GallstonesPhase 2NCT02325492
Medical Dissolution of Cholesterol Gallstones Using Oral Aramchol - A Proof of Concept Phase IIa Study
A Phase 2 study testing Aramchol and Ultrasound in people with Gallstones, run by Galmed Pharmaceuticals Ltd at 1 site in Israel.
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 .. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gallstones
- What is being tested?
- Aramchol and Ultrasound
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2014to Oct 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
- Patients who are treated with Valproic acid, Tamoxifen, Methotreksate, Amiodaron.
- Treatment with Rifaximin.
- Homeopathic and/or Alternative treatments. Any treatment should be stopped before the screening period.
- Serum creatine phosphokinase (CPK), ALT, AST and/or alkaline phosphatase >3X the upper limit of normal (ULN). Patients with an intermittent CPK elevation may have the repeated measurement prior to randomization; a CPK retest > 3X ULN leads to exclusion.
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Trial locations and contacts
1 site in 1 country.
About this study
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 ..
Read the detailed 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.
- Conditions
- Gallstones
- Being tested
- Aramchol, Placebo, Ultrasound
- Keywords
- bariatric surgery, NASH, ARAMCHOL
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AramcholDrug
PlaceboDrug
UltrasoundDevice
| Study group | Role | What they receive |
|---|---|---|
| Aramchol 400 mg | Experimental | • One tablet of Aramchol 400 mg and one tablet of Placebo Receives: Drug: Aramchol; Drug: Placebo; Device: Ultrasound |
| Aramchol 600 mg | Experimental | • One tablet of Aramchol 400 mg and one tablet of Aramchol 200 mg. Receives: Drug: Aramchol; Device: Ultrasound |
| Placebo | Placebo comparator | • Two tablet of Aramchol matching placebo. Receives: Drug: Placebo; Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete dissolution of existing gallstones proven by repeated US examined gallbladder
Change from baseline measured by US scan
Measured: At baseline and week 12
Secondary outcomes (3)
Decrease of more than a 50% in number of stones. (change from baseline)
change from baseline measured by US scan
Measured: At baseline and week 12
Prevention of formation of new gallstones during the study period
change from baseline measured by US scan
Measured: At baseline and week 12
Dissolution of sludge.
change from baseline measured by US scan
Measured: At baseline and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2015
- Study completionOct 2015
Why it stopped: Protocol redesign
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GallstonesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galmed Pharmaceuticals Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Asnat Raziel, MD, Principal investigator, Assuta Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325492
- Sponsor's protocol ID
- Aramchol006
- Status last verified
- Dec 2014
- First submitted
- 12 Nov 2014
- Last updated
- 5 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Dissolution of Cholesterol Gallstones Using Oral Aramchol - A Proof of Concept Phase IIa Study
- ClinicalTrials.gov ID
- NCT02325492
- Acronym / sponsor ID
- Aramchol006
- Conditions
- Gallstones
- Keywords
- bariatric surgery, NASH, ARAMCHOL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Protocol redesign
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Galmed Pharmaceuticals LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 25 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aramchol 400 mg | Experimental | Drug: Aramchol, Drug: Placebo, Device: Ultrasound• One tablet of Aramchol 400 mg and one tablet of Placebo |
| Aramchol 600 mg | Experimental | Drug: Aramchol, Device: Ultrasound• One tablet of Aramchol 400 mg and one tablet of Aramchol 200 mg. |
| Placebo | Placebo comparator | Drug: Placebo, Device: Ultrasound• Two tablet of Aramchol matching placebo. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aramchol | Drug | Aramchol 400 mg, Aramchol 600 mg |
| Placebo | Drug | Aramchol 400 mg, Placebo |
| Ultrasound | Device | Aramchol 400 mg, Aramchol 600 mg, Placebo |
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
3 secondary outcomes
Decrease of more than a 50% in number of stones. (change from baseline)
Time frame: At baseline and week 12
Prevention of formation of new gallstones during the study period
Time frame: At baseline and week 12
Dissolution of sludge.
Time frame: At baseline and week 12
Results and safety
The study was stopped early (reason given: Protocol redesign). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asnat Raziel, MD principal investigator
Assuta Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aramchol and Ultrasound in people with Gallstones, run by Galmed Pharmaceuticals Ltd at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Protocol redesign). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete dissolution of existing gallstones proven by repeated US examined gallbladder (time frame: At baseline and week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2015.