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Kb195    (DrugBank: -)

1 disease
告示番号疾患名（ページ内リンク）臨床試験数
251尿素サイクル異常症6

251. 尿素サイクル異常症　［臨床試験数：42，薬物数：45（DrugBank：10），標的遺伝子数：4，標的パスウェイ数：29］
Searched query = "Urea cycle disorder", "N-acetylglutamate synthase deficiency", "NAGS deficiency", "Carbamoyl phosphate synthetase I deficiency", "CPS1 deficiency", "Ornithine transcarbamylase deficiency", "OTC deficiency", "Classic citrullinemia", "Citrullinemia type I", "Argininosuccinic aciduria", "Argininemia", "Hiperornitinemia-hiperamonemia-homocitrulinuria syndrome", "HHH syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
6 / 42 trials found
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2018-004842-40-FR
(EUCTR)		14/01/202018/11/2019International 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]		Kaleido BiosciencesNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes		29Phase 2United States;France;Saudi Arabia;Mexico;Canada;Belgium;Spain;Turkey;Netherlands;Germany;United Kingdom;Switzerland
2EUCTR2018-004842-40-DE
(EUCTR)		25/11/201904/06/2019International 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]		Kaleido BiosciencesNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes		29Phase 2France;United States;Saudi Arabia;Mexico;Canada;Belgium;Spain;Turkey;Netherlands;Germany;United Kingdom;Switzerland
3EUCTR2018-004842-40-ES
(EUCTR)		06/11/201911/06/2019International 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 BiosciencesNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		29Phase 2France;United States;Saudi Arabia;Mexico;Canada;Belgium;Spain;Turkey;Netherlands;Germany;United Kingdom;Switzerland
4NCT03933410
(ClinicalTrials.gov)		September 17, 201929/4/2019UNLOCKED: A Phase 2, Open-label Trial With KB195 in Subjects With a Urea Cycle DisorderA 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 CareUrea Cycle DisorderDrug: KB195Kaleido BiosciencesNULLRecruiting12 Years70 YearsAll24Phase 2United States;Belgium;Germany;Spain;Switzerland;Turkey;United Kingdom;Mexico
5EUCTR2018-004842-40-GB
(EUCTR)		30/08/201922/10/2020International 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 BiosciencesNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		29Phase 1;Phase 2United States;France;Saudi Arabia;Mexico;Canada;Spain;Belgium;Turkey;Germany;Switzerland;United Kingdom
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
6EUCTR2018-004842-40-BE
(EUCTR)		21/08/201928/05/2019International 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 BiosciencesNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		29Phase 2United States;France;Saudi Arabia;Mexico;Canada;Spain;Belgium;Turkey;Germany;United Kingdom;Switzerland

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