BIS-CHOLINE TETRATHIOMOLYBDATE, bis[(2-Hydroxyethyl)trimethylammonium] tetrathiomolybdate ( DrugBank: Choline, Tetrathiomolybdate )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
171ウィルソン病3

171. ウィルソン病


臨床試験数 : 79 薬物数 : 77 - (DrugBank : 17) / 標的遺伝子数 : 6 - 標的パスウェイ数 : 30
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-001015-82-DE
(EUCTR)
26/11/202110/08/2021Phase 3, open-label study of ALXN1840 versus standard of care in pediatric participants with Wilson diseaseA multicenter, randomized, controlled, open-label, rater-blinded study to evaluate efficacy, safety, pharmacokinetics, and pharmacodynamics of ALXN1840 versus standard of care in pediatric participants with Wilson disease. Wilson Disease
MedDRA version: 20.0;Level: LLT;Classification code 10047988;Term: Wilson's disease;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: ALXN1840
Product Code: ALXN1840
INN or Proposed INN: tiomolibdic acid
Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE, bis[(2-Hydroxyethyl)trimethylammonium] tetrathiomolybdate
Product Name: ALXN1840
Product Code: ALXN1840
INN or Proposed INN: tiomolibdic acid
Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE, bis[(2-Hydroxyethyl)trimethylammonium] tetrathiomolybdate
Alexion Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 3France;United States;Canada;Spain;Poland;Australia;Germany;United Kingdom;Japan;Korea, Republic of
2EUCTR2021-001015-82-ES
(EUCTR)
22/11/202123/08/2021Phase 3, open-label study of ALXN1840 versus standard of care in pediatric participants with Wilson diseaseA multicenter, randomized, controlled, open-label, rater-blinded study to evaluate efficacy, safety, pharmacokinetics, and pharmacodynamics of ALXN1840 versus standard of care in pediatric participants with Wilson disease. Wilson Disease
MedDRA version: 20.0;Level: LLT;Classification code 10047988;Term: Wilson's disease;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: ALXN1840
Product Code: ALXN1840
INN or Proposed INN: tiomolibdic acid
Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE, bis[(2-Hydroxyethyl)trimethylammonium] tetrathiomolybdate
Product Name: ALXN1840
Product Code: ALXN1840
INN or Proposed INN: tiomolibdic acid
Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE, bis[(2-Hydroxyethyl)trimethylammonium] tetrathiomolybdate
Alexion Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 3United Kingdom;France;Hungary;Canada;Poland;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of;Serbia;United States;Czechia;Spain;Turkey;Austria;Russian Federation
3EUCTR2021-001015-82-PL
(EUCTR)
15/09/2021Phase 3, open-label study of ALXN1840 versus standard of care in pediatric participants with Wilson diseaseA multicenter, randomized, controlled, open-label, rater-blinded study to evaluate efficacy, safety, pharmacokinetics, and pharmacodynamics of ALXN1840 versus standard of care in pediatric participants with Wilson disease. Wilson Disease
MedDRA version: 20.0;Level: LLT;Classification code 10047988;Term: Wilson's disease;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: ALXN1840
Product Code: ALXN1840
INN or Proposed INN: tiomolibdic acid
Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE, bis[(2-Hydroxyethyl)trimethylammonium] tetrathiomolybdate
Product Name: ALXN1840
Product Code: ALXN1840
INN or Proposed INN: tiomolibdic acid
Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE, bis[(2-Hydroxyethyl)trimethylammonium] tetrathiomolybdate
Alexion Pharmaceuticals, Inc.NULLNAFemale: yes
Male: yes
48Phase 3Serbia;United States;Czechia;Spain;Turkey;Austria;Russian Federation;United Kingdom;France;Hungary;Canada;Poland;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of