Obeticholic acid (oca)    (DrugBank: Obeticholic acid)

3 diseases
IDDisease name (Link within this page)Number of trials
93Primary biliary cholangitis [Primary biliary cirrhosis (~Mar 2017)]5
265Lipodystrophy0
296Biliary atresia5

93. Primary biliary cholangitis [Primary biliary cirrhosis (~Mar 2017)]    [ 230 clinical trials,   215 drugs,   (DrugBank: 51 drugs),   34 drug target genes,   107 drug target pathways]
Searched query = "Primary biliary cholangitis", "Primary biliary cirrhosis", "PBC"
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.
5 / 230 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03633227
(ClinicalTrials.gov)
June 22, 20188/4/2018Study of OCA Evaluating Pharmacokinetics and Safety in Patients With PBC and Hepatic ImpairmentA Phase 4, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Pharmacokinetics and Safety of Obeticholic Acid in Patients With Primary Biliary Cholangitis and Moderate to Severe Hepatic ImpairmentLiver Cirrhosis, BiliaryDrug: Obeticholic Acid (OCA);Drug: PlaceboIntercept PharmaceuticalsNULLActive, not recruiting18 Years85 YearsAll50Phase 4United States;Argentina;Australia;Belgium;Brazil;Canada;Estonia;Germany;Hungary;Italy;Lithuania;Spain
2EUCTR2016-002965-67-NL
(EUCTR)
07/07/201729/03/2017A study on the effect of obetihcolic acid on bile composition in patients with PBC (chronic liver disease of the small bile ducts), NASH (chronic liver disease as a result of fatty liver) and healthy volunteersAn open, non-randomized, parallel-group pharmokinetic and -dynamic, investigator-initiated study on effects of obeticholic acid (OCA) in bile of patients with primary biliary cholangitis (PBC) and non-alcoholic steatohepatitis (NASH) in comparison to healthy controls - OCABILE Primary biliairy cholangitis (PBC)Non-alcoholic steatohepatitis (NASH)
MedDRA version: 20.0;Level: SOC;Classification code 10019805;Term: Hepatobiliary disorders;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: OCA (INT-747)
Product Code: OCA (INT-747)
AMCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2Netherlands
3NCT02308111
(ClinicalTrials.gov)
December 201410/11/2014Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary CholangitisA Phase 4, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Patients With Primary Biliary CholangitisLiver Cirrhosis, BiliaryDrug: Obeticholic Acid (OCA);Drug: PlaceboIntercept PharmaceuticalsNULLRecruiting18 YearsN/AAll428Phase 4United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;Denmark;Estonia;Finland;France;Germany;Hong Kong;Hungary;Israel;Italy;Korea, Republic of;Lithuania;Mexico;Netherlands;New Zealand;Poland;Portugal;Serbia;Spain;Sweden;Switzerland;Turkey;United Kingdom;Former Serbia and Montenegro
4NCT01865812
(ClinicalTrials.gov)
November 201323/5/2013Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Subjects With Primary Biliary CirrhosisA Phase 2 Clinical Trial Investigating the Effects of Obeticholic Acid on Lipoprotein Metabolism in Subjects With Primary Biliary CirrhosisPrimary Biliary CirrhosisDrug: obeticholic acid (OCA)Intercept PharmaceuticalsNULLCompleted18 YearsN/AAll26Phase 2United States
5NCT01473524
(ClinicalTrials.gov)
January 201214/11/2011Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary CirrhosisA Phase 3, Double-Blind, Placebo-Controlled Trial and Long-Term Safety Extension of Obeticholic Acid in Patients With Primary Biliary CirrhosisPrimary Biliary CirrhosisDrug: Obeticholic Acid (OCA);Drug: PlaceboIntercept PharmaceuticalsNULLCompleted18 YearsN/AAll217Phase 3United States;Australia;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Poland;Spain;Sweden;United Kingdom

265. Lipodystrophy    [ 109 clinical trials,   164 drugs,   (DrugBank: 59 drugs),   26 drug target genes,   94 drug target pathways]
Searched query = "Lipodystrophy", "Berardinelli-Seip syndrome", "Lawrence syndrome", "Barraquer-Simons syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: . Trials are sorted by Date_enrollment from most recent to oldest in the table.
0 / 109 trial found

296. Biliary atresia    [ 53 clinical trials,   56 drugs,   (DrugBank: 31 drugs),   43 drug target genes,   50 drug target pathways]
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.
5 / 53 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2014-004693-42-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
2EUCTR2014-004693-42-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
3EUCTR2014-004693-42-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
4EUCTR2014-004693-42-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
5EUCTR2014-004693-42-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