Have used other investigational drugs within 1 month or within 5 drug half-lives.Active hepatitis B infection (positive hepatitis B surface antigen and/or positive hepatitis B core antibody).Positive hepatitis C virus antibody or history of positive tests. ![]() HIV test positive or history of positive tests.Patients who have previously received or are currently receiving Tofersen treatment.Patients with SOD1 mutations occurring at nucleotides 44 to 66 (calculated from the start of SOD1 protein translation), patients with P.F21C mutation.Subjects (including male subjects) are willing to have no birth plan and voluntarily take effective contraceptive measures during the entire study period and within 3 months after the end of the study, and have no plan to donate sperm or eggs.The patient or patient's legal representative clearly understands and voluntarily participates in the study and signs the informed consent form.Diagnosis of confirmed or probable familial or sporadic ALS in accordance with the revised EI Escorial diagnostic criteria for amyotrophic lateral sclerosis of the World Federation of Neurology.Forced vital capacity ≥ 80% of predicted vital capacity during the screening period.ALS patients with confirmed SOD1 gene mutations document (known SOD1 mutation sites and related disease progression have been reported).18 years old ≤ age ≤ 75 years old, males or females.Patients who are judged by professional medical staff to still be able to carry out the clinical trial project cycle.Why Should I Register and Submit Results?.
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