Phase 3 Study Comparing Intravenous and Subcutaneous LAENNEC Injections for Treating Chronic Liver Disease

What this Trial Is About

Researchers are studying patients aged 18 to 70 years with chronic liver disease, including alcoholic liver disease and non-alcoholic fatty liver disease. This phase 3, multi-center, randomized, open-label trial compares the safety, tolerability, and effectiveness of LAENNEC Human Placenta Hydrolysate given as intravenous IV or subcutaneous SC injections. The goal is to evaluate how these two methods affect liver health, particularly by measuring changes in liver enzymes such as ALT. Participants are randomly assigned to receive either 10 ml of LAENNEC by intravenous injection or 4 ml by subcutaneous injection. Both groups will receive their assigned treatment twice a week for six weeks. The ratio of patients with alcoholic liver disease to those with non-alcoholic fatty liver disease is maintained at 13 in both treatment groups. Follow-up visits occur at weeks 2, 4, and 6 to monitor safety and effectiveness. During the study, participants will undergo laboratory tests to measure liver enzyme levels including ALT, AST, total bilirubin, and r-GT at various points. The primary outcome is the change in ALT level at week 6 compared to baseline. Secondary outcomes include changes in other liver enzymes and fatigue severity scores. Participants adherence and safety are closely monitored throughout the trial, which lasts for six weeks of treatment plus follow-up assessments.

In Patients With Chronic Liver Diseases(Alcoholic Liver Disease and Non-Alcoholic Fatty Liver Disease), LAENNEC(Human Placenta Hydrolysate) is to Evaluate the Efficacy and Safety of Intravenous Drop