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Clinical trials for Obeticholic acid

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    20 result(s) found for: Obeticholic acid. Displaying page 1 of 1.
    EudraCT Number: 2020-004180-13 Sponsor Protocol Number: OCARINA Start Date*: 2021-10-18
    Sponsor Name:KU Leuven
    Full Title: The effect of obeticholic acid on gut microbiota, gastric motility, accommodation, gastrointestinal peptide in healthy volunteers
    Medical condition: The study will focus on the underlying mechanisms of gastrointestinal motility and gut microbiota in healthy subjects.
    Disease: Version SOC Term Classification Code Term Level
    21.0 10022891 - Investigations 10017782 Gastric emptying study PT
    20.1 100000004856 10061247 Intestinal functional disorder LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-003777-28 Sponsor Protocol Number: OBADIAH1 Start Date*: 2012-04-26
    Sponsor Name:Imperial College London and Imperial College Healthcare NHS Trust
    Full Title: Obeticholic acid treatment in patients with bile acid diarrhoea: an open-label, pilot study of mechanisms, safety and symptom response.
    Medical condition: Bile acid diarrhoea (also known as bile acid malabsorption)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2018-002575-17 Sponsor Protocol Number: 747-213 Start Date*: 2019-07-25
    Sponsor Name:Intercept Pharmaceuticals, Inc.
    Full Title: 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 w...
    Medical condition: Primary Biliary Cholangitis (PBC) in patients with Inadequate Response or who were Unable to Tolerate Ursodeoxycholic Acid
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004871 10036680 Primary biliary cirrhosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Trial now transitioned) FR (Trial now transitioned) SE (Completed) ES (Restarted) BE (Trial now transitioned) GB (GB - no longer in EU/EEA) SK (Prematurely Ended) DE (Trial now transitioned) CZ (Trial now transitioned) LT (Trial now transitioned) GR (Trial now transitioned) NL (Trial now transitioned) PL (Completed) AT (Completed) HR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-023241-29 Sponsor Protocol Number: 747-204 Start Date*: 2011-02-10
    Sponsor Name:Intercept Pharmaceuticals Inc
    Full Title: A Pilot Study to Evaluate the Safety, Tolerability and Efficacy of Obeticholic Acid (INT-747) for the Treatment of Portal Hypertension (PESTO)
    Medical condition: Portal Hypertension in Patients with Cirrhosis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10019805 - Hepatobiliary disorders 10036200 Portal hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2014-005012-42 Sponsor Protocol Number: 747-302 Start Date*: 2016-01-05
    Sponsor Name:Intercept Pharmaceuticals Inc.
    Full Title: 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 S...
    Medical condition: Primary Biliary Cholangitis
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004871 10036680 Primary biliary cirrhosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) LT (Prematurely Ended) AT (Prematurely Ended) BE (Completed) DK (Prematurely Ended) FI (Prematurely Ended) GB (GB - no longer in EU/EEA) EE (Prematurely Ended) ES (Prematurely Ended) NL (Prematurely Ended) FR (Ongoing) DE (Completed) BG (Prematurely Ended) PT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-001762-13 Sponsor Protocol Number: 747-401 Start Date*: 2018-08-01
    Sponsor Name:Intercept Pharmaceuticals, Inc.
    Full Title: 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 Hepa...
    Medical condition: Primary Biliary Cholangitis and Moderate to Severe Hepatic Impairment
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) DE (Prematurely Ended) BE (Completed) HU (Prematurely Ended) EE (Prematurely Ended) LT (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-002965-67 Sponsor Protocol Number: 57877.018.016 Start Date*: 2017-07-07
    Sponsor Name:AMC
    Full Title: An 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 ...
    Medical condition: Primary biliairy cholangitis (PBC) Non-alcoholic steatohepatitis (NASH)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10019805 - Hepatobiliary disorders 10019805 Hepatobiliary disorders SOC
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-000474-11 Sponsor Protocol Number: 747-304 Start Date*: 2018-12-07
    Sponsor Name:Intercept Pharmaceuticals, Inc.
    Full Title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatoh...
    Medical condition: Compensated Cirrhosis due to Nonalcoholic Steatohepatitis
    Disease: Version SOC Term Classification Code Term Level
    24.1 10019805 - Hepatobiliary disorders 10053219 Non-alcoholic steatohepatitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Ongoing) GB (GB - no longer in EU/EEA) HU (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2015-002560-16 Sponsor Protocol Number: 747-303 Start Date*: 2015-12-10
    Sponsor Name:Intercept Pharmaceuticals Inc.
    Full Title: A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects with Nonalcoholic Steatohepatitis
    Medical condition: Nonalcoholic steatohepatitis
    Disease: Version SOC Term Classification Code Term Level
    22.0 100000004871 10029530 Non-alcoholic fatty liver LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Prematurely Ended) AT (Completed) SE (Completed) BE (Completed) DK (Completed) ES (Completed) FI (Completed) PT (Prematurely Ended) HU (Completed) PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-004728-36 Sponsor Protocol Number: 747-301 Start Date*: 2012-03-30
    Sponsor Name:Intercept Pharmaceuticals, Inc.
    Full Title: A Phase 3, Double Blind, Placebo Controlled Trial and Long Term Safety Extension of Obeticholic Acid in Patients with Primary Biliary Cirrhosis
    Medical condition: Primary biliary cirrhosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10019805 - Hepatobiliary disorders 10019805 Hepatobiliary disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Prematurely Ended) NL (Completed) DE (Completed) SE (Completed) AT (Completed) ES (Completed) GB (Completed) IT (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2019-001531-32 Sponsor Protocol Number: Obadiah-2 Start Date*: 2019-12-20
    Sponsor Name:Imperial College Healthcare NHS Trust
    Full Title: OBADIAH-2: A randomised, double-blind, placebo-controlled trial of two doses of obeticholic acid and placebo in patients with primary bile acid diarrhoea
    Medical condition: Bile acid diarrhoea (also known as bile acid malabsorption)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10080051 Bile acid diarrhoea LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2022-001241-20 Sponsor Protocol Number: 747-214 Start Date*: 2022-11-23
    Sponsor Name:INTERCEPT PHARMACEUTICALS INC.
    Full Title: A Phase 2a, Double-Blind, Randomized, Active Controlled, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Bezafibrate Administered in Combination with Obeticholic Acid in S...
    Medical condition: Primary Biliary Cholangitis
    Disease: Version SOC Term Classification Code Term Level
    21.0 10019805 - Hepatobiliary disorders 10080429 Primary biliary cholangitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-004693-42 Sponsor Protocol Number: 747-206 Start Date*: 2015-06-29
    Sponsor Name:Intercept Pharmaceuticals, Inc.
    Full Title: A Multicenter, Open Label, Single- and Multiple-Dose, Dose Finding Study to Assess the Effects of Obeticholic Acid in Pediatric Subjects with Biliary Atresia
    Medical condition: Biliary atresia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10004653 Biliary atresia LLT
    20.1 100000004850 10004654 Biliary atresia, congenital LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Prematurely Ended) NL (Prematurely Ended) BE (Prematurely Ended) FI (Prematurely Ended) FR (Prematurely Ended) PL (Prematurely Ended) ES (Ongoing) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-001424-12 Sponsor Protocol Number: 747-201 Start Date*: 2009-04-21
    Sponsor Name:Intercept Pharmaceuticals
    Full Title: A Study of INT-747 (6-ECDCA) Monotherapy in Patients with Primary Biliary Cirrhosis
    Medical condition: Primary biliary cirrhosis
    Disease: Version SOC Term Classification Code Term Level
    18.0 10019805 - Hepatobiliary disorders 10004661 Biliary cirrhosis primary PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) FR (Completed) ES (Completed) AT (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2011-000813-37 Sponsor Protocol Number: OCABSGS Start Date*: 2012-05-16
    Sponsor Name:Sahlgrenska Academy
    Full Title: Effects of obeticholic acid on hepatic fatty acid/triglyceride metabolism and hepatobiliary detoxification/elimination in morbidly obese and gallstone patients.
    Medical condition: Fatty liver disease, morbid obesity, gallstone disease
    Disease: Version SOC Term Classification Code Term Level
    14.1 10019805 - Hepatobiliary disorders 10029530 Non-alcoholic fatty liver LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-002205-38 Sponsor Protocol Number: 747-207 Start Date*: 2015-12-02
    Sponsor Name:INTERCEPT PHARMACEUTICALS INC.
    Full Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled,Dose-Finding, Clinical Trial Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects with Primary Sclerosing Cholangitis
    Medical condition: Primary Sclerosing Cholangitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10019805 - Hepatobiliary disorders 10019805 Hepatobiliary disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-001425-10 Sponsor Protocol Number: 747-202 Start Date*: 2008-10-13
    Sponsor Name:Intercept Pharmaceuticals
    Full Title: A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis
    Medical condition: Primary biliary cirrhosis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10004661 Biliary cirrhosis primary PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) FR (Completed) AT (Completed) NL (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2022-000875-37 Sponsor Protocol Number: VanC-IT Start Date*: 2022-11-03
    Sponsor Name:UNIVERSITÀ DEGLI STUDI MILANO BICOCCA
    Full Title: A Prospective, Randomized, Placebo-controlled Clinical Trial of oral vancomycin in adults and young adults (15-17 years old) affected by Primary Sclerosing Cholangitis with or without Inflammatory ...
    Medical condition: Primary Sclerosing Cholangitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004871 10036732 Primary sclerosing cholangitis LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-002526-25 Sponsor Protocol Number: EP-547-201 Start Date*: 2022-11-30
    Sponsor Name:Escient Pharmaceuticals, Inc.
    Full Title: Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP547 in Subjects with Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis
    Medical condition: Subjects with Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis
    Disease: Version SOC Term Classification Code Term Level
    24.1 10040785 - Skin and subcutaneous tissue disorders 10064190 Cholestatic pruritus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-005185-18 Sponsor Protocol Number: HEPA-CRV431-207 Start Date*: 2022-07-13
    Sponsor Name:Hepion Pharmaceuticals, Inc.
    Full Title: ASCEND-NASH: A PHASE 2B, RANDOMIZED, MULTI-CENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CRV431 IN ADULT SUBJECTS WITH NONALCOHOLIC STEATOHEPATITIS AND ADVAN...
    Medical condition: NONALCOHOLIC STEATOHEPATITIS AND ADVANCED LIVER FIBROSIS
    Disease: Version SOC Term Classification Code Term Level
    24.1 100000004871 10086370 NASH with fibrosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) HU (Prematurely Ended) IT (Prematurely Ended) ES (Prematurely Ended)
    Trial results: (No results available)
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