Trials / Completed
CompletedNCT03145623
Retrospective Efficacy and Safety Study With Elbasvir/Grazoprevir in HCV-infected Patients With Chronic Kidney Disease
Retrospective Efficacy and Safety Study With Elbasvir 50 mg/Grazoprevir 100 mg in HCV-infected Patients With Chronic Kidney Disease Stage 4-5 During the French Temporary Authorization for Use (ATU) Program: Data From Real-life
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (actual)
- Sponsor
- University Hospital, Toulouse · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Retrospective Efficacy and Safety Study With Elbasvir (EBR) 50 mg/Grazoprevir (GZR) 100 mg in Hepatitis C Virus (HCV)-infected Patients With Chronic Kidney Disease (CKD) Stage 4-5 During the French Temporary Authorization for Use (ATU) Program: Data From Real-life
Detailed description
Primary objective : Retrospectively collect and describe the real life efficacy (SVR 12)\* and safety data of EBR 50 mg/GZR 100 mg based therapy, 12 or 16 weeks dosed in HCV-infected patients with chronic kidney disease. These data are collected following French ATU allocation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Elbasvir and Grazoprevir | Elbasvir 50 mg and grazoprevir 100 mg during the French temporary authorization for use (ATU) program |
Timeline
- Start date
- 2017-06-02
- Primary completion
- 2017-12-31
- Completion
- 2017-12-31
- First posted
- 2017-05-09
- Last updated
- 2018-02-15
Locations
2 sites across 1 country: France
Source: ClinicalTrials.gov record NCT03145623. Inclusion in this directory is not an endorsement.