Hepatitis CPhase 4NCT04508907
A Study to Evaluate Preemptive Therapy in Hepatitis C (HCV) Organ Transplant Recipients
A Phase 4 study testing Mavyret in people with Hepatitis C and Kidney Transplant; Complications, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is being done to determine the effectiveness of using a combination of two different drugs in preventing the transmission of HCV from a HCV positive donor to a HCV negative solid organ recipient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Kidney Transplant; Complications, Heart Transplant Infection
- What is being tested?
- Mavyret
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2020to 1 Nov 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Listed kidney, heart, lung and/or pancreas patients who are negative for chronic hepatitis C infection
- Willing to accept and consent for accepting hepatitis C positive graft
Who cannot join
- Existing chronic liver disease (liver cirrhosis)
- Concomitant infection with HIV or Chronic hepatitis B
- Patient or any member of patient family or care giver team who does not understand or accept the risk of an acquired HCV infection
- Pregnancy (Pregnant patients do not undergo solid organ transplants)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study for the Use of Shortened Preemptive Therapy With Glecaprevir/Pibrentasvir (G/P) and Ezetimibe in Hepatitis C Seronegative Solid Organ Transplant Recipients (Kidney, Heart, Lung and/or Pancreas) of Hepatitis C Viremic Donors
This study is being done to determine the effectiveness of using a combination of two different drugs in preventing the transmission of HCV from a HCV positive donor to a HCV negative solid organ recipient.
- Being tested
- Mavyret
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MavyretDrug
Also called Zetia
Mavyret and Zetia for 8 days to prevent HCV infection in solid organ recipients
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Pre-emptive Treatment Arm | Experimental | Single arm study were all recipients of HCV viremic organs will receive combination therapy. Receives: Drug: Mavyret |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of prevention of HCV viremia in recipients of HCV viremic solid organs
The study will assess the percentage of patient who will not become HCV viremic using this preemptive treatment protocol.
Measured: 3 months
Graft and patient survival
Study will assess the overall 1 year patient and graft survival.
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 posted11 Aug 2020
- Study start10 Sep 2020
- Primary completion1 Nov 2025
- Study completion1 Nov 2026 (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.
- More trials run by Mayo ClinicThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bashar Aqel, Mayo Clinic
- Investigators
- Bashar A Aqel, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04508907
- Sponsor's protocol ID
- 20-001964
- Status last verified
- Dec 2025
- First submitted
- 30 Jul 2020
- Last updated
- 17 Dec 2025
- 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 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for the Use of Shortened Preemptive Therapy With Glecaprevir/Pibrentasvir (G/P) and Ezetimibe in Hepatitis C Seronegative Solid Organ Transplant Recipients (Kidney, Heart, Lung and/or Pancreas) of Hepatitis C Viremic Donors
- ClinicalTrials.gov ID
- NCT04508907
- Acronym / sponsor ID
- 20-001964
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 11 Aug 2020 (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 is being done to determine the effectiveness of using a combination of two different drugs in preventing the transmission of HCV from a HCV positive donor to a HCV negative solid organ recipient.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Pre-emptive Treatment Arm | Experimental | Drug: MavyretSingle arm study were all recipients of HCV viremic organs will receive combination therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Listed kidney, heart, lung and/or pancreas patients who are negative for chronic hepatitis C infection
- Willing to accept and consent for accepting hepatitis C positive graft
Key exclusion criteria (4 listed)
- Existing chronic liver disease (liver cirrhosis)
- Concomitant infection with HIV or Chronic hepatitis B
- Patient or any member of patient family or care giver team who does not understand or accept the risk of an acquired HCV infection
- Pregnancy (Pregnant patients do not undergo solid organ transplants)
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 |
|---|---|---|
| MavyretAlso: ZetiaMavyret and Zetia for 8 days to prevent HCV infection in solid organ recipients | Drug | Arm 1: Pre-emptive Treatment Arm |
Primary outcome
Rate of prevention of HCV viremia in recipients of HCV viremic solid organs
Time frame: 3 months
The study will assess the percentage of patient who will not become HCV viremic using this preemptive treatment protocol.
Graft and patient survival
Time frame: 1 year
Study will assess the overall 1 year patient and graft survival.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Bashar A Aqel principal investigator
Mayo Clinic
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 Mavyret in people with Hepatitis C and Kidney Transplant; Complications, run by Mayo Clinic 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 2 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 17 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Rate of prevention of HCV viremia in recipients of HCV viremic solid organs (time frame: 3 months). The study lists 2 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 17 Dec 2025.