An observational study in Hepatitis C, sponsored by San Francisco Veterans Affairs Medical Center. Status unknown at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-18.
Sponsored by San Francisco Veterans Affairs Medical Center · Observational
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.
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.
25 Genotype 1 or 4 HCV-infected women from the San Francisco WIHS site and 25 Genotype 1 or 4 HCV-infected men from the San Francisco VA Medical Center
Exclusion Criteria:
HCV treatment
Glomerular filtration rate and injury
measured by Cystatin C
Time frame: 1 year
glomerular filtration rate and injury
measured by Creatinine
Time frame: 1 year
glomerular filtration rate and injury
measured by albuminuria
Time frame: 1 year
Tubule dysfunction
measured by α1-microglobulin
Time frame: 1 year
Tubule dysfunction
measured by beta2-microglobulin
Time frame: 1 year
Tubule injury
measured by Interleukin-18
Time frame: 1 year
tubule injury
measured by Kidney injury molecule-1
Time frame: 1 year
tubule injury
measured by Neutrophil gelatinase-associated lipocalcin (NGAL)
Time frame: 1 year
tubule injury
measured by Clusterin
Time frame: 1 year
tubule injury
measured by Trefoil factor-3 (TFF-3)
Time frame: 1 year
HCV clearance
measured by HCV viral load
Time frame: 1 year
liver fibrosis
liver stiffness measured by transient elastography
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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San Francisco Veterans Affairs Medical Center