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
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05426733 (ClinicalTrials.gov) | July 5, 2022 | 13/6/2022 | An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat in Children With Biliary Atresia | An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat (A4250) in Children With Biliary Atresia (BOLD-EXT) | Biliary Atresia | Drug: Odevixibat | Albireo | NULL | Enrolling by invitation | N/A | N/A | All | 180 | Phase 3 | United States;Canada;Italy;Malaysia;New Zealand;Poland;Spain |
| 2 | EUCTR2019-003807-37-NL (EUCTR) | 01/12/2020 | 28/04/2020 | This Study Will Investigate the Efficacy and Safety of Odevixibat in Children with Biliary Atresia Who Have Undergone a Kasai HPE | 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 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 AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | United States;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Malaysia;Belgium;Australia;Germany;Netherlands;China;New Zealand;Korea, Republic of | ||
| 3 | EUCTR2019-003807-37-IT (EUCTR) | 10/09/2020 | 21/10/2020 | This Study Will Investigate the Efficacy and Safety of Odevixibat in Children with Biliary Atresia Who Have Undergone a Kasai HPE | 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 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 AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | United States;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Malaysia;Australia;Denmark;Germany;Netherlands;New Zealand;China;Korea, Republic of | ||
| 4 | EUCTR2019-003807-37-FR (EUCTR) | 08/09/2020 | 27/04/2020 | This Study Will Investigate the Efficacy and Safety of Odevixibat in Children with Biliary Atresia Who Have Undergone a Kasai HPE | 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 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 AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | United States;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Malaysia;Australia;Denmark;Germany;Netherlands;New Zealand;China;Korea, Republic of | ||
| 5 | EUCTR2019-003807-37-BE (EUCTR) | 08/09/2020 | 18/06/2020 | This Study Will Investigate the Efficacy and Safety of Odevixibat in Children with Biliary Atresia Who Have Undergone a Kasai HPE | 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 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 AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | United States;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Belgium;Malaysia;Poland;Australia;Germany;Netherlands;China;New Zealand;Korea, Republic of | ||
| 6 | EUCTR2019-003807-37-GB (EUCTR) | 11/08/2020 | 17/04/2020 | This Study Will Investigate the Efficacy and Safety of Odevixibat in Children with Biliary Atresia Who Have Undergone a Kasai HPE | 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 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 AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | New Zealand;United States;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Malaysia;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of | ||
| 7 | EUCTR2019-003807-37-HU (EUCTR) | 29/07/2020 | 17/04/2020 | This Study Will Investigate the Efficacy and Safety of Odevixibat in Children with Biliary Atresia Who Have Undergone a Kasai HPE | 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 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 AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | United States;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Malaysia;Australia;Denmark;Germany;Netherlands;New Zealand;China;Korea, Republic of | ||
| 8 | NCT04336722 (ClinicalTrials.gov) | July 10, 2020 | 27/3/2020 | Efficacy 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 Hepatoportoenterostomy | Biliary Atresia | Drug: Odevixibat;Drug: Placebo | Albireo | NULL | Active, not recruiting | N/A | 111 Days | All | 205 | Phase 3 | United States;Australia;Belgium;Canada;China;France;Germany;Hungary;Israel;Italy;Korea, Republic of;Malaysia;Netherlands;New Zealand;Poland;Spain;Taiwan;Turkey;United Kingdom |
| 9 | EUCTR2019-003807-37-PL (EUCTR) | 05/05/2020 | This Study Will Investigate the Efficacy and Safety of Odevixibat in Children with Biliary Atresia Who Have Undergone a Kasai HPE | 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 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 AB | NULL | NA | Female: yes Male: yes | 200 | Phase 3 | United States;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Malaysia;Belgium;Australia;Netherlands;Germany;China;New Zealand;Korea, Republic of | |||
| 10 | EUCTR2019-003807-37-DE (EUCTR) | 15/05/2020 | This Study Will Investigate the Efficacy and Safety of Odevixibat in Children with Biliary Atresia Who Have Undergone a Kasai HPE | 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 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 AB | NULL | NA | Female: yes Male: yes | 200 | Phase 3 | United States;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Malaysia;Belgium;Australia;Netherlands;Germany;China;New Zealand;Korea, Republic of |