A Phase II Study to Determine the Safety and Efficacy of Interferon-gamma in Patients With Chronic Hepatitis B

Summary

Open-label, prospective, two part study evaluating IFN-γ 1b at a dose of 200μg by subcutaneous injection every day either alone or in combination with Adefovir dipivoxil or Adefovir dipivoxil alone at a dose of 10mg QD in patients with chronic Hepatitis B.

Timeline

Start

2008-09

Primary completion

2009-08

Completion

2009-08

Publications

• Background Parvez MK, Sehgal D, Sarin SK, Basir SF, Jameel S. Inhibition of hepatitis B virus DNA replicative intermediate forms by recombinant interferon-gamma. World J Gastroenterol. 2006 May 21;12(19):3006-14. doi: 10.3748/wjg.v12.i19.3006.
• Background Lau JY, Lai CL, Wu PC, Chung HT, Lok AS, Lin HJ. A randomised controlled trial of recombinant interferon-gamma in Chinese patients with chronic hepatitis B virus infection. J Med Virol. 1991 Jul;34(3):184-7. doi: 10.1002/jmv.1890340310.
• Background Marcellin P, Loriot MA, Boyer N, Martinot-Peignoux M, Degott C, Degos F, Brandely M, Lenfant B, Benhamou JP. Recombinant human gamma-interferon in patients with chronic active hepatitis B: pharmacokinetics, tolerance and biological effects. Hepatology. 1990 Jul;12(1):155-8. doi: 10.1002/hep.1840120124.
• Results Narayan R, Buronfosse T, Schultz U, Chevallier-Gueyron P, Guerret S, Chevallier M, Saade F, Ndeboko B, Trepo C, Zoulim F, Cova L. Rise in gamma interferon expression during resolution of duck hepatitis B virus infection. J Gen Virol. 2006 Nov;87(Pt 11):3225-3232. doi: 10.1099/vir.0.82170-0.
• Results Wang J, Michalak TI. Inhibition by woodchuck hepatitis virus of class I major histocompatibility complex presentation on hepatocytes is mediated by virus envelope pre-S2 protein and can be reversed by treatment with gamma interferon. J Virol. 2006 Sep;80(17):8541-53. doi: 10.1128/JVI.00830-06.
• Results Wieland SF, Eustaquio A, Whitten-Bauer C, Boyd B, Chisari FV. Interferon prevents formation of replication-competent hepatitis B virus RNA-containing nucleocapsids. Proc Natl Acad Sci U S A. 2005 Jul 12;102(28):9913-7. doi: 10.1073/pnas.0504273102. Epub 2005 Jul 1.
• Results Park SG, Ryu HM, Lim SO, Kim YI, Hwang SB, Jung G. Interferon-gamma inhibits hepatitis B virus-induced NF-kappaB activation through nuclear localization of NF-kappaB-inducing kinase. Gastroenterology. 2005 Jun;128(7):2042-53. doi: 10.1053/j.gastro.2005.03.002.
• Results Bissett J, Eisenberg M, Gregory P, Robinson WS, Merigan TC. Recombinant fibroblast interferon and immune interferon for treating chronic hepatitis B virus infection: patients' tolerance and the effect on viral markers. J Infect Dis. 1988 May;157(5):1076-80. doi: 10.1093/infdis/157.5.1076. No abstract available.
• Results Porres JC, Mora I, Gutiez J, Bartolome J, Quiroga JA, Bas C, Compernolle C, Ordi J, Chocarro A, Carreno V. Antiviral effect of recombinant gamma interferon in chronic hepatitis B virus infection: a pilot study. Hepatogastroenterology. 1988 Feb;35(1):5-9.
• Results Di Bisceglie AM, Rustgi VK, Kassianides C, Lisker-Melman M, Park Y, Waggoner JG, Hoofnagle JH. Therapy of chronic hepatitis B with recombinant human alpha and gamma interferon. Hepatology. 1990 Feb;11(2):266-70. doi: 10.1002/hep.1840110217.

Drugs

Indications