PEGUNIGALSIDASE ALFA

( DrugBank: - / KEGG DRUG: - )

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	42

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

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No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT05710692 (ClinicalTrials.gov)	March 2023	13/12/2022	Study to Evaluate the Safety, PK, PD, and Efficacy of PRX-102 in Japanese Patients With Fabry Diseas ...	A Multicenter Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Effic ...	Fabry Disease	Drug: PRX-102 1 mg/kg every 2 weeks;Drug: PRX-102 2 mg/kg every 4 weeks	Chiesi Farmaceutici S.p.A.	NULL	Not yet recruiting	18 Years	60 Years	All	18	Phase 2/Phase 3	NULL
2	EUCTR2018-001148-67-FI (EUCTR)	16/04/2021	28/01/2021	Safety and Efficacy study assessing Pegunigalsidase Alfa (PRX-102) in Patients With Fabry Disease	Open Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegunigalsidase Alfa(PRX ...	MedDRA version: 24.1;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class ...	Product Name: Pegunigalsidase alfa Product Code: PRX-102 INN or Proposed INN: PEGUNIGALSIDASE ALFA Othe ...	Chiesi Farmaceutici S.p.A	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	110	Phase 3	United States;Czechia;Slovenia;Finland;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Cana ...
3	EUCTR2018-001148-67-IT (EUCTR)	11/11/2020	21/10/2020	Safety and Efficacy study assessing Pegunigalsidase Alfa (PRX-102) in Patients With Fabry Disease	Open Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegunigalsidase Alfa(PRX ...	Fabry disease (a-galactosidase A deficiency) MedDRA version: 20.0;Level: PT;Classification code 1001 ...	Product Name: Pegunigalsidase alfa Product Code: [PRX-102] INN or Proposed INN: PEGUNIGALSIDASE ALFA	PROTALIX LTD	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	110	Phase 3	United States;Slovenia;Finland;Spain;Turkey;United Kingdom;Italy;Switzerland;Czech Republic;Hungary; ...
4	NCT04552691 (ClinicalTrials.gov)	August 7, 2020	11/9/2020	Open-Label Expanded Access Treatment With Pegunigalsidase Alfa for Fabry Disease Patients	Expanded Access Treatment With Open-Label Pegunigalsidase Alfa for Fabry Patients	Fabry Disease	Drug: Pegunigalsidase Alfa	Protalix	Chiesi USA, Inc.	Available	18 Years	N/A	All			United States
5	EUCTR2018-001148-67-SI (EUCTR)	09/01/2020	03/04/2019	Safety and Efficacy study assessing Pegunigalsidase Alfa (PRX-102) in Patients With Fabry Disease	Open Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegunigalsidase Alfa(PRX ...	MedDRA version: 20.0;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class ...	Product Name: Pegunigalsidase alfa Product Code: PRX-102 INN or Proposed INN: PEGUNIGALSIDASE ALFA	Protalix Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	110	Phase 3	United States;Slovenia;Spain;Turkey;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;A ...
6	EUCTR2018-001148-67-HU (EUCTR)	07/11/2019	08/11/2019	Safety and Efficacy study assessing Pegunigalsidase Alfa (PRX-102) in Patients With Fabry Disease	Open Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegunigalsidase Alfa(PRX ...	MedDRA version: 20.0;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class ...	Product Name: Pegunigalsidase alfa Product Code: PRX-102 INN or Proposed INN: PEGUNIGALSIDASE ALFA	Protalix Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	110	Phase 3	United States;Slovenia;Spain;Turkey;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;A ...
7	EUCTR2018-001947-30-IT (EUCTR)	31/10/2019	01/09/2021	Safety and Efficacy study assessing Pegunigalsidase Alfa(PRX-102) Administered by Intravenous Infusi ...	Open Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegunigalsidase Alfa(PRX ...	Fabry disease (a-galactosidase A deficiency) MedDRA version: 20.0;Level: PT;Classification code 1001 ...	Product Name: Pegunigalsidase alfa Product Code: [PRX-102] INN or Proposed INN: PEGUNIGALSIDASE ALFA	PROTALIX LTD	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Phase 3	United States;Czechia;Taiwan;Finland;Spain;Turkey;United Kingdom;Italy;France;Canada;Belgium;Austral ...
8	EUCTR2018-001947-30-DK (EUCTR)	22/10/2019	13/06/2019	Safety and Efficacy study assessing Pegunigalsidase Alfa(PRX-102) Administered by Intravenous Infusi ...	Open Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegunigalsidase Alfa(PRX ...	MedDRA version: 24.1;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class ...	Product Name: Pegunigalsidase alfa Product Code: PRX-102 INN or Proposed INN: PEGUNIGALSIDASE ALFA	Protalix Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Phase 3	United States;Czechia;Belgium;Denmark;Norway;United Kingdom;Italy
9	EUCTR2018-001148-67-NL (EUCTR)	21/06/2019	24/07/2019	Safety and Efficacy study assessing Pegunigalsidase Alfa (PRX-102) in Patients With Fabry Disease	Open Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegunigalsidase Alfa(PRX ...	MedDRA version: 24.1;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class ...	Product Name: Pegunigalsidase alfa Product Code: PRX-102 INN or Proposed INN: PEGUNIGALSIDASE ALFA	Protalix Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	110	Phase 3	United States;Czechia;Slovenia;Finland;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Cana ...
10	EUCTR2018-001947-30-GB (EUCTR)	27/05/2019	24/10/2019	Safety and Efficacy study assessing Pegunigalsidase Alfa(PRX-102) Administered by Intravenous Infusi ...	Open Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegunigalsidase Alfa(PRX ...	MedDRA version: 20.0;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class ...	Product Name: Pegunigalsidase alfa Product Code: PRX-102 INN or Proposed INN: PEGUNIGALSIDASE ALFA	Protalix Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Phase 3	United States;Taiwan;Spain;Turkey;United Kingdom;Italy;Czech Republic;Canada;Belgium;Australia;Denma ...

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