NCT03359746

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: King Faisal Specialist Hospital & Research Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	Grazoprevir/Elbasvir	Medication for treatment of patient

Timeline

• Start date: 2017-12-15
• Primary completion: 2018-10-31
• Completion: 2018-12-31
• First posted: 2017-12-02
• Last updated: 2017-12-02

Regulatory

• FDA-regulated drug study