Trials / Withdrawn
WithdrawnNCT03585101
A Single-arm Evaluation of the Effect of HCV Treatment on Cardiovascular Disease Risk
A Single-arm Evaluation of the Effect of Elbasvir/Grazoprevir on Cardiometabolic Parameters in Patients With Hepatitis C Infection and Underlying Metabolic Disease
- Status
- Withdrawn
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- University of California, Los Angeles · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will assess the effect of treatment for hepatitis C virus (HCV) on cardiovascular disease risk. The study will enroll men and women who are infected with HCV and have underlying metabolic disease. All participants will receive a 12-week course of an HCV treatment (elbasvir/grazoprevir). Cardiovascular disease risk will be evaluated at baseline, week 4 on treatment, 12 weeks post-treatment, and 52 weeks post-treatment through noninvasive measurements of endothelial function, insulin resistance, liver fibrosis and steatosis, and circulating blood biomarkers.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Elbasvir/grazoprevir | Daily fixed-dose combination (FDC) elbasvir (EBR) (50 mg)/grazoprevir (GZR) (100 mg) for 12 weeks |
Timeline
- Start date
- 2018-08-01
- Primary completion
- 2019-06-01
- Completion
- 2020-04-01
- First posted
- 2018-07-12
- Last updated
- 2018-08-07
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03585101. Inclusion in this directory is not an endorsement.