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
| 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 | Orphan Cholestatic Liver Diseases;Progressive Familial Intrahepatic Cholestasis;Alagille Syndrome;Primary Biliary Cirrhosis | 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 | 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 | An Exploratory, Phase IIa Cross-Over Study to Demonstrate the Efficacyand Safety of A4250 in Patients with Primary Biliary Cirrhosis andCholestatic Pruritus | Primary biliary cirrhosis complicated by cholestatic pruritus.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | 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 | Orphan Cholestatic Liver Diseases;Primary Biliary Cirrhosis;Progressive Familial Intrahepatic Cholestasis;Alagille Syndrome | 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
| 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-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 | |||
| 10 | 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 |
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
| 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 | An Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT-EXT) | 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] | 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 | 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 | ||
| 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 | An Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT-EXT) - NA | 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] | 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 | 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 | ||
| 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) | 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) | 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] | 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 | 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 | ||
| 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) | 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] | 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 | 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 | ||
| 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) | 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 |
| 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 | 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] | 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 | 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 | ||
| 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) | 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] | 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 | 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 | ||
| 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 | Orphan Cholestatic Liver Diseases;Progressive Familial Intrahepatic Cholestasis;Alagille Syndrome;Primary Biliary Cirrhosis | 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 | Orphan Cholestatic Liver Diseases;Primary Biliary Cirrhosis;Progressive Familial Intrahepatic Cholestasis;Alagille Syndrome | Drug: A4250;Drug: CRC (A3384);Drug: Questran;Drug: Placebo | Albireo | NULL | Completed | 18 Years | 60 Years | Both | 94 | Phase 1 | NULL |
| 11 | EUCTR2021-000996-36-FR (EUCTR) | 25/06/2021 | A long term Investigation of the 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) | 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] | 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 | Albireo AB | NULL | NA | Female: yes Male: yes | 60 | Phase 3 | United States;Turkey;Israel;Italy;United Kingdom;France;Canada;Malaysia;Belgium;Poland;Germany;Netherlands;New Zealand | |||
| 12 | EUCTR2021-000996-36-DE (EUCTR) | 02/11/2021 | A long term Investigation of the 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) | 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] | 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 | Albireo AB | NULL | NA | Female: yes Male: yes | 60 | Phase 3 | United States;Turkey;Israel;Italy;United Kingdom;France;Canada;Malaysia;Belgium;Poland;Germany;Netherlands;New Zealand | |||
| 13 | EUCTR2021-000996-36-PL (EUCTR) | 01/09/2021 | A long term Investigation of the 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) | 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] | 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 | Albireo AB | NULL | NA | Female: yes Male: yes | 60 | Phase 3 | United States;Turkey;Israel;Italy;United Kingdom;France;Canada;Poland;Malaysia;Belgium;Germany;Netherlands;New Zealand | |||
| 14 | EUCTR2021-000996-36-BE (EUCTR) | 01/09/2021 | A long term Investigation of the 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) | 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] | 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 | Albireo AB | NULL | NA | Female: yes Male: yes | 51 | Phase 3 | France;United States;Poland;Malaysia;Belgium;Turkey;Germany;Netherlands;United Kingdom;Italy | |||
| 15 | EUCTR2020-004011-28-PL (EUCTR) | 07/12/2020 | 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) | 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] | 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 | Albireo AB | NULL | NA | Female: yes Male: yes | 60 | Phase 3 | United Kingdom;Italy;United States;France;Canada;Belgium;Poland;Denmark;Australia;Netherlands;Germany | |||
| 16 | EUCTR2020-004011-28-BE (EUCTR) | 19/01/2021 | 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) | 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] | 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 | Albireo AB | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | United States;Turkey;Israel;United Kingdom;Italy;France;Canada;Poland;Belgium;Malaysia;Australia;Denmark;Germany;Netherlands;New Zealand |
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
| 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) | 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. | 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) | 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] | 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) | 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 | ||
| 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. | 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) | 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] | 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) | 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 | ||
| 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. | 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) | 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] | 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) | 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 | ||
| 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. | 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) | 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] | 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) | 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 | ||
| 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. | 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) | 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] | 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) | 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 | ||
| 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. | 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) | 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] | 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) | 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 | ||
| 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) | 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 |
| 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 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) | 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] | 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) | 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 | ||
| 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. | 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) | 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] | 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) | 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 | United States;Saudi Arabia;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Poland;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 11 | EUCTR2017-002338-21-IT (EUCTR) | 05/06/2018 | 14/01/2021 | 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 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 study to determine if A4250 is safe and can be used to treat children with Progressive Familial In | 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] | Product Name: --- Product Code: [A4250] Other descriptive name: A4250 (1200 µg) Product Name: --- Product Code: [A4250] Other descriptive name: A4250 (600 µg) Product Name: --- Product Code: [A4250] Other descriptive name: A4250 (400 µg) Product Name: --- Product Code: [A4250] Other descriptive name: A4250 (200 µg) | 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 | ||
| 12 | EUCTR2017-002338-21-GB (EUCTR) | 04/06/2018 | 09/02/2018 | 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 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) | 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] | 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) | 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 | ||
| 13 | EUCTR2017-002338-21-NL (EUCTR) | 28/05/2018 | 19/02/2018 | 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 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) | 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] | 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) | 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;Netherlands;Germany;Sweden | ||
| 14 | NCT03566238 (ClinicalTrials.gov) | May 16, 2018 | 25/5/2018 | This Study Will Investigate the Efficacy and Safety of A4250 in Children With PFIC 1 or 2 | 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) | PFIC1;PFIC2 | Drug: A4250 (odevixibat);Drug: Placebo | Albireo | NULL | Completed | 6 Months | 18 Years | All | 62 | Phase 3 | United States;Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Poland;Saudi Arabia;Spain;Sweden;Turkey;United Kingdom |
| 15 | EUCTR2017-002338-21-ES (EUCTR) | 29/04/2018 | 08/03/2018 | 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 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) | 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] | 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) | 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 | ||
| 16 | EUCTR2017-002338-21-FR (EUCTR) | 23/04/2018 | 01/02/2018 | 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 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) | 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] | 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) | 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 | ||
| 17 | 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 | Orphan Cholestatic Liver Diseases;Progressive Familial Intrahepatic Cholestasis;Alagille Syndrome;Primary Biliary Cirrhosis | Drug: 3 mg [14C]-A4250 capsule | Albireo | NULL | Completed | 30 Years | 65 Years | Male | 6 | Phase 1 | United Kingdom |
| 18 | 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 | Orphan Cholestatic Liver Diseases;Primary Biliary Cirrhosis;Progressive Familial Intrahepatic Cholestasis;Alagille Syndrome | Drug: A4250;Drug: CRC (A3384);Drug: Questran;Drug: Placebo | Albireo | NULL | Completed | 18 Years | 60 Years | Both | 94 | Phase 1 | NULL |
| 19 | EUCTR2017-002338-21-SE (EUCTR) | 29/01/2018 | 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 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) | 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] | 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) | 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 | |||
| 20 | EUCTR2017-002325-38-PL (EUCTR) | 19/11/2018 | 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. | 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) | 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] | 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) | Albireo AB | NULL | NA | Female: yes Male: yes | 120 | Phase 3 | United States;Saudi Arabia;Spain;Turkey;Israel;Italy;United Kingdom;France;Canada;Poland;Belgium;Australia;Netherlands;Germany;Sweden | |||
| 21 | EUCTR2017-002338-21-PL (EUCTR) | 29/10/2018 | 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 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) | 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] | 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) | Albireo AB | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | United States;Saudi Arabia;Spain;Turkey;Israel;United Kingdom;Italy;France;Canada;Poland;Belgium;Australia;Germany;Netherlands;Sweden | |||
| 22 | EUCTR2017-002325-38-DE (EUCTR) | 06/06/2018 | 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. | 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) | 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] | 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) | Albireo AB | NULL | NA | 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 | |||
| 23 | EUCTR2017-002338-21-DE (EUCTR) | 30/01/2018 | 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 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) | 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] | 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) | 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 |