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

NCT02499562 | Completed Phase 2 DMC

• 1 other identifier: GNI-F351-201402
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 2

Brief Summary

To explore the effective dose and safety of the effect of hydronidone and entecavir on hepatic fibrosis in chronic viral hepatitis B.

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (1)

• Changes in hepatic fibrosis in chronic viral hepatitis B

  one year

Study Arms (4)

Hydronidone(180mg) & Entecavir & Placebo

EXPERIMENTAL

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.

Drug: Hydronidone; Drug: Placebo; Drug: Entecavir

Hydronidone(270mg) & Entecavir & Placebo

EXPERIMENTAL

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.

Drug: Hydronidone; Drug: Placebo; Drug: Entecavir

Hydronidone(360mg) & Entecavir

EXPERIMENTAL

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.

Drug: Hydronidone; Drug: Entecavir

Entecavir & Placebo(360mg)

EXPERIMENTAL

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.

Drug: Placebo; Drug: Entecavir

Interventions

Hydronidone DRUG

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.

Also known as: F351

Hydronidone(180mg) & Entecavir & Placebo; Hydronidone(270mg) & Entecavir & Placebo; Hydronidone(360mg) & Entecavir

Placebo DRUG

Entecavir & Placebo(360mg); Hydronidone(180mg) & Entecavir & Placebo; Hydronidone(270mg) & Entecavir & Placebo

Entecavir DRUG

Entecavir & Placebo(360mg); Hydronidone(180mg) & Entecavir & Placebo; Hydronidone(270mg) & Entecavir & Placebo; Hydronidone(360mg) & Entecavir

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Genomics, Inc.: lead

Study Sites (2)

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Location

Unknown Facility

Beijing, China

Location

Related Publications (1)

• 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.

  PMID: 35842120 DERIVED

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

hydronidone; 5-methyl-1-(4-hydroxylphenyl)-2-(1H)-pyridone; entecavir

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• LunGen Lu

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

• Jun Cheng

  Beijing Ditan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2015
• First Posted: July 16, 2015
• Study Start: June 25, 2015
• Primary Completion: November 20, 2020
• Study Completion: November 20, 2020
• Last Updated: June 23, 2022

Record last verified: 2022-06

Locations

CN (2)