drugset / Trial / NCT03359746
Grazoprevir/Elbasvir for Treatment of Hepatitis C Virus Genotype 4 Post Kidney Transplant
Phase 4
Unknown
40 enrolled
King Faisal Specialist Hospital & Research Center
Merck Sharp & Dohme LLC · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Elbasvir | Small molecule | — | — |
| Subject | GRAZOPREVIR ANHYDROUS | Small molecule | — | — |