Hepatitis C (HCV) Cure and Kidney Health

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03407703
• Other study ID #: 17-22790
• Status: Recruiting
• First received: January 9, 2018
• Last updated: April 16, 2018
• Start date: March 27, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2018
• Source: San Francisco Veterans Affairs Medical Center
• Contact: Phyllis C Tien, MD
• Phone: 415-221-4810
• Email: phyllis.tien[@]ucsf.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C

Intervention

Drug:
• Elbasvir / Grazoprevir Oral Tablet [Zepatier]
HCV treatment

Locations

Country	Name	City	State
United States	San Francisco VA Medical Center	San Francisco	California
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
San Francisco Veterans Affairs Medical Center	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glomerular filtration rate and injury	measured by Cystatin C	1 year
Primary	glomerular filtration rate and injury	measured by Creatinine	1 year
Primary	glomerular filtration rate and injury	measured by albuminuria	1 year
Primary	Tubule dysfunction	measured by a1-microglobulin	1 year
Primary	Tubule dysfunction	measured by beta2-microglobulin	1 year
Primary	Tubule injury	measured by Interleukin-18	1 year
Primary	tubule injury	measured by Kidney injury molecule-1	1 year
Primary	tubule injury	measured by Neutrophil gelatinase-associated lipocalcin (NGAL)	1 year
Primary	tubule injury	measured by Clusterin	1 year
Primary	tubule injury	measured by Trefoil factor-3 (TFF-3)	1 year
Secondary	HCV clearance	measured by HCV viral load	1 year
Secondary	liver fibrosis	liver stiffness measured by transient elastography	1 year