Study to Evaluate the Effectiveness of Legalon®

Non-alcoholic Fatty Liver Disease (NAFLD) Clinical Trial

Official title:

Observational, Single Arm, Prospective Study to Evaluate the Effectiveness of Legalon® in Addition to Diet and Exercise in Reducing Plasma Levels of Liver Enzymes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05051527
• Other study ID #: 2019-24-NIS-Multicountry-3327
• Status: Recruiting
• Start date: August 8, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: April 2023
• Source: Viatris Inc.
• Contact: Melanie Emmeluth
• Phone: +4961728881194
• Email: Melanie.Emmeluth[@]viatris.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 362
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 elevated plasma level of at least one liver enzyme with respect to normal ranges of local laboratory (>1 UNL)

5. NAFLD diagnosed by ultrasonography according to the protocol by Hamaguchi or by the protocol of Ballestri

6. Presence of metabolic syndrome, defined as the presence of at least 3 out of 5 of the

following:

1. Central obesity (for Asian population, waist circumference =90 cm in males, =80 cm in females)

2. Insulin resistance (fasting blood glucose =100mg/dl or under medication)

3. High blood pressure (= 130/85 mmHg or on medication)

4. High triglycerides (=150 mg/dl or on medication)

5. Low HDL-cholesterol (<40mg/dl in men, <50mg/dl in women)

7. Started diet and exercise interventions, as per treating Investigator's suggestion and in line with current guidelines within a 4-week window prior to enrolment into the study

Exclusion Criteria:

1. Significant alcohol intake >7 standard alcoholic drinks per week (70 g ethanol) in women and >14 (140 g) in men

2. Received Legalon® or any other hepatoprotective treatment before the allowed 4-week window prior to enrolment into the study.

3. On diet and exercise before the allowed 4-week window prior to enrolment into the study.

4. Other concomitant established / diagnosed liver diseases, including chronic hepatitis B, chronic hepatitis C, autoimmune liver diseases (including autoimmune hepatitis), celiac disease, primary biliary cholangitis, primary sclerosing cholangitis, biliary obstruction, drug-induced liver disease (including herbal medicines and dietary supplements), metabolic liver disorders (such as Wilson's disease, alpha-1- antitrypsin deficiency, hemochromatosis, glycogen storage disorders, cholesterol storage disorders), severe liver diseases, non-alcoholic steatohepatitis (NASH) or other 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-induced liver injury [DILI]), including herbal medicines and dietary supplements

6. Other major diseases that, in the treating Investigator opinion, can impair liver function, 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 study requirements

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)

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Non-alcoholic Fatty Liver Disease (NAFLD)

Intervention

Drug:
• Legalon® 140 mg
Legalon® 140 mg as per the Summary of Product Characteristics (SPC) and as per treating Investigator's decision

Locations

Country	Name	City	State
Thailand	Phramongkutklao Hospital, 315 Ratchawithi Rd, Thung Phaya Thai, Ratchathewi	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Mylan Inc.	Meda Pharma S.p.A.

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effectiveness of Legalon®	- To observe the effectiveness of Legalon® in addition to diet and exercise in lowering the plasma levels of liver enzymes in patients with non-alcoholic fatty liver disease (NAFLD) and concomitant metabolic syndrome	6 months