drugset / Trial / NCT02486406
A Study to Evaluate Treatment of Hepatitis C Virus Infection in Pediatric Subjects
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This was a Phase 2/3, open-label, multicenter study to evaluate the pharmacokinetics (PK), efficacy, and safety of ombitasvir/paritaprevir/ritonavir (OBV/PTV/RTV) with or without dasabuvir (DSV) and with or without ribavirin (RBV) in Hepatitis C virus (HCV) genotype 1 or 4 (GT1 or GT4)-infected pediatric participants of ≥ 3 to 17 years of age.
Timeline
- Start
- 2015-10-28
- Primary completion
- 2020-11-19
- Completion
- 2020-11-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ribavirin | Small molecule | 40 mg/ml | Oral |
| Subject | Ribavirin | Small molecule | 200 mg | Oral |
| Subject | Ritonavir | Other / unclassified | 1 mg | Oral |
| Subject | Ritonavir | Other / unclassified | 50 mg | Oral |
| Subject | dasabuvir | Small molecule | 3.08 mg | Oral |
| Subject | dasabuvir | Small molecule | 250 mg | Oral |
| Subject | ombitasvir | Small molecule | 0.3 mg | Oral |
| Subject | ombitasvir | Small molecule | 12.5 mg | Oral |
| Subject | paritaprevir | Small molecule | 1 mg | Oral |
| Subject | paritaprevir | Small molecule | 75 mg | Oral |