A single-centre, open single-arm study where the safety, tolerability and efficacy of subcutaneously administered ILB will be evaluated in patients with Amyotrophic Lateral Sclerosis

TikoMed AB0 个研究点目标入组 15 人开始时间: 2018年3月19日最近更新: 2019年12月10日

试验速览

暂无简介。

•1. Willing and able to give informed consent for participation in the study.
•2. Clinical diagnosis of Amyotrophic Lateral Sclerosis.
•3. Male or female patients between 18-80 years of age (inclusive).
•4. Forced Vital Capacity (FVC) >/=65 % of predicted value for gender, height and age at screening.
•5. Evaluated with ALSFRS-R and Norris clinical rating scales for at least the past 4 weeks before study drug administration.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 9
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 6

•1. Unable to understand information about the trial or are expected not to collaborate with the study team.
•2. Concurrent serious disease, other than ALS.
•3. Pregnancy.
•4. Patients of child-bearing potential not willing to use adequate double contraception with <1 % failure rate after the screening visit until the last visit.
•5. Addiction to drugs or alcohol.
•6. Confirmed HIV, Hepatitis B or C.
•7. Known bleeding disorders or abnormal bleeding events.
•8. Treatment with anticoagulant drugs warfarin and novel oral anticoagulants (NOAC) within the last 14 days prior to screening.
•9. Treatment with Riluzole or Lamotrigine within the last 28 days prior to study drug administration.
•10. Hypersensitivity to dextran sulfate
•11. Poor venous access.
•12. Patients with clinically significant abnormal PK-INR, fibrinogen, von Willebrand factor and activated partial thromboplastin time (APTT) at screening

发起方