Characteristics (N) 025 Phase I/II, Single Patients with Type 1 12 41.7 Male center; Open label; Gaucher disease who (18.8 - 69.8) and 15 U/kg to 60 U/kgb had received no Female velaglucerase alfa treatment within 12 ghu EOW, IV months prior to study infusion entry; patients 9 months exhibited anemia, thrombocytopaenia, deficient GCB activity as measured in leukocytes. Patients with splenectomy were excluded. 025EXT Phase I/II, Open label extension 10 38.8 Male Multicenter; 60 study of patients (18 - 63) and 30 U/kg completing week 41 Female velaglucerase alfa in TKT025 ghu EOW, IV infusion 60 monthsc 032 III, Multicenter, Patients with Type 1 25 26.0 Male Randomised, Gaucher disease who (4.0 - 62) and Double-blind, had received no Female Parallel group, treatment within Controlled; 45 U/kg months prior to study or 60 U/kg entry; patients had velaglucerase alfa deficient GCB activity ghu EOW, IV as measured in infusion leukocytes or by 12 months genotype analysis; patients exhibited decreased haemoglobin and platelet counts and increased spleen and liver volume. Patients with splenectomy were excluded. 039 Phase III, Patients with Type 1 35 29.7 Male Multicenter, Gaucher disease who (3.0 - 73) and Randomised, had received no Female Double-blind, Active treatment within 12 comparator, months to study Controlled; 60 U/kg entry; patients had velaglucerase alfa deficient GCB activity ghu EOW, IV as measured in infusion for 60 leukocytes or by minutes genotype analysis; 60 U/kg patients exhibited imiglucerase decreased EOW, IV infusion for haemoglobin and 1-2 hours platelet counts and 9 months increased spleen and liver volume. 034 Phase II/III, Patients previously 40 35.6 Male Multicenter, Open treated for a minimum (9.0 - 71) and
Characteristics (N) 025 Phase I/II, Single center; Open label; 15 U/kg to 60 U/kgb velaglucerase alfa ghu EOW, IV infusion 9 months Patients with Type 1 Gaucher disease who had received no treatment within 12 months prior to study entry; patients exhibited anemia, thrombocytopaenia, deficient GCB activity as measured in leukocytes. Patients with splenectomy were excluded. 12 41.7 (18.8 - 69.8) Male and Female 025EXT Phase I/II, Multicenter; 60 U/kg velaglucerase alfa ghu EOW, IV infusion 60 monthsc Open label extension study of patients completing week 41 in TKT025 10 38.8 (18 - 63) Male and Female 032 III, Multicenter, Randomised, Double-blind, Parallel group, Controlled; 45 U/kg or 60 U/kg velaglucerase alfa ghu EOW, IV infusion 12 months Patients with Type 1 Gaucher disease who had received no treatment within 30 months prior to study entry; patients had deficient GCB activity as measured in leukocytes or by genotype analysis; patients exhibited decreased haemoglobin and platelet counts and increased spleen and liver volume. Patients with splenectomy were excluded. 25 26.0 (4.0 - 62) Male and Female 039 Phase III, Multicenter, Randomised, Double-blind, Active comparator, Controlled; 60 U/kg velaglucerase alfa ghu EOW, IV infusion for 60 minutes 60 U/kg imiglucerase EOW, IV infusion for 1-2 hours 9 months Patients with Type 1 Gaucher disease who had received no treatment within 12 months to study entry; patients had deficient GCB activity as measured in leukocytes or by genotype analysis; patients exhibited decreased haemoglobin and platelet counts and increased spleen and liver volume. 35 29.7 (3.0 - 73) Male and Female 034 Phase II/III, Multicenter, Open Patients previously treated for a minimum 40 35.6 (9.0 - 71) Male and
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