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Placenta extract injection aims to tame chronic liver disease

NCT ID NCT06493799

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests a drug called LAENNEC, made from human placenta, in people with chronic liver disease. It compares giving the drug as an intravenous drip versus a standard shot under the skin. The main goal is to see if the IV form lowers liver enzyme levels more effectively over 6 weeks. About 226 adults with alcoholic or non-alcoholic fatty liver disease and elevated ALT levels are being recruited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LAENNEC (human placenta hydrolysate)
What this could lead to
If successful, this could offer a new way to deliver LAENNEC intravenously to better manage chronic liver disease and reduce liver enzyme levels.
What could go wrong
This is a Phase 3 trial, but it compares two forms of the same drug, not against a placebo. The benefit over standard care is unclear, and long-term outcomes are not measured.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 226 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • GC wellbeing

    RECRUITING

    Yongin-si, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.