Study of Namodenoson Treatment in Patients with Non-Alcoholic Steatohepatitis (NASH) and Liver Fibrosis

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What is this study about?

This study focuses on Non-Alcoholic Steatohepatitis (also known as NASH), a liver condition where fat accumulates in the liver along with inflammation and damage. The study will test a medication called Namodenoson (also known as CF102), which is taken as a capsule by mouth. Some participants will receive the actual medication while others will receive a placebo.

The purpose of this research is to determine if Namodenoson can improve the condition of patients with NASH who have mild to moderate scarring of the liver (fibrosis). The medication being studied is a synthetic substance that works by interacting with specific receptors in the body called adenosine A3 receptors.

The study will last 36 weeks, during which participants will take either Namodenoson capsules or placebo capsules daily. Throughout the study, participants will have their liver health monitored through various medical examinations. The maximum daily dose of Namodenoson that participants may receive is 50 mg. The study is designed to evaluate both how well the medication works and how safe it is for patients with NASH.

1 Initial evaluation

A medical evaluation will confirm if you have Non-Alcoholic Steatohepatitis (NASH) with liver fibrosis stage 1-3

A liver biopsy will be performed to confirm your diagnosis, unless you have had one within the past 6 months

Laboratory tests will check your liver function, blood cell counts, and kidney function

2 Treatment assignment

You will be randomly assigned to receive either namodenoson capsules or placebo capsules

Neither you nor your doctor will know which treatment you are receiving

The medication or placebo will be taken by mouth

3 Treatment period

The treatment period will last 36 weeks

Regular check-ups will monitor your health status

Blood tests will track changes in your liver function

You must maintain any existing stable treatments for other conditions

4 Final evaluation

At week 36, a second liver biopsy will be performed

The results will determine if there has been an improvement in your liver condition

Your liver enzyme levels will be compared to the start of the study

The study will evaluate if the treatment improved your NASH by at least 2 points on a specialized scoring system

Who Can Join the Study?

Must be at least 18 years old
Must agree to have 2 liver biopsies (a procedure where a small sample of liver tissue is taken for examination)
Must be willing to attend all scheduled visits, follow treatment plans, and complete required laboratory tests
Must have an AST level (a liver enzyme) of 20 IU/L or higher at screening
Must have confirmed NASH diagnosis through liver biopsy with a score of at least 4 on the NAFLD activity score, including evidence of fat accumulation, inflammation, and liver cell damage
Must have liver scarring (fibrosis) at stage 1-3
Must have at least 2 of these metabolic conditions:
- Increased waist size (more than 88 cm for women or 102 cm for men)
- High triglycerides (blood fats) above 150 mg/dL
- Low HDL cholesterol (less than 40 mg/dL in men or 50 mg/dL in women)
- Controlled high blood pressure
- High fasting blood sugar (100 mg/dL or higher)
Must have good liver function shown by:
- Blood albumin level of 3.5 gm/dL or higher
- Blood clotting test (INR) of 1.3 or less
- Total bilirubin of 2.0 mg/dL or less
Must have acceptable blood test results showing:
- Adequate white blood cell count
- Platelet count of 150 x 109/L or higher
- Kidney function (eGFR) of 50 mL/min/1.73m2 or higher
If taking herbal supplements or alternative treatments, must have been on a stable dose for at least 3 months
Must be able to understand and sign informed consent documents

Who Cannot Join the Study?

History of significant alcohol consumption (more than 2 drinks per day for women and 3 drinks per day for men)
Presence of other types of liver disease (such as viral hepatitis, autoimmune hepatitis, or drug-induced liver injury)
Advanced liver scarring (cirrhosis) or end-stage liver disease
Pregnancy or breastfeeding
Active cancer or cancer treatment within the past 5 years
Uncontrolled diabetes (blood sugar that is not well managed)
Severe heart, kidney, or lung disease
Use of medications that can affect the liver or interact with the study drug
Participation in another clinical trial within the past 30 days
History of poor compliance with medical treatments
Mental health conditions that could interfere with study participation
Inability to provide informed consent
Drug or substance abuse within the past 6 months
Body Mass Index (BMI) greater than 45
Any condition that, in the investigator’s opinion, makes the patient unsuitable for the study

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Acibadem City Clinic Diagnostic And Consultation Center Tokuda EAD	Sofia	Bulgaria
Centrul Medical Dr. Ianosi	Craiova	Romania
Spitalul Clinic Judetean De Urgenta Cluj	Cluj Napoca	Romania

Other Sites

Site Name	City	Country
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov	Sofia	Bulgaria
University Multiprofile Hospital For Active Treatment Sofiamed OOD	Sofia	Bulgaria
Saint Maria Hospital	Bucharest	Romania
Tvm Med Serv S.R.L.	Cluj Napoca	Romania
MBAL Sveta Karidad EAD	Plovdiv	Bulgaria
Hightech Medical Services S.R.L.	Bucharest	Romania
Spitalul Clinic Judetean De Urgenta Pius Brinzeu	Timisoara	Romania
Diagnostic-consultative center “Aleksandrovska” EOOD	Sofia	Bulgaria
Diagnostic Consultation Center XX-Sofia EOOD	Sofia	Bulgaria
Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila	Bucharest	Romania
Spital Judetean De Urgenta Satu Mare	Satu Mare	Romania
ID Clinic	Myslowice	Poland
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p.	Wroclaw	Poland
Clinical Study Center S.C.	Wroclaw	Poland
Centrum Medycznym K2J2	Wołomin	Poland
Prywatny Gabinet Lekarski Piotr Gryglas	Warsaw	Poland
Fundeni Clinical Institute	Bucharest	Romania
Fzkmclqw Dhl Vuypox Bzfon	Bucharest	Romania

Trial status

Country	Status	Recruitment Start
Bulgaria	Recruiting	09.01.2023
Poland	Not yet recruiting	09.01.2023
Romania	Recruiting	09.01.2023

Trial locations

Investigated drugs:

Namodenoson

Namodenoson is a medication being studied for the treatment of Non-Alcoholic Steatohepatitis (NASH), a severe form of fatty liver disease. This medication is designed to help reduce liver inflammation and improve liver health in patients who have accumulated excess fat in their liver not caused by alcohol consumption. It works by targeting specific receptors that may help decrease liver inflammation and reduce liver damage.

Non-Alcoholic Steatohepatitis (NASH) – A progressive liver condition characterized by fat accumulation in the liver, accompanied by inflammation and cell damage. NASH develops when excess fat builds up in liver cells, leading to swelling and damage over time. The condition can cause scarring (fibrosis) of liver tissue, with severity ranging from mild (F1) to advanced (F3) stages. This disease is not caused by alcohol consumption but rather by metabolic factors and can occur alongside conditions like obesity or diabetes. The liver may become enlarged and less efficient at performing its normal functions as the disease progresses.

Trial ID:

2023-510548-19-00

Protocol code:

CF102-212LD

NCT ID:

NCT04697810

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Namodenoson Treatment in Patients with Non-Alcoholic Steatohepatitis (NASH) and Liver Fibrosis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?