drugset / Trial / NCT01353911
Grazoprevir (MK-5172) Administered With Peginterferon and Ribavirin in Treatment-Naïve Participants With Chronic Hepatitis C (MK-5172-003)
RandomizedParallel-groupDouble-blindTreatment
Summary
This study will evaluate the safety, tolerability, and antiviral activity of grazoprevir (MK-5172) when administered in combination with peginterferon alfa-2b (Peg-IFN) and ribavirin (RBV) in treatment-naïve (TN) participants with chronic hepatitis C.
Timeline
- Start
- 2011-06-27
- Primary completion
- 2013-01-20
- Completion
- 2015-03-10
Publications
- Results Manns MP, Vierling JM, Bacon BR, Bruno S, Shibolet O, Baruch Y, Marcellin P, Caro L, Howe AY, Fandozzi C, Gress J, Gilbert CL, Shaw PM, Cooreman MP, Robertson MN, Hwang P, Dutko FJ, Wahl J, Mobashery N. The combination of MK-5172, peginterferon, and ribavirin is effective in treatment-naive patients with hepatitis C virus genotype 1 infection without cirrhosis. Gastroenterology. 2014 Aug;147(2):366-76.e6. doi: 10.1053/j.gastro.2014.04.006. Epub 2014 Apr 12.
- Howe AY, Black S, Curry S, Ludmerer SW, Liu R, Barnard RJ, Newhard W, Hwang PM, Nickle D, Gilbert C, Caro L, DiNubile MJ, Mobashery N. Virologic resistance analysis from a phase 2 study of MK-5172 combined with pegylated interferon/ribavirin in treatment-naive patients with hepatitis C virus genotype 1 infection. Clin Infect Dis. 2014 Dec 15;59(12):1657-65. doi: 10.1093/cid/ciu696. Epub 2014 Sep 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Boceprevir | Small molecule | 800 mg | Oral |
| Subject | GRAZOPREVIR ANHYDROUS | Small molecule | 100 mg | Oral |
| Subject | GRAZOPREVIR ANHYDROUS | Small molecule | 200 mg | Oral |
| Subject | GRAZOPREVIR ANHYDROUS | Small molecule | 400 mg | Oral |
| Subject | GRAZOPREVIR ANHYDROUS | Small molecule | 800 mg | Oral |
| Background | Peginterferon alfa-2b | Protein / enzyme biologic | 1.5 ug/kg | Subcutaneous |
| Background | Ribavirin | Small molecule | 300 mg | Oral |
| Background | Ribavirin | Small molecule | 700 mg | Oral |