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

Who is this study for? Patients with Nonalcoholic Fatty Liver Disease
What treatments are being studied? Namodenoson
Status: Recruiting
Location: See all (24) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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. At Week 36, all subjects will undergo liver biopsy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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:

‣ 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.

Locations
Other Locations
Bosnia and Herzegovina
941 Univ of Clinical Centre of the Republic of Srpska
NOT_YET_RECRUITING
Banja Luka
942 Health Inst General Hospital, Dept of Internal Medicine
NOT_YET_RECRUITING
Prijedor
Bulgaria
934 Second Dept of Internal Disease, MHAT Sveta Karidad EAD
NOT_YET_RECRUITING
Plovdiv
932 Office of Gastroenterology, Medical Center Sansi EOOD
NOT_YET_RECRUITING
Rousse
931 Clinic of Gastroenterology, Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda EAD, Sofia
NOT_YET_RECRUITING
Sofia
933 Clinic of Gastroenterology, University Multiprofile Hosptial for Active Treatment
NOT_YET_RECRUITING
Sofia
935 Dept of Gastroent., Univ Multiprofile Hospital for Active Treatment and Emergency Medicine
NOT_YET_RECRUITING
Sofia
936 Office of Gastroenterology, Diagnostic - Consultative Center XX
NOT_YET_RECRUITING
Sofia
937 Office of Gastroenterology, Diagnostic - Consultative Center Alexandrovska
NOT_YET_RECRUITING
Sofia
938 Clinic of Gastroenterology, University Multiprofile Hospital for Active Treatment Sv. Ivan Rilski
NOT_YET_RECRUITING
Sofia
Israel
517 Saroka University Medical Center
RECRUITING
Beersheba
Hadassah Medical Center
ACTIVE_NOT_RECRUITING
Jerusalem
Republic of Moldova
911 IMSP Spitalul Clinic Republican Timofei Mosneaga
RECRUITING
Chisinau
912 SP Spitalul Ministerului Sanatatii, Muncii si Protectiei Sociale
NOT_YET_RECRUITING
Chisinau
Romania
903 Central Pentru Studiul Metabolismului
RECRUITING
Bucharest
904 SUUMC Carol Davilla, Department Diabet
RECRUITING
Bucharest
906 Spitalul Sfanta Maria
RECRUITING
Bucharest
902 Cluj County Clinical Emergency Hospital, 3rd Dept of Internal Medicine
RECRUITING
Cluj-napoca
901 Medical Center Dr. Ianosi
RECRUITING
Craiova
905 County Hospital Timisoara
RECRUITING
Timișoara
Serbia
922 UCC Zvezdara Belgrade
NOT_YET_RECRUITING
Belgrade
923 Military Medical Academy Belgrade
NOT_YET_RECRUITING
Belgrade
924 CHC dr Dragisa Misovic - Dedinje Belgrade
NOT_YET_RECRUITING
Belgrade
921 UCC Nis
NOT_YET_RECRUITING
Niš
Contact Information
Primary
Zivit Harpaz
Zivit@canfite.co.il
+972-3-9241114
Backup
Pnina Fishman, PhD
pnina@canfite.co.il
+972-3-9241114
Time Frame
Start Date: 2021-12-10
Estimated Completion Date: 2025-10-15
Participants
Target number of participants: 114
Treatments
Experimental: Namodenoson
Namodenoson capsules orally 25 mg every 12 hours for 36 weeks
Placebo_comparator: Placebo
Matching placebo capsules orally 25 mg every 12 hours for 36 weeks
Sponsors
Leads: Can-Fite BioPharma

This content was sourced from clinicaltrials.gov