drugset / Trial / NCT03063879
Treating Hepatitis C in CRF Using Sofosbuvir and Daclatasvir
Phase 4
Completed
95 enrolled
Tehran University of Medical Sciences
Ahvaz Jundishapur University of Medical Sciences · collabHamadan University of Medical Science · collabShiraz University of Medical Sciences · collab
NaSingle-groupOpen-labelTreatment
Summary
Sofosbuvir is the base of most treatment regimens for hepatitis C. In patients with renal failure the blood level of one of its metabolites (GS-331007) rises up to 20 folds. Although no particular adverse event has been linked to this metabolite sofosbuvir is not recommended for patients with renal failure mainly because of lack of data. Nevertheless there are anecdotal reports and small studies proving the safety of sofosbuvir in renal failure. This study addresses this lack of information by evaluating the safety and efficacy of sofosbuvir and daclatasvir in treating hepatitis C in 100 patients with renal failure.
Timeline
- Start
- 2017-04-01
- Primary completion
- 2018-09-01
- Completion
- 2019-02-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Daclatasvir | Small molecule | 60 mg | — |
| Subject | Sofosbuvir | Small molecule | 400 mg | — |