Last updated: April 26, 2023
Sponsor: Mylan Inc.
Overall Status: Active - Recruiting
Phase
N/A
Condition
Liver Disease
Primary Biliary Cholangitis
Hepatic Fibrosis
Treatment
N/AClinical Study ID
NCT05051527
2019-24-NIS-Multicountry-3327
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Legalon® monotherapy prescribed by the treating Investigator according to the SPC,independently from and within a 4-week window prior to enrolment into the study.
- Male/female, 18 years of age and older
- Able to provide informed consent
- Available baseline blood results not older than 4 weeks from inclusion, with elevatedplasma level of at least one liver enzyme with respect to normal ranges of locallaboratory (>1 UNL)
- NAFLD diagnosed by ultrasonography according to the protocol by Hamaguchi or by theprotocol of Ballestri
- Presence of metabolic syndrome, defined as the presence of at least 3 out of 5 of thefollowing:
- Central obesity (for Asian population, waist circumference ≥90 cm in males, ≥80cm in females)
- Insulin resistance (fasting blood glucose ≥100mg/dl or under medication)
- High blood pressure (≥ 130/85 mmHg or on medication)
- High triglycerides (≥150 mg/dl or on medication)
- Low HDL-cholesterol (<40mg/dl in men, <50mg/dl in women)
- Started diet and exercise interventions, as per treating Investigator's suggestion andin line with current guidelines within a 4-week window prior to enrolment into thestudy
Exclusion
Exclusion Criteria:
- Significant alcohol intake >7 standard alcoholic drinks per week (70 g ethanol) inwomen and >14 (140 g) in men
- Received Legalon® or any other hepatoprotective treatment before the allowed 4-weekwindow prior to enrolment into the study.
- On diet and exercise before the allowed 4-week window prior to enrolment into thestudy.
- Other concomitant established / diagnosed liver diseases, including chronic hepatitisB, chronic hepatitis C, autoimmune liver diseases (including autoimmune hepatitis),celiac disease, primary biliary cholangitis, primary sclerosing cholangitis, biliaryobstruction, drug-induced liver disease (including herbal medicines and dietarysupplements), metabolic liver disorders (such as Wilson's disease, alpha-1-antitrypsin deficiency, hemochromatosis, glycogen storage disorders, cholesterolstorage disorders), severe liver diseases, non-alcoholic steatohepatitis (NASH) orother forms of advanced fatty liver disease (including clinically relevant fibrosis, >F2, or established cirrhosis), liver carcinoma
- Patients treated with drugs with known hepatotoxic effects (at risk of drug-inducedliver injury [DILI]), including herbal medicines and dietary supplements
- Other major diseases that, in the treating Investigator opinion, can impair liverfunction, as for example type 1 diabetes
- Pregnant and/or breastfeeding women
- Persons that, in treating Investigator's opinion, are not able to fulfil studyrequirements
- Persons that refuses to participate
- Patients that, in the Investigator's opinion, are or have been infected with COVID-19 (i.e. presence/referral of COVID-19 symptoms or positive antigenic/molecular test)
Study Design
Total Participants: 362
Study Start date:
August 08, 2022
Estimated Completion Date:
July 31, 2023
Connect with a study center
Phramongkutklao Hospital, 315 Ratchawithi Rd, Thung Phaya Thai, Ratchathewi
Bangkok, 10400
ThailandActive - Recruiting
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