NCT03063879

Treating Hepatitis C in CRF Using Sofosbuvir and Daclatasvir

Efficacy and Safety of Sofosbuvir and Daclatasvir in Treating Patients With Hepatitis C and Renal Failure.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Tehran University of Medical Sciences · Academic / Other
• Sex: All
• Age: 16 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C, Chronic
• Chronic Renal Failure

Interventions

Type	Name	Description
DRUG	Sofosbuvir 400 mg and daclatasvir 60 mg	Daily fixed dose combination pill (Sovodak) containing 400 mg sofosbuvir and 60 mg daclatasvir for 12 weeks if not cirrhotic (liver stiffness \< 12 KPa) or 24 weeks if cirrhotic

Timeline

• Start date: 2017-04-01
• Primary completion: 2018-09-01
• Completion: 2019-02-01
• First posted: 2017-02-24
• Last updated: 2019-09-30

Locations

1 site across 1 country: Iran