Hepatitis CPhase 4HEART-CNCT03585101
A Single-arm Evaluation of the Effect of HCV Treatment on Cardiovascular Disease Risk
A Phase 4 study testing Elbasvir/grazoprevir in people with Hepatitis C, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study will assess the effect of treatment for hepatitis C virus (HCV) on cardiovascular disease risk. The study will enroll men and women who are infected with HCV and have underlying metabolic disease. All participants will receive a 12-week course of an HCV treatment (elbasvir/grazoprevir). 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2018to Apr 2020
- Phase
- Phase 4
- 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
Who may be able to join
- Men and women ≥ 18 years of age.
- Presence of HCV infection for at least 12 weeks
- Serum or plasma HCV RNA > lower limit of quantification or detection at any time before or at the time of screening, and the absence of intervening HCV treatment
- Absence of HIV infection
- HCV treatment-naïve OR HCV treatment-experienced with PEG-IFN/RBV only (no prior HCV DAA exposure)
- Genotype 1 or 4 HCV infection. If HCV genotype 1a infection is present, absence of genotype 1a NS5A resistance associated substitutions (RASs) at amino acid positions 28, 30, 31, and 93 must be documented at screening
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- Evidence of metabolic disease defined as:
- Insulin resistance or impaired glucose tolerance by one of the following:
- HOMA-IR ≥2.5 at screening
- Hemoglobin A1c 5.7-6.4% at screening
- Diabetes mellitus with hemoglobin A1c <7% at screening and never on more than one oral hypoglycemic agent, as well as never requiring insulin
- OR
- Metabolic Syndrome, defined as at least 3 of the following:
- Waist circumference ≥102 cm for men and ≥ 88 cm for women
- Serum triglyceride level ≥150 mg/dL or on a triglyceride lowering agent
- Serum high-density lipoprotein (HDL) cholesterol <40 mg/dL in men and <50 mg/dL in women or drug treatment for low HDL cholesterol
- Blood pressure ≥130/85 mmHg or drug treatment for elevated blood pressure
- Fasting blood glucose ≥100 mg/dL
- Ability and willingness of subject to provide written informed consent
Who cannot join
- History of decompensated liver disease (Child Pugh Class B or C)
- Albumin below 3 g/dL
- Platelet count below 75,000
- HBsAg positivity.
- Pregnancy or breastfeeding
- Inability to conform to the following drug interruptions for PAT testing, whether due to safety (determined by the investigator) or willingness: No caffeine or recreational or prescription stimulant use for 24 hours prior; no nicotine for 4 hours prior; no vigorous exercise for 12 hours prior; stopping of beta blockers, short-acting calcium channel blockers (CCBs), nitrates, angiotensin-converting enzyme inhibitors (ACE-Is), angiotensin-receptor blockers (ARBs), and renin-inhibitors for 24 hours prior; and stopping of long acting CCBs 48 hours prior to testing.
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- Use of anticoagulant or antiplatelet agents (other than aspirin ≤ 325 mg orally daily) within 1 week prior to study entry or anticipated need for these agents for >7 days during the study follow-up period.
- Use of contraindicated concomitant medications, including OATP1B1/3 inhibitors and strong CYP3A inducers
- Serious illness including acute liver-related disease and malignancy requiring systemic treatment or hospitalization within 12 weeks prior to study entry.
- History of major organ transplantation with an existing functional graft and on immunosuppressive therapy.
- History of known vascular disorder or autoimmune processes including Crohn's disease, ulcerative colitis, severe psoriasis, rheumatoid arthritis, and cryoglobulinemia that may affect vascular studies.
- Decompensated congestive heart failure or acute cardiovascular event (such as stroke, myocardial infarction, arrhythmia, acute peripheral arterial insufficiency) within 6 months prior to study entry
- Use of immune-based therapies or systemic corticosteroids which may affect vascular studies or inflammatory/endothelial biomarkers within 12 weeks prior to study entry
- Advanced renal insufficiency as defined by glomerular filtration rate (GFR) < 30 mL/min/1.73 m2 or treatment by dialysis
- Anticipated inability to comply with research study visits as determined by the investigator
- Poor venous access not allowing screening laboratory collection
- Having any condition that the investigator considers a contraindication to study participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-arm Evaluation of the Effect of Elbasvir/Grazoprevir on Cardiometabolic Parameters in Patients With Hepatitis C Infection and Underlying Metabolic Disease
This study will assess the effect of treatment for hepatitis C virus (HCV) on cardiovascular disease risk. The study will enroll men and women who are infected with HCV and have underlying metabolic disease. All participants will receive a 12-week course of an HCV treatment (elbasvir/grazoprevir). Cardiovascular disease risk will be evaluated at baseline, week 4 on treatment, 12 weeks post-treatment, and 52 weeks post-treatment through noninvasive measurements of endothelial function, insulin resistance, liver fibrosis and steatosis, and circulating blood biomarkers.
- Conditions
- Hepatitis C
- Being tested
- Elbasvir/grazoprevir
- Keywords
- Hepatitis C virus, Endothelial function, Cardiovascular disease risk, Metabolic disease, Inflammation, Insulin resistance
- Medical subject headings
- Hepatitis C, Metabolic Diseases, Inflammation, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elbasvir/grazoprevirDrug
Also called Zepatier, serial number 86336186
Daily fixed-dose combination (FDC) elbasvir (EBR) (50 mg)/grazoprevir (GZR) (100 mg) for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | Intervention: Elbasvir/grazoprevir Receives: Drug: Elbasvir/grazoprevir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in reactive hyperemia index (RHI) by peripheral arterial tonometry (PAT)
Measured: Baseline to 12 weeks after end of EBR/GZR treatment.
Secondary outcomes (13)
Change in insulin resistance by HOMA-IR
Measured: Baseline to 12 weeks after end of treatment
Change in reactive hyperemia index (RHI) by PAT
Measured: Baseline to week 4 on treatment
Change in reactive hyperemia index (RHI) by PAT
Measured: Baseline to 52 weeks after end of treatment
Change in insulin resistance by HOMA-IR
Measured: Baseline to week 4 on treatment
Change in insulin resistance by HOMA-IR
Measured: Baseline to 52 weeks after end of treatment
Change in hemoglobin A1c
Measured: Baseline to week 4, baseline to 12 weeks after end of treatment, and baseline to 52 weeks after end of treatment
Change in total and LDL cholesterol levels
Measured: Baseline to week 4, baseline to 12 weeks after end of treatment, and baseline to 52 weeks after end of treatment
Change in levels of each soluble biomarker (sCD163, sCD14, sICAM-1, PAI-1, sE-selectin, oxidized LDL, Lp-PLA2, and lipoprotein particle quantification)
Measured: Baseline to week 4, baseline to 12 weeks after end of treatment, and baseline to 52 weeks after end of treatment
Cross-sectional levels of each soluble biomarker (sCD163, sCD14, sICAM-1, PAI-1, sE-selectin, oxidized LDL, Lp-PLA2, and lipoprotein particle quantification) at each time point for correlation with RHI
Measured: Baseline, week 4, post-treatment weeks 12 and 52
Cross-sectional fibrosis score in kPa by transient elastography (TE) for correlation with RHI and soluble biomarkers
Measured: Baseline and 12 and 52 weeks after end of treatment
Cross-sectional steatosis score in dB/m by CAP for correlation with RHI and soluble biomarkers at the same time points
Measured: Baseline and 12 and 52 weeks after end of treatment
Change in fibrosis score by transient elastography
Measured: Baseline to 52 weeks after end of treatment
Change in hepatic steatosis score by CAP
Measured: Baseline to 52 weeks after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study startAug 2018 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionApr 2020 (estimated)
Why it stopped: Funding no longer available
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.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Kara Chew, University of California, Los Angeles
- Investigators
- Kara W Chew, M.D., M.S., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03585101
- Sponsor's protocol ID
- 18-000650
- Acronym
- HEART-C
- Status last verified
- Aug 2018
- First submitted
- 29 Jun 2018
- Last updated
- 7 Aug 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 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Evaluation of the Effect of Elbasvir/Grazoprevir on Cardiometabolic Parameters in Patients With Hepatitis C Infection and Underlying Metabolic Disease
- ClinicalTrials.gov ID
- NCT03585101
- Acronym / sponsor ID
- HEART-C / 18-000650
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C virus, Endothelial function, Cardiovascular disease risk, Metabolic disease, Inflammation, Insulin resistance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding no longer available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Aug 2018 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 12 Jul 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.
This study will assess the effect of treatment for hepatitis C virus (HCV) on cardiovascular disease risk. The study will enroll men and women who are infected with HCV and have underlying metabolic disease. All participants will receive a 12-week course of an HCV treatment (elbasvir/grazoprevir). Cardiovascular disease risk will be evaluated at baseline, week 4 on treatment, 12 weeks post-treatment, and 52 weeks post-treatment through noninvasive measurements of endothelial function, insulin resistance, liver fibrosis and steatosis, and circulating blood biomarkers.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Drug: Elbasvir/grazoprevirIntervention: Elbasvir/grazoprevir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Men and women ≥ 18 years of age.
- Presence of HCV infection for at least 12 weeks
- Serum or plasma HCV RNA > lower limit of quantification or detection at any time before or at the time of screening, and the absence of intervening HCV treatment
- Absence of HIV infection
- HCV treatment-naïve OR HCV treatment-experienced with PEG-IFN/RBV only (no prior HCV DAA exposure)
Key exclusion criteria (17 listed)
- History of decompensated liver disease (Child Pugh Class B or C)
- Albumin below 3 g/dL
- Platelet count below 75,000
- HBsAg positivity.
- Pregnancy or breastfeeding
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/grazoprevirAlso: Zepatier, serial number 86336186Daily fixed-dose combination (FDC) elbasvir (EBR) (50 mg)/grazoprevir (GZR) (100 mg) for 12 weeks | Drug | All participants |
Primary outcome
Change in reactive hyperemia index (RHI) by peripheral arterial tonometry (PAT)
Time frame: Baseline to 12 weeks after end of EBR/GZR treatment.
13 secondary outcomes
Change in insulin resistance by HOMA-IR
Time frame: Baseline to 12 weeks after end of treatment
Change in reactive hyperemia index (RHI) by PAT
Time frame: Baseline to week 4 on treatment
Change in reactive hyperemia index (RHI) by PAT
Time frame: Baseline to 52 weeks after end of treatment
Change in insulin resistance by HOMA-IR
Time frame: Baseline to week 4 on treatment
Change in insulin resistance by HOMA-IR
Time frame: Baseline to 52 weeks after end of treatment
Change in hemoglobin A1c
Time frame: Baseline to week 4, baseline to 12 weeks after end of treatment, and baseline to 52 weeks after end of treatment
Change in total and LDL cholesterol levels
Time frame: Baseline to week 4, baseline to 12 weeks after end of treatment, and baseline to 52 weeks after end of treatment
Change in levels of each soluble biomarker (sCD163, sCD14, sICAM-1, PAI-1, sE-selectin, oxidized LDL, Lp-PLA2, and lipoprotein particle quantification)
Time frame: Baseline to week 4, baseline to 12 weeks after end of treatment, and baseline to 52 weeks after end of treatment
Cross-sectional levels of each soluble biomarker (sCD163, sCD14, sICAM-1, PAI-1, sE-selectin, oxidized LDL, Lp-PLA2, and lipoprotein particle quantification) at each time point for correlation with RHI
Time frame: Baseline, week 4, post-treatment weeks 12 and 52
Cross-sectional fibrosis score in kPa by transient elastography (TE) for correlation with RHI and soluble biomarkers
Time frame: Baseline and 12 and 52 weeks after end of treatment
Cross-sectional steatosis score in dB/m by CAP for correlation with RHI and soluble biomarkers at the same time points
Time frame: Baseline and 12 and 52 weeks after end of treatment
Change in fibrosis score by transient elastography
Time frame: Baseline to 52 weeks after end of treatment
Change in hepatic steatosis score by CAP
Time frame: Baseline to 52 weeks after end of treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 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.
Kara W Chew, M.D., M.S. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Elbasvir/grazoprevir in people with Hepatitis C, run by University of California, Los Angeles at 1 site 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 19 inclusion and 17 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: withdrawn, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in reactive hyperemia index (RHI) by peripheral arterial tonometry (PAT) (time frame: Baseline to 12 weeks after end of EBR/GZR treatment.). 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 7 Aug 2018.