Myrcludex B in Combination With Peginterferon Alfa-2a Versus Peginterferon Alfa-2a Alone in Patients With Chronic Viral Hepatitis B With Delta-agent

Summary

Randomised, Comparative, Parallel-Arm Study to Assess Efficacy and Safety of Myrcludex B in Combination with Peginterferon Alfa-2a Versus Peginterferon Alfa-2a Alone in Patients with Chronic Viral Hepatitis B with Delta-agent

Timeline

Start

2016-04

Primary completion

2019-11-22

Completion

2020-10-30

Publications

• Lampertico P, Bogomolov PO, Chulanov V, Stepanova T, Morozov V, Allweiss L, Dandri M, Burhenne J, Blank A, Ciesek S, Elsner C, Dittmer U, An Q, Manuilov D, Da BL, Flaherty JF, Urban S, Wedemeyer H. Phase 2 Randomised Study of Bulevirtide as Monotherapy or Combined With Peg-IFNalpha-2a as Treatment for Chronic Hepatitis Delta. Liver Int. 2025 Feb;45(2):e70008. doi: 10.1111/liv.70008.
• Asselah T, Lampertico P, Aleman S, Bourliere M, Streinu-Cercel A, Bogomolov P, Morozov V, Stepanova T, Lazar S, Manuilov D, Mercier RC, Tseng S, Ye L, Flaherty JF, Osinusi A, Da BL, Chee GM, Lau AH, Brunetto MR, Wedemeyer H. Bulevirtide Monotherapy Is Safe and Well Tolerated in Chronic Hepatitis Delta: An Integrated Safety Analysis of Bulevirtide Clinical Trials at Week 48. Liver Int. 2025 Apr;45(4):e16174. doi: 10.1111/liv.16174. Epub 2024 Dec 8.
• Allweiss L, Volmari A, Suri V, Wallin JJ, Flaherty JF, Manuilov D, Downie B, Lutgehetmann M, Bockmann JH, Urban S, Wedemeyer H, Dandri M. Blocking viral entry with bulevirtide reduces the number of HDV-infected hepatocytes in human liver biopsies. J Hepatol. 2024 Jun;80(6):882-891. doi: 10.1016/j.jhep.2024.01.035. Epub 2024 Feb 8.

Drugs

Indications