CClinicalTrials.gg
Status unknownNCT03407703Updated Apr 18, 2018

Hepatitis C (HCV) Cure and Kidney Health

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 sponsor has not verified this record recently (last verified Apr 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hepatitis C

Keywords

  • genotype 1
  • genotype 4
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  1. Active Genotype 1 or 4 HCV infection (If with Genotype 1a infection, only those without baseline NS5A resistance mutation will be included; Genotype 4 HCV infection is uncommon in both study populations). Subjects with HIV coinfection are included. We will not exclude patients who have severe Chronic Kidney Disease, are on dialysis, or have undergone kidney transplant.

Exclusion criteria

Exclusion Criteria:

  1. HCV genotype 2, 3, 5, or 6 infection
  2. Previous virologic failure to regimens containing an NS5A inhibitor
  3. Decompensated liver disease (Child-Pugh Class B or C)
  4. Albumin below 3g/dL
  5. Platelet count below 75,000
  6. Any condition that the investigator considers a contraindication to study participation including limited life expectancy
  7. Pregnant or breastfeeding woman
  8. Hepatitis B virus (HBV) surface antigen positive (Note: Patients positive for the HBV core antibody will not be excluded, but will have HBV DNA levels checked and will be monitored while on Direct Acting Antivirals (DAA) therapy and medically managed as considered appropriate)
  9. Documented ongoing nonadherence to prescribed medications or medical treatment, failure to complete HCV disease evaluation appointments and procedures or unable to commit to scheduled followup/monitoring for the duration of treatment
  10. Poor venous access not allowing screening laboratory collection
  11. Known hypersensitivity to elbasvir/grazoprevir
  12. Co-administration with drugs that are 1) strong CYP3A inducers (e.g., phenytoin, carbamazepine, rifampin); 2) OATP1B1/3 inhibitors (e.g., cyclosporine, darunavir, atazanavir, tipranavir, lopinavir or saquinavir) or 3) efavirenz
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • DrugElbasvir / Grazoprevir Oral Tablet [Zepatier]

    HCV treatment

05

What researchers measure

Primary outcomes

  1. Glomerular filtration rate and injury

    measured by Cystatin C

    Time frame: 1 year

  2. glomerular filtration rate and injury

    measured by Creatinine

    Time frame: 1 year

  3. glomerular filtration rate and injury

    measured by albuminuria

    Time frame: 1 year

  4. Tubule dysfunction

    measured by α1-microglobulin

    Time frame: 1 year

  5. Tubule dysfunction

    measured by beta2-microglobulin

    Time frame: 1 year

  6. Tubule injury

    measured by Interleukin-18

    Time frame: 1 year

  7. tubule injury

    measured by Kidney injury molecule-1

    Time frame: 1 year

  8. tubule injury

    measured by Neutrophil gelatinase-associated lipocalcin (NGAL)

    Time frame: 1 year

  9. tubule injury

    measured by Clusterin

    Time frame: 1 year

  10. tubule injury

    measured by Trefoil factor-3 (TFF-3)

    Time frame: 1 year

Secondary outcomes

  1. HCV clearance

    measured by HCV viral load

    Time frame: 1 year

  2. liver fibrosis

    liver stiffness measured by transient elastography

    Time frame: 1 year

06

Study locations

2 of 2 sites recruiting
  • University of California, San Francisco
    San Francisco, California 94115, United States
    Enrolling by invitation
  • San Francisco VA Medical Center
    San Francisco, California 94121, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03407703
Lead sponsor
San Francisco Veterans Affairs Medical Center
Collaborators
Merck Sharp & Dohme LLC
Responsible party
Phyllis Tien (Professor of Medicine and Clinical Pharmacy and Staff Physician, San Francisco Veterans Affairs Medical Center) — Principal investigator
First posted
Jan 23, 2018
Start date
Mar 27, 2018
Primary completion
Dec 31, 2019 (estimated)
Completion
Dec 31, 2019 (estimated)
Last update
Apr 18, 2018

Study contacts

Phyllis C Tien, MD
Contact
phyllis.tien@ucsf.edu
415-221-4810 ext. 22577
Heather S Freasier, MS
Contact
heather.freasier@ucsf.edu
415-379-5518
Phyllis C Tien, MD
principal investigator · San Francisco VA Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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