drugset / Trial / NCT01001754
Efficacy and Safety Study of PEG-rIL-29 Plus Ribavirin to Treat Chronic Hepatitis C Virus Infection
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Interleukin 29 (IL-29) is a substance that is produced in the body to help fight viral infections. The purpose of this study is to evaluate the safety and antiviral effects of several different doses of PEG-rIL-29 (a man-made form of IL-29) when it is given in combination with daily oral doses of ribavirin (an antiviral drug) to subjects with hepatitis C infection who have received no prior treatment for this disease.
Timeline
- Start
- 2010-05
- Primary completion
- 2010-11
- Completion
- 2012-05
Publications
- Wang X, Hruska M, Chan P, Ahmad A, Freeman J, Horga MA, Hillson J, Kansra V, Lopez-Talavera JC. Derivation of Phase 3 dosing for peginterferon lambda-1a in chronic hepatitis C, Part 1: Modeling optimal treatment duration and sustained virologic response rates. J Clin Pharmacol. 2015 Jan;55(1):63-72. doi: 10.1002/jcph.363. Epub 2014 Jul 24.
- Hruska M, Wang X, Chan P, Ahmad A, Freeman J, Horga MA, Hillson J, Kansra V, Lopez-Talavera JC. Derivation of Phase 3 dosing for peginterferon lambda-1a in chronic hepatitis C, Part 2: Exposure-response analyses for efficacy and safety variables. J Clin Pharmacol. 2015 Jan;55(1):73-80. doi: 10.1002/jcph.361. Epub 2014 Jul 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Peginterferon Lambda-1a | Protein / enzyme biologic | 120 ug | Subcutaneous |
| Subject | Peginterferon Lambda-1a | Protein / enzyme biologic | 180 ug | Subcutaneous |
| Comparator | Peginterferon alfa-2a | Protein / enzyme biologic | 180 ug | Subcutaneous |
| Background | Ribavirin | Small molecule | 400 mg | Oral |
| Background | Ribavirin | Small molecule | 600 mg | Oral |