A Phase II Clinical Trial of Hydronidone Capsules(F351) in Patients With Liver Fibrosis Induced by HBV Chronic Hepatitis
NCT ID: NCT02499562
Last Updated: 2022-06-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
168 participants
INTERVENTIONAL
2015-06-25
2020-11-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Hydronidone for the Treatment of Liver Fibrosis Associated with Chronic Viral Hepatitis B Phase 3 Trial.
NCT05115942
Hydronidone Capsules in Long-term Treatment in Patients With Chronic Viral Hepatitis B Liver Fibrosis
NCT05905172
Non-Invasive Model for Fibrosis Regression in HBV Patients
NCT06874127
Drug-Drug Interaction Study Between Hydronidone and Entecavir, Tenofovir Disoproxil Fumarate, Tenofovir Alafenamide, and Tenofovir Amibufenamide
NCT07295873
A Study of JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection
NCT04129554
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Hydronidone(180mg) & Entecavir & Placebo
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
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.
Placebo
Entecavir
Hydronidone(270mg) & Entecavir & Placebo
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
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.
Placebo
Entecavir
Hydronidone(360mg) & Entecavir
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.
Hydronidone
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.
Entecavir
Entecavir & Placebo(360mg)
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.
Placebo
Entecavir
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Hydronidone
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.
Placebo
Entecavir
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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.
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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shanghai Genomics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
LunGen Lu
Role: PRINCIPAL_INVESTIGATOR
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Jun Cheng
Role: PRINCIPAL_INVESTIGATOR
Beijing Ditan Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Beijing, , China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GNI-F351-201402
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.