NCT06493799

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

A Multicenter, Randomized, Open-label, Active-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Drop of 'LAENNEC INJ. (Human Placenta Hydrolysate) Compared With Subcutaneous Injection in Patients With Chronic Liver Disease

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 226 (estimated)
• Sponsor: Green Cross Wellbeing · Industry
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Control group : LAENNEC subcutaneous injection (4 ml) Experimental group : LAENNEC intravenous injection (10 ml)

Detailed description

This is a multi- center, randomized, open-label, Active-controlled phase 3 trial in participants aged 18 to 70 years with chronic liver disease. It is designed to assess the safety, tolerability and efficacy of both 4 ml SC and 10ml IV LAENNEC when administered twice of week for 6 weeks. A total of 226 participants will be randomised to received 4ml SC or 10ml IV of LAENNEC a 1:1 ratio. And in 4 ml SC and 10 ml IV, the ratio of ALD and NAFLD is 1:3. The investigational product will be administered SC or IV twice of week for a duration of 6 weeks. Participants will return to the clinic for follow-up safety and efficacy assessments on weeks 2, 4, 6.

Conditions

• Chronic Liver Disease

Interventions

Type	Name	Description
DRUG	LAENNEC (Human Placenta Hydrolysate) IV	Intravenous Injection
DRUG	LAENNEC (Human Placenta Hydrolysate) SC	Subcutaneous Injection

Timeline

• Start date: 2024-07-01
• Primary completion: 2026-03-31
• Completion: 2026-09-30
• First posted: 2024-07-10
• Last updated: 2026-02-25

Locations

1 site across 1 country: South Korea