| Ocaliva (obeticholic acid) / Intercept |
NCT06715319: Obeticholic Acid Versus Placebo, in Combination with Ursodeoxycholic Acid in Patients with Primary Biliary Cirrhosis |
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| Completed | 3 | 100 | RoW | OCA, Obeticholic Acid, UDCA, Placebo | Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. | PBC | 10/23 | 04/24 | | |
| Terminated | 3 | 2477 | Europe, Canada, US, RoW | Obeticholic Acid, Placebo | Intercept Pharmaceuticals | Non Alcoholic Steatohepatitis (NASH) | 09/23 | 09/23 | | |
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NCT04956328: Study of Obeticholic Acid（OCA） Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primay Biliary Cirrhosis (PBC) |
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| Recruiting | 3 | 120 | RoW | Obeticholic Acid Tablets, UDCA, Placebo | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Primary Biliary Cirrhosis | 09/23 | 09/23 | | |
NCT05450887: Efficacy and Safety of Obeticholic Acid in the Treatment of Primary Biliary Cholangitis |
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| Completed | 3 | 108 | RoW | Obeticholic Acid Tablets（OCA）, UDCA, Placebo | Nanjing Chia-tai Tianqing Pharmaceutical | Primary Biliary Cholangitis | 03/24 | 04/24 | | |
NCT06691412: Obeticholic Acid Among Chronic HBV Patients with Hepatic Steatosis : Clinical and Portal Doppler Outcomes |
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| Not yet recruiting | 3 | 100 | NA | Obeticholic Acid 5 mg | Assiut University | Hepatitis B Virus, Steatosis | 01/26 | 03/26 | | |
NCT06121375: Study to Assess Efficacy, Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Obeticholic Acid (OCA) Compared to Placebo in Pediatric Participants With Biliary Atresia, Post-hepatoportoenterostomy |
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| Recruiting | 2/3 | 144 | RoW | OCA, Matching Placebo | Intercept Pharmaceuticals | Biliary Atresia | 12/27 | 12/27 | | |
NCT05112822: Testing Obeticholic Acid (OCA) for Familial Adenomatous Polyposis (FAP) |
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| Not yet recruiting | 2a | 80 | US | Obeticholic Acid, Ocaliva, Placebo | M.D. Anderson Cancer Center | Familial Adenomatous Polyposis | 02/24 | 02/24 | | |
2016-002965-67: A 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 volunteers |
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| Ongoing | 2 | 33 | Europe | OCA (INT-747), OCA (INT-747), Tablet | AMC, AMC | Primary biliairy cholangitis (PBC)Non-alcoholic steatohepatitis (NASH), PBC = chronic liver disease which affects the small bile ductsNASH = chronic liver disease due to fatty liver, Diseases [C] - Digestive System Diseases [C06] | | | | |
2019-001531-32: A trial of a new drug, obeticholic acid, in patients with diarrhoea caused by bile acids |
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| Not yet recruiting | 2 | 48 | Europe | Ocaliva, N/A, Tablet, Ocaliva | Imperial College Healthcare NHS Trust, Intercept Pharma UK & Ireland | Bile acid diarrhoea (also known as bile acid malabsorption), Diarrhoea due to an over production or inadequate reabsorption of bile acids, Diseases [C] - Digestive System Diseases [C06] | | | | |
2020-004180-13: The effect of a Farnesoid X receptor (FXR) agonist on gut microbiota, gastric motility, accommodation, gastrointestinal hormones in healthy volunteers |
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| Not yet recruiting | 2 | 20 | Europe | Tablet, Ocaliva | KU Leuven, KU Leuven | The study will focus on the underlying mechanisms of gastrointestinal motility and gut microbiota in healthy subjects., The study will focus on the underlying mechanisms of gastrointestinal motility and gut microbiota in healthy subjects., Body processes [G] - Microbiological Phenomena [G06] | | | | |
2022-001241-20: Study 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). Studio per determinare se il farmaco sperimentale acido obeticolico (noto anche come OCA) in combinazione con il farmaco sperimentale bezafibrato (BZF) ha un effetto sulla colangite biliare primitiva (nota anche come PBC). |
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| Not yet recruiting | 2 | 60 | Europe | Obeticholic Acid, Bezafibrate, [-], Tablet, Ocaliva 5mg | INTERCEPT PHARMACEUTICALS INC., Intercept Pharmaceuticals, Inc. | Primary Biliary Cholangitis Colangite biliare primitiva, Primary Biliary Cholangitis Colangite biliare primitiva, Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | | | | |
| Terminated | 2 | 7 | Europe, RoW | OCA 0.1mg, Obeticholic Acid, 6alpha-ethylchenodeoxycholic acid (6-ECDCA), INT-747, OCA 1.5mg, OCA 5mg | Intercept Pharmaceuticals | Biliary Atresia | 03/23 | 03/23 | | |
NCT05573204: Comparative Study Between Obeticholic Acid Versus Vitamin E in Patients With Non-alcoholic Steatohepatitis |
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| Active, not recruiting | 2 | 59 | RoW | Obeticholic Acid Oral Tablet, Nashiliv 10 mg, Vit E, Vitamin E 400 mg | Tanta University | Non-alcoholic Steatohepatitis | 10/24 | 12/24 | | |
NCT06247735: Study to Evaluate the Efficacy and Safety of K-808 (Pemafibrate) in Participants With Primary Biliary Cholangitis (PBC) With Inadequate Response to Ursodeoxycholic Acid (UDCA) and/or Obeticholic Acid (OCA) Treatment. |
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| Recruiting | 2 | 45 | Canada, Japan, US | K-808 (Dose A), Pemafibrate, K-808 (Dose B), Placebo | Kowa Research Institute, Inc. | Primary Biliary Cholangitis | 04/25 | 04/26 | | |
NCT05239468: Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC |
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| Active, not recruiting | 2 | 60 | US | Bezafibrate 100 mg, Bezafibrate 200 mg, Obeticholic Acid 5 mg, Obeticholic Acid placebo, Bezafibrate Placebo | Intercept Pharmaceuticals | Primary Biliary Cholangitis | 11/24 | 02/25 | | |
| Active, not recruiting | 2 | 72 | Europe, RoW | Obeticholic acid, Bezafibrate 200 MG, OCA Placebo, Bezafibrate 200 mg Placebo, Bezafibrate 400 MG, Bezafibrate 400 mg Placebo, OCA, Bezafibrate | Intercept Pharmaceuticals | Primary Biliary Cholangitis | 10/25 | 10/25 | | |
NCT04939051: Obeticholic Acid for Prevention in Barrett's Esophagus |
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| Recruiting | 2 | 30 | US | Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Esophageal Biopsy, Biopsy of Esophagus, Esophagogastroduodenoscopy, EGD, Upper Endoscopy, Liver Ultrasonographic Elastography, Fibroscan, TE, Transient Elastography, VCTE, Vibration-Controlled Transient Elastrography, Obeticholic Acid, INT-747, Ocaliva, Placebo Administration, Questionnaire Administration | National Cancer Institute (NCI) | Barrett Esophagus, Esophageal Adenocarcinoma | 09/25 | 09/26 | | |
NCT05223036: Testing Obeticholic Acid for Familial Adenomatous Polyposis |
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| Recruiting | 2 | 80 | US | Biopsy, BIOPSY_TYPE, Bx, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Gastrointestinal Endoscopy, Enteroscopy, Obeticholic Acid, INT-747, Ocaliva, Placebo Administration, Questionnaire Administration | National Cancer Institute (NCI) | Attenuated Familial Adenomatous Polyposis, Colorectal Carcinoma, Duodenal Carcinoma, Familial Adenomatous Polyposis | 01/26 | 02/26 | | |
ChiCTR-IIR-17012723: An open label, randomized, single-dose, two-period, two-sequence, crossover pivotal study to assess the bioequivalence of Ocaliva Tablets 10mg in healthy adult subjects under fasting/ Fed condition |
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| Recruiting | 1 | 72 | | The first cycle of taking the test preparation on an empty stomach; the second cycle of taking the reference preparation on an empty stomach ;The first cycle of empty stomach taking reference preparation; the second cycle of empty taking the test preparation ;The first cycle after taking the test preparation; the second cycle after taking the reference preparation ;The first cycle after taking the reference preparation; the second week after taking the test preparation | The First Hospital of Jilin University; Chia Tai Tianqing Pharmaceutical Group Co, Ltd, Chia Tai Tianqing Pharmaceutical Group Co,Ltd | PBC | | | | |
| Recruiting | 1 | 16 | | Phase I: preparation 1; Phase II: Reference preparation ；Phase Ⅲ: preparation 2； Phase Ⅳ: Reference preparation ;Phase I:Reference preparation；Phase II: Preparation 1；PhaseⅢ:Reference preparation；Phase Ⅳ： Preparation 2 ;Phase I: preparation 2; Phase II: Reference preparation ；Phase Ⅲ: preparation 1； Phase Ⅳ: Reference preparation ;Phase I:Reference preparation；Phase II: Preparation 2；PhaseⅢ:Reference preparation；Phase Ⅳ: Preparation 1 | The Second Affiliated Hospital of Xingtai Medical College; The Second Affiliated Hospital of Xingtai Medical College, Brilliant Pharmaceutical CO.,ltd.Chengdu | Primary biliary cholangitis | | | | |
NCT02654236: Effect of Heavy Alcohol Consumption on Farnesoid X Receptor (FXR) Signaling |
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| Completed | N/A | 30 | US | Placebo, 10 mg Obeticholic Acid (OCA) | Suthat Liangpunsakul, National Institute on Alcohol Abuse and Alcoholism (NIAAA), Intercept Pharmaceuticals | Alcohol Consumption | 09/19 | 09/19 | | |
| Not yet recruiting | N/A | 16 | | TIRT2R ;RT1RT2 ;T2RT1R ;RT2RT1 | The Second Affiliated Hosptial of Xingtai Medical College; Brilliant pharmacutical co., LTD.CHENGDU, Brilliant pharmacutical co.,LTD.CHENGDU | Primary biliary cholangitis | | | | |
HEROES PBC, NCT05293938: A Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients |
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| Withdrawn | N/A | 2350 | US | Obeticholic Acid 5 MG, Ocaliva, Obeticholic Acid 10 MG, Standard of Care: UDCA | Intercept Pharmaceuticals, Global PBC Study Group, Target RWE, Syneos Health, UK PBC Study Group | Primary Biliary Cholangitis | 06/23 | 07/23 | | |
| Recruiting | N/A | 12 | Europe | Ocaliva, obeticholic acid, Placebo, Placebo Oral Tablet (Starch) | Universitaire Ziekenhuizen KU Leuven, Intercept Pharmaceuticals | Healthy | 07/23 | 07/23 | | |
| Recruiting | N/A | 1200 | Europe | UDCA, ursodeoxycholic acid, Ocaliva, obeticholic acid | University of Leipzig, RWTH 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 School | PBC, Primary Biliary Cholangitis | 03/24 | 03/24 | | |
| Bezalip SR (bezafibrate) / AbbVie, Intercept, Miravo |
NCT06488911: To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate |
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| Enrolling by invitation | 3 | 133 | Europe, Canada, US, RoW | FDC tablet (OCA 5 mg + BZF 400 mg SR) | Intercept Pharmaceuticals | Primary Biliary Cholangitis | 01/29 | 03/30 | | |
| INT-787 / Intercept |
2022-001639-10: The purpose of this trial is to assess dose related safety, early efficacy, pharmacokinetics and pharmacodynamics of INT-787 in patients with severe alcohol-associated hepatitis (sAH). |
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| Not yet recruiting | 2 | 50 | Europe | INT-787, INT-787, Capsule | Intercept Pharmaceuticals, Inc., Intercept Pharmaceuticals, Inc. | Severe Alcohol-Associated Hepatitis, Liver disease, Diseases [C] - Nutritional and Metabolic Diseases [C18] | | | | |
| Recruiting | 2 | 50 | Europe, US | INT-787, Placebo | Intercept Pharmaceuticals | Alcohol Associated Hepatitis | 12/24 | 12/24 | | |
