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Non-alcoholic Steatohepatitis (NASH)Phase 2NCT02927314

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

A Phase 2 study testing CF102 in people with Non-alcoholic Steatohepatitis (NASH), run by Can-Fite BioPharma at 3 sites in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a multicenter, randomized, double-blind, placebo-controlled clinical trial in subjects with NAFLD and NASH. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-alcoholic Steatohepatitis (NASH)
What is being tested?
CF102
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
3 sitesIsrael
Study dates
27 Nov 2017to 1 Mar 2020
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least 18 years of age.
  • Diagnosis of NAFLD by non-invasive determination of liver triglyceride concentration, as defined as triglyceride concentration ≥10.0% by NMRS.
  • 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)
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  • 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.
  • 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.
  • Absence of cirrhosis, defined as a Fibroscan score of ≤F4 and liver stiffness measurement (LSM) of 7 13 kPa.
  • 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.
  • For women of childbearing potential, negative serum pregnancy test result (not pregnant or lactating).
  • Understand and provide written informed consent to participate.
  • Patients taking herbal supplements, homeopathic medications, or other alternative treatments, must be on a stable regimen for at least 6 months prior to randomization.
  • Willing to comply with scheduled visits, treatment plans, laboratory assessments, and other study-related procedures.

Who cannot join

  • Presence of ascites, hepatic encephalopathy, or other clinical evidence of cirrhosis.
  • 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.
  • Familial dyslipidemia.
  • Weight loss of >5% within 6 months prior to Baseline.
  • History of bariatric surgery within 5 years of Screening.
  • Diabetes mellitus other than Type II.
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  • Daily alcohol intake >20 g/day for women and 30 g/day for men (on average per day), as per medical history.
  • 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.
  • Metformin, fibrates, statins, insulin, or sulfonylurea unless the dose has been stabilized for the last 1 month prior to Screening.
  • 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.
  • Uncontrolled or clinically unstable thyroid disease, in the judgment of the Principal Investigator.
  • Seropositivity for markers of viral hepatitis or human immunodeficiency virus (HIV) at Screening.
  • Uncontrolled arterial hypertension or congestive heart failure (New York Heart Association Classification 3 or 4).
  • 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.
  • 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.
  • Pregnant or lactating female.
  • 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.
  • 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.
  • 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.

Trial locations and contacts

3 sites in 1 country.

Israel3 sites

  • Can-Fite Investigational Site #318

    Jerusalem

  • Can-Fite Investigational Site #319

    Nazareth

  • Can-Fite Investigational Site #311

    Petah Tikva

Other trials in Israel

About this study

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)

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

Read the 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.

Being tested
CF102, Placebo
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CF102Drug

    Also called Cl-IB-MECA

    orally q12h

  • PlaceboDrug

    orally q12h

Study groups in NCT02927314
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo tablets orally q12h
Receives: Drug: Placebo
CF102 12.5mgActive comparatorCF102 tablets orally q12h
Receives: Drug: CF102
CF102 25mgActive comparatorCF102 tablets orally q12h
Receives: Drug: CF102

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of CF102 as determined by change in serum alanine aminotransferase (ALT) levels

    Mean percent change in serum alanine aminotransferase (ALT) levels

    Measured: 12 weeks

  2. Efficacy of CF102 as determined by change in magnetic resonance imaging-determined hepatic steatosis

    Percent change from Baseline in hepatic steatosis measured by magnetic resonance imaging-determined proton-density fat-fraction (MRI-PDFF)

    Measured: 12 weeks

Secondary outcomes (9)

  1. Body weight in subjects with NAFLD

    Change from baseline in body weight (kg)

    Measured: 12 weeks

  2. Waist circumference in subjects with NAFLD

    Change from baseline in waist circumference (cm)

    Measured: 12 weeks

  3. HDL cholesterol levels in subjects with NAFLD

    Change from baseline in serum triglyceride and HDL cholesterol levels (mg/dL)

    Measured: 12 weeks

  4. Normalization of serum ALT levels in subjects with NAFLD

    Proportion of all subjects whose serum ALT level normalizes

    Measured: 12 weeks

  5. Serum aspartate aminotransaminase (AST) levels in subjects with NAFLD

    Change from baseline in serum AST levels

    Measured: 12 weeks

  6. Hemoglobin A1c levels and degree of insulin resistance

    Change from baseline in Homeostasis Model Assessment (HOMA)

    Measured: 12 weeks

  7. Pharmacokinetics (PK) of CF102 in this population

    PK of CF102 will be assessed through steady state trough drug level

    Measured: 12 weeks

  8. Peripheral blood expression of the A3 adenosine receptor (A3AR).

    Change from baseline in A3 adenosine receptor (A3AR) expression level

    Measured: 12 weeks

  9. Nature, frequency, and severity of adverse events in this patient population

    Nature, frequency, and severity (by CTCAE or comparable scale) of adverse events

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2016 (estimated)
  2. Study start27 Nov 2017
  3. Primary completion1 Mar 2020
  4. Study completion1 Mar 2020

Resources

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02927314
Sponsor's protocol ID
CF102-211LD
Status last verified
Mar 2020
First submitted
25 Sep 2016
Last updated
17 Mar 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Muthiah MD, Siddiqui MS. Editorial: targeting aberrant hepatic inflammation for treatment of non-alcoholic steatohepatitis. Aliment Pharmacol Ther. 2022 Feb;55(4):483-484. doi: 10.1111/apt.16748. No abstract available.

    PubMed 35092056

  • Safadi R, Braun M, Francis A, Milgrom Y, Massarwa M, Hakimian D, Hazou W, Issachar A, Harpaz Z, Farbstein M, Itzhak I, Lev-Cohain N, Bareket-Samish A, Silverman MH, Fishman P. Randomised clinical trial: A phase 2 double-blind study of namodenoson in non-alcoholic fatty liver disease and steatohepatitis. Aliment Pharmacol Ther. 2021 Dec;54(11-12):1405-1415. doi: 10.1111/apt.16664. Epub 2021 Oct 20.

    PubMed 34671996

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CF102 in people with Non-alcoholic Steatohepatitis (NASH), run by Can-Fite BioPharma at 3 sites 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 21 inclusion and 19 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: finished, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Efficacy of CF102 as determined by change in serum alanine aminotransferase (ALT) levels (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02927314, which also lists 2 linked publications.

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 17 Mar 2020.

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