Prx-102 (pegunigalsidase alfa) (DrugBank: Pegunigalsidase alfa)
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 | 3 |
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 |
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1 | NCT03018730 (ClinicalTrials.gov) | February 23, 2017 | 9/1/2017 | Safety and Efficacy of PRX 102 in Patients With Fabry Disease Currently Treated With REPLAGAL® (Agalsidase Alfa) | An Open Label Study of the Safety and Efficacy of PRX 102 in Patients With Fabry Disease Currently Treated With REPLAGAL® (Agalsidase Alfa) | Fabry Disease | Biological: PRX-102 (pegunigalsidase alfa) | Protalix | NULL | Active, not recruiting | 18 Years | 60 Years | All | 22 | Phase 3 | Australia;Canada;Czechia;Germany;Netherlands;Norway;Slovenia;Spain;United Kingdom;Czech Republic |
2 | NCT02795676 (ClinicalTrials.gov) | June 2016 | 2/6/2016 | Study of the Safety and Efficacy of PRX-102 Compared to Agalsidase Beta on Renal Function | A Randomized, Double Blind, Active Control Study of the Safety and Efficacy of PRX-102 Compared to Agalsidase Beta on Renal Function in Patients With Fabry Disease Previously Treated With Agalsidase Beta | Fabry Disease | Biological: PRX-102 (pegunigalsidase alfa);Biological: agalsidase beta | Protalix | NULL | Active, not recruiting | 18 Years | 60 Years | All | 78 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Canada;Czechia;Finland;France;Germany;Hungary;Italy;Netherlands;Norway;Paraguay;Slovenia;Spain;Switzerland;Turkey;United Kingdom;Czech Republic |
3 | NCT01981720 (ClinicalTrials.gov) | December 2013 | 5/11/2013 | Extension Study of PRX-102 for up to 60 Months | A Multi Center Extension Study of PRX-102 Administered by Intravenous Infusions Every 2 Weeks for up to 60 Months to Adult Fabry Patients | Fabry Disease | Biological: PRX-102 (pegunigalsidase alfa) | Protalix | NULL | Active, not recruiting | 18 Years | N/A | All | 15 | Phase 1;Phase 2 | United States;Paraguay;Spain;United Kingdom |