Hepatitis CNCT03407703
Hepatitis C (HCV) Cure and Kidney Health
An observational study of Hepatitis C, run by San Francisco Veterans Affairs Medical Center at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Elbasvir / Grazoprevir Oral Tablet [Zepatier]
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Mar 2018to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Enrolling by invitation
University of California, San Francisco
San Francisco, California, 94115
- Recruiting
San Francisco VA Medical Center
San Francisco, California, 94121
Phyllis C Tien, MD, 415-221-4810 ext. 22577, phyllis.tien@ucsf.edu
Heather Freasier, MS, 415-379-5518, heather.freasier@ucsf.edu
About this study
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
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.
- Conditions
- Hepatitis C
- Being tested
- Elbasvir / Grazoprevir Oral Tablet [Zepatier]
- Keywords
- genotype 1, genotype 4
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elbasvir / Grazoprevir Oral Tablet [Zepatier]Drug
HCV treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
Glomerular filtration rate and injury
measured by Cystatin C
Measured: 1 year
glomerular filtration rate and injury
measured by Creatinine
Measured: 1 year
glomerular filtration rate and injury
measured by albuminuria
Measured: 1 year
Tubule dysfunction
measured by α1-microglobulin
Measured: 1 year
Tubule dysfunction
measured by beta2-microglobulin
Measured: 1 year
Tubule injury
measured by Interleukin-18
Measured: 1 year
tubule injury
measured by Kidney injury molecule-1
Measured: 1 year
tubule injury
measured by Neutrophil gelatinase-associated lipocalcin (NGAL)
Measured: 1 year
tubule injury
measured by Clusterin
Measured: 1 year
tubule injury
measured by Trefoil factor-3 (TFF-3)
Measured: 1 year
Secondary outcomes (2)
HCV clearance
measured by HCV viral load
Measured: 1 year
liver fibrosis
liver stiffness measured by transient elastography
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start27 Mar 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Francisco Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Phyllis Tien, San Francisco Veterans Affairs Medical Center
- Investigators
- Phyllis C Tien, MD, Principal investigator, San Francisco VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407703
- Sponsor's protocol ID
- 17-22790
- Status last verified
- Apr 2018
- First submitted
- 9 Jan 2018
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03407703
- Acronym / sponsor ID
- 17-22790
- Conditions
- Hepatitis C
- Keywords
- genotype 1, genotype 4
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- San Francisco Veterans Affairs Medical CenterUS federal agency
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 27 Mar 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elbasvir / Grazoprevir Oral Tablet [Zepatier]HCV treatment | Drug | – |
Primary outcome
Glomerular filtration rate and injury
Time frame: 1 year
measured by Cystatin C
glomerular filtration rate and injury
Time frame: 1 year
measured by Creatinine
glomerular filtration rate and injury
Time frame: 1 year
measured by albuminuria
Tubule dysfunction
Time frame: 1 year
measured by α1-microglobulin
Tubule dysfunction
Time frame: 1 year
measured by beta2-microglobulin
Tubule injury
Time frame: 1 year
measured by Interleukin-18
tubule injury
Time frame: 1 year
measured by Kidney injury molecule-1
tubule injury
Time frame: 1 year
measured by Neutrophil gelatinase-associated lipocalcin (NGAL)
tubule injury
Time frame: 1 year
measured by Clusterin
tubule injury
Time frame: 1 year
measured by Trefoil factor-3 (TFF-3)
2 secondary outcomes
HCV clearance
Time frame: 1 year
liver fibrosis
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phyllis C Tien, MD principal investigator
San Francisco VA Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by San Francisco Veterans Affairs Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Phyllis C Tien, MD (415-221-4810 ext. 22577, phyllis.tien@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glomerular filtration rate and injury (time frame: 1 year). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.