BMN 044 ( DrugBank: BMN-044 )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
113筋ジストロフィー3

113. 筋ジストロフィー


臨床試験数 : 646 薬物数 : 471 - (DrugBank : 105) / 標的遺伝子数 : 59 - 標的パスウェイ数 : 170
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1NCT02958202
(ClinicalTrials.gov)
April 201627/10/2016Extension Study of BMN 044 in Duchenne Muscular Dystrophy (DMD)A Multi Center, Multi National, Open Label, Extension Study to Evaluate the Long-term Efficacy and Safety of BMN 044 (PRO044) in Subjects With Duchenne Muscular DystrophyDuchenne Muscular DystrophyDrug: BMN 044 IV 6 mg/kg;Drug: BMN 044 IV 9 mg/kg;Drug: BMN 044 SC 6 mg/kgBioMarin PharmaceuticalNULLTerminated5 YearsN/AMale7Phase 2Belgium;Italy;Netherlands;Sweden
2EUCTR2015-003681-87-BE
(EUCTR)
12/01/201616/11/2015A study to assess the effect of BMN 044 in subjects with Duchenne muscular dystrophy (Extension study)A multi center, multi national, open label, extension study to evaluate the long-term efficacy and safety of BMN 044 (PRO044) in subjects with Duchenne muscular dystrophy Duchenne muscular dystrophy
MedDRA version: 18.1;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: BMN 044
Product Code: BMN 044
INN or Proposed INN: PS188 (company code)
Other descriptive name: PS188
Product Name: BMN 044
Product Code: BMN 044
INN or Proposed INN: PS188 (company code)
Other descriptive name: PS188
BioMarin Pharmaceutical Inc.NULLNot RecruitingFemale: no
Male: yes
50Phase 2United States;Belgium;Netherlands;Italy;Sweden
3EUCTR2015-003681-87-IT
(EUCTR)
19/01/2021A study to assess the effect of BMN 044 in subjects with Duchennemuscular dystrophy (Extension study)A multi center, multi national, open label, extension study to evaluate the long-term efficacy and safety of BMN 044 (PRO044) in subjects with Duchenne muscular dystrophy - NA Duchenne muscular dystrophy
MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: BMN 044
Product Code: BMN 044
Other descriptive name: PS188
Product Name: BMN 044
Product Code: BMN 044
INN or Proposed INN: PS188
Other descriptive name: PS188
BIOMARIN PHARMACEUTICAL INC.NULLNAFemale: no
Male: yes
50Phase 2Netherlands;Italy;Sweden;United States;Belgium