Global Research Initiative for Patients Screening on MASH

Recruiting

• Conditions: fatty liver; liver fibrosis; 10019654

• Registration Number: NL-OMON56985
• Lead Sponsor: Julius Clinical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 1000

Inclusion Criteria

- 18-75 year old;
- new or established diagnosis of at least 1 of the following 4 conditions:
type 2 diabetes mellitus, obesity, arterial hypertension or metabolic syndrome
(diagnostic criteria defined in protocol).

Exclusion Criteria

- The patient is known with hepatitis B, C or HIV or any other liver condition
(like hemochromatosis, Wilson*s disease, sarcoidosis, etc);
- The patient is known with any other condition that may lead to liver fibrosis
or cirrhosis;
- The patient engages in (Excessive) alcohol use (defined as > 3 units/day in
males [30 grams/day] and > 2 units/day in females [20 grams/day]);
- The patient has a history or evidence of any other clinically significant
condition or planned or expected procedure that in the opinion of the
Investigator, may compromise the patient*s safety or ability to be included in
this study;
-The patient is an employee or contractor of the facility that is conducting
the study or is a family member of the Investigator, sub-Investigator, or any
Sponsor personnel;
- The patient is not able to understand the details of the protocol and/or is
not able to provide written informed consent;
- The patient is pregnant or breastfeeding.
- The patient underwent bariatric surgery in the last 12 months.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified