296. 胆道閉鎖症 Biliary atresia Clinical trials / Disease details


臨床試験数 : 71 薬物数 : 70 - (DrugBank : 39) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 60

  
10 trials found
No.TrialIDDate_
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PhaseCountries
1NCT05426733
(ClinicalTrials.gov)
July 5, 202213/6/2022An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat in Children With Biliary AtresiaAn Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat (A4250) in Children With Biliary Atresia (BOLD-EXT)Biliary AtresiaDrug: OdevixibatAlbireoNULLEnrolling by invitationN/AN/AAll180Phase 3United States;Canada;Italy;Malaysia;New Zealand;Poland;Spain
2EUCTR2019-003807-37-NL
(EUCTR)
01/12/202028/04/2020This Study Will Investigate the Efficacy and Safety of Odevixibat in Children with Biliary Atresia Who Have Undergone a Kasai HPEA Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia Who Have Undergone a Kasai Hepatoportoenterostomy (BOLD) Biliary Atresia
MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Albireo ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3United States;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Malaysia;Belgium;Australia;Germany;Netherlands;China;New Zealand;Korea, Republic of
3EUCTR2019-003807-37-IT
(EUCTR)
10/09/202021/10/2020This Study Will Investigate the Efficacy and Safety of Odevixibat in Children with Biliary Atresia Who Have Undergone a Kasai HPEA Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia Who Have Undergone a Kasai Hepatoportoenterostomy (BOLD) - BOLD Biliary Atresia
MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Odevixibat
Product Code: [A4250]
INN or Proposed INN: Odevixibat
Product Name: Odevixibat
Product Code: [A4250]
INN or Proposed INN: Odevixibat
Product Name: Odevixibat
Product Code: [A4250]
INN or Proposed INN: Odevixibat
ALBIREO ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3United States;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Malaysia;Australia;Denmark;Germany;Netherlands;New Zealand;China;Korea, Republic of
4EUCTR2019-003807-37-BE
(EUCTR)
08/09/202018/06/2020This Study Will Investigate the Efficacy and Safety of Odevixibat in Children with Biliary Atresia Who Have Undergone a Kasai HPEA Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia Who Have Undergone a Kasai Hepatoportoenterostomy (BOLD) Biliary Atresia
MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Albireo ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3United States;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Belgium;Malaysia;Poland;Australia;Germany;Netherlands;China;New Zealand;Korea, Republic of
5EUCTR2019-003807-37-FR
(EUCTR)
08/09/202027/04/2020This Study Will Investigate the Efficacy and Safety of Odevixibat in Children with Biliary Atresia Who Have Undergone a Kasai HPEA Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia Who Have Undergone a Kasai Hepatoportoenterostomy (BOLD) Biliary Atresia
MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Albireo ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3United States;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Malaysia;Australia;Denmark;Germany;Netherlands;New Zealand;China;Korea, Republic of
6EUCTR2019-003807-37-GB
(EUCTR)
11/08/202017/04/2020This Study Will Investigate the Efficacy and Safety of Odevixibat in Children with Biliary Atresia Who Have Undergone a Kasai HPEA Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia Who Have Undergone a Kasai Hepatoportoenterostomy (BOLD) - Biliary Atresia Odevixibat Liver Disease (BOLD) Biliary Atresia
MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Albireo ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3New Zealand;United States;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Malaysia;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of
7EUCTR2019-003807-37-HU
(EUCTR)
29/07/202017/04/2020This Study Will Investigate the Efficacy and Safety of Odevixibat in Children with Biliary Atresia Who Have Undergone a Kasai HPEA Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia Who Have Undergone a Kasai Hepatoportoenterostomy (BOLD) Biliary Atresia
MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Albireo ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3United States;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Malaysia;Australia;Denmark;Germany;Netherlands;New Zealand;China;Korea, Republic of
8NCT04336722
(ClinicalTrials.gov)
July 10, 202027/3/2020Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixibat (A4250) in Children With Biliary Atresia Who Have Undergone a Kasai HepatoportoenterostomyBiliary AtresiaDrug: Odevixibat;Drug: PlaceboAlbireoNULLActive, not recruitingN/A111 DaysAll205Phase 3United States;Australia;Belgium;Canada;China;France;Germany;Hungary;Israel;Italy;Korea, Republic of;Malaysia;Netherlands;New Zealand;Poland;Spain;Taiwan;Turkey;United Kingdom
9EUCTR2019-003807-37-DE
(EUCTR)
15/05/2020This Study Will Investigate the Efficacy and Safety of Odevixibat in Children with Biliary Atresia Who Have Undergone a Kasai HPEA Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia Who Have Undergone a Kasai Hepatoportoenterostomy (BOLD) Biliary Atresia
MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Albireo ABNULLNAFemale: yes
Male: yes
200Phase 3United States;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Malaysia;Belgium;Australia;Netherlands;Germany;China;New Zealand;Korea, Republic of
10EUCTR2019-003807-37-PL
(EUCTR)
05/05/2020This Study Will Investigate the Efficacy and Safety of Odevixibat in Children with Biliary Atresia Who Have Undergone a Kasai HPEA Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia Who Have Undergone a Kasai Hepatoportoenterostomy (BOLD) Biliary Atresia
MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Albireo ABNULLNAFemale: yes
Male: yes
200Phase 3United States;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Malaysia;Belgium;Australia;Netherlands;Germany;China;New Zealand;Korea, Republic of