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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief 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 ..

Detailed 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 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.
    Sponsor: Galmed Pharmaceuticals Ltd

    Current Primary Outcome: Complete dissolution of existing gallstones proven by repeated US examined gallbladder [ Time Frame: At baseline and week 12 ]

    Change from baseline measured by US scan


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Decrease of more than a 50% in number of stones. (change from baseline) [ Time Frame: At baseline and week 12 ]
      change from baseline measured by US scan
    • Prevention of formation of new gallstones during the study period [ Time Frame: At baseline and week 12 ]
      change from baseline measured by US scan
    • Dissolution of sludge. [ Time Frame: At baseline and week 12 ]
      change from baseline measured by US scan


    Original Secondary Outcome: Same as current

    Information By: Galmed Pharmaceuticals Ltd

    Dates:
    Date Received: November 12, 2014
    Date Started: October 2014
    Date Completion:
    Last Updated: October 1, 2015
    Last Verified: December 2014