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Treating Hepatitis C in CRF Using Sofosbuvir and Daclatasvir | Clinical Trials | Clareo Health

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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.

NCT03063879•Tehran University of Medical Sciences

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.

Eligibility

Age

16 - 75 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Shariati Hospital

Tehran, Iran

Key Dates

Start Date

April 1, 2017

Primary Completion Date

September 1, 2018

Completion Date

February 1, 2019

Last Updated

September 30, 2019

Enrollment

ACTUAL participants

Conditions

Hepatitis C, ChronicChronic Renal Failure

Interventions

Sofosbuvir 400 mg and daclatasvir 60 mg

DRUG

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 30, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Treating Hepatitis C in CRF Using Sofosbuvir and Daclatasvir

Inclusion Criteria

Exclusion Criteria

A Clinical Study to Map the HLA Genomic Region in the Greek Population

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

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Prediabetes in End Stage Renal Disease on Dialysis

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