Prospective, multi-centre, clinical study to evaluate theefficacy, safety and pharmacokinetics of HemoRel-AÂ® in Hemophilia A patients

Dr Savita Rangarajan0 个研究点目标入组 44 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•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.
•4. Number of exposure days before inclusion greater than 50 ED.
•5.Immunocompetent with CD4 lymphocytes greater than 200/Î¼l.
•6. HIV negative or having a viral load less than 200 particles/Î¼l approx 400000 copies/ml.
•7.Willing to provide written Informed Consent.
•8.Able to adhere to study schedules and requirements.

•1. Subjects with history of inhibitors to FVIII
•2. Any other inherited or acquired bleeding disorder
•3. Subjects with any major systemic illness, and/or had known hypersensitivity to
•HemoRel-AÂ® or any of its component.
•4. Subjects with abnormal laboratory parameters like:
•ï?§ Serum creatinine greater than 1.5 times of upper normal limit
•ï?§ AST or ALT greater 3 times of upper normal limit
•ï?§ Platelet count less than 100,000/Î¼L
•ï?§ Hemoglobin less than 10.0 gm/dL
•ï?§ Neutrophils less than 1.5 X 10 raised to 3/Î¼L
•5. History of clinically significant diseases, e.g. epilepsy, diabetes, cardiovascular,
•gastro-intestinal, hepatic, renal, pulmonary, or abdominal disease.
•6. Subject participation in any other clinical trial 30 days prior to administration of IP.
•7. Any other condition which investigator feels would affect interpretation of the
•results or render the subject at high risk.

发起方

Dr Savita Rangarajan