Recruiting

HCV Cure

Sponsor:

San Francisco Veterans Affairs Medical Center

Code:

NCT03407703

Conditions

Hepatitis C

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Elbasvir / Grazoprevir Oral Tablet [Zepatier]

Study Details

Brief 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.

Conditions

Hepatitis C

Study ID

NCT03407703

Start date

Mar 27, 2018

Status verified date

Apr, 2018

Completion date

Dec 31, 2019

Anticipated

Primary completion date

Dec 31, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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:

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Interventions

Elbasvir / Grazoprevir Oral Tablet [Zepatier]

HCV treatment

Primary outcome measure

  • Glomerular filtration rate and injury [ Time Frame: 1 year ]
  • glomerular filtration rate and injury [ Time Frame: 1 year ]
  • glomerular filtration rate and injury [ Time Frame: 1 year ]
  • Tubule dysfunction [ Time Frame: 1 year ]
  • Tubule dysfunction [ Time Frame: 1 year ]
  • Tubule injury [ Time Frame: 1 year ]
  • tubule injury [ Time Frame: 1 year ]
  • tubule injury [ Time Frame: 1 year ]
  • tubule injury [ Time Frame: 1 year ]
  • tubule injury [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Locations

San Francisco VA Medical Center

Recruiting

San Francisco, California, United States, 94121

Contacts

More Information

Sponsor

San Francisco Veterans Affairs Medical Center

Last update posted

Apr 18, 2018

Last verified

Apr, 2018

Keywords

  • genotype 1
  • genotype 4

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by San Francisco Veterans Affairs Medical Center on 2018-04-18.