drugset / Trial / NCT03743727
Treatment of Egyptian Hepatitis C Genotype 4 Infected Children and Adolescents With Combined Ledipasvir/Sofosbuvir
NaSingle-groupOpen-labelTreatment
Summary
This is an open, uncontrolled study of twenty-five chronic HCV infected patients carried out at Yassin Abdel Ghaffar Charity Center for Liver Disease and Research. The aim of this study is to investigate the safety \& efficacy of combined therapy ledipasvir (LDV) and sofosbuvir (SOF) for treating HCV Genotype 4 in children aged 8 to 18. Due to previous positive results in other clinical studies of this drug it is expected that the drug will have high safety and high efficacy. Safety will be measured by checking for adverse effects, while efficacy will be measured by Real-Time Quantitative Polymerase Chain Reaction (qPCR) detecting viral nucleic acids in blood samples.
Timeline
- Start
- 2018-08-01
- Primary completion
- 2019-03-30
- Completion
- 2019-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ledipasvir | Small molecule | 45 mg | — |
| Subject | Ledipasvir | Small molecule | 90 mg | — |
| Subject | Sofosbuvir | Small molecule | 200 mg | — |
| Subject | Sofosbuvir | Small molecule | 400 mg | — |
Indications
No indication recorded.