcomes. Relatedness to study drug was based on physician discretion. Number of participants with serious TEAEs related to RIXUBIS were reported.
次要结局
- Annualized Bleeding Rate (ABR) With Prophylactic Use of RIXUBIS(From start of study drug administration up to EOT (up to 6 months))
- Number of Participants With TEAEs Related to RIXUBIS(From start of study drug administration up to EOT (up to 6 months))
- Number of Participants With Clinically Significant Laboratory Abnormalities(From start of study drug administration up to EOT (up to 6 months))
- Number of Participants Who Developed Binding Antibodies (Immunoglobulin G [IgG] and Immunoglobulin M [IgM]) to Factor IX (FIX)(From start of study drug administration up to EOT (up to 6 months))
- Number of Participants Who Developed Binding Antibodies to Chinese Hamster Ovary (CHO) Proteins and rFurin(From start of study drug administration up to EOT (up to 6 months))
- Rate of Success of RIXUBIS for Treatment of Bleeding Episodes(From screening up to EOT (up to 6 months))
研究者
研究点 (2)
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