drugset / Trial / NCT00277862
Pegylated Interferon and Ribavirin Therapy in Chronic Hepatitis Genotype 4
Phase 4
Completed
280 enrolled
Ain Shams University
Fulbright · collabInternational Society for Infectious Diseases · collabSchering-Plough · collabTempus AI · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
Genotype 4 is the least-studied hepatitis C virus genotype and was considered a difficult to treat genotype due to the disappointing response of chronic hepatitis C genotype 4 to conventional interferon monotherapy. Recent reports showed that pegylated interferon and ribavirin combination therapy markedly increased the SVR rate to 55-70%. The duration of treatment has not been accurately defined. The main objective of this is to assess the duration of pegylated interferon ribavirin therapy in chronic hepatitis genotype 4 and assess the clinical utility of rapid and early virologic response in determining the optimal duration of peg interferon ribavirin therapy in chronic hepatitis C.
Timeline
- Start
- 2002-04
- Primary completion
- 2007-03
- Completion
- 2007-04
Publications
- Background Kamal SM, El Tawil AA, Nakano T, He Q, Rasenack J, Hakam SA, Saleh WA, Ismail A, Aziz AA, Madwar MA. Peginterferon alpha-2b and ribavirin therapy in chronic hepatitis C genotype 4: impact of treatment duration and viral kinetics on sustained virological response. Gut. 2005 Jun;54(6):858-66. doi: 10.1136/gut.2004.057182.
- Background Kamal SM, Fehr J, Roesler B, Peters T, Rasenack JW. Peginterferon alone or with ribavirin enhances HCV-specific CD4 T-helper 1 responses in patients with chronic hepatitis C. Gastroenterology. 2002 Oct;123(4):1070-83. doi: 10.1053/gast.2002.36045.
- Kamal SM, El Kamary SS, Shardell MD, Hashem M, Ahmed IN, Muhammadi M, Sayed K, Moustafa A, Hakem SA, Ibrahiem A, Moniem M, Mansour H, Abdelaziz M. Pegylated interferon alpha-2b plus ribavirin in patients with genotype 4 chronic hepatitis C: The role of rapid and early virologic response. Hepatology. 2007 Dec;46(6):1732-40. doi: 10.1002/hep.21917.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Peginterferon alfa-2b | Protein / enzyme biologic | 1.5 ug/kg | — |
| Comparator | Ribavirin | Small molecule | 10.6 mg/kg | Oral |