IPN60120 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
272進行性骨化性線維異形成症2

272. 進行性骨化性線維異形成症


臨床試験数 : 40 薬物数 : 36 - (DrugBank : 6) / 標的遺伝子数 : 27 - 標的パスウェイ数 : 95
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-002244-70-SE
(EUCTR)
25/10/2021A Rollover Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged =14 Years with Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed the Relevant Parent Studies.Rollover Study; Multicentre, Phase III, Open-label Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged =14 Years with Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed Study PVO-1A-301 or PVO-1A-202/PVO-1A-204 and May Benefit from Palovarotene Therapy. - PIVOINE Fibrodysplasia Ossificans Progressiva (FOP)
MedDRA version: 20.0;Level: PT;Classification code 10068715;Term: Fibrodysplasia ossificans progressiva;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Palovarotene
Product Code: IPN60120
INN or Proposed INN: Palovarotene
Other descriptive name: PALOVAROTENE
Ipsen PharmaNULLNAFemale: yes
Male: yes
61Phase 3France;United States;Canada;Argentina;Spain;Brazil;Australia;United Kingdom;Italy;Sweden
2EUCTR2021-002244-70-FR
(EUCTR)
09/11/2021A Rollover Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged =14 Years with Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed the Relevant Parent Studies.Rollover Study; Multicentre, Phase III, Open-label Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged =14 Years with Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed Study PVO-1A-301 or PVO-1A-202/PVO-1A-204 and May Benefit from Palovarotene Therapy. - PIVOINE Fibrodysplasia Ossificans Progressiva (FOP)
MedDRA version: 20.0;Level: PT;Classification code 10068715;Term: Fibrodysplasia ossificans progressiva;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Palovarotene
Product Code: IPN60120
INN or Proposed INN: Palovarotene
Other descriptive name: PALOVAROTENE
Ipsen Pharma SASNULLNAFemale: yes
Male: yes
87Phase 3United States;France;Canada;Argentina;Spain;Brazil;Australia;United Kingdom;Italy;Sweden