A Prospective Clinical Trial in Chronic Hepatitis B Patients NAs (Nucleotides or Nucleosides) Experienced (Anchor Study)

Summary

This study is a multi-center, randomized, prospective, open-label Phase III Clinical trial to assess the efficacy and safety of combination and sequential treatment with Y peginterferon Alfa-2b,entecavir and GMCSF in chronic hepatitis B patients nucleotides or nucleosides experienced. Patients were randomized to one of 3 groups to receive different antiviral treatment.

Timeline

Start

2014-10

Primary completion

2018-12

Completion

2019-06

Publications

• Wu D, Huang D, Peng S, Chen Y, Yang F, Zhang X, Fu L, Xu L, Jiang J, Zheng Q, Chen X, Liu Y, Dou X, Ma K, Xi D, Wang P, Sun L, He R, Tian Y, Yin P, Yan W, Han M, Ning Q. Efficacy and safety of entecavir, peginterferon alfa-2b and GM-CSF combination therapy: the anchor randomized controlled trial. Hepatol Int. 2026 Feb;20(1):31-45. doi: 10.1007/s12072-025-10977-2. Epub 2025 Dec 9.
• Gu M, Wu W, You J, Wu Q, Huang F, Zhang Y, Wang P, Xi D, Yan W, Wang X, Chen T, Wu D, Ning Q, Han M. High-Throughput Viral Integration Detection Reveals Baseline Breakpoints Burden Associated With HBsAg Seroclearance. Aliment Pharmacol Ther. 2025 Nov;62(9):887-900. doi: 10.1111/apt.70270. Epub 2025 Jul 16.
• Huang D, Wu D, Wang P, Wang Y, Yuan W, Hu D, Hu J, Wang Y, Tao R, Xiao F, Zhang X, Wang X, Han M, Luo X, Yan W, Ning Q. End-of-treatment HBcrAg and HBsAb levels identify durable functional cure after Peg-IFN-based therapy in patients with CHB. J Hepatol. 2022 Jul;77(1):42-54. doi: 10.1016/j.jhep.2022.01.021. Epub 2022 Feb 8.

Drugs

Indications