drugset / Trial / NCT01995071
A Study to Evaluate the Safety and Antiviral Effect of Multiple Doses of ABT-493 and ABT-530 in Adults With Genotype 1 Hepatitis C Virus (HCV)
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the safety and antiviral effect of multiple doses of ABT-493 and ABT-530 in adults with genotype 1 HCV.
Timeline
- Start
- 2013-11
- Primary completion
- 2015-06
- Completion
- 2015-06
Publications
- Background Lawitz E, Freilich B, Link J, German P, Mo H, Han L, Brainard DM, McNally J, Marbury T, Rodriguez-Torres M. A phase 1, randomized, dose-ranging study of GS-5816, a once-daily NS5A inhibitor, in patients with genotype 1-4 hepatitis C virus. J Viral Hepat. 2015 Dec;22(12):1011-9. doi: 10.1111/jvh.12435. Epub 2015 Jul 16.
- Lawitz EJ, O'Riordan WD, Asatryan A, Freilich BL, Box TD, Overcash JS, Lovell S, Ng TI, Liu W, Campbell A, Lin CW, Yao B, Kort J. Potent Antiviral Activities of the Direct-Acting Antivirals ABT-493 and ABT-530 with Three-Day Monotherapy for Hepatitis C Virus Genotype 1 Infection. Antimicrob Agents Chemother. 2015 Dec 28;60(3):1546-55. doi: 10.1128/AAC.02264-15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | glecaprevir | Other / unclassified | 100 mg | — |
| Subject | glecaprevir | Other / unclassified | 200 mg | — |
| Subject | glecaprevir | Other / unclassified | 300 mg | — |
| Subject | glecaprevir | Other / unclassified | 400 mg | — |
| Subject | glecaprevir | Other / unclassified | 700 mg | — |
| Subject | pibrentasvir | Other / unclassified | 15 mg | — |
| Subject | pibrentasvir | Other / unclassified | 40 mg | — |
| Subject | pibrentasvir | Other / unclassified | 120 mg | — |
| Subject | pibrentasvir | Other / unclassified | 400 mg | — |
| Background | Ribavirin | Small molecule | 1000 mg | — |
| Background | Ribavirin | Small molecule | 1200 mg | — |
| Background | Ritonavir | Other / unclassified | 100 mg | — |
| Background | dasabuvir | Small molecule | 250 mg | — |
| Background | ombitasvir | Small molecule | 25 mg | — |
| Background | paritaprevir | Small molecule | 150 mg | — |