12 completed, 2 withdrawn, 1 terminated, 1 unknown. 5 Phase 4, 3 Not applicable, 3 Phase 2, 2 Phase 1, 1 Early Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 4 | 5 | Completed 5 |
| Not applicable | 3 | Completed 1, Terminated 1, Withdrawn 1 |
| Phase 2 | 3 | Completed 2, Unknown 1 |
| Phase 1 | 2 | Completed 2 |
| Early Phase 1 | 1 | Completed 1 |
| Phase 3 | 1 | Withdrawn 1 |
Follow Chenodeoxycholic Acid: new trials by email Literature Review of Chenodeoxycholic Acid trials Research Report on Chenodeoxycholic Acid
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study of Chenodeoxycholic Acid (CDCA) in Newly Diagnosed Participants With Cerebrotendinous Xanthomatosis (CTX) Chenodeoxycholic acid, Chenodeoxycholic acid Placebo - Cerebrotendinous Xanthomatoses | Phase 3 | Withdrawn | Leadiant Biosciences, Inc. | 2024-05-27 | 2024-11-18 | |
| Bioequivalence Study to Compare Chenodeoxycholic Acid Capsules (250mg Chenodeoxycholic Acid) Versus Chenodeoxycholic Acid Leadiant 250 mg Hard Capsules (250mg Chenodeoxycholic Acid) Chenodeoxycholic acid, Chenodeoxycholic acid leadiant - Cerebrotendinous Xanthomatoses | Phase 1 | Completed | Humanis Saglık Anonim Sirketi | 24 | 2022-06-12 | 2023-12-28 |
| Impact of Metformin and Polysorbate 80 on Drug Absorption and Disposition pravastatin and chenodeoxycholic acid, after metformin and placebo, valacyclovir, chenodeoxycholic acid, and enalaprilat, after polysorbate 80 and placebo - Bile Salt Export Pump (BSEP) Transporter, Polysorbate 80 | Phase 4 | Completed | University of Maryland, Baltimore | 18 | 2021-04-01 | 2024-07-16 |
| Changes in Bile Acid Homeostasis and Stool Habits After Cholecystectomy chenodeoxycholic acid - Bile Acid Malabsorption, Cholelithiasis | Phase 4 | Completed | Zealand University Hospital | 23 | 2017-06-22 | 2022-05-19 |
| Effect of Bile Acids and Bile Acid Sequstrants on GLP-1 Secretion After Roux-en-Y Gastric Bypass Chenodeoxycholic Acid, Colesevelam - Severe Obesity | Phase 4 | Completed | Hvidovre University Hospital | 8 | 2016-10-01 | 2020-11-30 |
| Effects of Bile Acids and Bile Acid Sequestrants on GLP-1 Secretion After Roux-en-Y Gastric Bypass Colesevelam, Chenodeoxycholic Acid, Water - Severe Obesity | Phase 4 | Completed | Hvidovre University Hospital | 12 | 2016-06-01 | 2020-11-30 |
| Therapeutic Metabolic Intervention in Patients With Spastic Paraplegia SPG5 Xenbilox, Resveratrol, Tahor - Spastic Paraplegia, Hereditary | Phase 2 | Completed | Institut National de la Santé Et de la Recherche Médicale, France | 12 | 2015-01-08 | 2025-09-02 |
| Safety and Efficacy of CDCA in CTX Chenodeoxycholic Acid (CDCA) in Patients Affected by Cerebrotendinous Xanthomatosis (CTX) Chenodeoxycholic Acid - Cerebrotendinous Xanthomatoses | Completed | Leadiant Biosciences Ltd. | 28 | 2014-12-09 | 2022-08-12 | |
| Effects of Bile Acids on GLP-1 Secretion After Roux-en-Y Gastric Bypass Water, Ursodeoxycholic Acid, Chenodeoxycholic Acid - Severe Obesity | Phase 4 | Completed | Hvidovre University Hospital | 11 | 2014-11-01 | 2016-06-30 |
| Effect of Bile Acids on GLP-1 Secretion Colesevelam, Chenodeoxycholic Acid, saline - Type 2 Diabetes, Obesity | Not applicable | Completed | University Hospital, Gentofte, Copenhagen | 20 | 2012-11-01 | 2013-12-24 |
| Effect of Bile Acids on the Secretion of Satiation Peptides in Humans saline, bile acid (CDCA, chenodeoxycholic acid), oleanolic acid - Echolocation | Phase 1 | Completed | University Hospital, Basel, Switzerland | 12 | 2011-09-01 | 2012-08-29 |
| Cheno Effect on Transit in Health and IBS-C Sodium chenodeoxycholate (NaCDC), Placebo - Constipation-predominant Irritable Bowel Syndrome | Phase 2 | Completed | Mayo Clinic | 36 | 2009-04-01 | 2012-07-02 |
| Effects of FXR Activation on Hepatic Lipid and Glucose Metabolism chenodeoxycholic acid, placebo capsules - Metabolic Syndrome, Familial Hypertriglyceridemia | Early Phase 1 | Completed | University Hospital, Basel, Switzerland | 30 | 2004-10-01 | 2012-03-09 |
| Cholestanol in Humans Chenodeoxycholic Acid - Cerebrotendinous Xanthomatosis | Not applicable | Withdrawn | US Department of Veterans Affairs | 1999-10-01 | 2013-10-14 | |
| Phase II Study of Cholesterol- and Cholestanol-Free Diet, Lovastatin, and Chenodeoxycholic Acid for Cerebrotendinous Xanthomatosis chenodeoxycholic acid, lovastatin - Cerebrotendinous Xanthomatosis | Phase 2 | Unknown | National Center for Research Resources (NCRR) | 5 | 1996-01-01 | 2005-06-24 |
| Study of Bile Acids in Patients With Peroxisomal Disorders chenodeoxycholic acid, cholic acid, ursodiol - Infantile Refsum's Disease, Zellweger Syndrome | Not applicable | Terminated | University of Cincinnati | 25 | 2015-03-25 |
Xanthomatosis, Cerebrotendinous (5) · Obesity, Morbid (3) · Metabolism, Inborn Errors (2) · Rare Diseases (2) · Adrenoleukodystrophy (1) · Cholelithiasis (1) · Cholestasis, progressive familial intrahepatic 2 (1) · Constipation (1) · Diabetes Mellitus, Type 2 (1) · Echolocation (1) · Hyperlipidemia, Familial Combined (1) · Hyperlipoproteinemia Type IV (1) · Ichthyosis Bullosa of Siemens (1) · Metabolic Syndrome (1) · Obesity (1)
Hvidovre University Hospital (3) · University Hospital, Basel, Switzerland (2) · Humanis Saglık Anonim Sirketi (1) · Institut National de la Santé Et de la Recherche Médicale, France (1) · Leadiant Biosciences Ltd. (1) · Leadiant Biosciences, Inc. (1) · Mayo Clinic (1) · National Center for Research Resources (NCRR) (1) · US Department of Veterans Affairs (1) · University Hospital, Gentofte, Copenhagen (1) · University of Cincinnati (1) · University of Maryland, Baltimore (1) · Zealand University Hospital (1)
Denmark (5) · United States (4) · Switzerland (2) · France (1) · Israel (1) · Jordan (1)
Christian Borup (1) · Christoph Beglinger, MD (1) · Gerald Salen (1) · Kenneth Setchell (1) · Michael L. Camilleri, M.D. (1) · Morten Hansen, MD (1) · Stefan Bilz, MD (1) · William Connor (1)
1RC1DK086182 (1), 2016 (1), 2023 (1), R01DK054681 (1), R01DK079866 (1), UL1RR024150 (1)