drugset / Trial / NCT00226447
Different Regimens of Pegylated Interferon and Lamivudine Combination Therapy in Chronic Hepatitis B Patients
Phase 2
Completed
30 enrolled
Chinese University of Hong Kong
GlaxoSmithKline · collabHoffmann-La Roche · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The aim is to investigate the best treatment regime of PEG-Intron A and lamivudine combination in terms of viral clearance in chronic hepatitis B patients.
Timeline
- Start
- 2002-12
- Primary completion
- 2006-07
- Completion
- 2006-07
Publications
- Background Lok AS, Wu PC, Lai CL, Lau JY, Leung EK, Wong LS, Ma OC, Lauder IJ, Ng CP, Chung HT. A controlled trial of interferon with or without prednisone priming for chronic hepatitis B. Gastroenterology. 1992 Jun;102(6):2091-7. doi: 10.1016/0016-5085(92)90337-x.
- Background Lai CL, Chien RN, Leung NW, Chang TT, Guan R, Tai DI, Ng KY, Wu PC, Dent JC, Barber J, Stephenson SL, Gray DF. A one-year trial of lamivudine for chronic hepatitis B. Asia Hepatitis Lamivudine Study Group. N Engl J Med. 1998 Jul 9;339(2):61-8. doi: 10.1056/NEJM199807093390201.
- Background Leung NW, Lai CL, Chang TT, Guan R, Lee CM, Ng KY, Lim SG, Wu PC, Dent JC, Edmundson S, Condreay LD, Chien RN; Asia Hepatitis Lamivudine Study Group. Extended lamivudine treatment in patients with chronic hepatitis B enhances hepatitis B e antigen seroconversion rates: results after 3 years of therapy. Hepatology. 2001 Jun;33(6):1527-32. doi: 10.1053/jhep.2001.25084.
- Background Schalm SW, Heathcote J, Cianciara J, Farrell G, Sherman M, Willems B, Dhillon A, Moorat A, Barber J, Gray DF. Lamivudine and alpha interferon combination treatment of patients with chronic hepatitis B infection: a randomised trial. Gut. 2000 Apr;46(4):562-8. doi: 10.1136/gut.46.4.562.
- Background Barbaro G, Zechini F, Pellicelli AM, Francavilla R, Scotto G, Bacca D, Bruno M, Babudieri S, Annese M, Matarazzo F, Di Stefano G, Barbarini G; Lamivudine Italian Study Group Investigators. Long-term efficacy of interferon alpha-2b and lamivudine in combination compared to lamivudine monotherapy in patients with chronic hepatitis B. An Italian multicenter, randomized trial. J Hepatol. 2001 Sep;35(3):406-11. doi: 10.1016/s0168-8278(01)00145-3.
- Background Tsiang M, Rooney JF, Toole JJ, Gibbs CS. Biphasic clearance kinetics of hepatitis B virus from patients during adefovir dipivoxil therapy. Hepatology. 1999 Jun;29(6):1863-9. doi: 10.1002/hep.510290626.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lamivudine | Other / unclassified | — | — |
| Subject | PEG-Intron A | Unknown | — | — |