Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-29 @ 1:38 AM
Study NCT ID:
NCT03868566
Status:
TERMINATED
Last Update Posted:
2023-01-06
First Post:
2019-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-Label Study to Assess the Hepatic Protection Effect of SNP-612, in Patients With NAFLD
Sponsor:
Sinew Pharma Inc.
Organization:
Study Overview
Official Title:
An Open-Label Study to Assess the Hepatic Protection Effect of a Food Supplement Product, SNP-612, in Patients With Non-alcoholic Fatty Liver Disease
Status:
TERMINATED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
recruitment difficulties due to Covid-19
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of the study is to compare the changes in ALT to baseline among patients with non-alcoholic fatty liver disease (NAFLD) following the 3-month treatment of 3 different dosing regimens of SNP-612. The secondary objectives will be to compare the changes in other liver function tests, cytokeratin-18 (CK-18) fragment level and adverse event / serious adverse event rates.
Detailed Description:
An open-label study will be conducted in medical centers around Taiwan. The objective of the study is to investigate the efficacy and safety of SNP-612 for the treatment of NAFLD.
Subjects who fulfill all the entry criteria and have written informed consent will be enrolled to the study. Considering a 10% drop-out rate, approximately 72 subjects will be enrolled in order to recruit 64 evaluable subject subjects to complete the enrollment.
Subjects will be administered the study agents oral daily for 3 months or until treatment terminates prematurely. Subjects will return to the study center for clinical evaluation once every 4 weeks throughout the treatment period. Clinical assessment procedures and laboratory tests including ultrasound imaging, hematology with differential, biochemistry, liver function panel, and urinalysis, will be performed at each study visit. The primary endpoint assessment will be the reduction of ALT, at completion of Week 12 compared to baseline. With 64 evaluable patients, there will be an 80% chance of detecting a significant difference at a two sided 0.05 significance level.
Subjects who finish treatment or discontinue prematurely from the study for any reason after receiving one or more doses of study agent will be assessed for safety for 2 (±1) weeks after the last study agent dose or longer in the case of any significant AE or abnormal biochemical or clinical finding.
Each subject will participate in the study for approximately 14 weeks (including the enrollment/baseline visit, 3 routine monthly visits during treatment period, and 1 follow-up visit after 2 weeks of the end of treatment).
It is assumed the study will include a 6 months enrollment period and a further 4 months to complete the follow-up for all enrolled patients.
Subjects who fulfill all the entry criteria and have written informed consent will be enrolled to the study. Considering a 10% drop-out rate, approximately 72 subjects will be enrolled in order to recruit 64 evaluable subject subjects to complete the enrollment.
Subjects will be administered the study agents oral daily for 3 months or until treatment terminates prematurely. Subjects will return to the study center for clinical evaluation once every 4 weeks throughout the treatment period. Clinical assessment procedures and laboratory tests including ultrasound imaging, hematology with differential, biochemistry, liver function panel, and urinalysis, will be performed at each study visit. The primary endpoint assessment will be the reduction of ALT, at completion of Week 12 compared to baseline. With 64 evaluable patients, there will be an 80% chance of detecting a significant difference at a two sided 0.05 significance level.
Subjects who finish treatment or discontinue prematurely from the study for any reason after receiving one or more doses of study agent will be assessed for safety for 2 (±1) weeks after the last study agent dose or longer in the case of any significant AE or abnormal biochemical or clinical finding.
Each subject will participate in the study for approximately 14 weeks (including the enrollment/baseline visit, 3 routine monthly visits during treatment period, and 1 follow-up visit after 2 weeks of the end of treatment).
It is assumed the study will include a 6 months enrollment period and a further 4 months to complete the follow-up for all enrolled patients.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: