Ignite Creation Date:
2024-07-17 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06493799
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-06-30
Brief Title:
In Patients With Chronic Liver DiseasesAlcoholic Liver Disease and Non-Alcoholic Fatty Liver Disease LAENNECHuman Placenta Hydrolysate is to Evaluate the Efficacy and Safety of Intravenous Drop
Sponsor:
Green Cross Wellbeing
Organization:
Green Cross Wellbeing
Study Overview
Official Title:
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:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Control group LAENNEC subcutaneous injection 4 ml
Experimental group LAENNEC intravenous injection 10 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 11 ratio And in 4 ml SC and 10 ml IV the ratio of ALD and NAFLD is 13 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None