A Study Evaluating the Safety, Tolerability, and Efficacy of Aramchol Meglumine in Primary Sclerosing Cholangitis
NCT06095986 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2025-06-12
Summary
The objectives of this study is to Evaluate the Safety, Tolerability, and Efficacy of Aramchol Meglumine in Patients with Primary Sclerosing Cholangitis
Conditions
- Primary Sclerosing Cholangitis
Interventions
- DRUG
-
Aramchol meglumine
Aramchol meglumine is derived from a weak acid (Aramchol) and an amino-sugar (meglumine)
Sponsors & Collaborators
-
Virginia Commonwealth University
collaborator OTHER -
Galmed Pharmaceuticals Ltd
lead INDUSTRY
Principal Investigators
-
Arun Sanyal, MD · The Sanyal Institute for Liver Disease & Metabolic Health at VCU
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-30
- Primary Completion
- 2026-09-30
- Completion
- 2027-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
An Efficacy Trial of Low Dose All-trans Retinoic Acid in Patients With Primary Sclerosing Cholangitis
NCT03359174 ·Status: TERMINATED ·Phase: PHASE2
-
Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment
NCT03633227 ·Status: TERMINATED ·Phase: PHASE4
-
Colesevelam Versus Placebo in Cholestatic Pruritus
NCT00756171 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
A Study Of Ursolic Acid For Primary Sclerosing Cholangitis
NCT03216876 ·Status: WITHDRAWN ·Phase: PHASE1
-
GlycoCholic Acid Treatment for Patients With Inborn Errors in Bile Acid Synthesis
NCT01589523 ·Status: COMPLETED ·Phase: PHASE3
-
A Trial of 18-22mg/kg/d Ursodeoxycholic in Refractory Primary Biliary Cholangitis
NCT03345589 ·Status: UNKNOWN ·Phase: PHASE4
-
Combination Therapy With Ursodeoxycholic Acid (UDCA) and All-Trans Retinoic Acid (ATRA) for Treatment of Primary Sclerosing Cholangitis
NCT01456468 ·Status: COMPLETED ·Phase: PHASE1
-
A4250, an IBAT Inhibitor in Pediatric Cholestasis
NCT02630875 ·Status: COMPLETED ·Phase: PHASE2
-
A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy (OHANA)
NCT04718961 ·Status: TERMINATED ·Phase: PHASE2
-
Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Participants With Primary Biliary Cirrhosis
NCT01865812 ·Status: COMPLETED ·Phase: PHASE2
-
Mindfulness - Based Intervention in the Treatment of Fatigue in Patients With Primary Biliary Cholangitis
NCT03684187 ·Status: TERMINATED ·Phase: NA
-
Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary Cirrhosis
NCT01473524 ·Status: COMPLETED ·Phase: PHASE3
-
Essentiale® Paste in Patients With Gastrointestinal Symptoms in Acute or Chronic Liver Diseases
NCT02517385 ·Status: COMPLETED ·Phase: PHASE3
-
Phase I Trial of Silymarin for Chronic Liver Diseases
NCT00389376 ·Status: COMPLETED ·Phase: PHASE1
-
Effectiveness of S-adenosyl-L-methionine in Patients With Primary Biliary Cirrhosis
NCT02557360 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy, Safety, and Tolerability of 4-MUST Tablets in Chronic Cholecystitis and Biliary Dyskinesia
NCT06842966 ·Status: RECRUITING ·Phase: PHASE2
-
A Study Evaluating the Safety and Efficacy of Curcumin in Patients With Primary Sclerosing Cholangitis (PSC)
NCT02978339 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Gluten-free Diet in PSC and IBD
NCT06026449 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Compassionate Treatment of Patients With Inborn Errors of Bile Acid Metabolism With Cholic Acid
NCT00007020 ·Status: COMPLETED ·Phase: PHASE3
-
An Evaluation of a Novel Food Product in Adults Residing in an Area Endemic for Helminths
NCT01271049 ·Status: TERMINATED ·Phase: NA
-
Gastric Emptying and Gallbladder Motility Study
NCT00940849 ·Status: COMPLETED ·Phase: NA
-
Trial of Obeticholic Acid in Patients With Moderately Severe Alcoholic Hepatitis (AH)
NCT02039219 ·Status: TERMINATED ·Phase: PHASE2
-
Efficacy and Safety of S-adenosyl-l-methionine in Treatment of Alcoholic Hepatitis With Cholestasis
NCT02024295 ·Status: UNKNOWN ·Phase: PHASE4
-
Prevention of Parenteral Nutrition-Associated Cholestasis With Cyclic Parenteral Nutrition in Infants
NCT01062815 ·Status: TERMINATED ·Phase: NA
-
The Effectiveness of Combining Ursodeoxycholic Acid With Vitamin D in Treating Patients With Primary Biliary Cholangitis
NCT06309589 ·Status: COMPLETED ·Phase: NA