171. ウィルソン病 Wilson disease Clinical trials / Disease details


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

  
4 trials found
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
3EUCTR2017-004135-36-DK
(EUCTR)
16/10/201905/08/2019A Phase 3 clinical study to Evaluate the Efficacy and Safety of ALXN1840 in adult and adolescent patients who suffer from Wilson Disease.A Phase 3, Randomized, Rater-Blinded, Multi-Center Study To Evaluate The Efficacy And Safety Of ALXN1840 Administered For 48 Weeks Versus Standard Of Care In Patients With Wilson Disease Aged 12 Years And Older With An Extension Period Of Up To 60 Months - ALXN1840 Efficacy Safety administered for 48 Weeks Versus SOC in patients 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
INN or Proposed INN: tiomolibdic acid
Other descriptive name: BIS-CHOLINE TETRATHIOMOLYBDATE
Trade Name: Penicillamine
INN or Proposed INN: PENICILLAMINE
Trade Name: Trientine dihydrochloride
INN or Proposed INN: TRIENTINE DIHYDROCHLORIDE
Trade Name: Wilzin
INN or Proposed INN: ZINC ACETATE DIHYDRATE
Alexion Pharmaceuticals, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3Serbia;United States;Portugal;Taiwan;Hong Kong;Spain;Israel;Russian Federation;Colombia;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Poland;Belgium;Singapore;Germany;New Zealand;Japan;Sweden
4EUCTR2021-001015-82-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