Clinical trial NCT02499562: A Phase II Clinical Trial of Hydronidone Capsules(F351) in Patients With Liver Fibrosis Induced by HBV Chronic Hepatitis
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis B, Chronic
Lead sponsor: Shanghai Genomics, Inc.
Sponsor class: INDUSTRY
First posted: 2015-07-16
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 :

1. Negative conversion ratio of HBV DNA after treatment (HBV DNA\<1×103copies/mL) and falling range.
2. The falling proportion of Fibrocan Kpa value after treatment compared with that before treatment.
3. The falling proportion that decreases not less than 1 level and progression-free fibrosis after treatment compared with that before treatment.
4. The improvement of ALT of liver function.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in hepatic fibrosis in chronic viral hepatitis B
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
city: Beijing
country: China
Study officials:
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: LunGen Lu
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Ditan Hospital
name: Jun Cheng
role: PRINCIPAL_INVESTIGATOR
References:
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.