PRO051 ( DrugBank: - )


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 : 622 薬物数 : 485 - (DrugBank : 99) / 標的遺伝子数 : 59 - 標的パスウェイ数 : 168
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2007-004819-54-SE
(EUCTR)
19/03/200831/01/2008A study to assess the effect and safety of multiple subcutaneous doses of drisapersen in patients with Duchenne DiseaseA phase I/II, open label, escalating dose, pilot study to assess the effect, safety, tolerability and pharmacokinetics of multiple subcutaneous doses of drisapersen in patients with Duchenne muscular dystrophy and to assess the potential for intravenous dosing as an alternative route of administration Duchenne Muscular Dystrophy
MedDRA version: 17.0;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: Drisapersen
Product Code: PRO051
INN or Proposed INN: PRO051
Product Name: Drisapersen
Product Code: PRO051
INN or Proposed INN: PRO051
Prosensa Therapeutics BVNULLNot RecruitingFemale: no
Male: yes
12Phase 1;Phase 2Belgium;Netherlands;Sweden
2EUCTR2007-004819-54-NL
(EUCTR)
22/02/200807/01/2008A phase I/II, open label, escalating dose, pilot study to assess the effect, safety, tolerability and pharmacokinetics of multiple subcutaneous doses of PRO051 in patients with Duchenne muscular dystrophyA phase I/II, open label, escalating dose, pilot study to assess the effect, safety, tolerability and pharmacokinetics of multiple subcutaneous doses of PRO051 in patients with Duchenne muscular dystrophy Duchenne Muscular Dystrophy
MedDRA version: 9.1;Level: LLT;Classification code 10013801;Term: Duchenne muscular dystrophy
Product Name: PRO051
Product Code: h51AON23
Prosensa Holding B.V.NULLNot RecruitingFemale: no
Male: yes
18Phase 1/2Netherlands;Belgium;Sweden
3EUCTR2007-004819-54-BE
(EUCTR)
22/01/200814/12/2007A study to assess the effect and safety of multiple subcutaneous doses of drisapersen in patients with Duchenne DiseaseA phase I/II, open label, escalating dose, pilot study to assess the effect, safety, tolerability and pharmacokinetics of multiple subcutaneous doses of drisapersen in patients with Duchenne muscular dystrophy and to assess the potential for intravenous dosing as an alternative route of administration Duchenne Muscular Dystrophy
MedDRA version: 17.1;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: Drisapersen
Product Code: PRO051
INN or Proposed INN: PRO051
Product Name: Drisapersen
Product Code: PRO051
INN or Proposed INN: PRO051
Prosensa Therapeutics BVNULLNot RecruitingFemale: no
Male: yes
12Phase 1;Phase 2Belgium;Netherlands;Sweden