Ignite Creation Date:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2026-01-14 @ 9:00 PM
Study NCT ID:
NCT02930161
Status:
TERMINATED
Last Update Posted:
2019-02-08
First Post:
2016-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Runihol in Nonalcoholic Fatty Liver Disease and Metabolic Syndrome
Sponsor:
POLYSAN Scientific & Technological Pharmaceutical Company
Organization:
Study Overview
Official Title:
Многоцентровое двойное слепое плацебо-контролируемое рандомизированное исследование препарата Рунихол® у пациентов с неалкогольной жировой болезнью печени на фоне метаболического синдрома
Status:
TERMINATED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: