Part A: In Patients With Chronic Liver Diseases, LAENNEC (Human Placenta Hydrolysate) is to Assess Safety and Tolerability After the Doses of Doses. Part B: Part A, it is to Determine the Optimal Dose by Evaluating Two Capacity and Placebo Groups.

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/A

Clinical Study ID

NCT05532124
LAEN-IV2A
  • Ages 19-74
  • All Genders

Study Summary

Part A: In Patients With Chronic Liver Diseases, LAENNEC (Human Placenta Hydrolysate) is to Assess Safety and Tolerability After the Doses of Doses.

Part B: Part A, it is to Determine the Optimal Dose by Evaluating Two Capacity and Placebo Groups.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. At the time of screening, 18 or 75 years
  2. Those who have been diagnosed with alcoholic or non -alcoholic fatty liver disease andhave persisted for more than 6 months
  3. Those who are 1.5 times (60 IU/L) of the ALT level of Baseline (60 IU/L)
  4. A person who can complete the signature agreement and compliance the requirements forclinical trials.

Exclusion

Exclusion Criteria:

  1. Liver function abnormalities caused by the following cause disease: viral hepatitis,biliary obstructions, autoimmune hepatitis, wilson disease, hematoprive
  2. Drug allergic symptoms (oscillation, heat, itching)
  3. Those with systemic infection (including tuberculosis)
  4. 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.
  5. Those who have experienced use of human -derived medicines within 6 months beforeselecting a test subject
  6. Those who have received other clinical drugs within 3 months before selecting a testsubject
  7. Magnetic Resonance Spectroscopy (MRS) is impossible
  8. 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)
  9. Those who cannot inject intravenous infusions
  10. 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 of

    Active - Recruiting

  • Yeungnam university

    Daegu,
    Korea, Republic of

    Active - Recruiting

  • Hanyang University Hospital.

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Korea university guro hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Severance hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Soonchunhyang university hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Wonju severance christian hospital

    Wŏnju,
    Korea, Republic of

    Active - Recruiting

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