Liver safety assessment in clinical trials of new agents for chronic hepatitis B-Reference-Cited by-同舟云学术

Liver safety assessment in clinical trials of new agents for chronic hepatitis B

Published:2019-12-11 Issue:2 Volume:27 Page:96-109
ISSN:1352-0504
Container-title:Journal of Viral Hepatitis
language:en
Short-container-title:J Viral Hepat

Author:

Fontana Robert J.¹,Avigan Mark I.²,Janssen Harry L. A.³,Regev Arie⁴,Mishra Poonam⁵,Gaggar Anuj⁶,Brown Nathaniel⁷,Wat Cynthia⁸,Mendez Patricia⁹,Anderson Ryan T.¹⁰^ORCID,Given Bruce¹¹,Miller Veronica¹⁰^ORCID,Beumont Maria¹²

Affiliation:

1. Division of Gastroenterology and Hepatology University of Michigan Ann Arbor MI USA

2. Office of Surveillance and Epidemiology Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring MD USA

3. Toronto Centre for Liver Disease University Health Network Toronto Canada

4. Eli Lilly and Company, Indianapolis IN USA

5. Division of Antiviral Products Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring MD USA

6. Gilead Sciences Foster City CA USA

7. Hepatitis B Foundation Doylestown PA USA

8. Roche Products Welwyn Garden City UK

9. Arbutus Biopharma Inc. Warminster PA USA

10. Forum for Collaborative Research University of California Berkeley

11. Arrowhead Pharmaceuticals, Inc Pasadena CA USA

12. Janssen Research & Development Janssen Pharmaceutica NV Beerse Belgium

Funder

Gilead Sciences

GlaxoSmithKline

Novartis

Janssen Pharmaceuticals

Publisher

Wiley

Subject

Virology,Infectious Diseases,Hepatology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/jvh.13223

Reference58 articles.

1. Challenges, Considerations, and Principles to Guide Trials of Combination Therapies for Chronic Hepatitis B Virus

2. Hepatitis B cure: From discovery to regulatory approval

3. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance

4. Peginterferon alpha-based therapy for chronic hepatitis B focusing on HBsAg clearance or seroconversion: a meta-analysis of controlled clinical trials

5. Perspectives and limitations for nucleo(t)side analogs in future HBV therapies

Cited by 9 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Consensus Guidelines: Best Practices for the Prevention, Detection and Management of Hepatitis B Virus Reactivation in Clinical Trials with Immunosuppressive/Immunomodulatory Therapy;Drug Safety;2024-02-14

2. First-in-human randomized study of RNAi therapeutic RG6346 for chronic hepatitis B virus infection;Journal of Hepatology;2023-11

3. Design and analysis considerations for early phase clinical trials in hepatitis B (HBV) cure research: the ACTG A5394 study in persons with both HIV and HBV;Journal of Virus Eradication;2023-09

4. AASLD practice guidance on drug, herbal, and dietary supplement–induced liver injury;Hepatology;2023-02-17

5. Safety, pharmacokinetics, and antiviral activity of the capsid inhibitor AB ‐506 from Phase 1 studies in healthy subjects and those with hepatitis B;Hepatology Communications;2022-10-04