Ocaliva    (DrugBank: -)

2 diseases
IDDisease name (Link within this page)Number of trials
93Primary biliary cholangitis [Primary biliary cirrhosis (~Mar 2017)]27
296Biliary atresia3

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.
27 / 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
1EUCTR2018-002575-17-AT
(EUCTR)
20/07/202007/04/2020Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as Primary Biliary Cirrhosis or PBC).A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate, in Subjects with Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid Primary Biliary Cholangitis (PBC)
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Ocaliva 10mg
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Ocaliva 5mg
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Bezalip
Product Name: Bezafibrate IR
INN or Proposed INN: BEZAFIBRATE
Other descriptive name: Bezafibrate, Beza, BZF, Bezalip
Trade Name: Bezalip mono
Product Name: Bezafibrate SR
INN or Proposed INN: BEZAFIBRATE
Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2United States;Estonia;Slovakia;Greece;Spain;Ireland;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Croatia;Australia;Denmark;Norway;Netherlands;Germany;Sweden;Korea, Republic of
2EUCTR2018-002575-17-HR
(EUCTR)
05/06/202025/06/2020Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as PBC).A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary BiliaryCholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid Primary Biliary Cholangitis (PBC)
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Ocaliva 10mg
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Ocaliva 5mg
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Bezalip
Product Name: Bezafibrate IR
INN or Proposed INN: BEZAFIBRATE
Other descriptive name: Bezafibrate, Beza, BZF, Bezalip
Trade Name: Bezalip mono
Product Name: Bezafibrate SR
INN or Proposed INN: BEZAFIBRATE
Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2United States;Estonia;Slovakia;Greece;Spain;Ireland;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Croatia;Australia;Denmark;Norway;Netherlands;Germany;Sweden;Korea, Republic of
3EUCTR2018-002575-17-PL
(EUCTR)
05/05/202009/01/2020Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as Primary Biliary Cirrhosis or PBC).A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid Primary Biliary Cholangitis (PBC)
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Ocaliva 10mg
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Ocaliva 5mg
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Bezalip
Product Name: Bezafibrate IR
INN or Proposed INN: BEZAFIBRATE
Other descriptive name: Bezafibrate, Beza, BZF, Bezalip
Trade Name: Bezalip mono
Product Name: Bezafibrate SR
INN or Proposed INN: BEZAFIBRATE
Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2Czechia;Estonia;Slovakia;Greece;Spain;Ireland;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Croatia;Australia;Denmark;Norway;Netherlands;Germany;Sweden;Korea, Republic of
4EUCTR2018-002575-17-CZ
(EUCTR)
27/02/202016/10/2019Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as PBC).A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary BiliaryCholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid Primary Biliary Cholangitis (PBC)
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Ocaliva 10mg
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Ocaliva 5mg
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Bezalip
Product Name: Bezafibrate IR
INN or Proposed INN: BEZAFIBRATE
Other descriptive name: Bezafibrate, Beza, BZF, Bezalip
Trade Name: Bezalip mono
Product Name: Bezafibrate SR
INN or Proposed INN: BEZAFIBRATE
Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2United States;Estonia;Slovakia;Greece;Spain;Ireland;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Croatia;Australia;Denmark;Norway;Netherlands;Germany;Sweden;Korea, Republic of
5EUCTR2018-002575-17-GR
(EUCTR)
14/02/202005/11/2019Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as Primary Biliary Cirrhosis or PBC).A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid Primary Biliary Cholangitis (PBC)
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Ocaliva 10mg
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Ocaliva 5mg
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Bezalip
Product Name: Bezafibrate IR
INN or Proposed INN: BEZAFIBRATE
Other descriptive name: Bezafibrate, Beza, BZF, Bezalip
Trade Name: Bezalip mono
Product Name: Bezafibrate SR
INN or Proposed INN: BEZAFIBRATE
Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2Czechia;Estonia;Slovakia;Greece;Spain;Ireland;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Croatia;Australia;Denmark;Norway;Netherlands;Germany;Sweden;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
6EUCTR2018-002575-17-GB
(EUCTR)
14/02/202019/08/2019Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as PBC).A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary BiliaryCholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid Primary Biliary Cholangitis (PBC)
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Ocaliva 10mg
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Ocaliva 5mg
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Bezalip
Product Name: Bezafibrate IR
INN or Proposed INN: BEZAFIBRATE
Other descriptive name: Bezafibrate, Beza, BZF, Bezalip
Trade Name: Bezalip mono
Product Name: Bezafibrate SR
INN or Proposed INN: BEZAFIBRATE
Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2Estonia;Slovakia;Greece;Spain;Ireland;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Croatia;Australia;Denmark;Norway;Netherlands;Germany;Sweden;Korea, Republic of
7EUCTR2018-002575-17-LT
(EUCTR)
17/01/202017/10/2019Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as Primary Biliary Cirrhosis or PBC).A Phase 2, Double-Blind, Randomized, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid Primary Biliary Cholangitis (PBC)
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Ocaliva 10mg
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Ocaliva 5mg
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Bezalip
Product Name: Bezafibrate IR
INN or Proposed INN: BEZAFIBRATE
Other descriptive name: Bezafibrate, Beza, BZF, Bezalip
Trade Name: Bezalip mono
Product Name: Bezafibrate SR
INN or Proposed INN: BEZAFIBRATE
Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2Czechia;Estonia;Slovakia;Greece;Spain;Ireland;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Croatia;Australia;Denmark;Norway;Netherlands;Germany;Sweden;Korea, Republic of
8EUCTR2018-002575-17-ES
(EUCTR)
15/10/201926/07/2019Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as Primary Biliary Cirrhosis or PBC).A Phase 2, Double-Blind, Randomized, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid, Administered Alone or in Combination with Bezafibrate, in Subjects with Primary BiliaryCholangitis who had an Inadequate Response or who were Unable to Tolerate Ursodeoxycholic Acid Primary Biliary Cholangitis (PBC) in patients with Inadequate Response or who were Unable to Tolerate Ursodeoxycholic Acid
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Ocaliva 10mg
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Ocaliva 5mg
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Bezalip
Product Name: Bezafibrate IR
INN or Proposed INN: BEZAFIBRATE
Other descriptive name: Bezafibrate, Beza, BZF, Bezalip
Trade Name: Bezalip mono
Product Name: Bezafibrate SR
INN or Proposed INN: BEZAFIBRATE
Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
54Phase 2Estonia;Slovakia;Greece;Spain;Ireland;Israel;France;Denmark;Australia;Latvia;Netherlands;Korea, Republic of;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Belgium;Poland;Croatia;Germany;Norway;Sweden
9NCT04076527
(ClinicalTrials.gov)
September 201929/8/2019Prospective, Multicenter Cohort Study on Primary Biliary CholangitisProspective, Multicenter Cohort Study on Primary Biliary CholangitisPBC;Primary Biliary CholangitisDrug: UDCA;Drug: OcalivaUniversity of LeipzigRWTH Aachen University;Zentrum für Klinische Studien Leipzig;Intercept Pharma Europe Limited (IPEL);Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA);University Hospital Erlangen;Medical care center for Gastroenterology, Berlin;Institute for Interdisciplinary Medicine, Hamburg;Leberhilfe Projekt gUG, Cologne;Hannover Medical SchoolNot yet recruiting18 YearsN/AAll1200Germany
10EUCTR2017-001762-13-LT
(EUCTR)
31/12/201825/10/2018A clinical trial where neither the doctor, patient or sponsor know whether aplacebo or active medicine is being given to the patient with cirrhosis to see if the medicine is safe in the treatment of that disease and to see how study drug is absorbed, distributed through the body and excreted out of the body.A 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 Impairment Primary Biliary Cholangitis and Moderate to Severe Hepatic Impairment;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Ocaliva
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Ocaliva
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), oCA, INT-747
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 3;Phase 4United States;Estonia;Spain;Lithuania;Italy;Switzerland;United Kingdom;Hungary;Argentina;Belgium;Brazil;Australia;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2017-001762-13-EE
(EUCTR)
04/12/201815/10/2018A clinical trial where neither the doctor, patient or sponsor know whether aplacebo or active medicine is being given to the patient with cirrhosis to see if the medicine is safe in the treatment of that disease and to see how study drug is absorbed, distributed through the body and excreted out of the body.A 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 Impairment Primary Biliary Cholangitis and Moderate to Severe Hepatic Impairment;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Ocaliva
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Ocaliva
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), oCA, INT-747
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 3;Phase 4United States;Estonia;Spain;Lithuania;Switzerland;United Kingdom;Italy;Hungary;Argentina;Belgium;Brazil;Australia;Germany
12EUCTR2017-001762-13-DE
(EUCTR)
27/11/201827/06/2018A clinical trial where neither the doctor, patient or sponsor know whether aplacebo or active medicine is being given to the patient with cirrhosis to see if the medicine is safe in the treatment of that disease and to see how study drug is absorbed, distributed through the body and excreted out of the body.A 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 Impairment Primary Biliary Cholangitis and Moderate to Severe Hepatic Impairment;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Ocaliva
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Ocaliva
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), oCA, INT-747
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 3;Phase 4United States;Estonia;Spain;Lithuania;Italy;Switzerland;United Kingdom;Hungary;Argentina;Belgium;Brazil;Australia;Germany
13EUCTR2017-001762-13-BE
(EUCTR)
24/10/201814/08/2018A clinical trial where neither the doctor, patient or sponsor know whether aplacebo or active medicine is being given to the patient with cirrhosis to see if the medicine is safe in the treatment of that disease and to see how study drug is absorbed, distributed through the body and excreted out of the body.A 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 Impairment Primary Biliary Cholangitis and Moderate to Severe Hepatic Impairment;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Ocaliva
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Ocaliva
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), oCA, INT-747
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 3;Phase 4United States;Estonia;Spain;Lithuania;Switzerland;United Kingdom;Italy;Hungary;Argentina;Belgium;Brazil;Australia;Germany
14EUCTR2017-001762-13-ES
(EUCTR)
01/08/201820/06/2018A clinical trial where neither the doctor, patient or sponsor know whether aplacebo or active medicine is being given to the patient with cirrhosis to see if the medicine is safe in the treatment of that disease and to see how study drug is absorbed, distributed through the body and excreted out of the body.A 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 Impairment Primary Biliary Cholangitis and Moderate to Severe Hepatic Impairment;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Ocaliva
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747
Trade Name: Ocaliva
Product Name: Obeticholic Acid
Product Code: INT-747, OCA
INN or Proposed INN: obeticholic acid
Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), oCA, INT-747
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 4United States;Estonia;Spain;Lithuania;Switzerland;United Kingdom;Italy;Hungary;Argentina;Belgium;Brazil;Australia;Germany
15EUCTR2014-005012-42-PT
(EUCTR)
08/01/201829/08/2017A Phase 4 clinical trial to measure the effect of Obeticholic acid against a placebo, in conjunction with standard treatment, on selected clinical measurements in patients with the liver disease, Primary Biliary Cholangitis.The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT).A Phase 4, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cholangitis. The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT). Primary Biliary Cholangitis
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Ocaliva
Product Name: Obeticholic acid
Product Code: OCA, INT-747
INN or Proposed INN: Obeticholic Acid
Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, INT-747
Trade Name: Ocaliva
Product Name: Obeticholic acid
Product Code: OCA, INT-747
INN or Proposed INN: Obeticholic Acid
Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, Int-747
Intercept Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
428Phase 4United States;Portugal;Serbia;Estonia;Hong Kong;Spain;Chile;Israel;Switzerland;Italy;France;Denmark;Australia;Netherlands;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2014-005012-42-BG
(EUCTR)
23/08/201606/07/2016A Phase 4 clinical trial to measure the effect of Obeticholic acid against a placebo, in conjunction with standard treatment, on selected clinical measurements in patients with the liver disease, Primary Biliary CholangitisThe COBALT Study Clinical Outcomes with OBeticholic Acid in LiverTreatment (COBALT)A Phase 4, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary CholangitisThe COBALT Study Clinical Outcomes with OBeticholic Acid in LiverTreatment (COBALT) Primary Biliary Cholangitis
MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Ocaliva
Product Name: Obeticholic acid
Product Code: OCA, INT-747
INN or Proposed INN: Obeticholic Acid
Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, INT-747
Trade Name: Ocaliva
Product Name: Obeticholic acid
Product Code: OCA, INT-747
INN or Proposed INN: Obeticholic Acid
Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, Int-747
Intercept Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
428Phase 4United States;Portugal;Serbia;Estonia;Hong Kong;Spain;Chile;Israel;Switzerland;Italy;France;Denmark;Australia;Netherlands;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;New Zealand;Sweden
17EUCTR2014-005012-42-DE
(EUCTR)
08/02/201604/01/2016A Phase 4 clinical trial to measure the effect of Obeticholic acid against a placebo, in conjunction with standard treatment, on selected clinical measurements in patients with the liver disease, Primary Biliary CholangitisThe COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT)A Phase 4, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary CholangitisThe COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT) Primary Biliary Cholangitis
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Ocaliva
Product Name: Obeticholic acid
Product Code: OCA, INT-747
INN or Proposed INN: Obeticholic Acid
Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, INT-747
Trade Name: Ocaliva
Product Name: Obeticholic acid
Product Code: OCA, INT-747
INN or Proposed INN: Obeticholic Acid
Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, Int-747
Intercept Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
428Phase 4United States;Portugal;Serbia;Estonia;Hong Kong;Spain;Chile;Israel;Switzerland;Italy;France;Denmark;Australia;Netherlands;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;New Zealand;Sweden
18EUCTR2014-005012-42-HU
(EUCTR)
05/01/201623/09/2015A Phase 4 clinical trial to measure the effect of Obeticholic acid against a placebo, in conjunction with standard treatment, on selected clinical measurements in patients with the liver disease, Primary Biliary Cholangitis.The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT).A Phase 4, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cholangitis.The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT). Primary Biliary Cholangitis
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Ocaliva
Product Name: Obeticholic acid
Product Code: OCA, INT-747
INN or Proposed INN: Obeticholic Acid
Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, INT-747
Trade Name: Ocaliva
Product Name: Obeticholic acid
Product Code: OCA, INT-747
INN or Proposed INN: Obeticholic Acid
Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, Int-747
Intercept Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
428Phase 4United States;Portugal;Serbia;Estonia;Hong Kong;Spain;Chile;Israel;Switzerland;Italy;France;Denmark;Australia;Netherlands;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;New Zealand;Sweden
19EUCTR2014-005012-42-LT
(EUCTR)
31/12/201528/09/2015A Phase 4 clinical trial to measure the effect of Obeticholic acid against a placebo, in conjunction with standard treatment, on selected clinical measurements in patients with the liver disease, Primary Biliary Cholangitis.The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT).A Phase 4, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cholangitis. The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT). Primary Biliary Cholangitis
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Ocaliva
Product Name: Obeticholic acid
Product Code: OCA, INT-747
INN or Proposed INN: Obeticholic Acid
Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, INT-747
Trade Name: Ocaliva
Product Name: Obeticholic acid
Product Code: OCA, INT-747
INN or Proposed INN: Obeticholic Acid
Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, Int-747
Intercept Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
428Phase 4United States;Portugal;Serbia;Estonia;Hong Kong;Spain;Chile;Israel;Switzerland;Italy;France;Denmark;Australia;Netherlands;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;New Zealand;Sweden
20EUCTR2014-005012-42-FI
(EUCTR)
14/12/201502/10/2015A Phase 4 clinical trial to measure the effect of Obeticholic acid against aplacebo, in conjunction with standard treatment, on selected clinicalmeasurements in patients with the liver disease, Primary BiliaryCholangitis.The COBALT Study Clinical Outcomes with OBeticholic Acid in LiverTreatment (COBALT).A Phase 4, Double Blind, Randomized, Placebo Controlled, MulticenterStudy Evaluating the Effect of Obeticholic Acid on Clinical Outcomes inSubjects with Primary Biliary Cholangitis.The COBALT Study Clinical Outcomes with OBeticholic Acid in LiverTreatment (COBALT). Primary Biliary Cholangitis
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Ocaliva
Product Name: Obeticholic acid
Product Code: OCA, INT-747
INN or Proposed INN: Obeticholic Acid
Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, INT-747
Trade Name: Ocaliva
Product Name: Obeticholic acid
Product Code: OCA, INT-747
INN or Proposed INN: Obeticholic Acid
Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, Int-747
Intercept Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
428Phase 4United States;Portugal;Serbia;Estonia;Hong Kong;Spain;Chile;Israel;Switzerland;Italy;France;Denmark;Australia;Netherlands;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2014-005012-42-AT
(EUCTR)
26/11/201528/09/2015A Phase 4 clinical trial to measure the effect of Obeticholic acid against a placebo, in conjunction with standard treatment, on selected clinical measurements in patients with the liver disease, Primary Biliary Cholangitis.The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT)A Phase 4, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cholangitis.The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT) Primary Biliary Cholangitis
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Ocaliva
Product Name: Obeticholic acid
Product Code: OCA, INT-747
INN or Proposed INN: Obeticholic Acid
Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, INT-747
Trade Name: Ocaliva
Product Name: Obeticholic acid
Product Code: OCA, INT-747
INN or Proposed INN: Obeticholic Acid
Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, Int-747
Intercept Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
428Phase 4Estonia;Serbia;Portugal;United States;Hong Kong;Spain;Chile;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand;Sweden
22EUCTR2014-005012-42-GB
(EUCTR)
19/11/201509/10/2015A Phase 4 clinical trial to measure the effect of Obeticholic acid against a placebo, in conjunction with standard treatment, on selected clinical measurements in patients with the liver disease, Primary Biliary Cholangitis.The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT).A Phase 4, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cholangitis. The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT). Primary Biliary Cholangitis
MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Ocaliva
Product Name: Obeticholic acid
Product Code: OCA, INT-747
INN or Proposed INN: Obeticholic Acid
Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, INT-747
Trade Name: Ocaliva
Product Name: Obeticholic acid
Product Code: OCA, INT-747
INN or Proposed INN: Obeticholic Acid
Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, Int-747
Intercept Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
428Phase 4United States;Portugal;Serbia;Estonia;Hong Kong;Spain;Chile;Israel;Switzerland;Italy;France;Denmark;Australia;Netherlands;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;New Zealand;Sweden
23EUCTR2011-004728-36-PL
(EUCTR)
30/05/201220/04/2012A study of Obeticholic Acid versus Placebo in Patients with Primary Biliary Cirrhosis plus long term extension study only with Obeticholic AcidA Phase 3, Double Blind, Placebo Controlled Trial and Long Term SafetyExtension of Obeticholic Acid in Patients with Primary Biliary Cirrhosis Primary biliary cirrhosis
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]
Trade Name: Ocaliva
Product Name: OCA (INT-747)
Product Code: OCA (INT-747)
INN or Proposed INN: Obeticholic acid
Trade Name: Ocaliva
Product Name: OCA (INT-747)
Product Code: OCA (INT-747)
INN or Proposed INN: Obeticholic acid
Intercept Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3United States;Spain;Austria;Switzerland;United Kingdom;Italy;Canada;Poland;Belgium;Australia;Netherlands;Germany;Sweden
24EUCTR2011-004728-36-SE
(EUCTR)
16/04/201216/02/2012A study of Obeticholic Acid versus Placebo in Patients with Primary Biliary Cirrhosis plus long term extension study only with Obeticholic AcidA Phase 3, Double Blind, Placebo Controlled Trial and Long Term SafetyExtension of Obeticholic Acid in Patients with Primary Biliary Cirrhosis Primary biliary cirrhosis
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]
Trade Name: Ocaliva
Product Name: OCA (INT-747)
Product Code: OCA (INT-747)
INN or Proposed INN: Obeticholic acid
Trade Name: Ocaliva
Product Name: OCA (INT-747)
Product Code: OCA (INT-747)
INN or Proposed INN: Obeticholic acid
Intercept Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Canada;Poland;Spain;Belgium;Austria;Australia;Germany;Netherlands;Italy;United Kingdom;Sweden
25EUCTR2011-004728-36-BE
(EUCTR)
30/03/201213/02/2012A study of Obeticholic Acid versus Placebo in Patients with Primary Biliary Cirrhosis plus long term extension study only with Obeticholic AcidA Phase 3, Double Blind, Placebo Controlled Trial and Long Term SafetyExtension of Obeticholic Acid in Patients with Primary Biliary Cirrhosis Primary biliary cirrhosis
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]
Trade Name: Ocaliva
Product Name: OCA (INT-747)
Product Code: OCA (INT-747)
INN or Proposed INN: Obeticholic acid
Trade Name: Ocaliva
Product Name: OCA (INT-747)
Product Code: OCA (INT-747)
INN or Proposed INN: Obeticholic acid
Intercept Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Canada;Poland;Spain;Belgium;Austria;Australia;Germany;Netherlands;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2011-004728-36-DE
(EUCTR)
22/03/201216/02/2012A study of Obeticholic Acid versus Placebo in Patients with Primary Biliary Cirrhosis plus long term extension study only with Obeticholic AcidA Phase 3, Double Blind, Placebo Controlled Trial and Long Term SafetyExtension of Obeticholic Acid in Patients with Primary Biliary Cirrhosis Primary biliary cirrhosis
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]
Trade Name: Ocaliva
Product Name: OCA (INT-747)
Product Code: OCA (INT-747)
INN or Proposed INN: Obeticholic acid
Trade Name: Ocaliva
Product Name: OCA (INT-747)
Product Code: OCA (INT-747)
INN or Proposed INN: Obeticholic acid
Product Name: OCA (INT-747)
Product Code: OCA (INT-747)
INN or Proposed INN: Obeticholic acid
Intercept Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Canada;Poland;Spain;Belgium;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden
27EUCTR2011-004728-36-GB
(EUCTR)
09/03/201223/02/2012A study of Obeticholic Acid versus Placebo in Patients with Primary Biliary Cirrhosis plus long term extension study only with Obeticholic AcidA Phase 3, Double Blind, Placebo Controlled Trial and Long Term SafetyExtension of Obeticholic Acid in Patients with Primary Biliary Cirrhosis Primary biliary cirrhosis
MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Ocaliva
Product Name: OCA (INT-747)
Product Code: OCA (INT-747)
INN or Proposed INN: Obeticholic acid
Trade Name: Ocaliva
Product Name: OCA (INT-747)
Product Code: OCA (INT-747)
INN or Proposed INN: Obeticholic acid
Product Name: OCA (INT-747)
Product Code: OCA (INT-747)
INN or Proposed INN: Obeticholic acid
Intercept Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Canada;Poland;Spain;Belgium;Austria;Australia;Germany;Netherlands;Italy;United Kingdom;Sweden

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.
3 / 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-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
3EUCTR2014-004693-42-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