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A Study of the Efficacy and Safety of CF102 in the Treatment of Non-Alcoholic Fatty Liver Disease

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ClinicalTrials.gov Identifier: NCT02927314
Recruitment Status : Recruiting
First Posted : October 7, 2016
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Can-Fite BioPharma

Brief Summary:
This is a multicenter, randomized, double-blind, placebo-controlled clinical trial in subjects with NAFLD and NASH.

Condition or disease Intervention/treatment Phase
Non-alcoholic Steatohepatitis (NASH) Drug: CF102 Drug: Placebo Phase 2

Detailed Description:
This is a multicenter, randomized, double-blind, placebo-controlled study in subjects with a diagnosis of NAFLD. Subjects will undergo Screening procedures during the 4 weeks preceding Baseline. Subjects will be randomly assigned in a 1:1:1 ratio to oral doses of CF102 12.5 mg BID, CF102 25 mg BID, or matching placebo BID for 12 weeks using a stratified randomization, with stratification by presence or absence of diabetes mellitus. Subjects will be evaluated regularly for safety, and indicators of efficacy will be measured at Baseline and Week 12. Subjects will return for a follow-up visit 4 weeks after completion of the last dose of study drug.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study of the Efficacy and Safety of CF102 in the Treatment of Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH)
Actual Study Start Date : November 27, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo tablets orally q12h
Drug: Placebo
orally q12h

Active Comparator: CF102 12.5mg
CF102 tablets orally q12h
Drug: CF102
orally q12h
Other Name: Cl-IB-MECA

Active Comparator: CF102 25mg
CF102 tablets orally q12h
Drug: CF102
orally q12h
Other Name: Cl-IB-MECA




Primary Outcome Measures :
  1. Efficacy of CF102 as determined by change in serum alanine aminotransferase (ALT) levels [ Time Frame: 12 weeks ]
    Mean percent change in serum alanine aminotransferase (ALT) levels

  2. Nature, frequency, and severity of adverse events in this patient population [ Time Frame: 12 weeks ]
    Nature, frequency, and severity (by CTCAE or comparable scale) of adverse events


Secondary Outcome Measures :
  1. Efficacy of CF102 as determined by change in magnetic resonance imaging-determined hepatic steatosis [ Time Frame: 12 weeks ]
    Percent change from Baseline in hepatic steatosis measured by magnetic resonance imaging-determined proton-density fat-fraction (MRI-PDFF)

  2. Body weight in subjects with NAFLD [ Time Frame: 12 weeks ]
    Change from baseline in body weight (kg)

  3. Waist circumference in subjects with NAFLD [ Time Frame: 12 weeks ]
    Change from baseline in waist circumference (cm)

  4. HDL cholesterol levels in subjects with NAFLD [ Time Frame: 12 weeks ]
    Change from baseline in serum triglyceride and HDL cholesterol levels (mg/dL)

  5. Normalization of serum ALT levels [ Time Frame: 12 weeks ]
    Proportion of all subjects whose serum ALT level normalizes

  6. Serum aspartate aminotransaminase (AST) levels in subjects with NAFLD [ Time Frame: 12 weeks ]
    Change from baseline in serum AST levels

  7. Hemoglobin A1c levels and degree of insulin resistance [ Time Frame: 12 weeks ]
    Change from baseline in Homeostasis Model Assessment (HOMA)

  8. Pharmacokinetics (PK) of CF102 in this population [ Time Frame: 12 weeks ]
    PK of CF102 will be assessed through steady state trough drug level

  9. Peripheral blood expression of the A3 adenosine receptor (A3AR). [ Time Frame: 12 weeks ]
    Change from baseline in A3 adenosine receptor (A3AR) expression level



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. At least 18 years of age.
  2. Diagnosis of NAFLD by non-invasive determination of liver triglyceride concentration, as defined as triglyceride concentration ≥10.0% by NMRS.
  3. At least 2 of the following:

    • Obesity, defined as body mass index (BMI) of ≥25 and ≤40 kg/m2; or waist circumference >88 and <200 cm for women or >102 and <200 cm for men
    • Type II diabetes mellitus, defined by the criteria of the American Diabetes Association (Appendix 1)
    • Blood pressure of 130/85 or higher (either systolic or diastolic)
    • Hypertriglyceridemia, defined as >150 mg/dL (>1.7 mmol/L)
    • Reduced high-density lipoprotein (HDL) cholesterol, defined as <40 mg/dL (<1.04 mmol/L) in men or <50 mg/dL (<1.3 mmol/L) in women.
  4. Acceptable hepatic metabolic and synthetic function, as indicated at Screening by:

    • Serum albumin ≥3.5 gm/dL
    • INR ≤1.2
    • Serum total bilirubin ≤2.0 mg/dL.
  5. Absence of cirrhosis, defined as a Fibroscan score of ≤F4 and liver stiffness measurement (LSM) of 7 13 kPa.
  6. The following laboratory values must be documented at Screening prior to initiation of study drug:

    • Absolute neutrophil count >1.5x109/L
    • Platelet count >100x109/L
    • Serum creatinine <2.0 mg/dL.
  7. For women of childbearing potential, negative serum pregnancy test result (not pregnant or lactating).
  8. Understand and provide written informed consent to participate.
  9. Patients taking herbal supplements, homeopathic medications, or other alternative treatments, must be on a stable regimen for at least 6 months prior to randomization.
  10. Willing to comply with scheduled visits, treatment plans, laboratory assessments, and other study-related procedures.

Exclusion Criteria:

  1. Presence of ascites, hepatic encephalopathy, or other clinical evidence of cirrhosis.
  2. Other active acute or chronic liver disease, such as autoimmune hepatitis, hepatitis B, hepatitis C, alcoholic liver disease, or hepatocellular carcinoma at the time of Screening and randomization.
  3. Familial dyslipidemia.
  4. Weight loss of >5% within 6 months prior to Baseline.
  5. History of bariatric surgery within 5 years of Screening.
  6. Diabetes mellitus other than Type II.
  7. Daily alcohol intake >20 g/day for women and 30 g/day for men (on average per day), as per medical history.
  8. Treatment with the following anti-diabetic medications: DPP-4 inhibitor unless it was stopped 3 months before Screening, GLP-1 receptor agonists (such as Januvia [sitagliptin], Byetta [incretin], etc.) unless it was started at least 12 months and on stable dose at least 3 months prior to Screening.
  9. Metformin, fibrates, statins, insulin, or sulfonylurea unless the dose has been stabilized for the last 1 month prior to Screening.
  10. More than 7 days of treatment with valproic acid, tamoxifen, methotrexate, amiodarone, rifaximin, other antibiotics, or anti-cholinergic agents within 3 months prior to Screening.
  11. Uncontrolled or clinically unstable thyroid disease, in the judgment of the Principal Investigator.
  12. Seropositivity for markers of viral hepatitis or human immunodeficiency virus (HIV) at Screening.
  13. Uncontrolled arterial hypertension or congestive heart failure (New York Heart Association Classification 3 or 4).
  14. Angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months prior to initiation of study drug.
  15. History of or ongoing cardiac dysrhythmias requiring treatment, atrial fibrillation of any grade, or persistent prolongation of the QTc (Fridericia) interval to >450 msec for males or >470 msec for females.
  16. Pregnant or lactating female.
  17. Women of childbearing potential, unless they agree to use dual contraceptive methods which, in the opinion of the Principal Investigator, are effective and adequate for that patient's circumstances while on study drug.
  18. Men who partner with a woman of childbearing potential, unless they agree to use effective, dual contraceptive methods (ie, a condom, with female partner using oral, injectable, or barrier method) while on study drug.
  19. Any severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, may interfere with the informed consent process and/or with compliance with the requirements of the study, or may interfere with the interpretation of study results and, in the investigator's opinion, would make the patient inappropriate for entry into this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02927314


Contacts
Contact: Michael H Silverman, MD 972-3-9241114 msilverman@biostrategics.com
Contact: Zivit Harpaz 972-3-9241114 zivit@canfite.co.il

Locations
Israel
Can-Fite Investigational Site #318 Recruiting
Jerusalem, Israel
Contact: Study Coordinator         
Can-Fite Investigational Site #319 Recruiting
Nazareth, Israel
Contact: Study Coordinator         
Can-Fite Investigational Site #311 Recruiting
Petach Tikva, Israel
Contact: Study Coordinator         
Sponsors and Collaborators
Can-Fite BioPharma
Investigators
Study Director: Michael H Silverman, MD Can-Fite BioPharma Ltd

Responsible Party: Can-Fite BioPharma
ClinicalTrials.gov Identifier: NCT02927314     History of Changes
Other Study ID Numbers: CF102-211LD
First Posted: October 7, 2016    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases