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Evaluate the Efficacy and Safety of LivPhcD Capsules in the NAFLD Subjects

Primary Purpose

NAFLD

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Placebo
2 cap.LivPhcD/per day
4 cap.LivPhcD/per day
6 cap.LivPhcD/per day
Sponsored by
TCM Biotech International Corp.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NAFLD

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female between 20 and 75 years of age. Capable of giving written informed consent and able to effectively communicate with the investigator and study personnel. Has a body mass index (BMI) ≥20 kg/m^2 and ≤50 kg/m^2 and stable weight for the past 3 months CAP ≥ 238 db/m Fibro scan (transient elastography) F0~F3 Exclusion Criteria: Pregnant or breastfeeding or planning to become pregnant or unwilling to use an acceptable contraceptive method to avoid pregnancy during the study period Type 1 diabetes mellitus. History of other causes of chronic liver disease [autoimmune, primary biliary cirrhosis, HBV (HBsAg positive) and HCV, Wilson disease, alpha-1-antitrypsin deficiency, hemochromatosis etc. Use of medications that could induce steatosis, such as estrogen or other hormonal replacement therapy, amiodarone, methotrexate, tamoxifen, raloxifene, pharmacological doses of oral glucocorticoids (≥10 mg per day of prednisone or equivalent), or chloroquine. Use of vitamin E (doses ≥800 IU/dy) or pioglitazone or SGLT2 inhibitor or GLP-1 agonists any FDA-approved drug for NASH to be approved during the study. Has significant systemic or major illnesses other than liver disease, ex: recent events (≤6 months before study entry) of congestive heart failure, unstable coronary artery disease, serious COPD, renal failure and need hemodialysis, stroke, transient ischemic attack, or organ transplantation Known alcohol abuse or alcohol use disorder (>20 g/day for women; >30 g/day for men) Has the abnormal data including: fasting TG >400 mg/dL ; ALT or GGT>5.0 x ULN;Bilirubin >2 x ULN,unless due to an alternative etiology such as Gilbert's syndrome; INR ≥1.3; Albumin < LLN; Platelet <0.95x LLN Subjects with hemoglobin A1c (HbA1c) >8.5% within 3 months before study entry Plan to have major surgery during the study period (bariatric surgery, biliary diversion surgery) Participation in any other investigational clinical trial within 30 days of entry to this protocol; History of HIV

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Placebo Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Placebo

    2 cap.LivPhcD/per day

    4 cap.LivPhcD/per day

    6 cap.LivPhcD/per day

    Arm Description

    Placebo without active ingredient

    515mg/LivPhcD cap. 2 cap./per day

    515mg/LivPhcD cap. 4 cap./per day, BID

    515mg/LivPhcD cap. 6 cap./per day, TID

    Outcomes

    Primary Outcome Measures

    Reduction of Liver Fat
    Between group difference in the proportion of patients with ≥ 10% reduction of baseline of liver fat by CAP(Controlled Attenuation Parameter)

    Secondary Outcome Measures

    Change in liver fat at least 30% reduction
    Between group difference in the proportion of patients with ≥ 30% reduction of baseline of liver fat by CAP
    Change in liver fat at least 1 stage reduction
    Between group difference in the proportion of patients with 1 stage reduction of baseline of liver fat by CAP
    Change in liver fat
    Between group difference in mean change of liver fat by CAP
    Stable in liver fat
    Between group difference in the proportion of patients with stable of baseline of liver fat by CAP
    Change in liver fibrosis at least 10% reduction
    Between group difference in the proportion of patients with ≥ 10% reduction of baseline of liver fibrosis by Fibroscan
    Change in liver fibrosis at least 1 stage reduction
    Between group difference in the proportion of patients with 1 stage reduction of baseline of liver fibrosis by Fibroscan
    Stable in liver fibrosis
    Between group difference in the proportion of patients with stable reduction of baseline of liver fibrosis by Fibroscan
    Change in liver fibrosis
    Between group difference in mean change of FIB-4
    Change in ALT
    Between group difference in mean change or in the proportion of patients of ALT
    Change in AST
    Between group difference in mean change or in the proportion of patients of AST
    Change in GGT
    Between group difference in mean change or in the proportion of patients of GGT
    Change in AP
    Between group difference in mean change or in the proportion of patients of AP
    Change in Bilirubin
    Between group difference in mean change or in the proportion of patients of Bilirubin
    Change in Triglyceride
    Between group difference in mean change or in the proportion of patients of Triglyceride
    Change in Total Cholesterol
    Between group difference in mean change or in the proportion of patients of Total Cholesterol
    Change in HDL-C
    Between group difference in mean change or in the proportion of patients of HDL-C
    Change in LDL-C
    Between group difference in mean change or in the proportion of patients of LDL-C
    Change in TNF-α
    Between group difference in mean change or in the proportion of patients of TNF-α
    Change in C-Reactive Protein
    Between group difference in mean change or in the proportion of patients of C-Reactive Protein
    Change in Albumin
    Between group difference in mean change or in the proportion of patients of Albumin
    Occurrence of adverse events and serious adverse events
    Between group difference in the occurrence of adverse events and serious adverse events.

    Full Information

    First Posted
    May 28, 2023
    Last Updated
    June 25, 2023
    Sponsor
    TCM Biotech International Corp.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05930093
    Brief Title
    Evaluate the Efficacy and Safety of LivPhcD Capsules in the NAFLD Subjects
    Official Title
    Multi-center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LivPhcD Capsules in the NAFLD Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2, 2023 (Anticipated)
    Primary Completion Date
    March 1, 2025 (Anticipated)
    Study Completion Date
    May 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    TCM Biotech International Corp.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Non-alcoholic fatty liver disease (also called NAFLD) is a disease in which excessive fat accumulates in the liver of a patient without a history of alcohol abuse. Early-stage NAFLD does not usually cause any harm but nonalcoholic steatohepatitis (NASH) can lead to serious liver damage, including fibrosis or cirrhosis. Nearly 25% of the world's population is affected by NAFLD. There are no FDA-approved medications for the treatment of NAFLD currently and although lifestyle modifications with appropriate diet and exercise have been shown to be beneficial, this has been difficult to achieve and sustain for the majority of patients. LivPhcD™ capsule have shown hepatoprotective effects in both animal and human data. This study aims to investigate the effects of LivPhcD™ capsule in hepatocellular lipid content using Fibroscan.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    NAFLD

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    108 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo without active ingredient
    Arm Title
    2 cap.LivPhcD/per day
    Arm Type
    Active Comparator
    Arm Description
    515mg/LivPhcD cap. 2 cap./per day
    Arm Title
    4 cap.LivPhcD/per day
    Arm Type
    Active Comparator
    Arm Description
    515mg/LivPhcD cap. 4 cap./per day, BID
    Arm Title
    6 cap.LivPhcD/per day
    Arm Type
    Active Comparator
    Arm Description
    515mg/LivPhcD cap. 6 cap./per day, TID
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo matching LivPhcD cap.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    2 cap.LivPhcD/per day
    Intervention Description
    2 caps. LivPhcD cap. after meal, once a day
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    4 cap.LivPhcD/per day
    Intervention Description
    4 caps. LivPhcD cap. after meal, BID
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    6 cap.LivPhcD/per day
    Intervention Description
    6 caps. LivPhcD cap. after meal, TID
    Primary Outcome Measure Information:
    Title
    Reduction of Liver Fat
    Description
    Between group difference in the proportion of patients with ≥ 10% reduction of baseline of liver fat by CAP(Controlled Attenuation Parameter)
    Time Frame
    36 weeks
    Secondary Outcome Measure Information:
    Title
    Change in liver fat at least 30% reduction
    Description
    Between group difference in the proportion of patients with ≥ 30% reduction of baseline of liver fat by CAP
    Time Frame
    24 weeks and 36 weeks
    Title
    Change in liver fat at least 1 stage reduction
    Description
    Between group difference in the proportion of patients with 1 stage reduction of baseline of liver fat by CAP
    Time Frame
    24 weeks and 36 weeks
    Title
    Change in liver fat
    Description
    Between group difference in mean change of liver fat by CAP
    Time Frame
    24 weeks and 36 weeks
    Title
    Stable in liver fat
    Description
    Between group difference in the proportion of patients with stable of baseline of liver fat by CAP
    Time Frame
    24 weeks and 36 weeks
    Title
    Change in liver fibrosis at least 10% reduction
    Description
    Between group difference in the proportion of patients with ≥ 10% reduction of baseline of liver fibrosis by Fibroscan
    Time Frame
    24 weeks and 36 weeks
    Title
    Change in liver fibrosis at least 1 stage reduction
    Description
    Between group difference in the proportion of patients with 1 stage reduction of baseline of liver fibrosis by Fibroscan
    Time Frame
    24 weeks and 36 weeks
    Title
    Stable in liver fibrosis
    Description
    Between group difference in the proportion of patients with stable reduction of baseline of liver fibrosis by Fibroscan
    Time Frame
    24 weeks and 36 weeks
    Title
    Change in liver fibrosis
    Description
    Between group difference in mean change of FIB-4
    Time Frame
    24 weeks and 36 weeks
    Title
    Change in ALT
    Description
    Between group difference in mean change or in the proportion of patients of ALT
    Time Frame
    24 weeks and 36 weeks
    Title
    Change in AST
    Description
    Between group difference in mean change or in the proportion of patients of AST
    Time Frame
    24 weeks and 36 weeks
    Title
    Change in GGT
    Description
    Between group difference in mean change or in the proportion of patients of GGT
    Time Frame
    24 weeks and 36 weeks
    Title
    Change in AP
    Description
    Between group difference in mean change or in the proportion of patients of AP
    Time Frame
    24 weeks and 36 weeks
    Title
    Change in Bilirubin
    Description
    Between group difference in mean change or in the proportion of patients of Bilirubin
    Time Frame
    24 weeks and 36 weeks
    Title
    Change in Triglyceride
    Description
    Between group difference in mean change or in the proportion of patients of Triglyceride
    Time Frame
    24 weeks and 36 weeks
    Title
    Change in Total Cholesterol
    Description
    Between group difference in mean change or in the proportion of patients of Total Cholesterol
    Time Frame
    24 weeks and 36 weeks
    Title
    Change in HDL-C
    Description
    Between group difference in mean change or in the proportion of patients of HDL-C
    Time Frame
    24 weeks and 36 weeks
    Title
    Change in LDL-C
    Description
    Between group difference in mean change or in the proportion of patients of LDL-C
    Time Frame
    24 weeks and 36 weeks
    Title
    Change in TNF-α
    Description
    Between group difference in mean change or in the proportion of patients of TNF-α
    Time Frame
    24 weeks and 36 weeks
    Title
    Change in C-Reactive Protein
    Description
    Between group difference in mean change or in the proportion of patients of C-Reactive Protein
    Time Frame
    24 weeks and 36 weeks
    Title
    Change in Albumin
    Description
    Between group difference in mean change or in the proportion of patients of Albumin
    Time Frame
    24 weeks and 36 weeks
    Title
    Occurrence of adverse events and serious adverse events
    Description
    Between group difference in the occurrence of adverse events and serious adverse events.
    Time Frame
    24 weeks and 36 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female between 20 and 75 years of age. Capable of giving written informed consent and able to effectively communicate with the investigator and study personnel. Has a body mass index (BMI) ≥20 kg/m^2 and ≤50 kg/m^2 and stable weight for the past 3 months CAP ≥ 238 db/m Fibro scan (transient elastography) F0~F3 Exclusion Criteria: Pregnant or breastfeeding or planning to become pregnant or unwilling to use an acceptable contraceptive method to avoid pregnancy during the study period Type 1 diabetes mellitus. History of other causes of chronic liver disease [autoimmune, primary biliary cirrhosis, HBV (HBsAg positive) and HCV, Wilson disease, alpha-1-antitrypsin deficiency, hemochromatosis etc. Use of medications that could induce steatosis, such as estrogen or other hormonal replacement therapy, amiodarone, methotrexate, tamoxifen, raloxifene, pharmacological doses of oral glucocorticoids (≥10 mg per day of prednisone or equivalent), or chloroquine. Use of vitamin E (doses ≥800 IU/dy) or pioglitazone or SGLT2 inhibitor or GLP-1 agonists any FDA-approved drug for NASH to be approved during the study. Has significant systemic or major illnesses other than liver disease, ex: recent events (≤6 months before study entry) of congestive heart failure, unstable coronary artery disease, serious COPD, renal failure and need hemodialysis, stroke, transient ischemic attack, or organ transplantation Known alcohol abuse or alcohol use disorder (>20 g/day for women; >30 g/day for men) Has the abnormal data including: fasting TG >400 mg/dL ; ALT or GGT>5.0 x ULN;Bilirubin >2 x ULN,unless due to an alternative etiology such as Gilbert's syndrome; INR ≥1.3; Albumin < LLN; Platelet <0.95x LLN Subjects with hemoglobin A1c (HbA1c) >8.5% within 3 months before study entry Plan to have major surgery during the study period (bariatric surgery, biliary diversion surgery) Participation in any other investigational clinical trial within 30 days of entry to this protocol; History of HIV
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chun-Jen Liu, Ph.D
    Phone
    +886-2-23123456
    Ext
    67503
    Email
    cjliu@ntu.edu.tw

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluate the Efficacy and Safety of LivPhcD Capsules in the NAFLD Subjects

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