Treating Hepatitis C in CRF Using Sofosbuvir and Daclatasvir

Phase 4

Completed

• Conditions: Hepatitis C, Chronic; Chronic Renal Failure
• Interventions: Drug: Sofosbuvir 400 mg and daclatasvir 60 mg

• Registration Number: NCT03063879
• Lead Sponsor: Tehran University of Medical Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-21
• Study First Submitted QC: 2017-02-23
• Study First Posted: 2017-02-24
• Study Start: 2017-04-01
• Status Verified: 2018-02
• Primary Completion: 2018-09-01
• Study Completion: 2019-02-01
• Last Update Submitted: 2019-09-27
• Last Update Posted: 2019-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sovodak	Sofosbuvir 400 mg and daclatasvir 60 mg	Sofosbuvir 400 mg and daclatasvir 60 mg

Primary Outcome Measures

Name	Time	Method
Sustained Viral Response (SVR12)	12 weeks after end of treatment	Lack of detectable hepatitis C virus in blood 12 weeks after end of treatment

Secondary Outcome Measures

Name	Time	Method
Safety as assessed by adverse drug events	From start of treatment to 12 weeks after end of treatment	Adverse drug events recorded by direct questioning

Trial Locations

Locations (1)

Shariati Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of