NCT03407703

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

March 27, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

1.8 years

First QC Date

January 9, 2018

Last Update Submit

April 16, 2018

Conditions

Hepatitis C

Keywords

genotype 1genotype 4

Outcome Measures

Primary Outcomes (10)

  • Glomerular filtration rate and injury

    measured by Cystatin C

    1 year

  • glomerular filtration rate and injury

    measured by Creatinine

    1 year

  • glomerular filtration rate and injury

    measured by albuminuria

    1 year

  • Tubule dysfunction

    measured by α1-microglobulin

    1 year

  • Tubule dysfunction

    measured by beta2-microglobulin

    1 year

  • Tubule injury

    measured by Interleukin-18

    1 year

  • tubule injury

    measured by Kidney injury molecule-1

    1 year

  • tubule injury

    measured by Neutrophil gelatinase-associated lipocalcin (NGAL)

    1 year

  • tubule injury

    measured by Clusterin

    1 year

  • tubule injury

    measured by Trefoil factor-3 (TFF-3)

    1 year

Secondary Outcomes (2)

  • HCV clearance

    1 year

  • liver fibrosis

    1 year

Interventions

Elbasvir / Grazoprevir Oral Tablet [Zepatier]DRUG

HCV treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • \. 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.

You may not qualify if:

  • HCV genotype 2, 3, 5, or 6 infection
  • Previous virologic failure to regimens containing an NS5A inhibitor
  • Decompensated liver disease (Child-Pugh Class B or C)
  • Albumin below 3g/dL
  • Platelet count below 75,000
  • Any condition that the investigator considers a contraindication to study participation including limited life expectancy
  • Pregnant or breastfeeding woman
  • 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)
  • 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
  • Poor venous access not allowing screening laboratory collection
  • Known hypersensitivity to elbasvir/grazoprevir
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Biospecimen

Retention: SAMPLES WITH DNA

serum, plasma and PBMC (peripheral blood mononuclear cell)

MeSH Terms

Conditions

Hepatitis C

Interventions

elbasvirgrazoprevirelbasvir-grazoprevir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Phyllis C Tien, MD

    San Francisco VA Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Phyllis C Tien, MD

CONTACT

415-221-4810phyllis.tien@ucsf.edu

Heather S Freasier, MS

CONTACT

415-379-5518heather.freasier@ucsf.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine and Clinical Pharmacy and Staff Physician

Study Record Dates

First Submitted

January 9, 2018

First Posted

January 23, 2018

Study Start

March 27, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

April 18, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)