A4250 ( DrugBank: - )
4 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 93 | 原発性胆汁性胆管炎 | 4 |
| 296 | 胆道閉鎖症 | 10 |
| 297 | アラジール症候群 | 16 |
| 338 | 進行性家族性肝内胆汁うっ滞症 | 23 |
93. 原発性胆汁性胆管炎
臨床試験数 : 298 / 薬物数 : 252 - (DrugBank : 59) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 115
Showing 1 to 4 of 4 diseases
| 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 | NCT03082937 (ClinicalTrials.gov) | January 31, 2017 | 27/2/2017 | An Open Label, Single-dose, Single Period ADME Study of A4250 in Healthy Subjects | An Open Label, Single-Dose, Single Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-A4250 in Healthy Male Subjects An Open Label, Single-Dose, Single Period Study Designed to Assess the Mass Balance Recovery, Metabo ... | Orphan Cholestatic Liver Diseases;Progressive Familial Intrahepatic Cholestasis;Alagille Syndrome;Primary Biliary Cirrhosis Orphan Cholestatic Liver Diseases;Progressive Familial Intrahepatic Cholestasis;Alagille Syndrome;Pr ... | Drug: 3 mg [14C]-A4250 capsule | Albireo | NULL | Completed | 30 Years | 65 Years | Male | 6 | Phase 1 | United Kingdom |
| 2 | NCT02360852 (ClinicalTrials.gov) | January 2015 | 14/1/2015 | IBAT Inhibitor A4250 for Cholestatic Pruritus | An Exploratory, Phase IIa Study to Demonstrate the Safety and Efficacy of A4250 in Patients With Primary Biliary Cirrhosis and Cholestatic Pruritus An Exploratory, Phase IIa Study to Demonstrate the Safety and Efficacy of A4250in Patients With Prim ... | Biliary Cirrhosis, Primary | Drug: A4250 | Sahlgrenska University Hospital, Sweden | Albireo | Terminated | 18 Years | 80 Years | All | 9 | Phase 2 | Sweden |
| 3 | EUCTR2014-004070-42-SE (EUCTR) | 09/12/2014 | 15/10/2014 | Study to Demonstrate the Efficacy and Safety of A4250 in Patients withPrimary Biliary Cirrhosis and Cholestatic Pruritus Study to Demonstrate the Efficacy and Safety of A4250in Patients withPrimary Biliary Cirrhosis and C ... | An Exploratory, Phase IIa Cross-Over Study to Demonstrate the Efficacyand Safety of A4250 in Patients with Primary Biliary Cirrhosis andCholestatic Pruritus An Exploratory, Phase IIa Cross-Over Study to Demonstrate the Efficacyand Safety of A4250in Patients ... | Primary biliary cirrhosis complicated by cholestatic pruritus.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] Primary biliary cirrhosis complicated by cholestatic pruritus.;Therapeutic area: Diseases [C] - Dige ... | Product Code: A4250 | Sahlgrenska Academy | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 2 | Sweden | ||
| 4 | NCT02963077 (ClinicalTrials.gov) | July 2013 | 1/11/2016 | A Safety and Pharmakokinetic Study of A4250 Alone or in Combination With A3384 | A Phase I, Double-Blind Single and Multiple Ascending Dose Study to Assess Safety and Pharmacokinetics of A4250 as Monotherapy, and in Combination With Colonic Release Cholestyramine (A3384) or Commercially Available Cholestyramine (Questran™) in Healthy Subjects A Phase I, Double-Blind Single and Multiple Ascending Dose Study to Assess Safety and Pharmacokineti ... | Orphan Cholestatic Liver Diseases;Primary Biliary Cirrhosis;Progressive Familial Intrahepatic Cholestasis;Alagille Syndrome Orphan Cholestatic Liver Diseases;Primary Biliary Cirrhosis;Progressive Familial Intrahepatic Choles ... | Drug: A4250;Drug: CRC (A3384);Drug: Questran;Drug: Placebo | Albireo | NULL | Completed | 18 Years | 60 Years | Both | 94 | Phase 1 | NULL |
296. 胆道閉鎖症
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
Showing 1 to 10 of 10 diseases
| 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 in Children Wi ... | An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat (A4250) in Children With Biliary Atresia (BOLD-EXT) An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat (A4250) in Chi ... | 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 This Study Will Investigate the Efficacy and Safety of Odevixibat in Children with Biliary Atresia W ... | 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) A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixib ... | 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] Biliary Atresia MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;S ... | 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 Product Name: Odevixibat Product Code: A4250 INN or Proposed INN: Odevixibat Product Name: Odevixibat Pr ... | 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 United States;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Malaysia; ... | ||
| 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 This Study Will Investigate the Efficacy and Safety of Odevixibat in Children with Biliary Atresia W ... | 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 A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixib ... | 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] Biliary Atresia MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;S ... | 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 Product Name: Odevixibat Product Code: [A4250] INN or Proposed INN: Odevixibat Product Name: 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 United States;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;M ... | ||
| 4 | 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 This Study Will Investigate the Efficacy and Safety of Odevixibat in Children with Biliary Atresia W ... | 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) A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixib ... | 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] Biliary Atresia MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;S ... | 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 Product Name: Odevixibat Product Code: A4250 INN or Proposed INN: Odevixibat Product Name: Odevixibat Pr ... | 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 United States;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Belgium;Malaysia ... | ||
| 5 | 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 This Study Will Investigate the Efficacy and Safety of Odevixibat in Children with Biliary Atresia W ... | 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) A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixib ... | 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] Biliary Atresia MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;S ... | 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 Product Name: Odevixibat Product Code: A4250 INN or Proposed INN: Odevixibat Product Name: Odevixibat Pr ... | 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 United States;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;M ... | ||
| 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 This Study Will Investigate the Efficacy and Safety of Odevixibat in Children with Biliary Atresia W ... | 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) A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixib ... | 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] Biliary Atresia MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;S ... | 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 Product Name: Odevixibat Product Code: A4250 INN or Proposed INN: Odevixibat Product Name: Odevixibat Pr ... | 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 New Zealand;United States;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Pola ... | ||
| 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 This Study Will Investigate the Efficacy and Safety of Odevixibat in Children with Biliary Atresia W ... | 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) A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixib ... | 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] Biliary Atresia MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;S ... | 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 Product Name: Odevixibat Product Code: A4250 INN or Proposed INN: Odevixibat Product Name: Odevixibat Pr ... | 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 United States;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;M ... | ||
| 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) Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (B ... | 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 A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixib ... | 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 United States;Australia;Belgium;Canada;China;France;Germany;Hungary;Israel;Italy;Korea, Republic of; ... |
| 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 This Study Will Investigate the Efficacy and Safety of Odevixibat in Children with Biliary Atresia W ... | 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) A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixib ... | 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] Biliary Atresia MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;S ... | 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 Product Name: Odevixibat Product Code: A4250 INN or Proposed INN: Odevixibat Product Name: Odevixibat Pr ... | 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 United States;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Malaysia; ... | |||
| 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 This Study Will Investigate the Efficacy and Safety of Odevixibat in Children with Biliary Atresia W ... | 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) A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixib ... | 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] Biliary Atresia MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;S ... | 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 Product Name: Odevixibat Product Code: A4250 INN or Proposed INN: Odevixibat Product Name: Odevixibat Pr ... | 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 United States;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Malaysia; ... |
297. アラジール症候群
臨床試験数 : 45 / 薬物数 : 21 - (DrugBank : 10) / 標的遺伝子数 : 3 - 標的パスウェイ数 : 5
Showing 1 to 10 of 16 diseases
| 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 | EUCTR2021-000996-36-NL (EUCTR) | 04/03/2022 | 02/09/2021 | A long term Investigation of the Safety and Efficacy of Odevixibat in Patients with Alagille syndrome A long term Investigation of the Safety and Efficacy of Odevixibat in Patients with Alagille syndrom ... | An Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT-EXT) An Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients ... | Alagille Syndrome MedDRA version: 20.0;Level: PT;Classification code 10053870;Term: Alagille syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] Alagille Syndrome MedDRA version: 20.0;Level: PT;Classification code 10053870;Term: Alagille syndrom ... | Product Name: Odevixibat Product Code: A4250 INN or Proposed INN: Odevixibat Other descriptive name: A4250 Product Name: Odevixibat Product Code: A4250 INN or Proposed INN: Odevixibat Other descriptive name: A4250 Product Name: Odevixibat Product Code: A4250 INN or Proposed INN: Odevixibat Other descriptive name: A4250 Product Name: Odevixibat Product Code: A4250 INN or Proposed INN: Odevixibat Other descriptive name: A4250 Product Name: Odevixibat Product Code: A4250 INN or Proposed INN: Odevixibat Other descriptive name: A4 ... | Albireo AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | United States;Turkey;Israel;Italy;United Kingdom;France;Canada;Malaysia;Belgium;Poland;Netherlands;Germany;New Zealand United States;Turkey;Israel;Italy;United Kingdom;France;Canada;Malaysia;Belgium;Poland;Netherlands;G ... | ||
| 2 | EUCTR2021-000996-36-IT (EUCTR) | 09/11/2021 | 27/01/2022 | A long term Investigation of the Safety and Efficacy of Odevixibat in Patients with Alagille syndrome A long term Investigation of the Safety and Efficacy of Odevixibat in Patients with Alagille syndrom ... | An Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT-EXT) - NA An Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients ... | Alagille Syndrome MedDRA version: 20.0;Level: PT;Classification code 10053870;Term: Alagille syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] Alagille Syndrome MedDRA version: 20.0;Level: PT;Classification code 10053870;Term: Alagille syndrom ... | Product Name: Odevixibat Product Code: [A4250] INN or Proposed INN: Odevixibat Other descriptive name: A4250 Product Name: Odevixibat Product Code: [A4250] INN or Proposed INN: Odevixibat Other descriptive name: A4250-015 Product Name: Odevixibat Product Code: [A4250] INN or Proposed INN: Odevixibat Other descriptive name: A4250 Product Name: Odevixibat Product Code: [A4250] INN or Proposed INN: Odevixibat Other descriptive name: A4250 Product Name: Odevixibat Product Code: [A4250] INN or Proposed INN: Odevixibat Other descriptive name: ... | ALBIREO AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | United States;Turkey;Israel;Italy;United Kingdom;France;Canada;Belgium;Malaysia;Poland;Germany;Netherlands;New Zealand United States;Turkey;Israel;Italy;United Kingdom;France;Canada;Belgium;Malaysia;Poland;Germany;Nethe ... | ||
| 3 | NCT05035030 (ClinicalTrials.gov) | September 3, 2021 | 13/8/2021 | Long-term Safety and Efficacy of Odevixibat in Patients With Alagille Syndrome | An Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients With Alagille Syndrome (ASSERT-EXT) An Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients ... | Alagille Syndrome | Drug: Odevixibat | Albireo | NULL | Active, not recruiting | N/A | N/A | All | 63 | Phase 3 | United States;Belgium;France;Germany;Italy;Malaysia;Netherlands;Poland;Turkey;United Kingdom |
| 4 | EUCTR2020-004011-28-DE (EUCTR) | 21/07/2021 | 15/04/2021 | An Investigation of the Safety and Efficacy of Odevixibat in Patients with Alagille syndrome | A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT) A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixiba ... | Alagille Syndrome MedDRA version: 20.0;Level: PT;Classification code 10053870;Term: Alagille syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] Alagille Syndrome MedDRA version: 20.0;Level: PT;Classification code 10053870;Term: Alagille syndrom ... | Product Name: Odevixibat Product Code: A4250 INN or Proposed INN: Odevixibat Other descriptive name: A4250 Product Name: Odevixibat Product Code: A4250 INN or Proposed INN: Odevixibat Other descriptive name: A4250 Product Name: Odevixibat Product Code: A4250 INN or Proposed INN: Odevixibat Other descriptive name: A4250 Product Name: Odevixibat Product Code: A4250 INN or Proposed INN: Odevixibat Other descriptive name: A4250 Product Name: Odevixibat Product Code: A4250 INN or Proposed INN: Odevixibat Other descriptive name: A4 ... | Albireo AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | United States;Turkey;Israel;Italy;United Kingdom;France;Canada;Belgium;Malaysia;Poland;Germany;Netherlands;New Zealand United States;Turkey;Israel;Italy;United Kingdom;France;Canada;Belgium;Malaysia;Poland;Germany;Nethe ... | ||
| 5 | EUCTR2020-004011-28-NL (EUCTR) | 08/06/2021 | 16/12/2020 | An Investigation of the Safety and Efficacy of Odevixibat in Patients with Alagille syndrome | A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT) A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixiba ... | Alagille Syndrome MedDRA version: 20.0;Level: PT;Classification code 10053870;Term: Alagille syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] Alagille Syndrome MedDRA version: 20.0;Level: PT;Classification code 10053870;Term: Alagille syndrom ... | Product Name: Odevixibat Product Code: A4250 INN or Proposed INN: Odevixibat Other descriptive name: A4250 Product Name: Odevixibat Product Code: A4250 INN or Proposed INN: Odevixibat Other descriptive name: A4250 Product Name: Odevixibat Product Code: A4250 INN or Proposed INN: Odevixibat Other descriptive name: A4250 Product Name: Odevixibat Product Code: A4250 INN or Proposed INN: Odevixibat Other descriptive name: A4250 Product Name: Odevixibat Product Code: A4250 INN or Proposed INN: Odevixibat Other descriptive name: A4 ... | Albireo AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | United States;France;Canada;Poland;Belgium;Denmark;Australia;Germany;Netherlands;United Kingdom;Italy United States;France;Canada;Poland;Belgium;Denmark;Australia;Germany;Netherlands;United Kingdom;Ital ... | ||
| 6 | NCT04674761 (ClinicalTrials.gov) | March 19, 2021 | 10/12/2020 | Efficacy and Safety of Odevixibat in Patients With Alagille Syndrome | A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixibat (A4250) in Patients With Alagille Syndrome (ASSERT) A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixiba ... | Alagille Syndrome | Drug: Odevixibat;Drug: Placebo | Albireo | NULL | Active, not recruiting | N/A | N/A | All | 63 | Phase 3 | United States;Belgium;Canada;France;Germany;Israel;Italy;Malaysia;Netherlands;New Zealand;Poland;Turkey;United Kingdom United States;Belgium;Canada;France;Germany;Israel;Italy;Malaysia;Netherlands;New Zealand;Poland;Tur ... |
| 7 | EUCTR2020-004011-28-IT (EUCTR) | 24/02/2021 | 20/05/2021 | An Investigation of the Safety and Efficacy of Odevixibat in Patients with Alagille syndrome | A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT) - NA A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixiba ... | Alagille Syndrome MedDRA version: 20.0;Level: PT;Classification code 10053870;Term: Alagille syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] Alagille Syndrome MedDRA version: 20.0;Level: PT;Classification code 10053870;Term: Alagille syndrom ... | Product Name: Odevixibat Product Code: [A4250] INN or Proposed INN: Odevixibat Other descriptive name: A4250 Product Name: Odevixibat Product Code: [A4250] INN or Proposed INN: Odevixibat Other descriptive name: A4250 Product Name: Odevixibat Product Code: [A4250] INN or Proposed INN: Odevixibat Other descriptive name: A4250 Product Name: Odevixibat Product Code: [A4250] INN or Proposed INN: Odevixibat Other descriptive name: A4250 Product Name: Odevixibat Product Code: [A4250] INN or Proposed INN: Odevixibat Other descriptive name: ... | ALBIREO AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | France;United States;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy France;United States;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;United Kingdom;Ital ... | ||
| 8 | EUCTR2020-004011-28-FR (EUCTR) | 09/02/2021 | 25/11/2020 | An Investigation of the Safety and Efficacy of Odevixibat in Patients with Alagille syndrome | A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT) A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixiba ... | Alagille Syndrome MedDRA version: 20.0;Level: PT;Classification code 10053870;Term: Alagille syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] Alagille Syndrome MedDRA version: 20.0;Level: PT;Classification code 10053870;Term: Alagille syndrom ... | Product Name: Odevixibat Product Code: A4250 INN or Proposed INN: Odevixibat Other descriptive name: A4250 Product Name: Odevixibat Product Code: A4250 INN or Proposed INN: Odevixibat Other descriptive name: A4250 Product Name: Odevixibat Product Code: A4250 INN or Proposed INN: Odevixibat Other descriptive name: A4250 Product Name: Odevixibat Product Code: A4250 INN or Proposed INN: Odevixibat Other descriptive name: A4250 Product Name: Odevixibat Product Code: A4250 INN or Proposed INN: Odevixibat Other descriptive name: A4 ... | Albireo AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 63 | Phase 3 | United States;France;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy United States;France;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;United Kingdom;Ital ... | ||
| 9 | NCT03082937 (ClinicalTrials.gov) | January 31, 2017 | 27/2/2017 | An Open Label, Single-dose, Single Period ADME Study of A4250 in Healthy Subjects | An Open Label, Single-Dose, Single Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-A4250 in Healthy Male Subjects An Open Label, Single-Dose, Single Period Study Designed to Assess the Mass Balance Recovery, Metabo ... | Orphan Cholestatic Liver Diseases;Progressive Familial Intrahepatic Cholestasis;Alagille Syndrome;Primary Biliary Cirrhosis Orphan Cholestatic Liver Diseases;Progressive Familial Intrahepatic Cholestasis;Alagille Syndrome;Pr ... | Drug: 3 mg [14C]-A4250 capsule | Albireo | NULL | Completed | 30 Years | 65 Years | Male | 6 | Phase 1 | United Kingdom |
| 10 | NCT02963077 (ClinicalTrials.gov) | July 2013 | 1/11/2016 | A Safety and Pharmakokinetic Study of A4250 Alone or in Combination With A3384 | A Phase I, Double-Blind Single and Multiple Ascending Dose Study to Assess Safety and Pharmacokinetics of A4250 as Monotherapy, and in Combination With Colonic Release Cholestyramine (A3384) or Commercially Available Cholestyramine (Questran™) in Healthy Subjects A Phase I, Double-Blind Single and Multiple Ascending Dose Study to Assess Safety and Pharmacokineti ... | Orphan Cholestatic Liver Diseases;Primary Biliary Cirrhosis;Progressive Familial Intrahepatic Cholestasis;Alagille Syndrome Orphan Cholestatic Liver Diseases;Primary Biliary Cirrhosis;Progressive Familial Intrahepatic Choles ... | Drug: A4250;Drug: CRC (A3384);Drug: Questran;Drug: Placebo | Albireo | NULL | Completed | 18 Years | 60 Years | Both | 94 | Phase 1 | NULL |
338. 進行性家族性肝内胆汁うっ滞症
臨床試験数 : 60 / 薬物数 : 26 - (DrugBank : 6) / 標的遺伝子数 : 2 - 標的パスウェイ数 : 2
Showing 1 to 10 of 23 diseases
| 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 | NCT04483531 (ClinicalTrials.gov) | June 1, 2021 | 13/7/2020 | Odevixibat for the Treatment of Progressive Familial Intrahepatic Cholestasis | Odevixibat (A4250) for the Treatment of Progressive Familial Intrahepatic Cholestasis (Expanded Access Program) Odevixibat (A4250) for the Treatment of Progressive Familial Intrahepatic Cholestasis (Expanded Acce ... | Progressive Familial Intrahepatic Cholestasis | Drug: Odevixibat | Albireo | NULL | Approved for marketing | N/A | N/A | All | United States | ||
| 2 | EUCTR2017-002325-38-BE (EUCTR) | 11/02/2019 | 04/09/2018 | A study to determine the long term effect and safety of A4250 in treatment of children with Progressive Familial Intrahepatic Cholestasis Types 1 and 2. A study to determine the long term effect and safety of A4250in treatment of children with Progressi ... | An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250 in Children with Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 2) An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250in Children with Pro ... | Progressive Familial Intrahepatic Cholestasis Types 1 and 2 MedDRA version: 20.0;Level: PT;Classification code 10076033;Term: Progressive familial intrahepatic cholestasis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] Progressive Familial Intrahepatic Cholestasis Types 1 and 2 MedDRA version: 20.0;Level: PT;Classific ... | Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (1200 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (600 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (400 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (200 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250(1200 µg) Product ... | Albireo AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Saudi Arabia;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden United States;Saudi Arabia;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Belgium;Poland;Aus ... | ||
| 3 | EUCTR2017-002325-38-ES (EUCTR) | 12/12/2018 | 17/09/2018 | A study to determine the long term effect and safety of A4250 in treatment of children with Progressive Familial Intrahepatic Cholestasis Types 1 and 2. A study to determine the long term effect and safety of A4250in treatment of children with Progressi ... | An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250 in Children with Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 2) An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250in Children with Pro ... | Progressive Familial Intrahepatic Cholestasis Types 1 and 2 MedDRA version: 20.0;Level: PT;Classification code 10076033;Term: Progressive familial intrahepatic cholestasis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] Progressive Familial Intrahepatic Cholestasis Types 1 and 2 MedDRA version: 20.0;Level: PT;Classific ... | Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (1200 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (600 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (400 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (200 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250(1200 µg) Product ... | Albireo AB | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | United States;Saudi Arabia;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden United States;Saudi Arabia;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Belgium;Poland;Aus ... | ||
| 4 | EUCTR2017-002325-38-IT (EUCTR) | 09/11/2018 | 11/10/2018 | A study to determine the long term effect and safety of A4250 in treatment of children with Progressive Familial Intrahepatic Cholestasis Types 1 and 2. A study to determine the long term effect and safety of A4250in treatment of children with Progressi ... | An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250 in Children with Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 2) An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250in Children with Pro ... | Progressive Familial Intrahepatic Cholestasis Types 1 and 2 MedDRA version: 20.0;Level: PT;Classification code 10076033;Term: Progressive familial intrahepatic cholestasis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] Progressive Familial Intrahepatic Cholestasis Types 1 and 2 MedDRA version: 20.0;Level: PT;Classific ... | Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (1200 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (600 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (400 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (200 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250(1200 µg) Product ... | Albireo AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | United States;Saudi Arabia;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden United States;Saudi Arabia;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Belgium;Poland;Aus ... | ||
| 5 | EUCTR2017-002325-38-GB (EUCTR) | 02/11/2018 | 26/06/2018 | A study to determine the long term effect and safety of A4250 in treatment of children with Progressive Familial Intrahepatic Cholestasis Types 1 and 2. A study to determine the long term effect and safety of A4250in treatment of children with Progressi ... | An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250 in Children with Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 2) An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250in Children with Pro ... | Progressive Familial Intrahepatic Cholestasis Types 1 and 2 MedDRA version: 20.0;Level: PT;Classification code 10076033;Term: Progressive familial intrahepatic cholestasis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] Progressive Familial Intrahepatic Cholestasis Types 1 and 2 MedDRA version: 20.0;Level: PT;Classific ... | Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (1200 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (600 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (400 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (200 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250(1200 µg) Product ... | Albireo AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Saudi Arabia;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Poland;Belgium;Australia;Germany;Netherlands;Sweden United States;Saudi Arabia;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Poland;Belgium;Aus ... | ||
| 6 | EUCTR2017-002325-38-NL (EUCTR) | 31/10/2018 | 01/08/2018 | A study to determine the long term effect and safety of A4250 in treatment of children with Progressive Familial Intrahepatic Cholestasis Types 1 and 2. A study to determine the long term effect and safety of A4250in treatment of children with Progressi ... | An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250 in Children with Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 2) An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250in Children with Pro ... | Progressive Familial Intrahepatic Cholestasis Types 1 and 2 MedDRA version: 20.0;Level: PT;Classification code 10076033;Term: Progressive familial intrahepatic cholestasis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] Progressive Familial Intrahepatic Cholestasis Types 1 and 2 MedDRA version: 20.0;Level: PT;Classific ... | Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (1200 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (600 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (400 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (200 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250(1200 µg) Product ... | Albireo AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Saudi Arabia;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Belgium;Poland;Australia;Netherlands;Germany;Sweden United States;Saudi Arabia;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Belgium;Poland;Aus ... | ||
| 7 | EUCTR2017-002325-38-SE (EUCTR) | 30/10/2018 | 07/06/2018 | A study to determine the long term effect and safety of A4250 in treatment of children with Progressive Familial Intrahepatic Cholestasis Types 1 and 2. A study to determine the long term effect and safety of A4250in treatment of children with Progressi ... | An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250 in Children with Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 2) An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250in Children with Pro ... | Progressive Familial Intrahepatic Cholestasis Types 1 and 2 MedDRA version: 20.0;Level: PT;Classification code 10076033;Term: Progressive familial intrahepatic cholestasis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] Progressive Familial Intrahepatic Cholestasis Types 1 and 2 MedDRA version: 20.0;Level: PT;Classific ... | Product Code: A4250 INN or Proposed INN: Odevixibat Other descriptive name: A4250 (1200 µg) Product Code: A4250 INN or Proposed INN: Odevixibat Other descriptive name: A4250 (600 µg) Product Code: A4250 INN or Proposed INN: Odevixibat Other descriptive name: A4250 (400 µg) Product Code: A4250 INN or Proposed INN: Odevixibat Other descriptive name: A4250 (200 µg) Product Code: A4250 INN or Proposed INN: Odevixibat Other descriptive name: A4250(1200 µg) Product Code ... | Albireo AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Saudi Arabia;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden United States;Saudi Arabia;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Belgium;Poland;Aus ... | ||
| 8 | NCT03659916 (ClinicalTrials.gov) | September 28, 2018 | 24/8/2018 | Long Term Safety & Efficacy Study Evaluating The Effect of A4250 in Children With PFIC | An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250 in Children With Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 2) An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250in Children With Pro ... | Progressive Familial Intrahepatic Cholestasis | Drug: A4250 (odevixibat) | Albireo | NULL | Active, not recruiting | 0 Months | 100 Years | All | 120 | Phase 3 | United States;Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom United States;Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;S ... |
| 9 | EUCTR2017-002338-21-BE (EUCTR) | 13/09/2018 | 30/03/2018 | A study to determine if A4250 is safe and can be used to treat children with Progressive Familial Intrahepatic Cholestasis Types 1 and 2. A study to determine if A4250is safe and can be used to treat children with Progressive Familial Int ... | A Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study to Demonstrate Efficacy and Safety of A4250 in Children with Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 1) A Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study to Demonstrate Efficacy and Safety of ... | Progressive Familial Intrahepatic Cholestasis Types 1 and 2 MedDRA version: 20.0;Level: PT;Classification code 10076033;Term: Progressive familial intrahepatic cholestasis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] Progressive Familial Intrahepatic Cholestasis Types 1 and 2 MedDRA version: 20.0;Level: PT;Classific ... | Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (1200 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (600 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (400 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (200 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250(1200 µg) Product ... | Albireo AB | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | United States;Saudi Arabia;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden United States;Saudi Arabia;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Belgium;Poland;Aus ... | ||
| 10 | EUCTR2017-002325-38-FR (EUCTR) | 11/09/2018 | 07/06/2018 | A study to determine the long term effect and safety of A4250 in treatment of children with Progressive Familial Intrahepatic Cholestasis Types 1 and 2. A study to determine the long term effect and safety of A4250in treatment of children with Progressi ... | An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250 in Children with Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 2) An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250in Children with Pro ... | Progressive Familial Intrahepatic Cholestasis Types 1 and 2 MedDRA version: 20.0;Level: PT;Classification code 10076033;Term: Progressive familial intrahepatic cholestasis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] Progressive Familial Intrahepatic Cholestasis Types 1 and 2 MedDRA version: 20.0;Level: PT;Classific ... | Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (1200 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (600 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (400 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250 (200 µg) Product Code: A4250 INN or Proposed INN: Not applicable Other descriptive name: A4250(1200 µg) Product ... | Albireo AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (P ... | United States;Saudi Arabia;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Poland;Belgium;Australia;Germany;Netherlands;Sweden United States;Saudi Arabia;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Poland;Belgium;Aus ... |