NCT03407703

Hepatitis C (HCV) Cure and Kidney Health

HCV Cure and Kidney Health: A Prospective, Observational Cohort Study of HCV Genotype 1 and 4 Infected Adults With and Without HIV Infection

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: San Francisco Veterans Affairs Medical Center · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to learn how 12 weeks of HCV treatment with elbasvir and grazoprevir (brand name Zepatier) impacts your kidney function.

Detailed description

Prospective data collection of 25 Genotype 1 or 4 HCV-infected women from the San Francisco Women's Interagency HIV Study (WIHS) site and 25 Genotype 1 or 4 HCV-infected men from the San Francisco VA Medical Center who are initiated on Zepatier for 12 weeks (Total n=50). For women and men with HCV genotype 1a infection, only those without baseline NS5A resistance mutations will be included. Blood/urine samples will be collected before initiation of treatment, 4 weeks after treatment initiation, 12 weeks after treatment initiation (end of treatment), 24 weeks after treatment initiation to determine Sustained Virological Response (SVR), and at 48 weeks after treatment initiation.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	Elbasvir / Grazoprevir Oral Tablet [Zepatier]	HCV treatment

Timeline

• Start date: 2018-03-27
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2018-01-23
• Last updated: 2018-04-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study