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Hydronidone for the Treatment of Liver Fibrosis Associated With Chronic Viral Hepatitis B Phase 3 Trial.

Primary Purpose

Liver Fibrosis

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Hydronidone capsules
The placebo capsules
Sponsored by
Beijing Continent Pharmaceutical Co, Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Fibrosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age from 18 to 65 years old (including 18 and 65 years old, based on the time of signing the written informed consent); gender is not limited.
  2. History of chronic hepatitis B and/or hepatitis B surface antigen (HBsAg) positive≥6 months.
  3. Percutaneous liver biopsy confirmed liver fibrosis (Ishak score ≥3).
  4. Positive HBV DNA.
  5. ALT < 8 x ULN (standard upper limit).
  6. No antiviral therapy with interferon and/or nucleoside analogues within 3 months prior to enrollment.
  7. 3 months before inclusion, he/she had not received any of the following proprietary Chinese medicines that may have anti-fibrosis effects: Fuzheng Huayu Capsule (tablet), Anluo Huayu Pill, compound Bijiaruangan tablet, etc.
  8. The subject (or his/her sexual partner) had no pregnancy plan during the trial period and within 6 months after the trial, voluntarily used effective physical contraception, and had no sperm or egg donation plan.
  9. Before the trial, they have understood the nature, significance, potential benefits, inconvenience and potential dangers of the trial in detail, and have voluntarily participated in the clinical trial, have good communication with the researchers, comply with the requirements of the whole study, and have signed a written informed consent form.

Exclusion Criteria:

  1. Massive upper gastrointestinal hemorrhage within 3 months before enrolment.
  2. Total bilirubin (TBIL) > 3×ULN, or 3×ULN < ALT < 8×ULN and TBIL > 2×ULN.
  3. AFP > 100 μg/L although there was no indication of liver cancer.
  4. Platelets (PLT) ≤60×109/L.
  5. Prothrombin activity (PTA) < 50% or INR > 1.5.
  6. Imaging showed obvious space-occupying lesions in the liver, suggesting tumor.
  7. Body mass index (BMI) > 30 kg/m2.
  8. Patients with decompensated liver cirrhosis and liver malignant tumor.
  9. Patients with chronic hepatitis C or non-viral (alcoholic, non-alcoholic, drug, etc.) chronic hepatitis.
  10. Serious diseases of cardiovascular, pulmonary, renal, endocrine, neurological and haematological systems, as well as mental disorders .
  11. Women who are pregnant and/or breastfeeding.
  12. Have participated in clinical trials of other drugs in the last 3 months.
  13. The Investigator considers that there are any conditions that may affect the subjects' informed consent or adherence to the study protocol, or participation in the study may affect the study results or their own safety.

Sites / Locations

  • Beijing Ditan Hospital Capital Medical UniversityRecruiting
  • Shanghai General Hospital,Shanghai Jiao Tong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Hydronidone group

The placebo group

Arm Description

Patients were given three capsules of hydronidone three times a day for 52 weeks.

Patients were given three capsules of placebo three times a day for 52 weeks.

Outcomes

Primary Outcome Measures

Pathological score of Ishak stage
After 52 weeks of treatment, the proportion of Ishak of liver fibrosis decreased by more than 1 point from baseline

Secondary Outcome Measures

Full Information

First Posted
October 9, 2021
Last Updated
March 31, 2022
Sponsor
Beijing Continent Pharmaceutical Co, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05115942
Brief Title
Hydronidone for the Treatment of Liver Fibrosis Associated With Chronic Viral Hepatitis B Phase 3 Trial.
Official Title
Hydronidone for the Treatment of Liver Fibrosis Associated With Chronic Hepatitis B:Randomized,Double-blind,Placebo-controlled,Entecavir Basic Treatment,Multicentre Phase 3 Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 30, 2021 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Continent Pharmaceutical Co, Ltd.

4. Oversight

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

5. Study Description

Brief Summary
This study was a randomized, double-blind, placebo-controlled, entecavir basic treatment, multicentre clinical study. The main objective of this study was to confirm the efficacy and safety of hydronidone in the treatment of chronic hepatitis B liver fibrosis.
Detailed Description
248 patients with chronic viral hepatitis B liver fibrosis were enrolled in this 52-week study, and randomized into hydronidone or placebo group. Each group has 124 subjects. Both groups were treated with entecavir antiviral basic therapy.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
248 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hydronidone group
Arm Type
Experimental
Arm Description
Patients were given three capsules of hydronidone three times a day for 52 weeks.
Arm Title
The placebo group
Arm Type
Placebo Comparator
Arm Description
Patients were given three capsules of placebo three times a day for 52 weeks.
Intervention Type
Drug
Intervention Name(s)
Hydronidone capsules
Other Intervention Name(s)
F351
Intervention Description
After randomization, the experimental group received hydronidone capsules three times a day, 3 capsules each time, for 52 weeks.
Intervention Type
Drug
Intervention Name(s)
The placebo capsules
Other Intervention Name(s)
N
Intervention Description
After randomization, The control group received three placebo capsules three times a day. 3 capsules each time, for 52 weeks.
Primary Outcome Measure Information:
Title
Pathological score of Ishak stage
Description
After 52 weeks of treatment, the proportion of Ishak of liver fibrosis decreased by more than 1 point from baseline
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age from 18 to 65 years old (including 18 and 65 years old, based on the time of signing the written informed consent); gender is not limited. History of chronic hepatitis B and/or hepatitis B surface antigen (HBsAg) positive≥6 months. Percutaneous liver biopsy confirmed liver fibrosis (Ishak score ≥3). Positive HBV DNA. ALT < 8 x ULN (standard upper limit). No antiviral therapy with interferon and/or nucleoside analogues within 3 months prior to enrollment. 3 months before inclusion, he/she had not received any of the following proprietary Chinese medicines that may have anti-fibrosis effects: Fuzheng Huayu Capsule (tablet), Anluo Huayu Pill, compound Bijiaruangan tablet, etc. The subject (or his/her sexual partner) had no pregnancy plan during the trial period and within 6 months after the trial, voluntarily used effective physical contraception, and had no sperm or egg donation plan. Before the trial, they have understood the nature, significance, potential benefits, inconvenience and potential dangers of the trial in detail, and have voluntarily participated in the clinical trial, have good communication with the researchers, comply with the requirements of the whole study, and have signed a written informed consent form. Exclusion Criteria: Massive upper gastrointestinal hemorrhage within 3 months before enrolment. Total bilirubin (TBIL) > 3×ULN, or 3×ULN < ALT < 8×ULN and TBIL > 2×ULN. AFP > 100 μg/L although there was no indication of liver cancer. Platelets (PLT) ≤60×109/L. Prothrombin activity (PTA) < 50% or INR > 1.5. Imaging showed obvious space-occupying lesions in the liver, suggesting tumor. Body mass index (BMI) > 30 kg/m2. Patients with decompensated liver cirrhosis and liver malignant tumor. Patients with chronic hepatitis C or non-viral (alcoholic, non-alcoholic, drug, etc.) chronic hepatitis. Serious diseases of cardiovascular, pulmonary, renal, endocrine, neurological and haematological systems, as well as mental disorders . Women who are pregnant and/or breastfeeding. Have participated in clinical trials of other drugs in the last 3 months. The Investigator considers that there are any conditions that may affect the subjects' informed consent or adherence to the study protocol, or participation in the study may affect the study results or their own safety.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ling Zhang, Dr.
Phone
+86-13501209210
Email
zhangling@bjcontinent.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lungen Lu, Dr.
Organizational Affiliation
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jun Cheng, Dr.
Organizational Affiliation
Beijing Ditan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Ditan Hospital Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Cheng, Dr.
Phone
010-84322291
Email
chengj0817@sina.cn
Facility Name
Shanghai General Hospital,Shanghai Jiao Tong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201620
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lungen Lu, Dr.
Phone
021-37798576
Email
lungenlu1965@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Hydronidone for the Treatment of Liver Fibrosis Associated With Chronic Viral Hepatitis B Phase 3 Trial.

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