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New treatment option for End Stage Liver Disease
Official title Allogenic Hepatocyte Transplantation Into Periduodenal Lymph Nodes
ClinicalTrials.gov ID: NCT04496479
What this study is testing
What is LYG-LIV0001?
LYG-LIV0001 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for end stage liver disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This Phase 2a clinical trial is a dose escalation study of the safety, tolerability, and efficacy of hepatocyte transplantation into lymph nodes via endoscopic ultrasound among subjects with end-stage liver disease.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Have read, understood, and signed the informed consent form (ICF).
- Adults of either gender and ages 18 to 70 years old with a diagnosis of ESLD due to alcohol, chronic hepatitis B virus (HBV) and/or hepatitis C virus...
- people must have a body mass index (BMI) \<35.
- people with HCV associated ESLD must have been treated and demonstrate 24 weeks of negative HCV ribonucleic acid (RNA).
- people with HBV must be on stable therapy for 6 months and have HBV deoxyribonucleic acid \<500 c/mL.
You likely can't join if
- Has primary hepatic neoplasms (hepatocellular carcinoma and cholangiocarcinoma).
- Has active and/or uncontrolled severe infections requiring hospitalization and prolonged antimicrobial therapy.
- Has severe coagulopathy (international normalized ratio [INR] \>2, and/or platelet count \<50,000/μL).
- Has psychiatric and/or social issues that could lead to noncompliance.
- Has an extrahepatic neoplastic disease requiring active chemotherapy, immunotherapy, and/or surgical resection.
- Has previously treated neoplastic disease with less than a 2-year cancer free period.
See the full eligibility criteria
- Have read, understood, and signed the informed consent form (ICF).
- Adults of either gender and ages 18 to 70 years old with a diagnosis of ESLD due to alcohol, chronic hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infections, autoimmune hepatitis, primary sclerosis...
- people must have a body mass index (BMI) \<35.
- people with HCV associated ESLD must have been treated and demonstrate 24 weeks of negative HCV ribonucleic acid (RNA).
- people with HBV must be on stable therapy for 6 months and have HBV deoxyribonucleic acid \<500 c/mL.
- Women of childbearing potential (WOCBP) or sexual partners of male people who are WOCBP must be able and willing to use at least 1 highly effective method of contraception during the study and for 1 month after the last...
- Has stable control of portal hypertension and upper gastrointestinal bleeding with medical therapy and/or endoscopic therapy.
- If the subject has undergone a TIPS procedure for the clinical management of portal hypertension, they must be stable after the successful TIPS procedure, and not experiencing serious complications from the TIPS...
- Has blood urea nitrogen (BUN) \<80 mg/dL.
- Has an estimated glomerular filtration rate (eGFR) ≥45 mL/min/1.73 m2.
- Agrees to avoid alcohol consumption during the study.
- Is willing and able to comply with all requirements of the study protocol.
- Has primary hepatic neoplasms (hepatocellular carcinoma and cholangiocarcinoma).
- Has active and/or uncontrolled severe infections requiring hospitalization and prolonged antimicrobial therapy.
- Has severe coagulopathy (international normalized ratio [INR] \>2, and/or platelet count \<50,000/μL).
- Has psychiatric and/or social issues that could lead to noncompliance.
- Has an extrahepatic neoplastic disease requiring active chemotherapy, immunotherapy, and/or surgical resection.
- Has previously treated neoplastic disease with less than a 2-year cancer free period.
- Pregnant and lactating women should not be in the study.
- Known hypersensitivity to human serum albumin.
- people with uncontrolled hypertension (defined as a diastolic blood pressure of 110 mmHg or higher).
- Has recurrent/intractable ascites refractory to diuretics and requiring periodic large volume paracentesis.
- Has primary alcoholic liver disease and has not demonstrated abstinence for at least 24 weeks (6 months) prior to enrollment while attending mandatory rehab programs (e.g., Alcoholics Anonymous) and psychotherapy.
- Has grade 3 esophageal varices requiring the continuous use of propranolol and cannot afford to have this medication withheld and/or discontinued.
- Has a Child-Turcotte-Pugh (CTP) Class of C.
- Is receiving or plans to receive treatment with another investigational product or device.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.