NCT02499562 (HBV) is a Phase 2 clinical trial of Hydronidone in Hepatitis B, Chronic, sponsored by Shanghai Genomics, Inc..

Who is sponsoring NCT02499562?

NCT02499562 is sponsored by Shanghai Genomics, Inc..

What drugs are being tested in NCT02499562?

Interventions in NCT02499562: Hydronidone, Placebo, Entecavir.

What condition does NCT02499562 study?

NCT02499562 studies Hepatitis B, Chronic.

Is NCT02499562 still recruiting?

NCT02499562 is currently completed. Last updated 23 June 2022.

Last reviewed 2022-06-23 · How we verify

NCT02499562: HBV

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Last updated 23 June 2022

What this trial tests

Phase 2 trial testing Hydronidone in Hepatitis B, Chronic in 168 participants. Completed in 20 November 2020.

Timeline

25 June 2015

Primary endpoint
20 November 2020

20 November 2020

Quick facts

Lead sponsor	Shanghai Genomics, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	168
Start date	25 June 2015
Primary completion	20 November 2020
Estimated completion	20 November 2020
Sites	2 locations across China

Drugs / interventions tested

Hydronidone — full drug profile →
Placebo
Entecavir (ENTECAVIR) — full drug profile →

Conditions studied

Hepatitis B, Chronic — all drugs for Hepatitis B, Chronic →

Sponsor

Shanghai Genomics, Inc.

Who can join

Adults 18 to 65, any sex, with Hepatitis B, Chronic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Liver Fibrosis: Therapeutic Targets and Advances in Drug Therapy.
Tan Z, Sun H, Xue T, Gan C, et al · · 2021 · cited 147× · PMID 34621747 · DOI 10.3389/fcell.2021.730176
Pathophysiology and Treatment Options for Hepatic Fibrosis: Can It Be Completely Cured?
Khanam A, Saleeb PG, Kottilil S. · · 2021 · cited 86× · PMID 34064375 · DOI 10.3390/cells10051097
Drugs and Targets in Fibrosis.
Li X, Zhu L, Wang B, Yuan M, et al · · 2017 · cited 71× · PMID 29218009 · DOI 10.3389/fphar.2017.00855
Research progress on drugs targeting the TGF-β signaling pathway in fibrotic diseases.
Shi N, Wang Z, Zhu H, Liu W, et al · · 2022 · cited 49× · PMID 35147920 · DOI 10.1007/s12026-022-09267-y
Hydronidone for the Treatment of Liver Fibrosis Related to Chronic Hepatitis B: A Phase 2 Randomized Controlled Trial.
Cai X, Liu X, Xie W, Ma A, et al · · 2023 · cited 24× · PMID 35842120 · DOI 10.1016/j.cgh.2022.05.056
Antihepatic Fibrosis Drugs in Clinical Trials.
Guo YC, Lu LG. · · 2020 · cited 24× · PMID 33083254 · DOI 10.14218/jcth.2020.00023
Insights on drug and gene delivery systems in liver fibrosis.
Vyas K, Patel MM. · · 2023 · cited 20× · PMID 36845840 · DOI 10.1016/j.ajps.2023.100779
Prospective therapeutics for intestinal and hepatic fibrosis.
Li X, Yu M, Zhao Q, Yu Y. · · 2023 · cited 9× · PMID 38023697 · DOI 10.1002/btm2.10579

Verify or expand the search:

Other trials of Hydronidone

Trials testing the same drug.

NCT07263152 — QTc Assessment in a Single-Dose Study of Hydronidone Capsules · Phase 1 · completed
NCT04162821 — Study on Pharmacokinetics of Hydronidone · Phase 1 · completed
NCT04123769 — Study on PK of Hydronidone in Patients and Special Population · Phase 1 · completed

Other recruiting trials for Hepatitis B, Chronic

Currently open trials in the same condition.

NCT07370207 — Phase 2 Study of AHB-137 in HBeAg Negative Chronic Hepatitis B (CHB) Participants in Asia Pacific Region · Phase 2 · recruiting
NCT06550622 — Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion · recruiting
NCT06550128 — Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB). · Phase 2 · active not recruiting
NCT06525909 — A Real-world Study of Staging and Grading of Clinical Immune Status in Chronic Hepatitis B · recruiting
NCT05937178 — Real-world Study Optimizing Nucleotide-analogues · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02499562 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shanghai Genomics, Inc.
Last refreshed: 23 June 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02499562.

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