drugset / Trial / NCT02483156
Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Tablet Plus Ribavirin Tablet (Part A) Versus Single Dose (2 Tablets) of EHCV Containing Sofosbuvir, Ribavirin, and Natural Anti-hemolytic (B) in Egyptian Adults With Chronic Genotype 4 HCV Infection
RandomizedParallel-groupOpen-labelTreatment
Summary
Two Groups of Genotype 4 HCV Patients will participate through open-label randomized Study comparing Sofosbuvir tablet Plus Ribavirin tablet (Part A) versus single Dose (2 tablets) of EHCV containing Sofosbuvir, Ribavirin, and Natural anti-hemolytic (B) evaluating the safety and efficacy for both arms. Sponsor: Wadi El Nil Hospital Study Centers Planned: Approximately 2 sites in Egypt
Timeline
- Start
- 2015-07
- Primary completion
- 2015-08
- Completion
- —
Publications
- Background Doss W, Shiha G, Hassany M, Soliman R, Fouad R, Khairy M, Samir W, Hammad R, Kersey K, Jiang D, Doehle B, Knox SJ, Massetto B, McHutchison JG, Esmat G. Sofosbuvir plus ribavirin for treating Egyptian patients with hepatitis C genotype 4. J Hepatol. 2015 Sep;63(3):581-5. doi: 10.1016/j.jhep.2015.04.023. Epub 2015 May 1.
- Shiha G, Soliman R, Elbasiony M, Darwish NHE, Mousa SA. Novel combined single dose anti-hepatitis C therapy: a pilot study. Sci Rep. 2021 Feb 25;11(1):4623. doi: 10.1038/s41598-021-84066-3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Epigallocatechin gallate | Small molecule | 400 mg | — |
| Comparator | Ribavirin | Small molecule | 1000 mg | — |
| Comparator | Sofosbuvir | Small molecule | 400 mg | Oral |