Runihol in Nonalcoholic Fatty Liver Disease and Metabolic Syndrome

NCT02930161 | Terminated Phase 2

• 1 other identifier: RUN-II-2015
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Non-alcoholic Fatty Liver Disease

Keywords

Nonalcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis; Methionine; Succinic acid

Outcome Measures

Primary Outcomes (1)

• Proportion of responders to treatment

  The proportion of responders with non-alcoholic fatty liver disease, as demonstrated by assessment of liver function by the following laboratory findings: decrease in ALT and AST iby at least 40% from baseline, and / or reduction of GGT by at least 30% from baseline at the end of the course of treatment

  102 days, including the screening period (14 days)

Secondary Outcomes (7)

• Severity of dyslipidemia

  102 days, including the screening period (14 days)

• The insulin resistance index (HOMA-IR)

  102 days, including the screening period (14 days)

• Transaminases

  102 days

• cholestasis markers (alkaline phosphatase, GGT)

  102 days

• Bilirubin

  102 days

Other Outcomes (1)

• Serum homocysteine

  102 days

Study Arms (3)

Runihol 2 tablets x 2 times a day

EXPERIMENTAL

Intake of 1 tablet of Runihol and 1 placebo tablet orally, with drinking 100 ml of water, 30 minutes before meals three times a day (morning, afternoon and evening) for 84 days (12 weeks).

Drug: Runihol

Runihol 1 tablet x 3 times a day

EXPERIMENTAL

Intake of Runihol, 2 tablets orally, with drinking 100 ml of water, 30 minutes before meals, 2 times a day (morning and evening) for 84 days (12 weeks), and 2 placebo tablets orally, with drinking 100 ml of water, 30 minutes before meals, 1 time a day (afternoon) for 84 days (12 weeks).

Drug: Runihol

Placebo

PLACEBO COMPARATOR

Two placebo tablets orally, with drinking 100 ml of water, 30 minutes before meals three times a day (morning, afternoon and evening) for 84 days (12 weeks).

Other: Placebo

Interventions

Runihol DRUG

Composition of Runihol®: One tablet contains: Active ingredients: succinic acid - 0.250 g; Riboxinum (inosine) - 0.100 g; taurine - 0.050 g; Methionine - 0.050 g Excipients - 0.184 g: potato starch, povidone, microcrystalline cellulose, calcium stearate, hypromellose, polysorbate-80. Enteric coat - 0.061 g: methacrylic acid-ethyl acrylate copolymer, talc, titanium dioxide, triethyl citrate, colloidal silicon dioxide, sodium hydrogencarbonate, sodium lauryl sulfate.

Also known as: Runihol, coated pill, produced by POLYSAN Ltd (Russia)

Runihol 1 tablet x 3 times a day; Runihol 2 tablets x 2 times a day

Placebo OTHER

The composition of the drug in one tablet: Active substance: None. The tablet core - 0.634 g: potato starch, povidone, microcrystalline cellulose, calcium stearate, hypromellose, polysorbate-80. Enteric coat - 0.061 g: methacrylic acid-ethyl acrylate copolymer, talc, titanium dioxide, triethyl citrate, colloidal silicon dioxide, sodium hydrogencarbonate, sodium lauryl sulfate. Tablet weight enteric coated - 0.695 g

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A signed informed consent to participate in the study.
• Men and women aged 18 to 65 years.
• Diagnosis: non-alcoholic fatty liver disease (code ICD-10: K76.0 Fatty degeneration of the liver, not classified elsewhere), defined as non-alcoholic steatohepatitis.
• Metabolic syndrome (according to the national criteria accepted in 2013).
• The body mass index (BMI) of 30-45 kg / m2.
• The presence of signs of steatosis on ultrasound examination of the liver (distal signal attenuation and / or increased echogenicity of the liver).
• The level of total cholesterol\> 6.0 mmol/l and / or triglyceride levels\> 1.7 mmol/l.
• ALT, AST serum levels exceed upper normal limits by 1,5-7 times.
• GGT level higher that upper normal limit by 1,5-7 times.
• The level of SBP\>140 and / or DBP\> 90 mm Hg or antihypertensive therapy required to maintain normal blood pressure values.
• A negativepregnancy test for female participants.
• 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.
• 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.

You may not qualify if:

• Chronic liver disease of any other aetiology.
• Disorders of copper metabolism, and/or ceruloplasmin serum level beyond the reference value on screening.
• Disorders of iron metabolism in the past medical history or revealed at screening.
• Cirrhotic stage of nonalcoholic fatty liver disease (Class A-C by Child-Pugh).
• Type I diabetes mellitus.
• 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.
• Any severely decompensated somatic disease
• The history of clinically significant allergic reactions.
• Hypersensitivity to any component of the study drug and / or intolerance to any component of the study drug.
• Bariatric surgery in less than 6 months prior to the study.
• Pregnancy or lactation.
• Hyperhomocysteinemia (homocysteine serum levels \>15 mmol/dL for men, \>12 mmol/dL for women).
• Exacerbation of the stomach ulcer and / or duodenal ulcers and / or erosive gastritis.
• Chronic kidney failure (stage C4-C5) and / or glomerular filtration rate \<30 ml / min on screening.
• Gout, with the need of drugs that reduce uric acid levels

Sponsors & Collaborators

• POLYSAN Scientific & Technological Pharmaceutical Company: lead

Study Sites (3)

Company "Clinic of professor Gorbakov" Ltd.

Krasnogorsk, 143405, Russia

Location

City Hospital of the Holy Martyr Elizabeth

Saint Petersburg, 197706, Russia

Location

Medical Company "Hepatologist" Ltd.

Samara, 443063, Russia

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Igor G Nikitin

  Central Clinical Hospital of the Russian Academy of Sciences

  PRINCIPAL INVESTIGATOR

• Vladimir B Grinevich

  Military Medical Academy named after SM Kirov," the Russian Defense Ministry, 2nd Department and Clinic of medical postrgaduate education

  PRINCIPAL INVESTIGATOR

• Alexander V Gordienko

  Military Medical Academy named after SM Kirov," the Russian Ministry of Defense, Hospital Therapeutic Department and Clinic

  PRINCIPAL INVESTIGATOR

• Vyacheslav G Morozov

  Medical company "Hepatologist" Ltd.

  PRINCIPAL INVESTIGATOR

• Vladimir V Gorbakov

  Company "Clinic of professor Gorbakov" Ltd.

  PRINCIPAL INVESTIGATOR

• Chavdar S Pavlov

  First Moscow State Medical University named after IM Sechenov, Russian Federation Ministry of Public Health, University Clinical Hospital №2,

  PRINCIPAL INVESTIGATOR

• Michael A Osadchuk

  First Moscow State Medical University named after IM Sechenov, Health Ministry of the Russian Federation, Outpatient Department

  PRINCIPAL INVESTIGATOR

• Andrew Yu Baranovsky

  St. Petersburg State health care institution "City Clinical Hospital №31"

  PRINCIPAL INVESTIGATOR

• Lyudmila S Oreshko

  Federal State Educational Institution of Higher Education "Northwest State Medical University named after II Mechnikov," the Ministry of Health and Social Development of the Russian Federation

  PRINCIPAL INVESTIGATOR

• Viktor D Pasechnikov

  Stavropol State Medical University, Ministry of Health of the Russian Federation, Department of therapy with a course of dietetics

  PRINCIPAL INVESTIGATOR

• Maria A Livzan

  Omsk State Medical Academy, Ministry of Health and Social Development of the Russian Federation, Department of faculty therapy

  PRINCIPAL INVESTIGATOR

• Yuri P Uspenskiy

  St. Petersburg City Hospital of the Holy Martyr Elizabeth

  PRINCIPAL INVESTIGATOR

• David L Nepomnyashchikh

  State Novosibirsk Regional Clinical Hospital

  PRINCIPAL INVESTIGATOR

• Polina M Hlyabova

  Limited Liability Company "BioEk" Ltd.

  PRINCIPAL INVESTIGATOR

• Sergei L Grishaev

  St. Petersburg state healthcare institution "Mariinsky Outpatient Clinic"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: October 12, 2016
• Study Start: May 30, 2016
• Primary Completion: October 10, 2018
• Study Completion: October 10, 2018
• Last Updated: February 8, 2019

Record last verified: 2019-02

Locations

RU (3)