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. | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2011-005040-10-IT (EUCTR) | 16/05/2013 | 27/02/2013 | A study to test if multiple injections of PRO045 are safe and effective in people who suffer from Duchenne muscular dystrophy | A 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 BV | NULL | Not Recruiting | Female: no Male: yes | 45 | Phase 1;Phase 2 | Belgium;United Kingdom;Italy | ||
| 2 | EUCTR2011-005040-10-GB (EUCTR) | 22/04/2013 | 10/10/2012 | A study to test if multiple injections of BMN 045 under the skin are safe and effective in people who suffer from Duchenne muscular dystrophy | A 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. | NULL | Not Recruiting | Female: no Male: yes | 45 | Phase 1;Phase 2 | France;Belgium;Italy;United Kingdom | ||
| 3 | NCT01826474 (ClinicalTrials.gov) | January 2013 | 20/3/2013 | Phase IIb Study of PRO045 in Subjects With Duchenne Muscular Dystrophy | A 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 | Drug: 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 dose | BioMarin Pharmaceutical | NULL | Terminated | 5 Years | 18 Years | Male | 15 | Phase 1/Phase 2 | Belgium;France;Italy;Netherlands;United Kingdom |
| 4 | EUCTR2011-005040-10-BE (EUCTR) | 03/12/2012 | 04/09/2012 | A study to test if multiple injections of PRO045 under the skin are safe and effective in people who suffer from Duchenne muscular dystrophy | A 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. | NULL | Not Recruiting | Female: no Male: yes | 45 | Phase 1;Phase 2 | Belgium;Italy;United Kingdom | ||
| 5 | EUCTR2011-005040-10-FR (EUCTR) | 16/06/2015 | A study to test if multiple injections of PRO045 are safe and effective in people who suffer from Duchenne muscular dystrophy | A 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 BV | NULL | Not Recruiting | Female: no Male: yes | 45 | Phase 1;Phase 2 | France;Belgium;Italy;United Kingdom |