Using FibroScan to guide lowering immune-suppressing drugs after liver transplant
Use of Transient Elastography to Guide Immunosuppression Minimization Post Liver Transplantation
This will test whether using FibroScan to measure liver stiffness lets doctors safely reduce immunosuppressive drugs in adults at least 2 years after a liver transplant who don't have autoimmune liver disease or recent rejection.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT07206277 on ClinicalTrials.gov |
What this trial studies
The trial enrolls adult liver transplant recipients who are at least 2 years and up to 6 years post-transplant with normal liver tests and no recent rejection, viral hepatitis, or class II donor-specific antibodies. Participants will undergo FibroScan to measure liver stiffness and fat, and those with readings consistent with a healthy graft will be offered stepwise reduction of immunosuppression. Investigators will monitor patients with blood tests, repeat FibroScan and clinical follow-up to detect rejection or other complications. The approach tests whether FibroScan-guided minimization can safely reduce long-term drug exposure.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18 years) 2–6 years after liver transplant with normal liver biochemistry, no history of rejection in the past year, no autoimmune liver disease, no active HBV/HCV, and no class II donor-specific antibodies.
Not a fit: Patients with autoimmune liver disease, recent or ongoing rejection, abnormal liver tests, detectable HBV/HCV, class II DSA, decompensated disease, significant kidney failure, or those more than 6 years post-transplant are unlikely to benefit from minimization in this protocol.
Why it matters
Potential benefit: If successful, this could let some transplant recipients take fewer immunosuppressive drugs and lower their long-term risks of kidney disease, diabetes, cardiovascular disease, and certain cancers.
How similar studies have performed: Small prior studies have suggested FibroScan can help identify patients who tolerate immunosuppression reduction, but larger controlled trials remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 2 years or more post-liver transplant * 18 years or older Exclusion Criteria: * diagnosis of either acute or chronic rejection in the past 12 months * abnormal liver enzymes (ALT \> 50; bilirubin \> 19 umol/L) * transplant for autoimmune liver disease (autoimmune hepatitis, primary sclerosing cholangitis, and primary biliary cholangitis) * presence of HCV RNA * presence of HBV DNA * presence of class II donor specific antibodies (DSA; pre-existing or de novo) * beyond 6 years of transplantation * presence of ascites, decompensated heart failure, biliary obstruction, CKD (bl eGFR 30 ml/min/1.73m2 or less), re-transplantation, or multi-visceral transplant.
Where this trial is running
Edmonton, Alberta
- University of Alberta — Edmonton, Alberta, Canada (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.