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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04793360
Other study ID # SN-C-00015
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 26, 2021
Est. completion date March 31, 2028

Study information

Verified date April 2024
Source CareDx
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The objective of this protocol is to conduct longitudinal and prospective studies of liver transplant recipients, using a multimodality approach, akin to that used in kidney transplantation. The primary aim will compare the clinical outcomes of LiverCare post-transplant surveillance in liver transplant with standard of care consisting of liver function tests, DSA measurements, drug level monitoring, and 'for cause' biopsy. The protocol will assess the correlation between clinical events (e.g. rejection, recurrent disease, biliary obstruction), dd-cfDNA levels, gene expression profiling, ability to assess microchimerism, develop predictive analytics, infectious disease diagnoses and finally examine graft histology.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1500
Est. completion date March 31, 2028
Est. primary completion date December 31, 2027
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria: - Liver transplant recipients <60 days post-transplant (de-novo or re-transplant). - Participant is willing and able to give informed consent for participation in the trial. - Male or Female, aged 12 years or above (Gillick Competent). - In the Investigator's opinion, is able and willing to comply with all trial requirements. Exclusion Criteria: - Female participant who is pregnant, lactating or planning pregnancy during the course of the trial. - Has evidence of significant post-transplant impairment of hepatic function which is unlikely to improve (determined by the PI). - Scheduled elective surgery or other procedures requiring general anaesthesia during the trial. - Participant with life expectancy of less than 6 months or is inappropriate for diagnostic monitoring through regular blood sampling. - Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial. - Participants who have participated in another research trial involving an investigational product in the past 12 weeks*. - Multi-organ transplant recipients or dual organ transplant recipients. - Patients with significant needle phobia.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
LiverCare
The LiverCare kits contains Streck tubes and PAX gene tubes, which will be collected at the surveillance schedule outlined above, but also prior to any liver biopsy or DSA measurement. For patients who have a histological diagnosis of allograft rejection who are undergoing treatment, serial monitoring of LiverCare will be performed following the schedule above. All research blood tests will be timed with standard clinical testing to avoid any additional needle sticks.

Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan
United States Piedmont Healthcare Atlanta Georgia
United States University of Maryland Medical Center Baltimore Maryland
United States Beth Israel Deaconess Medical Center (BIDMC) Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Medical Unversity of South Carolina Charleston South Carolina
United States Atrium Health Charlotte North Carolina
United States University of Cincinnati Cincinnati Ohio
United States Ohio State University Medical Center Columbus Ohio
United States Methodist Health System Dallas Texas
United States Henry Ford Health System Detroit Michigan
United States Duke University Durham North Carolina
United States University of Iowa Iowa City Iowa
United States Saint Luke's Hospital of Kansas City Kansas City Missouri
United States University of Kansas Medical Center Kansas City Kansas
United States Keck Medical Center of USC Los Angeles California
United States University of Tennessee_Methodist Healthcare Memphis Tennessee
United States Intermountain Medical Center Murray Utah
United States Tulane University New Orleans Louisiana
United States Icahn School of Medicine at Mount Sinai New York New York
United States INTEGRIS Baptist Medical Center Oklahoma City Oklahoma
United States University of Nebraska Medical Center/ Nebraska Medicine Omaha Nebraska
United States Virginia Commonwealth University Richmond Virginia
United States Washington Unversity in St. Louis Saint Louis Missouri
United States University of California San Diego San Diego California
United States University of Washington Seattle Washington
United States Tampa General Hospital Tampa Florida
United States Westchester Medical Center Valhalla New York
United States MedStar Georgetown University Hospital Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
CareDx

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To correlate the results of LiverCare with clinically significant events impacting post-transplant clinical outcomes, histological findings, and the development of de novo Donor Specific Antibody (DSA) LiverCare will be measured 7 times in year 1 and quarterly each year. A total of 15 surveillance points per subject in addition to for-cause testing based on clinical changes. Liver care will be collected at the time of all histologic analyses whether 'for cause' or 'surveillance' 2 years of accrual and 3 years follow up
See also
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