Trial | NCT03063879  Report issue

Title

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.

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    95
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.
Study Started
Apr 01
2017
Primary Completion
Sep 01
2018
Study Completion
Feb 01
2019
Last Update
Sep 30
2019

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

  • Other names: Sovodak

Sovodak Experimental

Sofosbuvir 400 mg and daclatasvir 60 mg

Criteria 

Inclusion Criteria:

Positive qualitative hepatitis C virus RNA test on two occasions at least 6 months apart
Renal failure (eGFR < 30 cc/min) or under hemodialysis

Exclusion Criteria:

Model for End-stage Liver Disease (MELD) score > 20,
Child's C (CTP score > 12),
Heart rate < 50/min,
Taking amiodarone
No Results Posted