Last updated: January 31, 2023
Sponsor: Green Cross Wellbeing
Overall Status: Active - Recruiting
Phase
2
Condition
Primary Biliary Cholangitis
Hepatitis C; Chronic
Hepatic Fibrosis
Treatment
N/AClinical Study ID
NCT05532124
LAEN-IV2A
Ages 19-74 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- At the time of screening, 18 or 75 years
- Those who have been diagnosed with alcoholic or non -alcoholic fatty liver disease andhave persisted for more than 6 months
- Those who are 1.5 times (60 IU/L) of the ALT level of Baseline (60 IU/L)
- A person who can complete the signature agreement and compliance the requirements forclinical trials.
Exclusion
Exclusion Criteria:
- Liver function abnormalities caused by the following cause disease: viral hepatitis,biliary obstructions, autoimmune hepatitis, wilson disease, hematoprive
- Drug allergic symptoms (oscillation, heat, itching)
- Those with systemic infection (including tuberculosis)
- If the test person judges that it is difficult to participate in clinical trials dueto the next disease: Cirrhosis of CHILD C or higher, cirrhosis with edema and plural,malignant tumors, severe disorders, severe renal disorders, severe cardiovasculardisease, severe nerve Mental disorders, preferences, etc.
- Those who have experienced use of human -derived medicines within 6 months beforeselecting a test subject
- Those who have received other clinical drugs within 3 months before selecting a testsubject
- Magnetic Resonance Spectroscopy (MRS) is impossible
- A person who does not perform appropriate contraception as a pregnant woman, a nursingor a woman of childbearing age (effective contraception method: Barrier methods usinginfertility surgery, uterine device, condom, killer)
- Those who cannot inject intravenous infusions
- Those who judged that other testors were inappropriate as clinical trials
Study Design
Total Participants: 49
Study Start date:
June 01, 2021
Estimated Completion Date:
June 30, 2023
Connect with a study center
Keimyung university dongsan medical center
Daegu,
Korea, Republic ofActive - Recruiting
Yeungnam university
Daegu,
Korea, Republic ofActive - Recruiting
Hanyang University Hospital.
Seoul,
Korea, Republic ofActive - Recruiting
Korea university guro hospital
Seoul,
Korea, Republic ofActive - Recruiting
Severance hospital
Seoul,
Korea, Republic ofActive - Recruiting
Soonchunhyang university hospital
Seoul,
Korea, Republic ofActive - Recruiting
Wonju severance christian hospital
Wŏnju,
Korea, Republic ofActive - Recruiting
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