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

NCT02325492 | Terminated Phase 2

• 1 other identifier: Aramchol006
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 ..

Conditions

Gallstones

Keywords

bariatric surgery; NASH; ARAMCHOL

Outcome Measures

Primary Outcomes (1)

• Complete dissolution of existing gallstones proven by repeated US examined gallbladder

  Change from baseline measured by US scan

  At baseline and week 12

Secondary Outcomes (3)

• Decrease of more than a 50% in number of stones. (change from baseline)

  At baseline and week 12

• Prevention of formation of new gallstones during the study period

  At baseline and week 12

• Dissolution of sludge.

  At baseline and week 12

Study Arms (3)

Aramchol 400 mg

EXPERIMENTAL

• One tablet of Aramchol 400 mg and one tablet of Placebo

Drug: Aramchol; Drug: Placebo; Device: Ultrasound

Aramchol 600 mg

EXPERIMENTAL

• One tablet of Aramchol 400 mg and one tablet of Aramchol 200 mg.

Drug: Aramchol; Device: Ultrasound

Placebo

PLACEBO COMPARATOR

• Two tablet of Aramchol matching placebo.

Drug: Placebo; Device: Ultrasound

Interventions

Aramchol DRUG

Aramchol 400 mg; Aramchol 600 mg

Placebo DRUG

Aramchol 400 mg; Placebo

Ultrasound DEVICE

Aramchol 400 mg; Aramchol 600 mg; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female age 18 to 75 years.
• Presence of newly formed gallstones (size up to 6 mm) with or without sludge diagnosed by ultrasound within 3 or 6 months after bariatric surgery following normal ultrasound.
• Bariatric surgery conducted during the last 12 months
• Patients with "sleeve gastrectomy" or laparoscopic banding of the upper stomach will be included.
• Signature of the written informed consent.
• Negative pregnancy test at study entry for females of child bearing potential.
• Females of child bearing potential practicing reliable contraception throughout the study period (not including oral contraceptives).
• Hypertensive patients must be well controlled by stable dose of anti-hypertensive medication for at least 2 months prior to screening (and the stable dose can be maintained throughout the study).
• Patients treated with vitamin E(\>400IU/die), or Polyunsaturated fatty acid (\>2g/d) or Ursodeoxycholic acid or fish oil can be included if drugs are stopped at least 3 months prior to study enrollment to the study and up to it end.
• For patients with type 2 Diabetes, glycaemia must be controlled (Glycosylated Hemoglobin A1C ≤ 8% while any HbA1C increment should not exceed 1% during 6 month prior to enrollment). If glycaemia is controlled by medications, qualitative change is not permitted within 3 months prior to randomization and should be avoided during the study. Treatments with Metformin, Sulfamides and Insulin are authorized. Sulfamides and insulin are permitted if glycaemia is self-monitored by the patient.

You may not qualify if:

• Patients with ultrasonography evidence of gallstones in gallbladder before having the bariatric surgery.
• Patients with no clear ultrasonography evidence of gallstones -free gallbladder during the year prior their bariatric surgery.
• Patients with ultrasonography evidence of gallstones more than 1 year following bariatric surgery.
• Patients with ultrasonography evidence of gallstones in size greater than 9 mm less than 1 year following bariatric surgery.
• Weight \>140 Kg or BMI \>40
• Known alcohol and/or any other drug abuse or dependence in the last five years
• Known history or presence of clinically significant cardiovascular, hepatic, gastrointestinal, neurologic, pulmonary, endocrine, psychiatric, neoplastic disorder or nephritic syndrome.
• History or presence of any disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs including bile salt metabolism (e.g. inflammatory bowel disease (IDB); previous intestinal (ileal or colonic) operation; chronic pancreatic; celiac disease or previous vagotomy
• Uncontrolled blood pressure
• Patients with HIV
• Patients with renal dysfunction eGFR\< 60.
• Patients with pancreatitis, cholangitis or cholecystitis in the previous 4 months.
• Women who are pregnant or breastfeeding
• Type 1 Diabetes.
• Metformin, Fibrates, Statins, Insulin, Sulfonilurea not provided on a stable dose in the last 6 months.

Sponsors & Collaborators

• Galmed Pharmaceuticals Ltd: lead

Study Sites (1)

Assuta Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Gallstones

Interventions

aramchol; Ultrasonography

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Asnat Raziel, MD

  Assuta Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2014
• First Posted: December 25, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 5, 2015

Record last verified: 2014-12

Locations

IL (1)