15N ammonium chloride (15NH4Cl) ( DrugBank: Ammonium chloride, Chloride )


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4

251. 尿素サイクル異常症


臨床試験数 : 54 薬物数 : 61 - (DrugBank : 15) / 標的遺伝子数 : 3 - 標的パスウェイ数 : 28
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agemin
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PhaseCountries
1EUCTR2021-000824-36-AT
(EUCTR)
22/12/202129/07/2021Clinical trial assessing urea formation capacity in babies up to 12 months old using 15N ammonium chloride tracerAn open-label, controlled, multi-site, Phase I clinical trial to assess the ureagenesis capacity in newborns and infants up to the age of 12 months with neonatal and infantile onset of urea cycle disorders (UCD) using a 15N ammonium chloride tracer compared to newborns and infants without UCD. - 15N ammonium chloride ureagenesis validation clinical trial Subject has a genetically confirmed diagnosis of any of the following urea cycle disorders: ASS, CPS1, ASL, OTC Subjects without UCD can have other stable illness that not interfere with the clinical trial according to the investigator judgement
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: 15N ammonium chloride (15NH4Cl)
INN or Proposed INN: Ammonium (15N) chloride
Other descriptive name: Ammonium (15N) chloride
Unicyte AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 1France;Saudi Arabia;Spain;Belgium;Turkey;Austria;Israel;Germany;United Kingdom;Switzerland;Italy
2EUCTR2021-000824-36-ES
(EUCTR)
09/12/202111/06/2021An open-label, controlled, multi-site, Phase I clinical trial to assess the ureagenesis capacity in newborns and infants up to the age of 12 months with neonatal and infantile onset of urea cycle disorders (UCD) using a 15N ammonium chloride tracer compared to newborns and infants without UCD. - 15N ammonium chloride ureagenesis validation clinical trial An open-label, controlled, multi-site, Phase I clinical trial to assess the ureagenesis capacity in newborns and infants up to the age of 12 months with neonatal and infantile onset of urea cycle disorders (UCD) using a 15N ammonium chloride tracer compared to newborns and infants without UCD. - 15N ammonium chloride ureagenesis validation clinical trial Subject has a genetically confirmed diagnosis of any of the following urea cycle disorders: ASS, CPS1, ASL, OTC Subjects without UCD can have other stable illness that not interfere with the clinical trial according to the investigator judgement
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: 15N ammonium chloride (15NH4Cl)
INN or Proposed INN: Ammonium (15N) chloride
Other descriptive name: Ammonium (15N) chloride
Unicyte AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 1Portugal;Czechia;Saudi Arabia;Spain;Turkey;Austria;Israel;United Kingdom;Italy;Switzerland;France;Belgium;Poland;Germany;Netherlands
3EUCTR2021-000824-36-BE
(EUCTR)
01/10/2021Clinical trial assessing urea formation capacity in babies up to 12 months old using 15N ammonium chloride tracerAn open-label, controlled, multi-site, Phase I clinical trial to assess the ureagenesis capacity in newborns and infants up to the age of 12 months with neonatal and infantile onset of urea cycle disorders (UCD) using a 15N ammonium chloride tracer compared to newborns and infants without UCD. - 15N ammonium chloride ureagenesis validation clinical trial Subject has a genetically confirmed diagnosis of any of the following urea cycle disorders: ASS, CPS1, ASL, OTC Subjects without UCD can have other stable illness that not interfere with the clinical trial according to the investigator judgement
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: 15N ammonium chloride (15NH4Cl)
INN or Proposed INN: Ammonium (15N) chloride
Other descriptive name: Ammonium (15N) chloride
Unicyte AGNULLNAFemale: yes
Male: yes
30Phase 1France;Saudi Arabia;Spain;Belgium;Turkey;Austria;Israel;Germany;United Kingdom;Switzerland;Italy
4EUCTR2021-000824-36-IT
(EUCTR)
16/08/202115N ammonium chloride ureagenesis validation clinical trialAn open-label, controlled, multi-site, Phase I clinical trial to assess the ureagenesis capacity in newborns and infants up to the age of 12 months with neonatal and infantile onset of urea cycle disorders (UCD) using a 15N ammonium chloride tracer compared to newborns and infants without UCD. - reLiver-1 Subject has a genetically confirmed diagnosis of any of the followingurea cycle disorders: ASS, CPS1, ASL, OTCSubjects without UCD can have other stable illness that not interferewith the clinical trial according to the investigator judgement
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: 15N ammonium chloride (15NH4Cl)
Product Code: [na]
INN or Proposed INN: Ammonium (15N) chloride
Other descriptive name: Ammonium (15N) chloride
Unicyte AGNULLNAFemale: yes
Male: yes
30Phase 1Portugal;Czechia;Saudi Arabia;Spain;Turkey;Austria;Israel;United Kingdom;Italy;Switzerland;France;Belgium;Poland;Germany;Netherlands