Study to Evaluate the Effectiveness of Legalon®

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/A

Clinical Study ID

NCT05051527
2019-24-NIS-Multicountry-3327
  • Ages > 18
  • All Genders

Study Summary

This is a multinational, multicentre, prospective, non-interventional study (NIS) in non-alcoholic fatty liver disease (NAFLD) patients with concomitant metabolic syndrome treated with Legalon® combined with diet and exercise.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 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.
  2. Male/female, 18 years of age and older
  3. Able to provide informed consent
  4. 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)
  5. NAFLD diagnosed by ultrasonography according to the protocol by Hamaguchi or by theprotocol of Ballestri
  6. Presence of metabolic syndrome, defined as the presence of at least 3 out of 5 of thefollowing:
  7. Central obesity (for Asian population, waist circumference ≥90 cm in males, ≥80cm in females)
  8. Insulin resistance (fasting blood glucose ≥100mg/dl or under medication)
  9. High blood pressure (≥ 130/85 mmHg or on medication)
  10. High triglycerides (≥150 mg/dl or on medication)
  11. Low HDL-cholesterol (<40mg/dl in men, <50mg/dl in women)
  12. 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:

  1. Significant alcohol intake >7 standard alcoholic drinks per week (70 g ethanol) inwomen and >14 (140 g) in men
  2. Received Legalon® or any other hepatoprotective treatment before the allowed 4-weekwindow prior to enrolment into the study.
  3. On diet and exercise before the allowed 4-week window prior to enrolment into thestudy.
  4. 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
  5. Patients treated with drugs with known hepatotoxic effects (at risk of drug-inducedliver injury [DILI]), including herbal medicines and dietary supplements
  6. Other major diseases that, in the treating Investigator opinion, can impair liverfunction, as for example type 1 diabetes
  7. Pregnant and/or breastfeeding women
  8. Persons that, in treating Investigator's opinion, are not able to fulfil studyrequirements
  9. Persons that refuses to participate
  10. 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
    Thailand

    Active - Recruiting

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