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NASH - Nonalcoholic SteatohepatitisPhase 2NCT04697810

Namodenoson in the Treatment of Non-Alcoholic Steatohepatitis (NASH)

A Phase 2 study testing Namodenoson in people with NASH - Nonalcoholic Steatohepatitis, run by Can-Fite BioPharma at 24 sites in 6 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Subjects with biopsy-proven NASH will be randomly assigned in a 2:1 ratio to oral doses of namodenoson 25 mg every 12 hours or matching placebo every 12 hours for 36 weeks. Subjects will be evaluated regularly for safety, and efficacy biomarkers will be measured at Baseline and Weeks 6, 12, 24, and 36. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NASH - Nonalcoholic Steatohepatitis
What is being tested?
Namodenoson
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
114 participants
Where
24 sitesin 6 countries
Study dates
10 Dec 2021to 15 Oct 2025
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.
  • AST at Screening of ≥20 IU/L.
  • FibroScan LSM ≥8.5 kPa
  • Diagnosis of NASH by biopsy at Screening showing NAS ≥4 by central read, with a score of at least 1 point in each of the 3 histologic categories of steatosis, inflammation, and hepatocellular ballooning (Kleiner 2005). If the subject has had a qualifying liver biopsy within 6 months prior to Baseline and the slides are available for central read prior to randomization, this biopsy can be waived.
  • Concomitant biopsy-proven Stage 1-3 hepatic fibrosis by NASH CRN criteria by central read (Kleiner 2005).
  • At least 2 of the following criteria for the metabolic syndrome:
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  • Obesity, defined waist circumference >88 cm for women or >102 cm for men
  • Hypertriglyceridemia, defined as >150 mg/dL (>1.7 mmol/L) or on drug treatment for hypertriglyceridemia
  • Reduced high-density lipoprotein (HDL) cholesterol, defined as <40 mg/dL (<1.03 mmol/L) in men or <50 mg/dL (<1.3 mmol/L) in women
  • History of hypertension, currently controlled in the judgment of the Investigator
  • Elevated fasting glucose, defined as ≥100 mg/dL (≥5.6 mmol/L).
  • Acceptable hepatic metabolic and synthetic function, as indicated at Screening by:
  • Serum albumin ≥3.5 gm/dL
  • International normalized ratio ≤1.3
  • Serum total bilirubin ≤2.0 mg/dL (unless subject has known Gilbert's Syndrome).
  • The following laboratory values must be documented at Screening:
  • Absolute neutrophil count at least 1.0 x 109/L
  • Platelet count at least 150 x 109/L
  • Estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m2
  • Female subjects may be enrolled if they are not of childbearing potential, permanently sterile or are post-menopausal, defined as no menses for at least 1 year without an alternative medical cause and FSH levels in the post-menopausal range.
  • Male subjects must refrain from sperm donation during treatment and until at least 90 days after the end of study drug dosing. Male subjects with fertile or pregnant partners must agree to use condoms throughout the course of the trial and for 3 months after.
  • Patients taking herbal supplements, homeopathic medications, or other alternative treatments, must be on a stable regimen for at least 3 months prior to randomization.
  • Understand and provide written informed consent to participate.
  • Willing to undergo 2 liver biopsies.
  • Willing to comply with scheduled visits, treatment plans, laboratory assessments, and other study-related procedures.

Who cannot join

  • 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.
  • Seropositivity for markers of viral hepatitis or human immunodeficiency virus (HIV) at Screening.
  • Weight loss of >5% within 3 months prior to Baseline.
  • History of bariatric surgery within 5 years of Screening.
  • Diabetes mellitus other than Type II.
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  • Hemoglobin A1c >9.0% (subjects with diabetes).
  • Any contraindication to percutaneous liver biopsy.
  • Daily alcohol intake >20 g (2 units)/day for women and 30 g (3 units)/day for men (on average), as per Alcohol Use Disorders Identification Test (AUDIT) questionnaire.
  • Treatment with therapeutic doses of Vitamin E (≥800-1000 IU daily), or any of the following anti-diabetic medications: GLP-1 receptor agonists (such as Januvia [sitagliptin], Byetta [incretin], etc.), pioglitazone, or SGLT2 inhibitors ("gliflozin" drugs); unless the dose and regimen has been stable for at least 3 months.
  • Active rheumatoid arthritis treated with small-molecule (including methotrexate) or biologic disease-modifying anti-rheumatic agent concurrently or within 1 year.
  • Use of any immunosuppressive medication, anti-inflammatory monoclonal antibody treatment, or chronic systemic corticosteroids >10 mg prednisone-equivalent concurrently or within 1 year.
  • More than 7 days of treatment with valproic acid, tamoxifen, amiodarone, or anti-cholinergic agents within 3 months.
  • Uncontrolled or clinically unstable thyroid disease.
  • Uncontrolled arterial hypertension or congestive heart failure (New York Heart Association Classification 3 or 4), or other heart disease which is, in the Investigator's judgment, clinically unstable.
  • Angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months.
  • QTcF interval on Screening Visit ECG or an average of triplicate Baseline Visit ECGs > 450 milliseconds (msec) for males or > 470 msec for females.
  • A condition which increases proarrhythmic risk, including hypokalemia, hypomagnesemia, or congenital Long QT Syndrome.
  • Ongoing or planned use of a concomitant medication that is on the CredibleMedsTM list of drugs known to cause Torsades des Pointes.
  • Active gastrointestinal disease which could interfere with the absorption of oral medication.
  • Any severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that would make the patient inappropriate for entry into this study.

Trial locations and contacts

24 sites in 6 countries.

Zivit Harpaz contact

+972-3-9241114

Zivit@canfite.co.il

Pnina Fishman, PhD contact

+972-3-9241114

pnina@canfite.co.il

24 sites in 6 countries

Bulgaria8 sites, 8 recruiting

  • 934 Second Dept of Internal Disease, MHAT Sveta Karidad EAD

    Plovdiv

    Study Coordinator

    Not yet recruiting

  • 932 Office of Gastroenterology, Medical Center Sansi EOOD

    Rousse

    Study Coordinator

    Not yet recruiting

  • 931 Clinic of Gastroenterology, Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda EAD, Sofia

    Sofia

    Study Coordinator

    Not yet recruiting

  • 933 Clinic of Gastroenterology, University Multiprofile Hosptial for Active Treatment

    Sofia

    Study Coordinator

    Not yet recruiting

  • 935 Dept of Gastroent., Univ Multiprofile Hospital for Active Treatment and Emergency Medicine

    Sofia

    Study Coordinator

    Not yet recruiting

  • 936 Office of Gastroenterology, Diagnostic - Consultative Center XX

    Sofia

    Study Coordinator

    Not yet recruiting

  • 937 Office of Gastroenterology, Diagnostic - Consultative Center Alexandrovska

    Sofia

    Study Coordinator

    Not yet recruiting

  • 938 Clinic of Gastroenterology, University Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski"

    Sofia

    Study Coordinator

    Not yet recruiting

Other trials in Bulgaria

Romania6 sites, 6 recruiting

  • 903 Central Pentru Studiul Metabolismului

    Bucharest

    Study Coordinator

    Recruiting

  • 904 SUUMC Carol Davilla, Department Diabet

    Bucharest

    Study Coordinator

    Recruiting

  • 906 Spitalul Sfanta Maria

    Bucharest

    Study Coordinator

    Recruiting

  • 902 Cluj County Clinical Emergency Hospital, 3rd Dept of Internal Medicine

    Cluj-Napoca

    Study Coordinator

    Recruiting

  • 901 Medical Center Dr. Ianosi

    Craiova

    Study Coordinator

    Recruiting

  • 905 County Hospital Timisoara

    Timișoara

    Study Coordinator

    Recruiting

Other trials in Romania

Serbia4 sites, 4 recruiting

  • 922 UCC Zvezdara Belgrade

    Belgrade

    Study Coordinator

    Not yet recruiting

  • 923 Military Medical Academy Belgrade

    Belgrade

    Study Coordinator

    Not yet recruiting

  • 924 CHC "dr Dragisa Misovic" - Dedinje Belgrade

    Belgrade

    Study Coordinator

    Not yet recruiting

  • 921 UCC Nis

    Niš

    Study Coordinator

    Not yet recruiting

Other trials in Serbia

Bosnia and Herzegovina2 sites, 2 recruiting

  • 941 Univ of Clinical Centre of the Republic of Srpska

    Banja Luka

    Study Coordinator

    Not yet recruiting

  • 942 Health Inst General Hospital, Dept of Internal Medicine

    Prijedor

    Study Coordinator

    Not yet recruiting

Other trials in Bosnia and Herzegovina

Israel2 sites, 1 recruiting

  • 517 Saroka University Medical Center

    Beersheba

    Hoad Etzion, MD

    Recruiting

  • Hadassah Medical Center

    Jerusalem, 91120

    Active, not recruiting

Other trials in Israel

Moldova2 sites, 2 recruiting

  • 911 IMSP Spitalul Clinic Republican "Timofei Mosneaga"

    Chisinau

    Eugen Tcaciuc

    Recruiting

  • 912 SP Spitalul Ministerului Sanatatii, Muncii si Protectiei Sociale

    Chisinau

    Study Coordinator

    Not yet recruiting

Other trials in Moldova

About this study

Official title: A Phase 2B Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Namodenoson in the Treatment of Non-Alcoholic Steatohepatitis (NASH)

Subjects with biopsy-proven NASH will be randomly assigned in a 2:1 ratio to oral doses of namodenoson 25 mg every 12 hours or matching placebo every 12 hours for 36 weeks. Subjects will be evaluated regularly for safety, and efficacy biomarkers will be measured at Baseline and Weeks 6, 12, 24, and 36. At Week 36, all subjects will undergo liver biopsy.

Read the detailed description

This is a multicenter, randomized, double-blind, placebo-controlled study in subjects with a diagnosis of NASH and F1-3 fibrosis. Subjects will undergo Screening procedures during the 6 weeks preceding Baseline. Subjects (n = ~114) will be randomly assigned in a 2:1 ratio to oral doses of namodenoson 25 mg every 12 hours or matching placebo every 12 hours for 36 weeks. Subjects will be evaluated regularly for safety, and efficacy biomarkers will be measured at Baseline and Weeks 6, 12, 24, and 36. At Week 36, all subjects will undergo post-treatment liver biopsy, which will be interpreted by a blinded expert hepatopathologist. Subjects will return for a follow-up visit 6 weeks after completion of the last dose of study drug.

Being tested
Namodenoson, 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.

  • NamodenosonDrug

    Also called CF102

    25 mg q12hours x 36 weeks

  • PlaceboDrug

    Also called Inactive control

    Matching capsules q12hours x 36 weeks

Study groups in NCT04697810
Study groupRoleWhat they receive
NamodenosonExperimentalNamodenoson capsules orally 25 mg every 12 hours for 36 weeks
Receives: Drug: Namodenoson
PlaceboPlacebo comparatorMatching placebo capsules orally 25 mg every 12 hours for 36 weeks
Receives: Drug: Placebo

What is being measured

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

  1. Non-Alcoholic Fatty Liver Disease (NAFLD) activity score (NAS)

    Proportion of subjects who achieve a ≥2-point improvement in the non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of the Non-Alcoholic Steatohepatitis Clinical Research Network (NASH CRN)

    Measured: 36 weeks

  2. Adverse events (AEs)

    Incidence of AEs

    Measured: 36 weeks

Secondary outcomes (2)

  1. Alanine transaminase (ALT) mean

    Mean percent change from Baseline in serum ALT level

    Measured: 36 weeks

  2. Steady-state blood level of namodenoson

    Plasma trough concentration (ng/mL) of namodenoson taken at pre-dose samples

    Measured: 36 weeks

Timeline

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

  1. First posted6 Jan 2021
  2. Study start10 Dec 2021
  3. Primary completion15 Apr 2025 (estimated)
  4. Study completion15 Oct 2025 (estimated)

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
Model description
Subjects will be randomly assigned in a 2:1 ratio of namodenoson 25 mg or matching placebo, according to a computer-generated randomization schedule. Blocked randomization will be programmed using a pre-specified block size. Double-blinding will be maintained throughout the trial.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
114 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04697810
Sponsor's protocol ID
CF102-212LD
Status last verified
Jul 2024
First submitted
4 Jan 2021
Last updated
31 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Cohen S, Stemmer SM, Zozulya G, Ochaion A, Patoka R, Barer F, Bar-Yehuda S, Rath-Wolfson L, Jacobson KA, Fishman P. CF102 an A3 adenosine receptor agonist mediates anti-tumor and anti-inflammatory effects in the liver. J Cell Physiol. 2011 Sep;226(9):2438-47. doi: 10.1002/jcp.22593.

    PubMed 21660967

  • 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 Namodenoson in people with NASH - Nonalcoholic Steatohepatitis, run by Can-Fite BioPharma at 24 sites in 6 countries.

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 25 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Bulgaria, Romania, Serbia, Bosnia and Herzegovina, Israel and 1 more country. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zivit Harpaz (+972-3-9241114, Zivit@canfite.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Non-Alcoholic Fatty Liver Disease (NAFLD) activity score (NAS) (time frame: 36 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 NCT04697810, 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 31 Jul 2024.

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