Liver Transplant; ComplicationsHERCULESNCT04057001
Hepatitis C Positive Organ to Recipient Hepatitis C Negative Longitudinal Transplant Study
An observational study of Liver Transplant; Complications and Hepatitis C, run by Yale University at 1 site in United States.
Trial summary
Compare wait list mortality and time to liver, heart or kidney transplant for registrants listed to consider allografts from Hepatitis C Virus (HCV) Nucleic Amplification Testing (NAT)+ donors versus those who are not . The umbrella protocol has been set up to include heart and kidney transplant recipients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant; Complications, Hepatitis C
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 6 Mar 2023
- 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: Adult patients active on the waiting list for liver transplantation who are HCV NAT-
Recipient Inclusion Criteria:
- Adult patients > or = 18 years of age
- Actively listed for Liver Transplant (LT) or Simultaneous Liver and Kidney (SLK)
- Current HCV NAT- status
- Review by multi-disciplinary transplant team that patient is appropriate for listing for HCV NAT+ liver offers
Recipient Exclusion Criteria:
- Unwilling to consent to post transplant DAA therapy
- Hepatitis B Virus (HBV) viremia
Donor Inclusion Criteria:
- HCV NAT+
- Deceased Donor organs
- HBV cAb donors will be considered on a case by case basis based on specific recipient factors and plan for post-transplant prophylaxis
Donor Exclusion Criteria:
- Bilirubin >3
- Positive nucleotide testing for HBV
- Radiographic, laboratory or other clinical evidence of portal hypertension
- Fibrosis on pre-procurement liver biopsy fibrosis > F1 or fibroscan >7 (if both are done and discordant, use biopsy to determine eligibility
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale School of Medicine
New Haven, Connecticut, 06510
About this study
Official title: Hepatitis C Positive Organ to Recipient Hepatitis C Negative Longitudinal Transplant Study (HERCULES)
Compare wait list mortality and time to liver, heart or kidney transplant for registrants listed to consider allografts from Hepatitis C Virus (HCV) Nucleic Amplification Testing (NAT)+ donors versus those who are not . The umbrella protocol has been set up to include heart and kidney transplant recipients.
Read the detailed description
The research project will take place within each transplant center and can be incorporated into routine pre- and post-transplant care (i.e., no extra visits are needed). Enrolling in this study will enable patients to accept offers of HCV NAT+ livers, in addition to the regular waitlist. All other transplant eligibility criteria have to be met per routine care. The multi-site project will establish a biorepository and prospective data collection with the goal of obtaining more generalizable results than single-center studies alone can.
Patients who enroll in the study but receive an HCV- organ instead, will be (data collection only) as part of the study.
Aims are to evaluate sustained virologic response (SVR) rates post-transplant with Direct Acting Anti-Viral (DAA) therapy, as well as long-term patient and graft outcomes.
Evaluate the financial impact of timely transplant and DAA therapy compared to traditional wait time health care expenditure.
Create a blood and tissue biorepository for future evaluation of HCV NAT+ allografts and their outcomes
- Conditions
- Liver Transplant; Complications, Hepatitis C
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients who received a HCV+ liver transplant | Patients on a wait list for a liver transplant who agree to receiving a hepatitis C+ virus positive tested liver transplant. | |
| Patients who received a HCV- liver transplant | Patients on a wait list for a liver transplant who agree to receiving a hepatitis C- virus positive tested liver transplant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Transplant
Number of days between date of adding patient to the waitlist and transplant date comparing waitlist registrants listed to accept HCV NAT+ donor organs with those followed per standard of care (not accepting HCV NAT+ donor organs).
Measured: 5 years
Secondary outcomes (1)
Wait list Mortality
Number of days between adding patient to the waitlist to death on the waitlist comparing waitlist registrants listed to accept HCV NAT+ donor organs with those followed per standard of care (not accepting HCV NAT+ donor organs).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start1 Jul 2019
- Primary completion6 Mar 2023
- Study completion6 Mar 2023
Why it stopped: Unable to achieve adequate number of HCV+ donor offers
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Yale 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- AnnMarie Liapakis, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04057001
- Sponsor's protocol ID
- 2000022932
- Acronym
- HERCULES
- Status last verified
- Aug 2023
- First submitted
- 13 Jun 2019
- Last updated
- 25 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatitis C Positive Organ to Recipient Hepatitis C Negative Longitudinal Transplant Study (HERCULES)
- ClinicalTrials.gov ID
- NCT04057001
- Acronym / sponsor ID
- HERCULES / 2000022932
- Conditions
- Liver Transplant; Complications, Hepatitis C
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unable to achieve adequate number of HCV+ donor offers
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 6 Mar 2023 (actual)
- Study completion
- 6 Mar 2023 (actual)
- First posted
- 14 Aug 2019 (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.
Compare wait list mortality and time to liver, heart or kidney transplant for registrants listed to consider allografts from Hepatitis C Virus (HCV) Nucleic Amplification Testing (NAT)+ donors versus those who are not . The umbrella protocol has been set up to include heart and kidney transplant recipients.
Detailed description
The research project will take place within each transplant center and can be incorporated into routine pre- and post-transplant care (i.e., no extra visits are needed). Enrolling in this study will enable patients to accept offers of HCV NAT+ livers, in addition to the regular waitlist. All other transplant eligibility criteria have to be met per routine care. The multi-site project will establish a biorepository and prospective data collection with the goal of obtaining more generalizable results than single-center studies alone can.
Patients who enroll in the study but receive an HCV- organ instead, will be (data collection only) as part of the study.
Aims are to evaluate sustained virologic response (SVR) rates post-transplant with Direct Acting Anti-Viral (DAA) therapy, as well as long-term patient and graft outcomes.
Evaluate the financial impact of timely transplant and DAA therapy compared to traditional wait time health care expenditure.
Create a blood and tissue biorepository for future evaluation of HCV NAT+ allografts and their outcomes
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who received a HCV+ liver transplant | – | –Patients on a wait list for a liver transplant who agree to receiving a hepatitis C+ virus positive tested liver transplant. |
| Patients who received a HCV- liver transplant | – | –Patients on a wait list for a liver transplant who agree to receiving a hepatitis C- virus positive tested liver transplant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients active on the waiting list for liver transplantation who are HCV NAT-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to Transplant
Time frame: 5 years
Number of days between date of adding patient to the waitlist and transplant date comparing waitlist registrants listed to accept HCV NAT+ donor organs with those followed per standard of care (not accepting HCV NAT+ donor organs).
1 secondary outcome
Wait list Mortality
Time frame: 5 years
Results and safety
The study was stopped early (reason given: Unable to achieve adequate number of HCV+ donor offers). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
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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.
AnnMarie Liapakis, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant; Complications and Hepatitis C, run by Yale 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?
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: stopped early, as of the sponsor's last update on 25 Aug 2023. 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 was stopped early (reason given: Unable to achieve adequate number of HCV+ donor offers). Results are not available in the source record.
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?
Time to Transplant (time frame: 5 years). 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 25 Aug 2023.