296. 胆道閉鎖症
[臨床試験数:53,薬物数:56(DrugBank:31),標的遺伝子数:43,標的パスウェイ数:50

Searched query = "Biliary atresia"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-003807-37-NL
(EUCTR)
01/12/202028/04/2020This Study Will Investigate the Efficacy and Safety of Odevixibat in Children with Biliary Atresia Who Have Undergone a Kasai HPEA Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia Who Have Undergone a Kasai Hepatoportoenterostomy (BOLD) Biliary Atresia
MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Albireo ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3United States;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Malaysia;Australia;Denmark;Netherlands;Germany;New Zealand;China;Korea, Republic of
2NCT04524390
(ClinicalTrials.gov)
December 1, 202020/8/2020Evaluation of Maralixibat in Biliary Atresia Response Post-KasaiRandomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of Maralixibat in the Treatment of Subjects With Biliary Atresia After HepatoportoenterostomyBiliary AtresiaDrug: Maralixibat;Other: PlaceboMirum Pharmaceuticals, Inc.NULLNot yet recruiting31 Days111 DaysAll72Phase 2NULL
3ChiCTR2000035667
2020-10-012020-08-16Efficacy and safety study of dimethyl fumarate in adjuvant therapy for biliary atresiaEfficacy and safety study of dimethyl fumarate in adjuvant therapy for biliary atresia Biliary Atresiacontrol group:Take a placebo;Experimental group:Take dimethyl fumarate;Children's Hospital of Fudan UniversityNULLPendingBothcontrol group:120;Experimental group:120;Phase 4China
4EUCTR2019-003807-37-IT
(EUCTR)
10/09/202021/10/2020This Study Will Investigate the Efficacy and Safety of Odevixibat in Children with Biliary Atresia Who Have Undergone a Kasai HPEA Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia Who Have Undergone a Kasai Hepatoportoenterostomy (BOLD) - BOLD Biliary Atresia
MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Odevixibat
Product Code: [A4250]
INN or Proposed INN: Odevixibat
Product Name: Odevixibat
Product Code: [A4250]
INN or Proposed INN: Odevixibat
Product Name: Odevixibat
Product Code: [A4250]
INN or Proposed INN: Odevixibat
ALBIREO ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3United States;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Malaysia;Australia;Denmark;Germany;Netherlands;New Zealand;China;Korea, Republic of
5EUCTR2019-003807-37-FR
(EUCTR)
08/09/202027/04/2020This Study Will Investigate the Efficacy and Safety of Odevixibat in Children with Biliary Atresia Who Have Undergone a Kasai HPEA Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia Who Have Undergone a Kasai Hepatoportoenterostomy (BOLD) Biliary Atresia
MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Albireo ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3United States;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Malaysia;Australia;Denmark;Germany;Netherlands;New Zealand;China;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT04494763
(ClinicalTrials.gov)
August 15, 202019/4/2018Primary Prophylaxis for Variceal Bleed in Biliary AtresiaPropanolol for Primary Prophylaxis for Variceal Bleed in Biliary Atresia - An Open Label Randomized Controlled StudyPortal Hypertension, Biliary AtresiaDrug: Propanolol;Other: PlaceboInstitute of Liver and Biliary Sciences, IndiaNULLNot yet recruiting6 Months5 YearsAll92N/AIndia
7EUCTR2019-003807-37-GB
(EUCTR)
11/08/202017/04/2020This Study Will Investigate the Efficacy and Safety of Odevixibat in Children with Biliary Atresia Who Have Undergone a Kasai HPEA Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia Who Have Undergone a Kasai Hepatoportoenterostomy (BOLD) - Biliary Atresia Odevixibat Liver Disease (BOLD) Biliary Atresia
MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Albireo ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3New Zealand;United States;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Malaysia;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of
8ChiCTR2000032983
2020-08-012020-05-17Development of Biomarkers for Biliary Atresia and Establishment of Artificial Intelligence Diagnostic ModelDevelopment of Biomarkers for Biliary Atresia and Establishment of Artificial Intelligence Diagnostic Model Biliary atresiaGold Standard:Cholangiography combined with liver biopsy;Index test:MMP7;bile acid profile;Children's Hospital of Fudan UniversityNULLRecruitingBothTarget condition:600;Difficult condition:600China
9NCT04506021
(ClinicalTrials.gov)
August 20203/8/2020A Real World Study on Clinical Efficacy of Bicarbonate Ringer's Solution in Biliary Atresia ChildrenA Multicenter Real World Study on Clinical Efficacy of Sodium Bicarbonate Ringer's Solution in Children With Biliary AtresiaBiliary AtresiaDrug: Bicarbonate Ringer's solution;Drug: Other CrystalloidTongji HospitalNULLNot yet recruitingN/A90 DaysAll110NULL
10EUCTR2019-003807-37-HU
(EUCTR)
29/07/202017/04/2020This Study Will Investigate the Efficacy and Safety of Odevixibat in Children with Biliary Atresia Who Have Undergone a Kasai HPEA Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia Who Have Undergone a Kasai Hepatoportoenterostomy (BOLD) Biliary Atresia
MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Albireo ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3United States;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Malaysia;Australia;Denmark;Germany;Netherlands;New Zealand;China;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11ChiCTR2000034127
2020-07-202020-06-25Application of MMP-7 in early diagnosis of neonatal biliary atresiaApplication of MMP-7 in early diagnosis of neonatal biliary atresia Biliary atresia diseaseGold Standard:Laparoscopic cholangiography;Index test:Serum MMP-7;Department of Pediatric Surgery, Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and TechnologyNULLPending0.1BothTarget condition:300;Difficult condition:0China
12NCT04336722
(ClinicalTrials.gov)
July 10, 202027/3/2020Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixibat (A4250) in Children With Biliary Atresia Who Have Undergone a Kasai HepatoportoenterostomyBiliary AtresiaDrug: Odevixibat;Drug: PlaceboAlbireoNULLRecruitingN/A111 DaysAll200Phase 3United States;Belgium;Canada;Hungary;Korea, Republic of;Malaysia;New Zealand;Poland;Spain
13NCT04373941
(ClinicalTrials.gov)
June 1, 202013/8/2019Part II: Granulocyte-Colony Stimulating Factor Adjunct Therapy for Biliary AtresiaGranulocyte-Colony Stimulating Factor Adjunct Therapy for Biliary Atresia: Part II of a Prospective, Randomized Controlled, Multi-Institutional TrialBiliary AtresiaDrug: FilgrastimHolterman, Ai-Xuan, M.D.T Rose Clinical, Inc.;Big Leap ResearchRecruitingN/A180 DaysAll400Phase 2Pakistan;Vietnam
14ChiCTR2000031738
2020-02-182020-04-08A clinical study for Rituximab in the treatment of biliary atresiaImmune pathogenesis and treatment of biliary atresia biliary atresiaControl:Conventional therapy;Experimental group:Rituximab;Guangzhou Women and Children Medical CenterNULLRecruiting0.10.3BothControl:6;Experimental group:6;Phase 4China
15NCT04522869
(ClinicalTrials.gov)
August 10, 20194/9/2019Umbilical Cord Derived Mesenchymal Stem Cell (UC -MSC) Transplantation for Children Suffering From Biliary AtresiaEvaluation Safety and Efficacy of Umbilical Cord Derived Mesenchymal Stem Cell (UC -MSC) Transplantation for Children Suffering From Liver Cirrhosis Due to Biliary Atresia: A Matched Control Prospective StudyPrimary Biliary CirrhosisBiological: Umbilical Cord Derived Mesenchymal Stem Cell (UC -MSC) TransplantationVinmec Research Institute of Stem Cell and Gene TechnologyChildren's Hospital Number 2, Ho Chi Minh City, VietnamRecruiting5 Months2 YearsAll34Phase 1;Phase 2Vietnam
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16ChiCTR1900023843
2019-07-012019-06-14Effects of intestinal flora distribution and mucosal structure on pediatric liver transplantation with biliary atresiaEffects of intestinal flora distribution and mucosal structure on pediatric liver transplantation with biliary atresia Biliary Atresia1:No;2:probiotics;3:Rifaximin;Tianjin First Center HospitalNULLPending018Both1:20;2:10;3:10;China
17ChiCTR1800019866
2019-01-012018-12-02Development and validation of novel diagnostic model for biliary atresiaDevelopment and validation of novel diagnostic model for biliary atresia: a multicenter diagnostic test biliary atresiaGold Standard:cholangiography combined with liver biopsy;Index test:Nomogram;Children's Hospital of Fudan UniversityNULLPendingBothTarget condition:1000;Difficult condition:200China
18EUCTR2014-004693-42-FI
(EUCTR)
02/11/201820/07/2018A study to look at how the study drug Obeticholic Acid (OCA), when given as a single dose and multiple doses, is tolerated in children who have biliary atresia and to look at the effects that the study drug has on the body.A Multicenter, Open-Label, Single- and Multiple-Dose, Dose-Finding Study to Assess the Effects of Obeticholic Acid in Pediatric Subjects with Biliary Atresia Biliary atresia
MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;System Organ Class: 100000004850
MedDRA version: 20.1;Classification code 10004654;Term: Biliary atresia, congenital;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: OCA 1.5mg
Product Code: OCA
INN or Proposed INN: obeticholic acid
Trade Name: Ocaliva
Product Name: OCA 5mg
Product Code: OCA
INN or Proposed INN: obeticholic acid
Product Name: OCA 0.1 mg
Product Code: OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: OBETICHOLIC ACID
Intercept Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
72Phase 2United States;Finland;Belgium;Netherlands;Germany;United Kingdom;Italy
19ChiCTR1800017428
2018-08-152018-07-30Machine learning based on the gallbladder morphology for screening biliary atresia among infants with conjugated hyperbilirubinemiaMachine learning based on the gallbladder morphology for screening biliary atresia among infants with conjugated hyperbilirubinemia Biliary atresiaGold Standard:Surgical exploration, puncture biopsy, intraoperative cholangiography or percutaneous cholecystography;Index test:machine learning based on the gallbladder morphology;Department of Medical Ultrasonics, the First Affiliated Hospital of Sun Yat-sen UniversityNULLPendingBothTarget condition:500;Difficult condition:100China
20NCT03563378
(ClinicalTrials.gov)
July 28, 201821/5/2018Effects of Intraoperative Normal Saline vs Lactated Ringer on Outcomes in Pediatric Liver TransplantationEffects of Intraoperative Normal Saline vs Lactated Ringer on Outcomes in Pediatric Liver Transplantation: A Double-blind Randomized TrialBiliary Atresia Intrahepatic Syndromic FormDrug: Lactated Ringer;Drug: Normal salineRenJi HospitalNULLUnknown status3 Months6 YearsAll200N/AChina
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21ChiCTR-IOR-17013585
2018-06-142017-11-24Comparison of renal injury in children with liver transplantation under combined anesthesia with sevoflurane and propofolThe influence of sevoflurane and propofol on acute kidney injury in pediatric living donor liver transplantion Congenital biliary atresiaP:Propofol compound anesthesia;Se:Sevoflurane compound anesthesia;Tianjin First Central HospitalNULLRecruiting0.52BothP:60;Se:60;China
22NCT03499249
(ClinicalTrials.gov)
May 18, 20184/4/2018N-Acetylcysteine in Biliary Atresia After Kasai PortoenterostomyA Phase 2 Trial of N-Acetylcysteine in Biliary Atresia After Kasai PortoenterostomyBiliary AtresiaDrug: N-Acetyl cysteineBaylor College of MedicineNULLRecruitingN/A90 DaysAll16Phase 2United States
23ChiCTR1800015778
2018-04-202018-04-20Myocardial protection in pediatric patients undergoing liver transplantationMyocardial protective strategies of pediatric liver transplantation with biliary atresia Congenital biliary atresiaPropofol:Propofol compound anesthesia;Sev:Sev compound anesthesia;Tianjin First Center HospitalNULLRecruiting02BothPropofol:60;Sev:60;China
24NCT03395028
(ClinicalTrials.gov)
January 15, 201822/12/2017GCSF Adjunct Therapy for Biliary AtresiaGranulocyte-Colony Stimulating Factor Adjunct Therapy for Biliary AtresiaBiliary AtresiaDrug: Granulocyte Colony-Stimulating FactorHolterman, Ai-Xuan, M.D.T. Rose Clinical, Inc., United States;Children's National Health System;Big Leap Research, VietnamCompletedN/A180 DaysAll6Early Phase 1United States;Vietnam
25ChiCTR1800015250
2018-01-012018-03-19The Effect of Adjuvant UDCA Therapy Post-Kasai Portoenterostomy in Biliary Atresia: a multicenter randomized controlled trialThe Effect of Adjuvant UDCA Therapy Post-Kasai Portoenterostomy in Biliary Atresia: a multicenter randomized controlled trial biliary atresiahigh-dose:UDCA 25mg/kg po;low-dose:UDCA 15mg/kg po;Children's Hospital of Fudan UniversityNULLRecruitingBothhigh-dose:100;low-dose:100;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26JPRN-UMIN000028549
2017/08/0305/08/2017The efficacy of navigation surgery using indocyanine green for visualizing bile duct Biliary atresia, Congenital biliary dilation, Cholelithiasis, hepato-biliary-pancreatic tumorInjection of indocyanine greenNagoya University Graduate School of MedicineNULLPendingNot applicableNot applicableMale and Female100Not selectedJapan
27JPRN-UMIN000027972
2017/01/0101/07/2017Assessment of Indocyanine Green excretion using pinpoint endoscopic fluorescence imaging system for diagnosis of biliary atresia; prospective study. Biliary atresiaTo inject the "Indocyanine Green" (0.5mg/kg) within 30 seconds.Juntendo University School of MedicineNULLComplete: follow-up complete1months-old4months-oldMale and Female10Phase 2Japan
28JPRN-UMIN000024625
2016/12/0130/10/2016The difference of the profile of fatty acids and eicosanoids in clinical course and the effect to the prognosis by collection of biliary atresiaThe difference of the profile of fatty acids and eicosanoids in clinical course and the effect to the prognosis by collection of biliary atresia - The effect of collection of fatty acids in biliary atresia biliary atresiaEPADEL 20-40 mg/kg/dNagoya UniversityNULLRecruitingNot applicableNot applicableMale and Female15Not selectedJapan
29JPRN-jRCTs041180088
01/12/201612/03/2019Influence of fatty acid metabolism for clinical course of biliary atresiaThe difference of the profile of fatty acids and eicosanoids in clinical course and the effect to the prognosis by collection of biliary atresia biliary atresia, neonatal hepatitis, Alagille syndrome, PFIC, etc.oral administration of 30(+/- 10)mg/kg/day of eicosapentaenoic acidSumida WataruUchida HirooRecruitingNot applicableNot applicableBoth30N/AJapan
30ChiCTR-IPR-16008609
2016-07-012016-06-07Therapeutic effect of prophylactic intravenous antibiotics after Kasai procedure in biliary atresiaA clinical randomized controlled study to investigate the preventive effect of prophylactic intravenous antibiotics against cholangitis after Kasai procedure in biliary atresia biliary atresiaShort-term Group:Cefoperazone 5 days;Long-term Group:Cefoperazone 14 days;Children's Hospital of Fudan UniversityNULLCompleted01BothShort-term Group:86;Long-term Group:86;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31ChiCTR-OOC-16008707
2016-06-012016-06-22Study on pharmacodynamics of continuous infusion of rocuronium during transplantation of living donor liver transplantation for infantsStudy on pharmacodynamics of continuous infusion of rocuronium during transplantation of living donor liver transplantation for infants congenital biliary atresiaobstructive jaundice group:continuous infusion of rocuronium;after Kasai portoenterostomy group :continuous infusion of rocuronium;Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong UniversityNULLRecruitingBothobstructive jaundice group:15;after Kasai portoenterostomy group :15;China
32EUCTR2014-004693-42-NL
(EUCTR)
05/01/201609/09/2015A study to look at how the study drug Obeticholic Acid (OCA), when given as a single dose and multiple doses, is tolerated in children who have biliary atresia and to look at the effects that the study drug has on the body.A Multicenter, Randomized, Open Label, Single- and Multiple-Dose, Dose Finding Study and Open-Label Extension to Assess the Effects of Obeticholic Acid in Pediatric Subjects with Biliary Atresia Biliary atresia
MedDRA version: 18.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;System Organ Class: 100000004850
MedDRA version: 18.0;Classification code 10004654;Term: Biliary atresia, congenital;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: OCA 1.5mg
Product Code: OCA
INN or Proposed INN: obeticholic acid
Product Name: OCA 5mg
Product Code: OCA
INN or Proposed INN: obeticholic acid
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60United States;Canada;Germany;Netherlands;United Kingdom
33EUCTR2014-004693-42-DE
(EUCTR)
06/11/201501/06/2015A study to look at how the study drug Obeticholic Acid (OCA), when given as a single dose and multiple doses, is tolerated in children who have biliary atresia and to look at the effects that the study drug has on the body.A Multicenter, Open-Label, Single- and Multiple-Dose, Dose-Finding Study to Assess the Effects of Obeticholic Acid in Pediatric Subjects with Biliary Atresia- P/0204/2019 Biliary atresia
MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;System Organ Class: 100000004850
MedDRA version: 20.1;Classification code 10004654;Term: Biliary atresia, congenital;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: OCA 1.5mg
Product Code: OCA
INN or Proposed INN: obeticholic acid
Trade Name: Ocaliva
Product Name: OCA 5mg
Product Code: OCA
INN or Proposed INN: obeticholic acid
Product Name: OCA 0.1 mg
Product Code: OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: OBETICHOLIC ACID
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2United States;Finland;Belgium;Netherlands;Germany;United Kingdom;Italy
34EUCTR2014-004693-42-BE
(EUCTR)
27/08/201526/10/2015A study to look at how the study drug Obeticholic Acid (OCA), when given as a single dose and multiple doses, is tolerated in children who have biliary atresia and to look at the effects that the study drug has on the body.A Multicenter, Randomized, Open Label, Single- and Multiple-Dose, Dose Finding Study and Open-Label Extension to Assess the Effects of Obeticholic Acid in Pediatric Subjects with Biliary Atresia Biliary atresia
MedDRA version: 19.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;System Organ Class: 100000004850
MedDRA version: 19.0;Classification code 10004654;Term: Biliary atresia, congenital;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: OCA 1.5mg
Product Code: OCA
INN or Proposed INN: obeticholic acid
Product Name: OCA 5mg
Product Code: OCA
INN or Proposed INN: obeticholic acid
Product Name: OCA 0.1 mg
Product Code: OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: OBETICHOLIC ACID
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2United States;Canada;Belgium;Netherlands;Germany;United Kingdom
35EUCTR2014-004693-42-GB
(EUCTR)
29/06/201523/12/2014A study to look at how the study drug Obeticholic Acid (OCA), when given as a single dose and multiple doses, is tolerated in children who have biliary atresia and to look at the effects that the study drug has on the body.A Multicenter, Open Label, Single- and Multiple-Dose, Dose Finding Study to Assess the Effects of Obeticholic Acid in Pediatric Subjects with Biliary Atresia Biliary atresia
MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;System Organ Class: 100000004850
MedDRA version: 20.1;Classification code 10004654;Term: Biliary atresia, congenital;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: OCA 1.5mg
Product Code: OCA
INN or Proposed INN: obeticholic acid
Trade Name: Ocaliva
Product Name: OCA 5mg
Product Code: OCA
INN or Proposed INN: obeticholic acid
Product Name: OCA 0.1 mg
Product Code: OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: OBETICHOLIC ACID
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2United States;Finland;Belgium;Netherlands;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36ChiCTR-DPD-15005847
2014-11-192015-01-19Evidence-based guideline of diagnosis and treatment of biliary atresiaEvidence-based guideline of diagnosis and treatment of biliary atresia biliary atresiaGold Standard:;Index test:;Children's Hospital of Fudan UniversityNULLPending018BothTarget condition:0;Difficult condition:0I (Phase 1 study)China
37NCT01854827
(ClinicalTrials.gov)
October 201327/9/2012Safety Study of Intravenous Immunoglobulin (IVIG) Post-Portoenterostomy in Infants With Biliary AtresiaA Phase 1/2A Trial of Intravenous Immunoglobulin (IVIG) Therapy Following Portoenterostomy in Infants With Biliary AtresiaBiliary AtresiaDrug: Intravenous immunoglobulin (IVIG)National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NULLCompletedN/A120 DaysAll30Phase 1;Phase 2United States;Canada
38NCT01774487
(ClinicalTrials.gov)
January 201322/1/2013Pentoxifylline Therapy in Biliary AtresiaA Phase II Trial of Pentoxifylline in Newly-Diagnosed Biliary AtresiaBiliary AtresiaDrug: PentoxifyllineBaylor College of MedicineNULLRecruitingN/A180 DaysAll60Phase 2United States
39NCT02471209
(ClinicalTrials.gov)
January 20123/6/2015Biliary Atresia, Hepatic Buffer Response and SevofluraneBiliary AtresiaDrug: SevofluraneChildren's Hospital of Fudan UniversityNULLCompleted1 Month3 MonthsBoth25N/ANULL
40NCT01443572
(ClinicalTrials.gov)
September 201116/9/2011The Comparison of Desflurane and Sevoflurane on Postoperative Recovery and Hepatic Function of Biliary Atresia Patients During Kasai OperationKasai Operation;Biliary AtresiaDrug: desflurane anesthetics;Drug: sevoflurane anestheticsYonsei UniversityNULLCompletedN/A1 YearBoth40N/AKorea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT02137668
(ClinicalTrials.gov)
July 201012/5/2014Treating Primary Sclerosing Cholangitis and Biliary Atresia With VancomycinThe Human Gastrointestinal Tract Microbiota in the Setting of Treating Primary Sclerosing Cholangitis and Biliary Atresia With VancomycinPrimary Sclerosing Cholangitis;Biliary AtresiaDrug: Oral VancomycinSacramento Pediatric GastroenterologyNULLRecruitingN/A40 YearsBoth200Phase 1United States
42EUCTR2009-014886-21-NL
(EUCTR)
26/01/201021/09/2009Intraoperative bile duct visualisation in children with biliary atresia using a fluorescence camera system: a pilot study - Bile duct mapping with fluorescence in BAIntraoperative bile duct visualisation in children with biliary atresia using a fluorescence camera system: a pilot study - Bile duct mapping with fluorescence in BA Biliary atresiaTrade Name: ICG-Pulsion 25mg
Product Name: ICG Pulsion
Product Code: VO4CX
University Medical Centre GroningenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
4Netherlands
43NCT02298218
(ClinicalTrials.gov)
September 200919/11/2014Clinical Study About the Role of COX-2 Inhibitor in Liver Cirrhosis With Biliary AtresiaBiliary Atresia, Kasai Portoenterostomy StatusDrug: MeloxicamYonsei UniversityNULLCompleted2 Years17 YearsBoth50Phase 4NULL
44NCT01322386
(ClinicalTrials.gov)
May 200710/2/2011Gastrointestinal Microbiota in Primary Sclerosing Cholangitis and Biliary Atresia With VancomycinThe Human Gastrointestinal Tract Microbiota in the Setting of Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin.Primary Sclerosing Cholangitis;Biliary AtresiaDrug: VancomycinStanford UniversityNULLCompleted1 Month20 YearsAll32Phase 1NULL
45ChiCTR-TNRC-09000331
2007-01-012009-02-11Intervention and Efficacy Evaluation Study of Combined Modality Therapy in Patients with Biliary Atrisia after Kasai OperationruIntervention and Efficacy Evaluation Study of Combined Modality Therapy in Patients with Biliary Atrisia after Kasai Operationru Biliary Atresiagroup 1:Given Yinzhihuang with Ligustrazine from the day 3 after operation;group 2:Given Yinzhihuang with placebo from the day 3;group A:Divide two groups according different glucocorticoid, group A is given dexamethasone from the seventh day after operation;group B:Divide two groups according different glucocorticoid, group B is given methylprednisolone from the seventh day after operation;The First Affiliated Hospital of Sun Yat Sen UniversityNULLCompletedBothgroup 1:50;group 2:50;group A:50;group B:50;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT00294684
(ClinicalTrials.gov)
November 200521/2/2006A Randomized, Double-Blinded, Placebo-Controlled Trial of Corticosteroid Therapy Following PortoenterostomyA Randomized, Double-Blinded, Placebo-Controlled Trial of Corticosteroid Therapy Following Portoenterostomy in Infants With Biliary AtresiaBiliary AtresiaDrug: Corticosteroids;Drug: PlaceboNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NULLCompletedN/A6 MonthsAll141N/AUnited States
47NCT00166868
(ClinicalTrials.gov)
December 200312/9/2005Use of Probiotics to Prevent Cholangitis in Children With Biliary Atresia After the Kasai PortoenterostomyUse of Probiotics to Prevent Cholangitis in Children With Biliary AtresiaBiliary AtresiaDrug: Lactobacillus casei rhamnosus (Lcr35);Drug: NeomycinNational Taiwan University HospitalNULLCompleted4 Months3 YearsBoth30N/ATaiwan
48NCT00007033
(ClinicalTrials.gov)
October 20006/12/2000Study of Magnesium Sulfate in Children With Reduced Bone Density Secondary to Chronic Cholestatic Liver DiseaseAlagille Syndrome;Cholestasis;Biliary AtresiaDrug: magnesium gluconate;Drug: magnesium sulfateNational Center for Research Resources (NCRR)Children's Hospital Medical Center, CincinnatiCompleted3 Years18 YearsBoth25N/AUnited States
49NCT00539565
(ClinicalTrials.gov)
January 20003/10/2007RCT of Steroids Following Kasai Portoenterostomy for Biliary Atresia.Phase IIIb Study of Corticosteroids as Post-Operative Adjuvant Therapy in Biliary AtresiaBiliary AtresiaDrug: prednisolone;Drug: placeboKing's College Hospital NHS TrustNULLEnrolling by invitationN/A100 DaysBoth100Phase 3United Kingdom
50EUCTR2019-003807-37-PL
(EUCTR)
05/05/2020This Study Will Investigate the Efficacy and Safety of Odevixibat in Children with Biliary Atresia Who Have Undergone a Kasai HPEA Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia Who Have Undergone a Kasai Hepatoportoenterostomy (BOLD) Biliary Atresia
MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Albireo ABNULLNAFemale: yes
Male: yes
200Phase 3United States;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Malaysia;Australia;Denmark;Netherlands;Germany;New Zealand;China;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2019-003807-37-DE
(EUCTR)
15/05/2020This Study Will Investigate the Efficacy and Safety of Odevixibat in Children with Biliary Atresia Who Have Undergone a Kasai HPEA Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia Who Have Undergone a Kasai Hepatoportoenterostomy (BOLD) Biliary Atresia
MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Albireo ABNULLNAFemale: yes
Male: yes
200Phase 3Canada;Poland;Belgium;Malaysia;Australia;Denmark;Germany;Netherlands;United States;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;New Zealand;China;Korea, Republic of
52EUCTR2019-003807-37-BE
(EUCTR)
18/06/2020This Study Will Investigate the Efficacy and Safety of Odevixibat in Children with Biliary Atresia Who Have Undergone a Kasai HPEA Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia Who Have Undergone a Kasai Hepatoportoenterostomy (BOLD) Biliary Atresia
MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Product Name: Odevixibat
Product Code: A4250
INN or Proposed INN: Odevixibat
Albireo ABNULLNAFemale: yes
Male: yes
200Phase 3United States;Taiwan;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Malaysia;Australia;Denmark;Germany;Netherlands;New Zealand;China;Korea, Republic of
53EUCTR2020-000974-22-GB
(EUCTR)
21/10/2020Clinical study to evaluate the Efficacy and Safety of Maralixibat used in treatment of Biliary Atresia subjects after HepatoportoenterostomyRandomized, Double-blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of Maralixibat in the Treatment of Subjects with Biliary Atresia after Hepatoportoenterostomy - EMBARK: Evaluation of Maralixibat in Biliary Atresia Response post Kasai Biliary atresia (BA) is a rare, inflammatory condition of the biliary tree that presents in the first weeks of life and leads to bile duct obstruction and consequent liver injury, fibrosis and cirrhosis which lead to portal hypertension and a decline in hepatic synthetic function. Untreated, the outcome of BA is uniformly fatal. The 2 most important improvements in the care of BA patients to date are the Kasai hepatoportoenterostomy (HPE; Kasai procedure) and orthotopic liver transplantation.
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: Maralixibat
INN or Proposed INN: MARALIXIBAT CHLORIDE
Product Name: Maralixibat
INN or Proposed INN: MARALIXIBAT CHLORIDE
Product Name: Maralixibat
INN or Proposed INN: MARALIXIBAT CHLORIDE
Product Name: Maralixibat
INN or Proposed INN: MARALIXIBAT CHLORIDE
Mirum Pharmaceuticals Inc.NULLNAFemale: yes
Male: yes
72Phase 2United States;France;Canada;Poland;Germany;Italy;United Kingdom