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A Phase II Clinical Trial of Hydronidone Capsules(F351) in Patients With Liver Fibrosis Induced by HBV Chronic Hepatitis (HBV)

Primary Purpose

Hepatitis B, Chronic

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Hydronidone
Placebo
Entecavir
Sponsored by
Shanghai Genomics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B, Chronic

Eligibility Criteria

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

Inclusion Criteria:

  1. Aged 18-65, all genders.
  2. History of chronic hepatitis B, HBsAg positive≧six months.
  3. ALT<eight-fold ULN (maximum).
  4. Significant liver fibrosis confirmed by liver biopsy.
  5. HBeAg positive patients, HBV DNA>2.0×104 IU/mL (copies/mL); HBeAg negative patients，HBV DNA>2.0×103 IU/mL (104copies/mL).
  6. Having not accepted the antiviral therapy with interferon and/or nucleoside analog.
  7. Having not taken anti-inflammatory drugs to protect liver within 1 month before selection.
  8. Capable of understanding and signing the informed consent before the study.

Exclusion Criteria:

  1. Failing to meet any one requirement of the inclusion criteria.
  2. Having suffered massive hemorrhage of gastrointestinal tract within 3 months before selection
  3. TBiL>three-fold ULN.
  4. AFP>100 ug/L
  5. PLT≦60×109/L
  6. PTA<50%
  7. Having obvious space-occupying lesion in liver as shown by B ultrasound examination.
  8. With a portal vein ≧1.2cm wide as shown by B ultrasound examination.
  9. BMI index>30.
  10. The patient who suffered from liver function decompensation hepatic cirrhosis and liver neoplasms.
  11. The patient with alcoholic, drug-induced, hereditary, immune and other viral and non- viral chronic hepatitis.
  12. The patient with angiocarpy, lung, kidney, incretion, nerve and blood system disease and mental disease.
  13. The patient with active peptic ulcer.
  14. Gestational and breast feeding women.
  15. The subject is the legal disabled person according to the Law of the People's Republic of China on the Protection of Disabled Persons of the April 2008 edition.
  16. The subject who participated in other drug tests within recent 3 months.
  17. The patient who is suspected with poor compliance or disagrees to participate in the test.
  18. The patient who is considered by other investigators not to be suitable for participating in the study.

Sites / Locations

  • Shanghai General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Hydronidone(180mg) & Entecavir & Placebo

Hydronidone(270mg) & Entecavir & Placebo

Hydronidone(360mg) & Entecavir

Entecavir & Placebo(360mg)

Arm Description

hydronidone capsule 30mg/capsule hydronidone capsule, three times a day, 2 capsules each time; with co-administration of placebo capsule, three times a day, 2 capsules each time, namely the daily dose of the investigational product is 180mg. The test groups and the control group take the entecavir capsule which is orally taken for antiviral therapy, one time a day, 0.5mg each time, oral administration on an empty stomach.

hydronidone capsule 30mg/capsule hydronidone capsule, three times a day, 3 capsules each time; with co-administration of placebo capsule, three times a day, 1 capsules each time, namely the daily dose of the investigational product is 270mg. The test groups and the control group take the entecavir capsule which is orally taken for antiviral therapy, one time a day, 0.5mg each time, oral administration on an empty stomach.

hydronidone capsule 30mg/capsule hydronidone capsule, three times a day, 4 capsules each time; namely the daily dose of the investigational product is 360mg. The test groups and the control group take the entecavir capsule which is orally taken for antiviral therapy, one time a day, 0.5mg each time, oral administration on an empty stomach.

placebo capsule 30mg/capsule placebo capsule, three times a day, 4 capsules each time. The test groups and the control group take the entecavir capsule which is orally taken for antiviral therapy, one time a day, 0.5mg each time, oral administration on an empty stomach.

Outcomes

Primary Outcome Measures

Changes in hepatic fibrosis in chronic viral hepatitis B

Secondary Outcome Measures

Full Information

First Posted
June 26, 2015
Last Updated
June 21, 2022
Sponsor
Shanghai Genomics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02499562
Brief Title
A Phase II Clinical Trial of Hydronidone Capsules(F351) in Patients With Liver Fibrosis Induced by HBV Chronic Hepatitis
Acronym
HBV
Official Title
Randomed and Double-blinded Phase II Clinical Trial of Hydronidone Capsules(F351) in Patients With Liver Fibrosis Induced by HBV Chronic Hepatitis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
June 25, 2015 (undefined)
Primary Completion Date
November 20, 2020 (Actual)
Study Completion Date
November 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Genomics, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To explore the effective dose and safety of the effect of hydronidone and entecavir on hepatic fibrosis in chronic viral hepatitis B.
Detailed Description
Primary observation indexes: Hepatic fibrosis Ishak score after treatment decreases by the proportion not less than 1 compared with that before treatment. Secondary observation indexes : Negative conversion ratio of HBV DNA after treatment (HBV DNA<1×103copies/mL) and falling range. The falling proportion of Fibrocan Kpa value after treatment compared with that before treatment. The falling proportion that decreases not less than 1 level and progression-free fibrosis after treatment compared with that before treatment. The improvement of ALT of liver function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hydronidone(180mg) & Entecavir & Placebo
Arm Type
Experimental
Arm Description
hydronidone capsule 30mg/capsule hydronidone capsule, three times a day, 2 capsules each time; with co-administration of placebo capsule, three times a day, 2 capsules each time, namely the daily dose of the investigational product is 180mg. The test groups and the control group take the entecavir capsule which is orally taken for antiviral therapy, one time a day, 0.5mg each time, oral administration on an empty stomach.
Arm Title
Hydronidone(270mg) & Entecavir & Placebo
Arm Type
Experimental
Arm Description
hydronidone capsule 30mg/capsule hydronidone capsule, three times a day, 3 capsules each time; with co-administration of placebo capsule, three times a day, 1 capsules each time, namely the daily dose of the investigational product is 270mg. The test groups and the control group take the entecavir capsule which is orally taken for antiviral therapy, one time a day, 0.5mg each time, oral administration on an empty stomach.
Arm Title
Hydronidone(360mg) & Entecavir
Arm Type
Experimental
Arm Description
hydronidone capsule 30mg/capsule hydronidone capsule, three times a day, 4 capsules each time; namely the daily dose of the investigational product is 360mg. The test groups and the control group take the entecavir capsule which is orally taken for antiviral therapy, one time a day, 0.5mg each time, oral administration on an empty stomach.
Arm Title
Entecavir & Placebo(360mg)
Arm Type
Experimental
Arm Description
placebo capsule 30mg/capsule placebo capsule, three times a day, 4 capsules each time. The test groups and the control group take the entecavir capsule which is orally taken for antiviral therapy, one time a day, 0.5mg each time, oral administration on an empty stomach.
Intervention Type
Drug
Intervention Name(s)
Hydronidone
Other Intervention Name(s)
F351
Intervention Description
The investigational products in the test groups and control group shall be orally taken 30 minutes before meals for 52 continuous weeks. There are respectively 60 cases in the test group I, II, III and the control group, totally 240 cases.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Entecavir
Primary Outcome Measure Information:
Title
Changes in hepatic fibrosis in chronic viral hepatitis B
Time Frame
one year

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: Aged 18-65, all genders. History of chronic hepatitis B, HBsAg positive≧six months. ALT<eight-fold ULN (maximum). Significant liver fibrosis confirmed by liver biopsy. HBeAg positive patients, HBV DNA>2.0×104 IU/mL (copies/mL); HBeAg negative patients，HBV DNA>2.0×103 IU/mL (104copies/mL). Having not accepted the antiviral therapy with interferon and/or nucleoside analog. Having not taken anti-inflammatory drugs to protect liver within 1 month before selection. Capable of understanding and signing the informed consent before the study. Exclusion Criteria: Failing to meet any one requirement of the inclusion criteria. Having suffered massive hemorrhage of gastrointestinal tract within 3 months before selection TBiL>three-fold ULN. AFP>100 ug/L PLT≦60×109/L PTA<50% Having obvious space-occupying lesion in liver as shown by B ultrasound examination. With a portal vein ≧1.2cm wide as shown by B ultrasound examination. BMI index>30. The patient who suffered from liver function decompensation hepatic cirrhosis and liver neoplasms. The patient with alcoholic, drug-induced, hereditary, immune and other viral and non- viral chronic hepatitis. The patient with angiocarpy, lung, kidney, incretion, nerve and blood system disease and mental disease. The patient with active peptic ulcer. Gestational and breast feeding women. The subject is the legal disabled person according to the Law of the People's Republic of China on the Protection of Disabled Persons of the April 2008 edition. The subject who participated in other drug tests within recent 3 months. The patient who is suspected with poor compliance or disagrees to participate in the test. The patient who is considered by other investigators not to be suitable for participating in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LunGen Lu
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
Organizational Affiliation
Beijing Ditan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai General Hospital
City
Shanghai
State/Province
Shanghai
Country
China
City
Beijing
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
35842120
Citation
Cai X, Liu X, Xie W, Ma A, Tan Y, Shang J, Zhang J, Chen C, Yu Y, Qu Y, Zhang L, Luo Y, Yin P, Cheng J, Lu L. Hydronidone for the Treatment of Liver Fibrosis Related to Chronic Hepatitis B: A Phase 2 Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2023 Jul;21(7):1893-1901.e7. doi: 10.1016/j.cgh.2022.05.056. Epub 2022 Jul 13.
Results Reference
derived

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A Phase II Clinical Trial of Hydronidone Capsules(F351) in Patients With Liver Fibrosis Induced by HBV Chronic Hepatitis

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