drugset / Trial / NCT03063879

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

EvaluationDrugModalityDoseRoute
Subject Daclatasvir Small molecule 60 mg
Subject Sofosbuvir Small molecule 400 mg