Idursulfase (ELAPRASE) ( DrugBank: Idursulfase )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
19ライソゾーム病4

19. ライソゾーム病


臨床試験数 : 899 薬物数 : 684 - (DrugBank : 99) / 標的遺伝子数 : 51 - 標的パスウェイ数 : 182
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
1EUCTR2021-005200-35-CZ
(EUCTR)
05/08/202224/05/2022Study to determine effectiveness and safety of DNL310 vs Idursulfase in Pediatric Participants With Neuronopathic or Non-Neuronopathic Hunter SyndromeA Phase 2/3, Multicenter, Double-Blind, Randomized Study to Determine the Efficacy and Safety of DNL310 vs Idursulfase in Pediatric Participants With Neuronopathic or Non-Neuronopathic Mucopolysaccharidosis Type II Mucopolysaccharidosis Type II [MPS II];Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: DNL310
Product Code: DNL310
INN or Proposed INN: DNL310
Other descriptive name: IDURONATE-2-SULFATASE FUSED TO A FC POLYPEPTIDE THAT BINDS TO THE HUMAN TRANSFERRIN RECEPTOR
Trade Name: Idursulfase (Elaprase)
Product Name: idursulfase (ELAPRASE)
INN or Proposed INN: Idursulfase
Other descriptive name: Purified form of the lysosomal enzyme iduronate-2-sulfatase
Denali Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
54Phase 2;Phase 3Colombia;Argentina;United States;Czechia;United Kingdom;Spain;Canada;Czech Republic;Sweden;Netherlands;Turkey;Belgium;Brazil;Mexico;Italy;Australia;France;Germany
2EUCTR2021-005200-35-NL
(EUCTR)
11/05/2022Study to determine effectiveness and safety of DNL310 vs Idursulfase in Pediatric Participants With Neuronopathic or Non-Neuronopathic Hunter SyndromeA Phase 2/3, Multicenter, Double-Blind, Randomized Study to Determine the Efficacy and Safety of DNL310 vs Idursulfase in Pediatric Participants With Neuronopathic or Non-Neuronopathic Mucopolysaccharidosis Type II Mucopolysaccharidosis Type II [MPS II];Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: DNL310
Product Code: DNL310
INN or Proposed INN: DNL310
Other descriptive name: IDURONATE-2-SULFATASE FUSED TO A FC POLYPEPTIDE THAT BINDS TO THE HUMAN TRANSFERRIN RECEPTOR
Trade Name: Idursulfase (Elaprase)
Product Name: idursulfase (ELAPRASE)
INN or Proposed INN: Idursulfase
Other descriptive name: Purified form of the lysosomal enzyme iduronate-2-sulfatase
Denali Therapeutics Inc.NULLNAFemale: yes
Male: yes
54Phase 2;Phase 3United States;Czechia;Spain;Turkey;Colombia;United Kingdom;Italy;France;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Netherlands;Germany;Sweden
3EUCTR2021-005200-35-FR
(EUCTR)
20/05/2022Study to determine effectiveness and safety of DNL310 vs Idursulfase in Pediatric Participants With Neuronopathic or Non-Neuronopathic Hunter SyndromeA Phase 2/3, Multicenter, Double-Blind, Randomized Study to Determine the Efficacy and Safety of DNL310 vs Idursulfase in Pediatric Participants With Neuronopathic or Non-Neuronopathic Mucopolysaccharidosis Type II Mucopolysaccharidosis Type II [MPS II];Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: DNL310
Product Code: DNL310
INN or Proposed INN: DNL310
Other descriptive name: IDURONATE-2-SULFATASE FUSED TO A FC POLYPEPTIDE THAT BINDS TO THE HUMAN TRANSFERRIN RECEPTOR
Trade Name: Idursulfase (Elaprase)
Product Name: idursulfase (ELAPRASE)
INN or Proposed INN: Idursulfase
Other descriptive name: Purified form of the lysosomal enzyme iduronate-2-sulfatase
Denali Therapeutics Inc.NULLNAFemale: yes
Male: yes
54Phase 2;Phase 3United States;Czechia;Spain;Turkey;Colombia;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Netherlands;Germany;Sweden
4EUCTR2021-005200-35-DE
(EUCTR)
27/04/2022Study to determine effectiveness and safety of DNL310 vs Idursulfase in Pediatric Participants With Neuronopathic or Non-Neuronopathic Hunter SyndromeA Phase 2/3, Multicenter, Double-Blind, Randomized Study to Determine the Efficacy and Safety of DNL310 vs Idursulfase in Pediatric Participants With Neuronopathic or Non-Neuronopathic Mucopolysaccharidosis Type II Mucopolysaccharidosis Type II [MPS II];Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: DNL310
Product Code: DNL310
INN or Proposed INN: DNL310
Other descriptive name: IDURONATE-2-SULFATASE FUSED TO A FC POLYPEPTIDE THAT BINDS TO THE HUMAN TRANSFERRIN RECEPTOR
Trade Name: Idursulfase (Elaprase)
Product Name: idursulfase (ELAPRASE)
INN or Proposed INN: Idursulfase
Other descriptive name: Purified form of the lysosomal enzyme iduronate-2-sulfatase
Denali Therapeutics Inc.NULLNAFemale: yes
Male: yes
54Phase 2;Phase 3United States;Czechia;Spain;Turkey;Colombia;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Australia;Netherlands;Germany;Sweden