drugset / Trial / NCT03359746

Grazoprevir/Elbasvir for Treatment of Hepatitis C Virus Genotype 4 Post Kidney Transplant

NCT03359746

NaSingle-groupOpen-labelTreatment

Summary

This is a prospective, interventional, case-control study at King Faisal Specialist Hospital \& Research Centre in post-renal transplant patients who are receiving Grazoprevir/Elbasvir combination. Data will be compared with matched historical controls, which will be selected according to the following matching criteria: age, time from transplant to initiation of therapy. Only patients who completed at least 48 weeks of pegylated Interferon + Ribavirin therapy in the control group and 12 weeks of therapy on the case group will be enrolled. Any patient who received at least one dose of Grazoprevir/Elbasvir combination will be included in the safety analysis.

Timeline

Start
2017-12-15
Primary completion
2018-10-31
Completion
2018-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Elbasvir Small molecule
Subject GRAZOPREVIR ANHYDROUS Small molecule