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Non-alcoholic Fatty Liver DiseasePhase 2NCT02930161

Runihol in Nonalcoholic Fatty Liver Disease and Metabolic Syndrome

A Phase 2 study testing Runihol in people with Non-alcoholic Fatty Liver Disease, run by POLYSAN Scientific & Technological Pharmaceutical Company at 3 sites in Russia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Non-alcoholic Fatty Liver Disease
What is being tested?
Runihol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
35 participants
Where
3 sitesRussia
Study dates
30 May 2016to 10 Oct 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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.
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  • Any severely decompensated somatic disease
  • Regular intake of the medications that are prohibited by the study protocol, or their intake within 4 weeks prior to inclusion.
  • 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
  • Any of the following parameters: Hb <80 g / L, platelets <80 x 10 9 / L, WBC> 15 x 10 9 / L at screening.
  • 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.
  • A significant (over 5 kg) weight loss or weight gain during the preceding 6 months prior to the study.
  • Unstable angina pectoris.
  • Myocardial infarction within 3 months before inclusion.
  • Chronic heart failure (III-IV functional class by NYHA).
  • A history of cancer, mental illness, HIV, tuberculosis, or drug addiction.
  • Mental, physical and other reasons that do not allow the patient to comply with the study procedures.
  • Any other condition which, according to the investigator's judgement, may interfere with the compliance to study procedures.
  • Participation in any other clinical trial within 3 months prior to the inclusion.
  • Employees of the research company or study site involved in the conduct of the present study, and their family members.

Trial locations and contacts

3 sites in 1 country.

Russia3 sites

  • Company "Clinic of professor Gorbakov" Ltd.

    Krasnogorsk, 143405

  • City Hospital of the Holy Martyr Elizabeth

    Saint Petersburg, 197706

  • Medical Company "Hepatologist" Ltd.

    Samara, 443063

Other trials in Russia

About this study

Official title: Многоцентровое двойное слепое плацебо-контролируемое рандомизированное исследование препарата Рунихол® у пациентов с неалкогольной жировой болезнью печени на фоне метаболического синдрома

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.

Read the detailed description

The aim of this study is a comparative assessment of the safety and efficacy of different doses and dosing regimens of Runihol drug tablets, enteric coated, produced by "NTFF" POLYSAN "(Russia) and placebo tablets, enteric coated, produced by" NTFF "POLYSAN" (Russia), when administered to patients with non-alcoholic fatty liver disease and metabolic syndrome.

Design: a multicenter, prospective, randomized, double-blind, placebo-controlled comparative study in parallel groups.

The study will be performed on the outpatient basis under the supervision of the physician-researcher who will be in charge of screening and the whole course of study drug therapy.

The study consists of the following periods:

  • Screening - preliminary examination of the eligible patients (duration 14 days).
  • The period of therapy - the use of the study drug Runihol®, tablets, enteric coated, produced by "NTFF" POLYSAN "(Russian) or placebo tablets, enteric coated, produced by" NTFF "POLYSAN" LLC (Russia), during 84 days (12 weeks).

Following screening, patients who meet the inclusion criteria and have no criteria for exclusion will be randomly assigned into three study groups in the proportion of 1: 1: 1):

  • Group I: treatment with Runihol®, 1 tablet 3 times a day, and placebo tablets, 1 tablet three times a day, for 84 days (12 weeks).
  • Group II: treatment with Runihol®, 2 tablets 2 times a day, morning and evening, and placebo tablets, 2 tablets once a day, in the afternoon, for 84 days (12 weeks).
  • Group III: patients will receive placebo tablets, 2 tablets 3 times a day, for 84 days (12 weeks).

Patient assessment will be carried out in the course of 6 visits.

Screening:

Visit 0 (-14 day ... Day 1) - Screening: preliminary evaluation of patients.

Period of treatment:

Visit 1 (Day 1) - evaluation of the patient based on the results of physical examination, assessment of vital signs, complex laboratory (clinical and biochemical blood tests, PTI, insulin resistance index calculation, the determination of homocysteine in the serum / plasma, general urine analysis) and instrumental (ECG ) investigations; randomization, the appointment of therapy, assessment of concomitant therapy, instructions to fill the patient's diary, registration of AEs.

Visit 2 (Day 15) - evaluation of the patient based on the results of physical examination, assessment of vital signs, laboratory complex (clinical and biochemical blood tests, PTI, determination of homocysteine in the blood serum, the total urine analysis) and instrumental (ECG) studies; control of intake of study medication / placebo, evaluation of concomitant therapy, checking patient diary, registration of AEs.

Visit 3 (Day 29) - evaluation of the patient based on the results of physical examination, assessment of vital signs, laboratory complex (clinical and biochemical blood tests, PTI, determination of homocysteine in the serum / plasma, total urine analysis) and instrumental (ECG ) investigations; control of intake of study medication / placebo, evaluation of concomitant therapy, checking patient diary, registration of AEs.

Visit 4 (Day 57) - evaluation of the patient based on the results of physical examination, assessment of vital signs, laboratory complex (clinical and biochemical blood tests, PTI, determination of homocysteine in the serum / plasma, total urine analysis) and instrumental (ECG ) studies; control of intake of study medication / placebo, evaluation of concomitant therapy, checking patient diary, registration of AEs.

Visit 5 (Day 85) - evaluation of the patient based on the results of physical examination, assessment of vital signs, laboratory complex (clinical and biochemical blood tests, PTI, determination of homocysteine in the serum / plasma, insulin resistance index calculation, the total urine analysis) and instrumental (ECG, ultrasound of the abdomen) investigations; control of intake of study medication / placebo, evaluation of concomitant therapy, checking patient diary, registration of AEs.

The study is expected to include, and randomize at least 162 patients (men and women aged 18 to 65 years) with clinically or histologically confirmed diagnosis of non-alcoholic fatty liver disease (code ICD-10: K76.0: Fatty degeneration of the liver, not classified elsewhere) in the form of non-alcoholic steatohepatitis and metabolic syndrome, provided with written informed consent to participate in the study, the relevant criteria for inclusion in the study and no criteria for exclusion; data collected will be used for further analysis of safety and efficacy .

In view of possible dropout of patients at screening and during the study a total of 204 patients are planned for inclusion.

Being tested
Runihol, Placebo
Keywords
Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis, Methionine, Succinic acid
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RuniholDrug

    Also called Runihol, coated pill, produced by POLYSAN Ltd (Russia)

    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.

  • PlaceboOther

    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

Study groups in NCT02930161
Study groupRoleWhat they receive
Runihol 2 tablets x 2 times a dayExperimentalIntake 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).
Receives: Drug: Runihol
Runihol 1 tablet x 3 times a dayExperimentalIntake 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).
Receives: Drug: Runihol
PlaceboPlacebo comparatorTwo 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).
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 102 days, including the screening period (14 days)

Secondary outcomes (7)

  1. Severity of dyslipidemia

    The dynamics of the severity of atherogenic dyslipidemia (as demonstrated by the level of total cholesterol, triglycerides, cholesterol, low density lipoprotein (LDL), high density lipoprotein cholesterol (HDL-C)) in patients by the end of the therapeutic course in comparison with baseline findings

    Measured: 102 days, including the screening period (14 days)

  2. The insulin resistance index (HOMA-IR)

    The change of the insulin resistance index (index HOMA-IR, calculated according to the level of fasting plasma glucose, fasting insulin) in patients by the end of the treatment course in comparison with the baseline findings

    Measured: 102 days, including the screening period (14 days)

  3. Transaminases

    Dynamics of transaminases serum levels (ALT, AST) in patients between the study visits

    Measured: 102 days

  4. cholestasis markers (alkaline phosphatase, GGT)

    Dynamics of cholestasis markers (alkaline phosphatase, GGT) in the serum of patients between study visits

    Measured: 102 days

  5. Bilirubin

    Dynamics of total bilirubin serum levels (ALT, AST) in patients between the study visits

    Measured: 102 days

  6. Body mass index

    Change of the BMI of patients at the end of the treatment course in comparison with the baseline measurements

    Measured: 102 days

  7. ultrasound signs of hepatic steatosis

    Dynamics of ultrasound signs of hepatic steatosis in patients by the end of the treatment course in comparison with the baseline

    Measured: 102 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2016 (estimated)
  2. Study start30 May 2016
  3. Primary completion10 Oct 2018
  4. Study completion10 Oct 2018

Why it stopped: Low recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02930161
Sponsor's protocol ID
RUN-II-2015
Status last verified
Feb 2019
First submitted
6 Oct 2016
Last updated
8 Feb 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Runihol in people with Non-alcoholic Fatty Liver Disease, run by POLYSAN Scientific & Technological Pharmaceutical Company at 3 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Low recruitment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of responders to treatment (time frame: 102 days, including the screening period (14 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02930161.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.

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