251. 尿素サイクル異常症 Urea cycle disorder Clinical trials / Disease details
臨床試験数 : 48 / 薬物数 : 52 - (DrugBank : 13) / 標的遺伝子数 : 4 - 標的パスウェイ数 : 29
| 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 | EUCTR2018-004842-40-FR (EUCTR) | 14/01/2020 | 18/11/2019 | International multicenter study to test the efficacy and safety of a new drug, KB195, in subjects with Urea Cycle Disorder with an inadequate control of the disease with current standard drugs. | A Phase 2, Open-label Study to Evaluate the Efficacy and Safety of KB195 in Subjects with a Urea Cycle Disorder with Inadequate Control on Standard of Care | Subjects with a Urea Cycle Disorder with Inadequate Control on Standard of Care MedDRA version: 20.1;Level: PT;Classification code 10080020;Term: Urea cycle disorder;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: KB195 Product Code: KB195 INN or Proposed INN: KB195 | Kaleido Biosciences | NULL | Not Recruiting | Female: yes Male: yes | 29 | Phase 2 | United States;France;Saudi Arabia;Mexico;Canada;Spain;Belgium;Turkey;Netherlands;Germany;United Kingdom;Switzerland | ||
| 2 | EUCTR2018-004842-40-DE (EUCTR) | 25/11/2019 | 04/06/2019 | International multicenter study to test the efficacy and safety of a new drug, KB195, in subjects with Urea Cycle Disorder with an inadequate control of the disease with current standard drugs. | A Phase 2, Open-label Study to Evaluate the Efficacy and Safety of KB195 in Subjects witha Urea Cycle Disorder with Inadequate Control on Standard of Care | Subjects with a Urea Cycle Disorder with Inadequate Control on Standard of Care MedDRA version: 20.1;Level: PT;Classification code 10080020;Term: Urea cycle disorder;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: KB195 Product Code: KB195 INN or Proposed INN: KB195 | Kaleido Biosciences | NULL | Not Recruiting | Female: yes Male: yes | 29 | Phase 2 | United States;France;Saudi Arabia;Mexico;Canada;Spain;Belgium;Turkey;Netherlands;Germany;United Kingdom;Switzerland | ||
| 3 | EUCTR2018-004842-40-ES (EUCTR) | 06/11/2019 | 11/06/2019 | International multicenter study to test the efficacy and safety of a new drug, KB195, in subjects with Urea Cycle Disorder with an inadequate control of the disease with current standard drugs. | A Phase 2, Open-label Study to Evaluate the Efficacy and Safety of KB195 in Subjects with a Urea Cycle Disorder with Inadequate Control on Standard of Care | Subjects with a Urea Cycle Disorder with Inadequate Control on Standard of Care MedDRA version: 20.1;Level: PT;Classification code 10080020;Term: Urea cycle disorder;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: KB195 Product Code: KB195 INN or Proposed INN: KB195 | Kaleido Biosciences | NULL | Not Recruiting | Female: yes Male: yes | 29 | Phase 2 | United States;France;Saudi Arabia;Mexico;Canada;Belgium;Spain;Turkey;Netherlands;Germany;United Kingdom;Switzerland | ||
| 4 | NCT03933410 (ClinicalTrials.gov) | September 17, 2019 | 29/4/2019 | UNLOCKED: A Phase 2, Open-label Trial With KB195 in Subjects With a Urea Cycle Disorder | A Phase 2, Open-label Study to Evaluate the Efficacy and Safety of KB195 in Subjects With A Urea Cycle Disorder With Inadequate Control on Standard of Care | Urea Cycle Disorder | Drug: KB195 | Kaleido Biosciences | NULL | Terminated | 18 Years | 65 Years | All | 13 | Phase 2 | United States;Belgium;Germany;Spain;Switzerland;Turkey;United Kingdom;Mexico |
| 5 | EUCTR2018-004842-40-GB (EUCTR) | 30/08/2019 | 22/10/2020 | International multicenter study to test the efficacy and safety of a new drug, KB195, in subjects with Urea Cycle Disorder with an inadequate control of the disease with current standard drugs. | A Phase 2, Open-label Study to Evaluate the Efficacy and Safety of KB195 in Subjects witha Urea Cycle Disorder with Inadequate Control on Standard of Care - Kaleido K020-218 | Subjects with a Urea Cycle Disorder with Inadequate Control on Standard of Care MedDRA version: 20.1;Level: PT;Classification code 10080020;Term: Urea cycle disorder;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: KB195 Product Code: KB195 INN or Proposed INN: KB195 | Kaleido Biosciences | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 29 | Phase 1;Phase 2 | United States;France;Saudi Arabia;Mexico;Canada;Spain;Belgium;Turkey;Germany;Switzerland;United Kingdom | ||
| 6 | EUCTR2018-004842-40-BE (EUCTR) | 21/08/2019 | 28/05/2019 | International multicenter study to test the efficacy and safety of a new drug, KB195, in subjects with Urea Cycle Disorder with an inadequate control of the disease with current standard drugs. | A Phase 2, Open-label Study to Evaluate the Efficacy and Safety of KB195 in Subjects witha Urea Cycle Disorder with Inadequate Control on Standard of Care | Subjects with a Urea Cycle Disorder with Inadequate Control on Standard of Care MedDRA version: 20.1;Level: PT;Classification code 10080020;Term: Urea cycle disorder;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: KB195 Product Code: KB195 INN or Proposed INN: KB195 | Kaleido Biosciences | NULL | Not Recruiting | Female: yes Male: yes | 29 | Phase 2 | United States;France;Saudi Arabia;Mexico;Canada;Spain;Belgium;Turkey;Germany;United Kingdom;Switzerland |