Prospective, multi-centre, clinical study to evaluate theefficacy, safety and pharmacokinetics of HemoRel-A® in Hemophilia A patients
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Response of acute bleeding events to treatment based on a 4-point scale (excellent, good, moderate or none)
研究概览
简要总结
This is a prospective, multi-centre, clinical study to evaluate the efficacy, safety and pharmacokinetics of HemoRel-A® in Hemophilia A patients.
Patients with hemophilia-A experience frequent life-threatening spontaneous and traumatic bleeding, particularly in joints and muscle. Recurrent hemarthrosis is a major cause of morbidity in patients with hemophilia.
The introduction of coagulation factor replacement therapy over the past half century has greatly contributed to the improvement in care of people with hemophilia. The improvement of viral inactivation methods and methods used to screen viruses in blood donation facilities and plasma pools also greatly improved the safety of plasma-derived products. Replacement of the specific missing plasma protein is necessary for hemostasis to occur and hence products are required for longer duration for such patients.
Many considerations including efficacy, cost, safety, and ease of administration are important in selection of any specific factor VIII for treatment.
Plasma Derived Factor-VIII (HemoRel-A®) manufactured by Reliance Life Sciences Pvt. Ltd., India, is being used in patients with severe hemophilia. Plasma Derived Factor-VIII (HemoRel-A®) is generally effective and well tolerated in patients. The aim of this study is to assess the efficacy and safety aspects of Plasma Derived Factor-VIII (HemoRel-A®) in a controlled environment.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Male subjects aged between 18 to 65 years (both inclusive.
- •2.Subjects with severe hemophilia A (documented factor VIII levels lesser than 1 percent) who are receiving on-demand treatment.
- •3.History of greater than 12 bleeding events in the past 12 months.
- •Number of exposure days before inclusion greater than 50 ED.
- •HIV negative or having a viral load less than 200 particles/μl approx 400000 copies/ml.
- •7.Willing to provide written Informed Consent.
- •8.Able to adhere to study schedules and requirements.
排除标准
- •Subjects with history of inhibitors to FVIII
- •Any other inherited or acquired bleeding disorder
- •Subjects with any major systemic illness, and/or had known hypersensitivity to HemoRel-A® or any of its component.
- •Subjects with abnormal laboratory parameters like:  Serum creatinine greater than 1.5 times of upper normal limit  AST or ALT greater 3 times of upper normal limit  Platelet count less than 100,000/μL  Hemoglobin less than 10.0 gm/dL  Neutrophils less than 1.5 X 10 raised to 3/μL
- •History of clinically significant diseases, e.g. epilepsy, diabetes, cardiovascular, gastro-intestinal, hepatic, renal, pulmonary, or abdominal disease.
- •Subject participation in any other clinical trial 30 days prior to administration of IP.
- •Any other condition which investigator feels would affect interpretation of the results or render the subject at high risk.
结局指标
主要结局
Response of acute bleeding events to treatment based on a 4-point scale (excellent, good, moderate or none)
时间窗: Response of acute bleeding will be assessed at 8 Hours and at 72 hours
次要结局
- Evaluation of safety(0, 3, 8, 24, 72 hrs)
- Immunogenecity(Baseline and End of study)
- Pharmacokinetic assessment(pre-infusion (within 15 minutes prior to infusion), and 10 minutes (end of)