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Phase 2
Age: 18Years +
All Genders
ID04697810
A Phase 2B Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of 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
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of namodenoson, a study drug, in adults with biopsy-confirmed non-alcoholic steatohepatitis (NASH) and liver fibrosis stages 1 to 3. This randomized, double-blind, placebo-controlled Phase 2B trial aims to better understand how namodenoson affects liver health and disease activity in people with NASH. The study includes careful monitoring of safety and liver biomarkers to assess treatment impact over time. Participants will be randomly assigned in a 2:1 ratio to receive oral namodenoson capsules 25 mg or matching placebo capsules every 12 hours for 36 weeks. After completing treatment, all subjects will undergo a liver biopsy to evaluate changes in liver tissue. A follow-up visit will occur 6 weeks after the last dose to check for any ongoing effects or safety concerns. During the study, participants will have regular visits for safety assessments and biomarker measurements at baseline and Weeks 6, 12, 24, and 36. Liver biopsies are performed at screening (or within 6 months prior if available) and after treatment to assess liver disease activity and fibrosis stage. The main outcomes measured include changes in the Non-Alcoholic Fatty Liver Disease activity score and recording of any adverse events over the 36-week treatment period.
CONDITIONS
Brief Title
Namodenoson in the Treatment of Non-Alcoholic Steatohepatitis (NASH)
Who Can Participate
Age: 18Years +
All Genders
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 of 8.5 kPa or higher
- Diagnosis of NASH by biopsy at screening showing NAS score of 4 or higher with at least 1 point in steatosis, inflammation, and hepatocellular ballooning
- Biopsy-proven Stage 1 to 3 hepatic fibrosis by NASH CRN criteria
- At least two metabolic syndrome criteria: obesity by waist circumference, high triglycerides, low HDL cholesterol, history of controlled hypertension, or elevated fasting glucose
- Acceptable liver metabolic and synthetic function: serum albumin 3.5 gm/dL or higher, INR 1.3 or lower, total bilirubin 2.0 mg/dL or lower (except Gilbert's Syndrome)
- Laboratory values at screening: absolute neutrophil count at least 1.0 x 10^9/L, platelet count at least 150 x 10^9/L, estimated glomerular filtration rate 50 mL/min/1.73m2 or higher
- Females must be not of childbearing potential, permanently sterile, or post-menopausal
- Males must agree to use condoms during treatment and for 3 months after
- Stable regimen of herbal or alternative treatments for at least 3 months prior
- Ability to understand and provide written informed consent
- Willingness to undergo 2 liver biopsies
- Willingness to comply with visits, treatment plans, and assessments
You will not qualify if you...
- Ascites, hepatic encephalopathy, or clinical evidence of cirrhosis
- Other active acute or chronic liver diseases including autoimmune hepatitis, hepatitis B or C, alcoholic liver disease, or liver cancer
- Positive tests for viral hepatitis or HIV at screening
- Weight loss over 5% within 3 months before baseline
- History of bariatric surgery within 5 years
- Diabetes other than Type II diabetes
- Hemoglobin A1c over 9.0% in diabetic subjects
- Contraindications to percutaneous liver biopsy
- High daily alcohol intake exceeding 20 g for women or 30 g for men
- Recent use or unstable dosing of certain anti-diabetic or vitamin E medications
- Active rheumatoid arthritis treated with specific medications within 1 year
- Use of immunosuppressive, anti-inflammatory monoclonal antibodies, or systemic corticosteroids above 10 mg prednisone equivalent within 1 year
- Recent treatment with valproic acid, tamoxifen, amiodarone, or anticholinergic agents
- Uncontrolled thyroid disease or unstable heart conditions
- Recent serious cardiovascular events within 3 months
- Prolonged QTcF interval on ECG
- Conditions increasing risk of dangerous heart rhythms
- Use of medications known to cause Torsades des Pointes
- Active gastrointestinal disease affecting drug absorption
- Any severe medical, psychiatric condition, or lab abnormality making participation unsafe or inappropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - Up to 6 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Treatment
Duration - 36 weeks
Participants take oral capsules of namodenoson or placebo every 12 hours.
Visits at Baseline and Weeks 6, 12, 24, and 36 for safety and efficacy evaluations
Follow-up
Duration - 6 weeks
Participants return for a follow-up visit after completing treatment to assess safety and treatment effects.
1 follow-up visit 6 weeks after last dose
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
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Research Team
Z
Zivit Harpaz
P
Pnina Fishman, PhD
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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Published Research Related To This Trial
Randomised clinical trial: A phase 2 double-blind study of namodenoson in non-alcoholic fatty liver disease and steatohepatitis.
Rifaat Safadi, Marius Braun, Adi Francis...
https://pubmed.ncbi.nlm.nih.gov/34671996