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Efficacy and Safety of Berberine in Non-alcoholic Steatohepatitis (EASYBEinNASH)

Primary Purpose

Non-alcoholic Steatohepatitis

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Lifestyle intervention
Placebo
Berberine
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-alcoholic Steatohepatitis focused on measuring Non-alcoholic steatohepatitis

Eligibility Criteria

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

The inclusion criteria are as follows:

  1. 18-75 years old, no limitation for ethnicity and gender.
  2. BMI is no more than 40 kg/m2.
  3. Patients with NASH based on liver biopsy obtained within 24 weeks before randomization. The histological evidence of NASH is defined as NAS ≥5 [] or NAS ≥4 with a minimum score of 1 for all of three components (steatosis, hepatocyte ballooning, and lobular inflammation), the diagnosis of NASH for EASYBEinNASH eligibility is based on reviews by three pathologists. If there are controversial pathologic diagnosis, at least 2 of the 3 pathologists are consistent with the pathologic diagnosis, which will be the final pathological diagnosis. If there are three different pathological diagnoses, it needs to be discussed and make a judgment by the chief pathologist to form the final pathology report.
  4. For patients with impaired glucose metabolism, one of the three following conditions needs to be met.

    ① For patients diagnosed as impaired glucose regulation, they will be treated with lifestyle intervention without hypoglycemic drugs;

    ② For patients diagnosed as diabetes and treated with hypoglycemic drugs, the treatment regimen should not be changed and the dosage should remain stable for more than 2 months before randomization;

    ③ For patients diagnosed as diabetes and treated with lifestyle intervention without hypoglycemic drugs, the treatment regimen should not be changed before randomization.

  5. All participants agree to sign the informed consent form.

Exclusion criteria

  1. Excessive alcohol intake ( > 140 g per week for men and >70 g per week for women within 6 months before enrollment);
  2. Liver enzymes (ALT or aspartate aminotransferase(AST) is 5 times higher than the upper limit of normal range;
  3. Liver diseases caused by other reasons, such as alcohol abuse, viral hepatitis, drugs, auto-immune hepatitis, hereditary liver disease, liver cirrhosis, liver cancer, etc;
  4. Biliary tract diseases, biliary obstructive disease, etc;
  5. Other diseases that affect glucose and lipid metabolism, such as hypothyroidism, hyperthyroidism, hypercortisolism, etc;
  6. Diabetic patients with poor blood glucose control: HbA1c >9.5%;
  7. Use of drugs that may affect the outcome measures of this study 3 months before enrollment, including pioglitazone, GLP-1 receptor agonist, DPP-4 inhibitor, insulin, and glycyrrhizic acid preparation, etc;
  8. Chronic kidney disease or severe renal impairment, defined as serum creatinine greater than 2.0mg/dL (176.8umol/L);
  9. Life expectancy is no more than 5 years;
  10. Pregnant or planning to become pregnant within the next 64 weeks for female participant;
  11. Any situation that may affect the implementation or results of the study;
  12. Continuous use of drugs that may affect steatohepatitis 3 months before enrollment, such as glucocorticoids, methotrexate, etc;
  13. Subjects participated in other clinical trials in the past 4 weeks; The researchers did not think they were suitable for the study.

Sites / Locations

  • Department of Endocrinology and Metabolism,Shanghai 6th People's Hospital
  • The Affiliated Hospital of Hangzhou Normal UniversityRecruiting
  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
  • Tianjin Third Central Hospital
  • Xinjiang Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Berberine

Placebo

Arm Description

Berberine was taken orally 0.5g three times per day for 48 weeks, based on lifestyle intervention.

Placebo was taken orally 0.5g three times per day for 48 weeks, based on lifestyle intervention.

Outcomes

Primary Outcome Measures

Improvement in histologic features of nonalcoholic steatohepatitis by NAFLD activity score (NAS)
A separate system of scoring the histological features of nonalcoholic fatty liver disease (NAFLD) called the NAFLD Activity Score (NAS) was used. An improvement in histologic findings require an improvement by 1 or more points in the hepatocellular ballooning score; no increase in the fibrosis score; and either a decrease in the activity score for nonalcoholic fatty liver disease to a score of 3 or less or a decrease in the activity score of at least 2 points, with at least a 1-point decrease in either the lobular inflammation or steatosis score.

Secondary Outcome Measures

Improvement in the composites of NAFLD activity scores for steatosis, lobular inflammation, hepatocellular ballooning
NAFLD activity score (NAS) is composed of steatosis (scale of 0 to 3), lobular inflammation (scale of 0 to 3), hepatocellular ballooning (scale of 0 to 2). Alteration in each component of NAS is measured.
Improvement in liver histological fibrosis staging
Fibrosis staging was measured as following criteria: 0=none, 1=perisinusoidal or periportal fibrosis, 2=perisinusoidal and portal/periportal fibrosis, 3=bridging fibrosis, and 4=cirrhosis.the definition of fibrosis stages improvement requires at least one stage.
Resolution of NASH
Resolution of NASH was defined as a diagnosis of no steatohepatitis at 48 weeks among those with possible or definite NASH at baseline.
Change in anthropometric measures
including BMI etc
Change in blood biochemistry
including serum aminotransferase levels etc
Change in liver fat content
liver fat content determined by 1H MRS (in part of clinical centers)
Change in serum cytokeratin 18 (CK-18) in U/L
serum cytokeratin 18 (CK-18) in U/L

Full Information

First Posted
June 18, 2017
Last Updated
August 7, 2023
Sponsor
Fudan University
Collaborators
Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, The Affiliated Hospital of Hangzhou Normal University, Tianjin Third Central Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Xinjiang Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03198572
Brief Title
Efficacy and Safety of Berberine in Non-alcoholic Steatohepatitis
Acronym
EASYBEinNASH
Official Title
Efficacy and Safety of Berberine in Non-alcoholic Steatohepatitis: a Multicentre, Randomised, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 16, 2017 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
Collaborators
Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, The Affiliated Hospital of Hangzhou Normal University, Tianjin Third Central Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Xinjiang Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of berberine treatment on Non-alcoholic Steatohepatitis.
Detailed Description
This is a multicenter, double-blinded, randomized, placebo-controlled clinical trial to investigate the efficacy and safety of berberine on subjects with Non-alcoholic Steatohepatitis.Patients with biopsy-proven non-alcoholic steatohepatitis (NASH) from 18-65 years of age were enrolled. Patients should had no excessive alcohol intake or use of any hepatoprotective or hepatotoxicity medication within 3 months before enrollment.Patients will have an screening period 12 weeks, and a 48-week double-blinded treatment period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Steatohepatitis
Keywords
Non-alcoholic steatohepatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Berberine
Arm Type
Experimental
Arm Description
Berberine was taken orally 0.5g three times per day for 48 weeks, based on lifestyle intervention.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo was taken orally 0.5g three times per day for 48 weeks, based on lifestyle intervention.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle intervention
Intervention Description
Lifestyle intervention is consisted of diet control and aerobic exercise. calorie restriction: to subtract 500 kcal from daily calorie intake aerobic exercise: medium intensity aerobic exercise for more than 150 min per week with heart rate around 50-70% of the maximal heart rate.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo tablets 0.5 tid, 30 minutes before each meal, for 48weeks
Intervention Type
Drug
Intervention Name(s)
Berberine
Intervention Description
Berberine tablets 0.5 tid, 30 minutes before each meal, for 48weeks
Primary Outcome Measure Information:
Title
Improvement in histologic features of nonalcoholic steatohepatitis by NAFLD activity score (NAS)
Description
A separate system of scoring the histological features of nonalcoholic fatty liver disease (NAFLD) called the NAFLD Activity Score (NAS) was used. An improvement in histologic findings require an improvement by 1 or more points in the hepatocellular ballooning score; no increase in the fibrosis score; and either a decrease in the activity score for nonalcoholic fatty liver disease to a score of 3 or less or a decrease in the activity score of at least 2 points, with at least a 1-point decrease in either the lobular inflammation or steatosis score.
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Improvement in the composites of NAFLD activity scores for steatosis, lobular inflammation, hepatocellular ballooning
Description
NAFLD activity score (NAS) is composed of steatosis (scale of 0 to 3), lobular inflammation (scale of 0 to 3), hepatocellular ballooning (scale of 0 to 2). Alteration in each component of NAS is measured.
Time Frame
48 weeks
Title
Improvement in liver histological fibrosis staging
Description
Fibrosis staging was measured as following criteria: 0=none, 1=perisinusoidal or periportal fibrosis, 2=perisinusoidal and portal/periportal fibrosis, 3=bridging fibrosis, and 4=cirrhosis.the definition of fibrosis stages improvement requires at least one stage.
Time Frame
48 weeks
Title
Resolution of NASH
Description
Resolution of NASH was defined as a diagnosis of no steatohepatitis at 48 weeks among those with possible or definite NASH at baseline.
Time Frame
48 weeks
Title
Change in anthropometric measures
Description
including BMI etc
Time Frame
48 weeks
Title
Change in blood biochemistry
Description
including serum aminotransferase levels etc
Time Frame
48 weeks
Title
Change in liver fat content
Description
liver fat content determined by 1H MRS (in part of clinical centers)
Time Frame
48 weeks
Title
Change in serum cytokeratin 18 (CK-18) in U/L
Description
serum cytokeratin 18 (CK-18) in U/L
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
The inclusion criteria are as follows: 18-75 years old, no limitation for ethnicity and gender. BMI is no more than 40 kg/m2. Patients with NASH based on liver biopsy obtained within 24 weeks before randomization. The histological evidence of NASH is defined as NAS ≥5 [] or NAS ≥4 with a minimum score of 1 for all of three components (steatosis, hepatocyte ballooning, and lobular inflammation), the diagnosis of NASH for EASYBEinNASH eligibility is based on reviews by three pathologists. If there are controversial pathologic diagnosis, at least 2 of the 3 pathologists are consistent with the pathologic diagnosis, which will be the final pathological diagnosis. If there are three different pathological diagnoses, it needs to be discussed and make a judgment by the chief pathologist to form the final pathology report. For patients with impaired glucose metabolism, one of the three following conditions needs to be met. ① For patients diagnosed as impaired glucose regulation, they will be treated with lifestyle intervention without hypoglycemic drugs; ② For patients diagnosed as diabetes and treated with hypoglycemic drugs, the treatment regimen should not be changed and the dosage should remain stable for more than 2 months before randomization; ③ For patients diagnosed as diabetes and treated with lifestyle intervention without hypoglycemic drugs, the treatment regimen should not be changed before randomization. All participants agree to sign the informed consent form. Exclusion criteria Excessive alcohol intake ( > 140 g per week for men and >70 g per week for women within 6 months before enrollment); Liver enzymes (ALT or aspartate aminotransferase(AST) is 5 times higher than the upper limit of normal range; Liver diseases caused by other reasons, such as alcohol abuse, viral hepatitis, drugs, auto-immune hepatitis, hereditary liver disease, liver cirrhosis, liver cancer, etc; Biliary tract diseases, biliary obstructive disease, etc; Other diseases that affect glucose and lipid metabolism, such as hypothyroidism, hyperthyroidism, hypercortisolism, etc; Diabetic patients with poor blood glucose control: HbA1c >9.5%; Use of drugs that may affect the outcome measures of this study 3 months before enrollment, including pioglitazone, GLP-1 receptor agonist, DPP-4 inhibitor, insulin, and glycyrrhizic acid preparation, etc; Chronic kidney disease or severe renal impairment, defined as serum creatinine greater than 2.0mg/dL (176.8umol/L); Life expectancy is no more than 5 years; Pregnant or planning to become pregnant within the next 64 weeks for female participant; Any situation that may affect the implementation or results of the study; Continuous use of drugs that may affect steatohepatitis 3 months before enrollment, such as glucocorticoids, methotrexate, etc; Subjects participated in other clinical trials in the past 4 weeks; The researchers did not think they were suitable for the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hong-Mei Yan
Phone
8613761666976
Email
yan.hongmei@zs-hospital.sh.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Ming-Feng Xia
Phone
8613611826871
Email
xia.mingfeng@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xin Gao
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Endocrinology and Metabolism,Shanghai 6th People's Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The Affiliated Hospital of Hangzhou Normal University
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun-Ping Shi
Facility Name
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
City
Shanghai
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
City
Shanghai
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Tianjin Third Central Hospital
City
Tianjin
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Xinjiang Medical University
City
Urumqi
Country
China
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
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Citation
Kleiner DE, Brunt EM, Van Natta M, Behling C, Contos MJ, Cummings OW, Ferrell LD, Liu YC, Torbenson MS, Unalp-Arida A, Yeh M, McCullough AJ, Sanyal AJ; Nonalcoholic Steatohepatitis Clinical Research Network. Design and validation of a histological scoring system for nonalcoholic fatty liver disease. Hepatology. 2005 Jun;41(6):1313-21. doi: 10.1002/hep.20701.
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Efficacy and Safety of Berberine in Non-alcoholic Steatohepatitis

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