6 results
7.2 Primary ObjectiveThe primary objective is to assess the incidence of FVIII inhibitory antibodies(>=0.6 Bethesda units [BU] using the Nijmegen modification of the Bethesda assay).7.3 Secondary Objectives1. To evaluate the PK parameters of…
Purpose of this study is to assess the feasibility, tolerability of a short thumb opposition splint and the initial efficacy of this splint on manual dexterity and perceived limitations in activities in patients with HMSN1a. Additionally, the…
Primary Objective:The primary objective of the study is to determine the safety including immunogenicity of BAX 855 based on the incidence of inhibitor development to FVIII (* 0.6 Bethesda unit (BU)/mL using the Nijmegen modification of the Bethesda…
This study will evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of GDC-0134 in patients with amyotrophic lateral sclerosis (ALS).The long term safety and tolerability of up to 48 weeks of GDC-0134 will…
Study Purpose* To continue the evaluation of the safety and efficacy of prophylaxis with BAX 855 for the prevention and treatment of bleeding episodes in PTPs (children and adults from 0 to 75 years of age) with severe hemophilia A.Primary…
This study will evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of GDC-0134 in patients with amyotrophic lateral sclerosis (ALS). Safety Objective: To evaluate the safety of single and multiple…