A Trial To Evaluate The Efficacy And Safety Of Multiple Combination Therapies In Participants With Chronic Hepatitis B
Summary
This is a study designed to evaluate the safety, tolerability and efficacy of New Molecular Entity (NME) combination therapies in Chronic Hepatitis B (CHB) participants with preserved liver function and without significant fibrosis/cirrhosis. The platform design allows comparison of multiple NME combination therapies against a common control, and introduction of additional treatment arms at later study time points. Each arm will consist of a screening phase (up to 8 weeks), treatment phase (up to 48 weeks) and post-treatment follow-up phase (48 weeks). The safety and efficacy will be monitored throughout the study.
Timeline
- Start
- 2020-07-05
- Primary completion
- 2024-07-19
- Completion
- 2024-07-19
Outcome
Met primary endpoint
registry analysis (superiority test); NUC Control Arm vs Combo 4: siRNA + PEG-IFN + NUC; Difference in Response Rate 24.3 (95% CI 9 to 39.5) NCT04225715 ↗
Publications
- Cheng C, Xie Q, Gane E, Morano Amado LE, Yang SS, Zhang W, Jia J, Asselah T, Kao JH, Peng CY, Su WW, Tanwandee T, Liang X, Catanese MT, Chen E, Chughlay F, Das S, Glavini K, Guerreiro N, Huang Y, Kazma R, Liang Y, McGeown C, Patil A, Upmanyu R, Wat C, Yuen MF, Hou J; Piranga Study Group. Outcomes of nucleos(t)ide analogue discontinuation following finite xalnesiran-based therapies in chronic hepatitis B. JHEP Rep. 2026 Jul 15:101958. doi: 10.1016/j.jhepr.2026.101958. Online ahead of print.
- Hou J, Zhang W, Xie Q, Hua R, Tang H, Morano Amado LE, Yang SS, Peng CY, Su WW, Chuang WL, Kim DJ, Avihingsanon A, Kao JH, Leerapun A, Yuen MF, Asselah T, Liang X, Bo Q, Canducci F, Catanese MT, Chen E, Cheng C, Chughlay F, Das S, Glavini K, Guerreiro N, Huang Y, Kakrana P, Kazma R, Patil A, Pavlovic V, Surujbally B, Triyatni M, Upmanyu R, Wat C, Gane E; Piranga Study Group. Xalnesiran with or without an Immunomodulator in Chronic Hepatitis B. N Engl J Med. 2024 Dec 5;391(22):2098-2109. doi: 10.1056/NEJMoa2405485.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LINVENCORVIR | Small molecule | 600 mg | Oral |
| Subject | Peg-IFN | Protein / enzyme biologic | 180 ug | Subcutaneous |
| Subject | RO7191863 | Oligonucleotide (other) | — | Subcutaneous |
| Subject | RUZOTOLIMOD | Small molecule | 150 mg | Oral |
| Subject | XALNESIRAN | Small interfering RNA (siRNA) | 100 mg | Subcutaneous |
| Subject | XALNESIRAN | Small interfering RNA (siRNA) | 200 mg | Subcutaneous |