Heart FailureNCT04452578
Hepatitis C Virus (HVC) Positive Heart Grafts in HCV Negative Recipients
A study testing Procedure: Heart Transplantation in people with Heart Failure, run by Loma Linda University at 1 site in United States.
Trial summary
To provide proof-of-concept data on the efficacy/safety of transplanting HCV positive donor grafts in HCV negative heart recipients who are currently listed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Procedure: Heart Transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2020to 17 Jun 2022
- Phase
- Interventional
- 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
- Male or female
- Age 18 and older
- Active on the transplant list
- Donor organ with Antibody and NAT (nucleic acid test) positive for HCV
- HCV negative recipient; this includes patients who never had HCV and those with HCV previously eradicated with antiviral therapy. The latter is defined as those with undetectable HCV viral load at least 3 months since stopping therapy.
- Willing and able to provide written informed consent or for those subjects where hepatic encephalopathy affects their ability to provide initial or ongoing consent, has an appropriate and legally-authorized representative willing and able to provide consent on behalf of the subject
- Patients listed for multiple organ transplant (heart and kidney or heart and liver) can be included based on agreement of non-cardiac organ transplant team
Who cannot join
- Participants co-infected with HIV
- Donor previously treated with an NS5a containing regimen (if treatment history of donor known)
- Known allergies or hypersensitivity to DAA or ribavarin
- Pregnancy and/or actively breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Transplant Institute
Loma Linda, California, 92354
About this study
Official title: Pilot Investigation Using HCV Positive Heart Grafts in HCV Negative or Previously Successfully Treated Recipients
To provide proof-of-concept data on the efficacy/safety of transplanting HCV positive donor grafts in HCV negative heart recipients who are currently listed.
- Conditions
- Heart Failure
- Being tested
- Procedure: Heart Transplantation
- Keywords
- HCV
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure: Heart TransplantationProcedure or surgery
A HCV negative or previously successfully treated recipient who recieves a HCV positive graft will be monitored. Patients who recieve an HCV graft will be treated for HCV according to accepted protocols.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Recipient of HCV positive heart graft | Experimental | A single center, open-label, pilot study examining 10 adult HCV negative heart transplant subjects who will receive an HCV infected graft. Target start date for antiviral therapy will be within 3 months after heart transplantation. Receives: Procedure: Procedure: Heart Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Survival Rate
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start10 Jun 2020
- Primary completion17 Jun 2022
- Study completion17 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04452578
- Sponsor's protocol ID
- 5190371
- Status last verified
- Nov 2022
- First submitted
- 26 Jun 2020
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Investigation Using HCV Positive Heart Grafts in HCV Negative or Previously Successfully Treated Recipients
- ClinicalTrials.gov ID
- NCT04452578
- Acronym / sponsor ID
- 5190371
- Conditions
- Heart Failure
- Keywords
- HCV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 17 Jun 2022 (actual)
- Study completion
- 17 Jun 2022 (actual)
- First posted
- 30 Jun 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.
To provide proof-of-concept data on the efficacy/safety of transplanting HCV positive donor grafts in HCV negative heart recipients who are currently listed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Recipient of HCV positive heart graft | Experimental | Procedure: Procedure: Heart TransplantationA single center, open-label, pilot study examining 10 adult HCV negative heart transplant subjects who will receive an HCV infected graft. Target start date for antiviral therapy will be within 3 months after heart transplantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female
- Age 18 and older
- Active on the transplant list
- Donor organ with Antibody and NAT (nucleic acid test) positive for HCV
- HCV negative recipient; this includes patients who never had HCV and those with HCV previously eradicated with antiviral therapy. The latter is defined as those with undetectable HCV viral load at least 3 months since stopping therapy.
Key exclusion criteria (4 listed)
- Participants co-infected with HIV
- Donor previously treated with an NS5a containing regimen (if treatment history of donor known)
- Known allergies or hypersensitivity to DAA or ribavarin
- Pregnancy and/or actively 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 |
|---|---|---|
| Procedure: Heart TransplantationA HCV negative or previously successfully treated recipient who recieves a HCV positive graft will be monitored. Patients who recieve an HCV graft will be treated for HCV according to accepted protocols. | Procedure or surgery | Experimental: Recipient of HCV positive heart graft |
Primary outcome
Patient Survival Rate
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procedure: Heart Transplantation in people with Heart Failure, run by Loma Linda University 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 7 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: finished, as of the sponsor's last update on 1 Dec 2022. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient Survival Rate (time frame: 15 months). 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 1 Dec 2022.