PRO045 ( DrugBank: PRO045 )


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5

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
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1EUCTR2011-005040-10-IT
(EUCTR)
16/05/201327/02/2013A study to test if multiple injections of PRO045 are safe and effective in people who suffer from Duchenne muscular dystrophyA phase I/II, open-label study to assess the efficacy, safety, pharmacodynamics and pharmacokinetics of multiple doses of PRO045 in subjects with Duchenne muscular dystrophy Duchenne muscular dystrophy resulting from a mutation correctable by PRO045-induced DMD exon 45 skipping
MedDRA version: 14.1;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: PRO045
Product Code: PRO045
INN or Proposed INN: PS220
Prosensa Therapeutics BVNULLNot RecruitingFemale: no
Male: yes
45Phase 1;Phase 2Belgium;United Kingdom;Italy
2EUCTR2011-005040-10-GB
(EUCTR)
22/04/201310/10/2012A study to test if multiple injections of BMN 045 under the skin are safe and effective in people who suffer from Duchenne muscular dystrophyA phase IIb, open-label study to assess the efficacy, safety, pharmacodynamics and pharmacokinetics of multiple doses of BMN 045 (previously known as PRO045) in subjects with Duchenne muscular dystrophy Duchenne muscular dystrophy resulting from a mutation correctable by BMN 045-induced DMD exon 45 skipping
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 045
Product Code: BMN 045
INN or Proposed INN: PS220
BioMarin Pharmaceutical Inc.NULLNot RecruitingFemale: no
Male: yes
45Phase 1;Phase 2France;Belgium;Italy;United Kingdom
3NCT01826474
(ClinicalTrials.gov)
January 201320/3/2013Phase IIb Study of PRO045 in Subjects With Duchenne Muscular DystrophyA Phase IIb, Open-label Study to Assess the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of Multiple Subcutaneous Doses of PRO045 in Subjects With Duchenne Muscular DystrophyDuchenne Muscular DystrophyDrug: PRO045, 0.15 mg/kg/week;Drug: PRO045, 1.0 mg/kg/week;Drug: PRO045, 3.0 mg/kg/week;Drug: PRO045, 6.0 mg/kg/week;Drug: PRO045, 9.0 mg/kg/week;Drug: PRO045, selected doseBioMarin PharmaceuticalNULLTerminated5 Years18 YearsMale15Phase 1/Phase 2Belgium;France;Italy;Netherlands;United Kingdom
4EUCTR2011-005040-10-BE
(EUCTR)
03/12/201204/09/2012A study to test if multiple injections of PRO045 under the skin are safe and effective in people who suffer from Duchenne muscular dystrophyA phase IIb, open-label study to assess the efficacy, safety, pharmacodynamics and pharmacokinetics of multiple subcutaneous doses of PRO045 in subjects with Duchenne muscular dystrophy Duchenne muscular dystrophy resulting from a mutation correctable by PRO045-induced DMD exon 45 skipping
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: PRO045
Product Code: PRO045
INN or Proposed INN: PS220
BioMarin Nederland B.V.NULLNot RecruitingFemale: no
Male: yes
45Phase 1;Phase 2Belgium;Italy;United Kingdom
5EUCTR2011-005040-10-FR
(EUCTR)
16/06/2015A study to test if multiple injections of PRO045 are safe and effective in people who suffer from Duchenne muscular dystrophyA phase IIb, open-label study to assess the efficacy, safety, pharmacodynamics and pharmacokinetics of multiple doses of PRO045 in subjects with Duchenne muscular dystrophy Duchenne muscular dystrophy resulting from a mutation correctable by PRO045-induced DMD exon 45 skipping
MedDRA version: 18.0;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: PRO045
Product Code: PRO045
INN or Proposed INN: PS220
Prosensa Therapeutics BVNULLNot RecruitingFemale: no
Male: yes
45Phase 1;Phase 2France;Belgium;Italy;United Kingdom