Medical Dissolution of Cholesterol Gallstones Using Oral Aramchol - A Proof of Concept Phase IIa Study

Gallstones Clinical Trial

Official title: Medical Dissolution of Cholesterol Gallstones Using Oral Aramchol - A Proof of Concept Phase IIa Study

Status Terminated

Clinical Trial Summary

This is a one center, Phase IIa, randomized, double blind, placebo controlled study designed to evaluate the efficacy and safety of two Aramchol doses in subjects 18 to 75 years of age, with newly formed cholesterol gallstones in their gallbladder following bariatric surgery confirmed by gallbladder ultrasound ..

Clinical Trial Description

This is a one center, Phase IIa, randomized, double blind, placebo controlled study designed to evaluate the efficacy and safety of two Aramchol doses in subjects 18 to 75 years of age, with newly formed cholesterol gallstones in their gallbladder following bariatric surgery confirmed by gallbladder ultrasound performed in a period of 3 & 6 months following surgery before entering the study. All patients have ultrasonography evidence of clear gallbladder before the bariatric surgery.

Eligible subjects will be enrolled into three treatments arms: Aramchol 400 mg and 600 mg tablets and placebo tablets in ratio 1:1:1.

The subjects will be evaluated at study sites for 6 scheduled visits: at weeks -4 - 0 screening visit, Day 0 - baseline, weeks 2, 4, 8& 12 (Termination/early termination visit).

During the screening period the presence and number of cholesterol gallstones will be evaluated by gallbladder Ultrasound.

During the study the following assessments will be performed:

• Vital signs will be measured at each study visit.

• A physical examination will be performed at the screening visit, and termination/early termination visit.

• The following safety blood tests will be performed: complete blood count (CBC), serum chemistry (including electrolytes, liver enzymes, direct and total bilirubin, glucose, HbA1C, lipid profile which include cholesterol, HDL, LDL and VLDL, CPK, creatinine, urea, albumin, alkaline phosphatase), coagulation (fibrinogen, PT/INR, aPTT), ESR and urinalysis during the screening visit, baseline, week 2, 4, 8 and 12 (termination/early termination) visits. Serology (HBV, HCV and HIV) will be performed during the screening visit. β-hCG in women of child bearing potential will be performed during the screening visit.

• Body weight will be measured in screening, baseline and end of treatment visits. Height will be measured during the screening visit.

• ECG will be performed during the screening and end of treatment visits.

• Blood for Metabolomics will be collected at baseline and end of treatment visits.

• Ultrasound will be performed at screening visit, baseline, week 4, 8 and termination/early termination visits.

• Adverse events will be monitored throughout the study.

• Concomitant Medications will be monitored throughout the study. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones

• NCT number: NCT02325492
• Study type: Interventional
• Source: Galmed Pharmaceuticals Ltd
• Status: Terminated
• Phase: Phase 2
• Start date: October 2014
• Completion date: October 2015