A Global Phase 3 Double-Blind, Placebo-Controlled study to assess Efficacy and Safety of Birtamimab Plus Standard of Care vs. Placebo Plus Standardof Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis A Global Phase 3 Double-Blind, Placebo-Controlled study to assess Efficacy and Safety of Birtamimab ...
A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. PlaceboPlus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis - NA A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of B ...
AL amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains.Overproduction of misfolded light chains results in both soluble, aggregated forms of light chains and insoluble, fibrillar deposits ofabnormal AL protein (amyloid), in the tissues and organs. This can cause a range of symptoms and organ dysfunction including cardiac, renal, andhepatic dysfunction, gastrointestinal involvement and neuropathy and macroglossia MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] AL amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded ...
Product Name: Birtamimab Product Code: [Birtamimab] INN or Proposed INN: BIRTAMIMAB Other descriptive name: Humanized IgG1 kappa antiamyloid Product Name: paracetamolo Zentiva Italia Product Code: [NA] INN or Proposed INN: PARACETAMOLO Trade Name: Bortezomib Accord Product Name: Bortezomib Accord Product Code: [Bortezomib Accord] INN or Proposed INN: BORTEZOMIB Other descriptive name: Bortezomib D-mannitol Product Name: Zirtec Product Code: [NA] INN or Proposed INN: CETIRIZINA DICLORIDRATO Other descriptive name: NA Product Name: Aciclin Product Code: [NA] INN or Proposed INN: ACICLOVIR Product Name: Birtamimab Product Code: [Birtamimab] INN or Proposed INN: BIRTAMIMAB Other descriptive n ...
Prothena Biosciences Limited
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Authorised-recruitment may be ongoing or finished
Female: yes Male: yes
150
Phase 3
United States;Portugal;Czechia;Taiwan;Greece;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Brazil;Australia;Denmark;Germany;Netherlands;Korea, Republic of United States;Portugal;Czechia;Taiwan;Greece;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary ...