Clinical Trials Logo
  1. Home
  2. Other
  3. NCT03868566

An Open-Label Study to Assess the Hepatic Protection Effect of SNP-612, in Patients With NAFLD

NASH - Nonalcoholic Steatohepatitis Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

  • Fatty Liver
  • NASH - Nonalcoholic Steatohepatitis
  • Non-alcoholic Fatty Liver Disease
Clinical Trial Details
NCT number NCT03868566
Study type Interventional
Source Sinew Pharma Inc.
Contact
Status Terminated
Phase Phase 2
Start date August 4, 2017
Completion date October 19, 2021
View Details
See also
  Status Clinical Trial Phase
Completed NCT03289897 - Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan N/A
Active, not recruiting NCT05479721 - LITMUS Imaging Study
Not yet recruiting NCT05120557 - Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH N/A
Recruiting NCT04976283 - Effect of Oral Anti-diabetic Medication on Liver Fat in Subjects With Type II Diabetes and Non-alcoholic Fatty Liver Phase 4
Completed NCT02784444 - A Study to Evaluate the Safety, Tolerability & Efficacy of MSDC-0602K in Patients With NASH Phase 2
Not yet recruiting NCT05499949 - The Franciscus Obesity NASH Study
Completed NCT04321343 - Study of PXL065 in Patients With Nonalcoholic Steatohepatitis (NASH) Phase 2
Recruiting NCT04371042 - PROtocol of Metabolic and Cryptogenic livEr Disease regisTry for intEgration of Omic Studies
Not yet recruiting NCT03648554 - Researching an Effect of GLP-1 Agonist on Liver STeatosis (REALIST) Phase 4
Completed NCT04972396 - ALT-801 DDI Study in Healthy Volunteers Phase 1
Completed NCT03748628 - Absorption, Metabolism and Excretion (AME) Study of [14C]EDP-305 in Healthy Male Subjects Phase 1
Enrolling by invitation NCT05195944 - Semaglutide vs Sitagliptin Phase 4
Completed NCT04643795 - Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Multiple Oral Doses of MGL-3196 in Subjects With Varying Degrees of Hepatic Impairment and Healthy Matched Control Subjects Phase 1
Terminated NCT03669133 - Vitamin E for NASH Treatment in HIV Infected Individuals Phase 2
Completed NCT04066400 - Role of a Wheat Containing Diet on Non-alcoholic Steatohepatitis N/A
Completed NCT03536650 - Effect of DMR in the Treatment of NASH N/A
Completed NCT03783897 - A Drug-drug Interaction Study to Investigate the Effect of Coadministration of EDP-305 on the PK of a Combined Oral Contraceptive in Healthy Female Subjects Phase 1
Completed NCT04618744 - A Study to Assess the Safety and Efficacy of Oral Insulin in T2DM Patients With Nonalcoholic Steatohepatitis (NASH) Phase 2
Active, not recruiting NCT05338034 - Phase 2a Study of HPG1860 in Subjects With NASH Phase 2
Active, not recruiting NCT04653103 - NASH in Subjects With Different Classes of Obesity