PRX-102
( 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 | 53 |
19. ライソゾーム病
臨床試験数 : 990 / 薬物数 : 584 - (DrugBank : 126) / 標的遺伝子数 : 62 - 標的パスウェイ数 : 192
Showing 1 to 10 of 53 trials
| 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 | NCT06328608 (ClinicalTrials.gov) | February 202520250200 | 10/8/202320230810 | A Study to Learn About the Safety and Effects of the Study Drug PRX-102 in Children and Adolescents With Fabry Disease A Study to Learn About the Safety and Effects of the Study Drug PRX-102in Children and Adolescents W ... | Multi-centre, Open-label Trial to Assess the saFety, Pharmacodynamics, Efficacy and Pharmacokinetics of pegunigaLsidase Alfa in Patients From 2 Years to Less Than 18 Years of Age With Confirmed FabrY Disease Multi-centre, Open-label Trial to Assess the saFety, Pharmacodynamics, Efficacy and Pharmacokinetics ... | Fabry Disease | Drug: PRX-102 1 mg/kg every two weeks | Chiesi Farmaceutici S.p.A. | ICON plc | Recruiting | 2 Years | 17 Years | All | 22 | Phase 2/Phase 3 | United States;Austria;France;Norway;Spain;United Kingdom |
| 2 | NCT05710692 (ClinicalTrials.gov) | August 1, 202320230801 | 13/12/202220221213 | Study to Evaluate the Safety, PK, PD, and Efficacy of PRX-102 in Japanese Patients With Fabry Disease Study to Evaluate the Safety, PK, PD, and Efficacy of PRX-102in Japanese Patients With Fabry Disease ... | A Multicenter Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Pegunigalsidase Alfa (PRX-102) in Japanese Patients With Fabry Disease (RISE) 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. | ICON plc | Recruiting | 13 Years | 60 Years | All | 18 | Phase 2/Phase 3 | Japan |
| 3 | EUCTR2018-001148-67-FR (EUCTR) | 15/06/202120210615 | 07/04/202120210407 | 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-102) in Patients With Fabry Disease Open Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegunigalsidase Alfa (PR ... | MedDRA version: 20.0;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] 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 | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | Argentina;Hungary;United States;Czechia;United Kingdom;Switzerland;Spain;Canada;Netherlands;Czech Republic;Turkey;Belgium;Norway;Finland;Brazil;Italy;Slovenia;France;Australia Argentina;Hungary;United States;Czechia;United Kingdom;Switzerland;Spain;Canada;Netherlands;Czech Re ... | ||
| 4 | EUCTR2018-001148-67-FI (EUCTR) | 16/04/202120210416 | 28/01/202120210128 | 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-102) in Patients With Fabry Disease Open Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegunigalsidase Alfa (PR ... | MedDRA version: 24.1;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] 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 Other descriptive name: CHF6657 Product Name: Pegunigalsidase alfa Product Code: PRX-102 INN or Proposed INN: PEGUNIGALSIDASE ALFA Othe ... | Chiesi Farmaceutici S.p.A | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | Hungary;United States;Czechia;United Kingdom;Spain;Canada;Netherlands;Czech Republic;Norway;Finland;Italy;Slovenia;Australia;France Hungary;United States;Czechia;United Kingdom;Spain;Canada;Netherlands;Czech Republic;Norway;Finland; ... | ||
| 5 | EUCTR2018-001148-67-IT (EUCTR) | 11/11/202020201111 | 21/10/202020201021 | 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-102) in Patients With Fabry Disease - na Open Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegunigalsidase Alfa (PR ... | Fabry disease (a-galactosidase A deficiency) MedDRA version: 20.0;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] 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 | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | Argentina;Hungary;United States;United Kingdom;Switzerland;Spain;Canada;Czech Republic;Netherlands;Turkey;Belgium;Norway;Finland;Brazil;Italy;Slovenia;Australia;France Argentina;Hungary;United States;United Kingdom;Switzerland;Spain;Canada;Czech Republic;Netherlands;T ... | ||
| 6 | EUCTR2018-001148-67-SI (EUCTR) | 09/01/202020200109 | 03/04/201920190403 | 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-102) in Patients With Fabry Disease Open Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegunigalsidase Alfa (PR ... | MedDRA version: 24.1;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] 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 Other descriptive name: CHF6657 Product Name: Pegunigalsidase alfa Product Code: PRX-102 INN or Proposed INN: PEGUNIGALSIDASE ALFA Othe ... | Chiesi Farmaceutici S.p.A | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | Hungary;Czechia;United States;United Kingdom;Spain;Canada;Netherlands;Czech Republic;Norway;Finland;Italy;Slovenia;Australia;France Hungary;Czechia;United States;United Kingdom;Spain;Canada;Netherlands;Czech Republic;Norway;Finland; ... | ||
| 7 | EUCTR2018-001148-67-HU (EUCTR) | 07/11/201920191107 | 08/11/201920191108 | 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-102) in Patients With Fabry Disease Open Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegunigalsidase Alfa (PR ... | MedDRA version: 24.1;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] 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 Other descriptive name: CHF6657 Product Name: Pegunigalsidase alfa Product Code: PRX-102 INN or Proposed INN: PEGUNIGALSIDASE ALFA Othe ... | Chiesi Farmaceutici S.p.A | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | Hungary;United States;Czechia;United Kingdom;Spain;Canada;Netherlands;Czech Republic;Norway;Finland;Italy;Slovenia;Australia;France Hungary;United States;Czechia;United Kingdom;Spain;Canada;Netherlands;Czech Republic;Norway;Finland; ... | ||
| 8 | EUCTR2018-001947-30-IT (EUCTR) | 31/10/201920191031 | 01/09/202120210901 | Safety and Efficacy study assessing Pegunigalsidase Alfa (PRX-102) Administered by Intravenous Infusion Every 4 Weeks in Patients With Fabry Disease Safety and Efficacy study assessing Pegunigalsidase Alfa (PRX-102) Administered by Intravenous Infus ... | Open Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegunigalsidase Alfa (PRX-102) 2 mg/kg Administered by Intravenous Infusion Every 4 Weeks in Patients with Fabry Disease - PB-102-F51 Open Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegunigalsidase Alfa (PR ... | Fabry disease (a-galactosidase A deficiency) MedDRA version: 20.0;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] 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 | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | United States;Czechia;United Kingdom;Spain;Canada;Netherlands;Sweden;Turkey;Belgium;Norway;Taiwan;Finland;Denmark;Italy;Australia;France United States;Czechia;United Kingdom;Spain;Canada;Netherlands;Sweden;Turkey;Belgium;Norway;Taiwan;Fi ... | ||
| 9 | EUCTR2018-001947-30-DK (EUCTR) | 22/10/201920191022 | 13/06/201920190613 | Safety and Efficacy study assessing Pegunigalsidase Alfa (PRX-102) Administered by Intravenous Infusion Every 4 Weeks in Patients With Fabry Disease Safety and Efficacy study assessing Pegunigalsidase Alfa (PRX-102) Administered by Intravenous Infus ... | Open Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegunigalsidase Alfa (PRX-102) 2 mg/kg Administered by Intravenous Infusion Every 4 Weeks in Patients with Fabry Disease Open Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegunigalsidase Alfa (PR ... | MedDRA version: 24.1;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] MedDRA version: 24.1;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class ... | Trade Name: Elfabrio Product Name: Pegunigalsidase alfa Product Code: PRX-102 INN or Proposed INN: PEGUNIGALSIDASE ALFA Other descriptive name: CHF6657 Trade Name: Elfabrio Product Name: Pegunigalsidase alfa Product Code: PRX-102 INN or Proposed INN: PEGU ... | Chiesi Farmaceutici S.p.A | NULL | Not Recruiting | Female: yes Male: yes | 28 | Phase 3 | Belgium;United States;Czechia;Norway;Denmark;United Kingdom;Italy | ||
| 10 | EUCTR2018-001148-67-NL (EUCTR) | 21/06/201920190621 | 24/07/201920190724 | 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-102)in Patients With Fabry Disease Open Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegunigalsidase Alfa (PR ... | MedDRA version: 24.1;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] 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 Other descriptive name: CHF6657 Product Name: Pegunigalsidase alfa Product Code: PRX-102 INN or Proposed INN: PEGUNIGALSIDASE ALFA Othe ... | Chiesi Farmaceutici S.p.A | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | Hungary;United States;Czechia;United Kingdom;Spain;Canada;Netherlands;Czech Republic;Norway;Finland;Italy;Slovenia;Australia;France Hungary;United States;Czechia;United Kingdom;Spain;Canada;Netherlands;Czech Republic;Norway;Finland; ... |