Actively Recruiting
Namodenoson in the Treatment of Non-Alcoholic Steatohepatitis (NASH)
Led by Can-Fite BioPharma · Updated on 2024-07-31
114
Participants Needed
24
Research Sites
200 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Namodenoson in the Treatment of Non-Alcoholic Steatohepatitis (NASH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age
- AST at Screening of 20 IU/L or higher
- FibroScan liver stiffness measurement (LSM) of 8.5 kPa or higher
- Biopsy-confirmed diagnosis of NASH with NAS of 4 or more, including at least 1 point in steatosis, inflammation, and hepatocellular ballooning
- Biopsy-proven Stage 1 to 3 hepatic fibrosis by NASH CRN criteria
- Presence of at least 2 metabolic syndrome criteria: obesity by waist circumference (>88 cm women or >102 cm men), hypertriglyceridemia (>150 mg/dL or treated), low HDL cholesterol (<40 mg/dL men or <50 mg/dL women), controlled hypertension, or elevated fasting glucose (≥100 mg/dL)
- Acceptable liver metabolic and synthetic function: serum albumin ≥3.5 gm/dL, INR ≤1.3, total bilirubin ≤2.0 mg/dL (except Gilbert's Syndrome)
- Laboratory values at Screening: absolute neutrophil count ≥1.0 x 10^9/L, platelet count ≥150 x 10^9/L, estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m2
- Female participants not of childbearing potential, permanently sterile, or post-menopausal with appropriate FSH levels
- Male participants agree to avoid sperm donation during treatment and for 90 days after, and to use condoms if their partner is fertile or pregnant
- Stable use of herbal supplements or alternative treatments for at least 3 months prior to randomization
- Able and willing to provide written informed consent
- Willing to undergo two liver biopsies
- Willing to comply with scheduled visits, treatments, laboratory tests, and study procedures
You will not qualify if you...
- Clinical evidence of cirrhosis such as ascites or hepatic encephalopathy
- Active acute or chronic liver diseases other than NASH including autoimmune hepatitis, hepatitis B or C, alcoholic liver disease, or hepatocellular carcinoma
- Positive test for viral hepatitis or HIV at Screening
- Weight loss greater than 5% within 3 months before Baseline
- History of bariatric surgery within 5 years prior to Screening
- Diabetes other than Type II
- Hemoglobin A1c greater than 9.0% in diabetic subjects
- Contraindications to percutaneous liver biopsy
- Daily alcohol intake over 20 g for women or 30 g for men
- Use of therapeutic doses of Vitamin E or certain anti-diabetic medications unless stable for 3 months
- Active rheumatoid arthritis treated with small-molecule or biologic agents currently or within 1 year
- Use of immunosuppressive or anti-inflammatory monoclonal antibodies or systemic corticosteroids over 10 mg prednisone-equivalent currently or within 1 year
- Recent use (more than 7 days in 3 months) of certain medications like valproic acid, tamoxifen, amiodarone, or anti-cholinergic agents
- Uncontrolled or unstable thyroid disease
- Uncontrolled hypertension, congestive heart failure (NYHA Class 3 or 4), or unstable heart disease
- Recent major cardiovascular events within 3 months
- QTcF interval over 450 ms in males or 470 ms in females
- Conditions increasing risk of arrhythmia including electrolyte imbalances or Long QT Syndrome
- Use of medications known to cause Torsades des Pointes
- Active gastrointestinal disease interfering with oral medication absorption
- Any severe acute or chronic medical or psychiatric condition or lab abnormality making participation inappropriate
AI-Screening
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Trial Site Locations
Total: 24 locations
1
941 Univ of Clinical Centre of the Republic of Srpska
Banja Luka, Bosnia and Herzegovina
Not Yet Recruiting
2
942 Health Inst General Hospital, Dept of Internal Medicine
Prijedor, Bosnia and Herzegovina
Not Yet Recruiting
3
934 Second Dept of Internal Disease, MHAT Sveta Karidad EAD
Plovdiv, Bulgaria
Not Yet Recruiting
4
932 Office of Gastroenterology, Medical Center Sansi EOOD
Rousse, Bulgaria
Not Yet Recruiting
5
931 Clinic of Gastroenterology, Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda EAD, Sofia
Sofia, Bulgaria
Not Yet Recruiting
6
933 Clinic of Gastroenterology, University Multiprofile Hosptial for Active Treatment
Sofia, Bulgaria
Not Yet Recruiting
7
935 Dept of Gastroent., Univ Multiprofile Hospital for Active Treatment and Emergency Medicine
Sofia, Bulgaria
Not Yet Recruiting
8
936 Office of Gastroenterology, Diagnostic - Consultative Center XX
Sofia, Bulgaria
Not Yet Recruiting
9
937 Office of Gastroenterology, Diagnostic - Consultative Center Alexandrovska
Sofia, Bulgaria
Not Yet Recruiting
10
938 Clinic of Gastroenterology, University Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski"
Sofia, Bulgaria
Not Yet Recruiting
11
517 Saroka University Medical Center
Beersheba, Israel
Actively Recruiting
12
Hadassah Medical Center
Jerusalem, Israel, 91120
Active, Not Recruiting
13
911 IMSP Spitalul Clinic Republican "Timofei Mosneaga"
Chisinau, Moldova
Actively Recruiting
14
912 SP Spitalul Ministerului Sanatatii, Muncii si Protectiei Sociale
Chisinau, Moldova
Not Yet Recruiting
15
903 Central Pentru Studiul Metabolismului
Bucharest, Romania
Actively Recruiting
16
904 SUUMC Carol Davilla, Department Diabet
Bucharest, Romania
Actively Recruiting
17
906 Spitalul Sfanta Maria
Bucharest, Romania
Actively Recruiting
18
902 Cluj County Clinical Emergency Hospital, 3rd Dept of Internal Medicine
Cluj-Napoca, Romania
Actively Recruiting
19
901 Medical Center Dr. Ianosi
Craiova, Romania
Actively Recruiting
20
905 County Hospital Timisoara
Timișoara, Romania
Actively Recruiting
21
922 UCC Zvezdara Belgrade
Belgrade, Serbia
Not Yet Recruiting
22
923 Military Medical Academy Belgrade
Belgrade, Serbia
Not Yet Recruiting
23
924 CHC "dr Dragisa Misovic" - Dedinje Belgrade
Belgrade, Serbia
Not Yet Recruiting
24
921 UCC Nis
Niš, Serbia
Not Yet Recruiting
Research Team
Z
Zivit Harpaz
CONTACT
P
Pnina Fishman, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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