Runihol in Nonalcoholic Fatty Liver Disease and Metabolic Syndrome

• Status: Terminated
• Trial end date: 2018-10-10
• Target enrollment: 0
• Participant gender: All

Summary

The study is designed to assess the safety and efficacy of different doses and dosing regimens of Runihol, tablets, enteric coated, produced by "NTFF" POLYSAN" (Russia), in prevention of liver disease progression in patients with non-alcoholic fatty liver disease and metabolic syndrome.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company; Scientific Technological Pharmaceutical Firm Polysan, Ltd.
• Treatments: Titanium dioxide

Criteria

Inclusion Criteria:

1. A signed informed consent to participate in the study.

2. Men and women aged 18 to 65 years.

3. Diagnosis: non-alcoholic fatty liver disease (code ICD-10: K76.0 Fatty degeneration of the liver, not classified elsewhere), defined as non-alcoholic steatohepatitis.

4. Metabolic syndrome (according to the national criteria accepted in 2013).

5. The body mass index (BMI) of 30-45 kg / m2.

6. The presence of signs of steatosis on ultrasound examination of the liver (distal signal attenuation and / or increased echogenicity of the liver).

7. The level of total cholesterol> 6.0 mmol/l and / or triglyceride levels> 1.7 mmol/l.

8. ALT, AST serum levels exceed upper normal limits by 1,5-7 times.

9. GGT level higher that upper normal limit by 1,5-7 times.

10. The level of SBP>140 and / or DBP> 90 mm Hg or antihypertensive therapy required to maintain normal blood pressure values.

11. A negativepregnancy test for female participants.

12. Consent to use of appropriate methods of contraception ( with contraceptive reliability over 90%: the cervical cap with spermicide, diaphragm with spermicide, condoms, intrauterine devices), or abstaining from sexual activity for the study period.

13. Consent to limit alcohol consumption to a maximum of 2 units of alcohol per month (1 unit of alcohol is equivalent to 0.5 liters of beer, 200 ml of dry wine or 50 ml of spirits), or total abstaining from alcohol consumption for the study period.

Exclusion Criteria:

1. Chronic liver disease of any other aetiology.

2. Disorders of copper metabolism, and/or ceruloplasmin serum level beyond the reference value on screening.

3. Disorders of iron metabolism in the past medical history or revealed at screening.

4. Cirrhotic stage of nonalcoholic fatty liver disease (Class A-C by Child-Pugh).

5. Type I diabetes mellitus.

6. Type II diabetes mellitus, which requires regular oral hypoglycemic therapy or insulin, or the level of fasting plasma glucose> 7 mmol / l and / or glycosylated hemoglobin> 7% on screening.

7. Any severely decompensated somatic disease

8. Regular intake of the medications that are prohibited by the study protocol, or their intake within 4 weeks prior to inclusion.

9. The history of clinically significant allergic reactions.

10. Hypersensitivity to any component of the study drug and / or intolerance to any component of the study drug.

11. Bariatric surgery in less than 6 months prior to the study.

12. Pregnancy or lactation.

13. Hyperhomocysteinemia (homocysteine serum levels >15 mmol/dL for men, >12 mmol/dL for women).

14. Exacerbation of the stomach ulcer and / or duodenal ulcers and / or erosive gastritis.

15. Chronic kidney failure (stage C4-C5) and / or glomerular filtration rate <30 ml / min on screening.

16. Gout, with the need of drugs that reduce uric acid levels

17. Any of the following parameters: Hb <80 g / L, platelets <80 x 10 9 / L, WBC> 15 x 10 9 / L at screening.

18. Regular intake of more than 5 units of alcohol per week (1 unit of alcohol is equivalent to 0.5 liters of beer, 200 ml of dry wine or 50 ml of spirits) or history of alcohol addiction.

19. A significant (over 5 kg) weight loss or weight gain during the preceding 6 months prior to the study.

20. Unstable angina pectoris.

21. Myocardial infarction within 3 months before inclusion.

22. Chronic heart failure (III-IV functional class by NYHA).

23. A history of cancer, mental illness, HIV, tuberculosis, or drug addiction.

24. Mental, physical and other reasons that do not allow the patient to comply with the study procedures.

25. Any other condition which, according to the investigator's judgement, may interfere with the compliance to study procedures.

26. Participation in any other clinical trial within 3 months prior to the inclusion.

27. Employees of the research company or study site involved in the conduct of the present study, and their family members.