Comparing intravenous and under-skin LAENNEC for alcoholic and non-alcoholic fatty liver disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, open-label, active-controlled Phase 3 trial will enroll 226 adults with chronic liver disease (alcoholic or non-alcoholic fatty liver disease) and elevated ALT. Participants are randomized 1:1 to receive either 4 ml subcutaneous LAENNEC or 10 ml intravenous LAENNEC twice weekly for six weeks, with an ALD:NAFLD ratio of about 1:3 within each arm. Safety, tolerability, and efficacy are assessed at baseline and at follow-up visits on weeks 2, 4, and 6. The trial compares clinical and laboratory liver outcomes and adverse events between the two administration routes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

A participant will be eligible for participation in the trial if all of the following inclusion criteria are met:

1. At the time of screening, 19 or 70 years
2. Those who have been diagnosed with alcoholic or non-alcoholic fatty liver disease
3. Those who have increased ALT level (Increased ALT level : 60 IU/L ≤ ALT ≤ 200 IU/L)
4. A person who can complete the signature agreement and comply with clinical trial requirements.

Exclusion Criteria:

A participant will not be eligible for trial participation if any of the following exclusion criteria are met:

1. If you have the following disease

   * Liver cancer or other malignant tumor within 5 years at screening point
   * Esophageal varix bleeding, hepatic coma, ascites etc. related disease or Child-Pugh Score Class B,C patient within 1 year at screening point
   * Organs or bone marrow transplant experience
   * Billiary atresia, Genetic metabolic liver disease, Fulminant Hepatic failure, toxicity or Clinically diagnosed hepatitis, bleeding or Platelet disease patient
   * Autoimmune hepatitis, Primary biliary cirrhosis, Sclerosing cholangitis, IgG4- associated cholangitis patient
   * Bariatric Surgery within 24 weeks at screening point
   * Uncontrolled diabetes mellitus (HBA1c \> 9.0%)
   * Uncontrolled serious Cardiopulmonary disease
   * Liver cancer or other malignant tumor within 5 years at screening point
   * Those who have alcohol abuse within 5 years at screening point
   * Hepatitis B, C virus (However, those who have been identified as HBV DNA undetectable or SVR after antiviral administration can participate)
   * Systemic infection (including tuberculosis)
2. If you are taking the following drug (Hepatotonics)

   * However, it is possible to register after having a drug holiday

     * Biphenyl dimethyl dicarboxylate (BDD), Silymarin(Milk thistle) : 14 days
     * Ursodeoxycholic acid (UDCA) : 30 days
     * Other Hepatotonics : 5 times half-life
3. If you are taking the following drug or need to take drugs during the clinical trial period

   * Antituberculous drug(Isoniazid, Rifampin etc.), antifungal agent and antibiotic
   * Acetaminophen, NSAIDs(Excluding low-dose aspirin for preventive purposes)
   * Lipid lowering agent(Niacin etc.) and Oral hypoglycemic agent(acarbose etc.) (Registered when administered during the clinical trial period with a certain dose without a change in dose currently being taken)
   * Antiseric agent (ARB, Beta-blocker, CCB etc.) (Registered when administered during the clinical trial period with a certain dose without a change in dose currently being taken)
   * Vitamin E (Purpose of treatment of more than 800 IU/day)
   * Astrogens
   * Systemic corticosteroids, Immunomodulator
4. If you take more alcohol than the recommended amount (Man 40 g/day, Woman 20 g/day)
5. Drug allergic symptoms (oscillation, heat, itching)
6. Those who have received other clinical drugs within 4 weeks before selecting a test subject
7. Those who cannot inject intravenous infusions (5% Dextrose Inj.)
8. A person who does not perform appropriate contraception as a pregnant woman, a nursing or a woman of childbearing age (effective contraception method: Barrier methods using infertility surgery, uterine device, condom, killer)
9. Those who judged that other testors were inappropriate as clinical trials

Where it's running

• GC wellbeing
  Yongin-si, South Korea Recruiting

Study contacts

• Study coordinator: Yeongmin Kwon
• Email: ymkwon@gccorp.com
• Phone: +82-70-8892-7881

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.