CompletedPhase 2

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

China168 participantsStarted 2015-06-25

Plain-language summary

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

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Changes in hepatic fibrosis in chronic viral hepatitis B

Timeframe: one year

NCT IDNCT02499562

SponsorShanghai Genomics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-11-20