drugset / Trial / NCT00892697
Intrahepatic HCV RNA and Telaprevir Kinetics in Hepatitis C Virus (HCV)
Phase 2
Completed
15 enrolled
Weill Medical College of Cornell University
Vertex Pharmaceuticals Incorporated · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to determine the decline of virus in the blood and liver in patients treated with telaprevir, pegylated interferon and ribavirin. Fine Needle Aspiration (FNA) procedure will be used to repeatedly sample the liver to enhance the understanding of how the virus decays in the liver in response to treatment with anti-viral compounds and the measurement of the concentration of the drugs in the liver. FNA is an alternative procedure to core needle biopsy in its ability to repeatedly sample the liver with significantly reduced morbidity.
Timeline
- Start
- 2009-05
- Primary completion
- 2012-12
- Completion
- 2012-12
Publications
- Results Talal AH, Dimova RB, Zhang EZ, Jiang M, Penney MS, Sullivan JC, Botfield MC, Chakilam A, Sawant R, Cervini CM, Zeremski M, Jacobson IM, Kwong AD. Telaprevir-based treatment effects on hepatitis C virus in liver and blood. Hepatology. 2014 Dec;60(6):1826-37. doi: 10.1002/hep.27202. Epub 2014 Jul 31.
- Zeremski M, Dimova RB, Benjamin S, Penney MS, Botfield MC, Talal AH. Intrahepatic and Peripheral CXCL10 Expression in Hepatitis C Virus-Infected Patients Treated With Telaprevir, Pegylated Interferon, and Ribavirin. J Infect Dis. 2015 Jun 1;211(11):1795-9. doi: 10.1093/infdis/jiu807. Epub 2014 Dec 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Telaprevir | Small molecule | 750 mg | — |
| Background | Peginterferon alfa-2a | Protein / enzyme biologic | 180 ug | Subcutaneous |
| Background | Ribavirin | Small molecule | 1000 mg | — |
| Background | Ribavirin | Small molecule | 1200 mg | — |