Clinical trial NCT05051527: Study to Evaluate the Effectiveness of Legalon®
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-alcoholic Fatty Liver Disease (NAFLD)
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
Collaborators: name: Meda Pharma S.p.A.
First posted: 2021-09-21
Enrollment: 362
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with non-alcoholic fatty liver disease and concomitant metabolic syndrome

Brief 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 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)

Primary outcomes:
measure: effectiveness of Legalon®
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital, 315 Ratchawithi Rd, Thung Phaya Thai, Ratchathewi
Study officials:
affiliation: Department of Medicine, Hospital Universiti Sains Malaysia,16150 Kelantan Darul Naim, MALAYSIA
name: Lee Yeong Yeh, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Internal Medicine, Phramongkutklao Hospital, Bangkok, 40002, Thailand
name: Sakkarin Chirapongsathorn, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Davao Doctors Hospital, Davao City, Philippines 8000
name: Marilyn Arguillas, Dr.
role: PRINCIPAL_INVESTIGATOR
References: