Obeticholic Acid (OCA) ( DrugBank: Obeticholic acid )


1 disease
IDDisease name (Link within this page)Number of trials
93Primary biliary cholangitis6

93. Primary biliary cholangitis


Clinical trials : 282 Drugs : 245 - (DrugBank : 56) / Drug target genes : 35 - Drug target pathways : 113
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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 PharmaceuticalsNULLTerminated18 Years85 YearsAll22Phase 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 PharmaceuticalsNULLActive, not recruiting18 YearsN/AAll428Phase 4United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Chile;Denmark;Estonia;Finland;France;Germany;Hong Kong;Hungary;Israel;Italy;Korea, Republic of;Lithuania;Mexico;Netherlands;Poland;Spain;Sweden;Switzerland;Turkey;United Kingdom;Bulgaria;Former Serbia and Montenegro;New Zealand;Portugal;Serbia
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
6EUCTR2007-001424-12-GB
(EUCTR)
21/04/200903/09/2007 A Study of INT 747 Monotherapy in Patients with Primary Biliary Cirrhosis A Study of INT-747 (6-ECDCA) Monotherapy in Patients with Primary Biliary Cirrhosis Primary biliary cirrhosis
MedDRA version: 18.0;Level: PT;Classification code 10004661;Term: Biliary cirrhosis primary;System Organ Class: 10019805 - Hepatobiliary disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: Obeticholic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o , obeticholic acid (OCA)
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: Obeticholic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o, obeticholic acid (OCA)
Product Name: INT-747
Product Code: INT-747
INN or Proposed INN: Obeticholic acid
Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o, obeticholic acid (OCA)
Intercept PharmaceuticalsNULLNot Recruiting Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Spain;Austria;Germany;United Kingdom