NCT06061341Leállítva
TruGraf Liver Gene Expression Serial Test
Usage of TruGraf Liver Gene Expression to Identify Subclinical Rejection as Well as Adjust Immunosuppression Medications in Liver Transplant Recipients Due to Autoimmune Disease
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. aug. 7.
Megadott ok: Funding discontinued
Rövid összefoglaló (regiszter, angolul)
This is an Investigator Initiated, single center, non-randomized, single arm study utilizing TruGraf liver gene expression serial testing in patients with autoimmune liver diseases (AIH, PSC, PBC) monthly for the first 6 months after transplant to help inform immunosuppression (IS) optimization. Approximately 20 patients will be enrolled in the study. Study outcomes will include 1-year graft survival, 1 year BPAR and clinically treated rejection rates, number of changes to IS based on the results of Trugraf, eGFR and immune mediated issues. TruGraf®, (Transplant Genomics, Inc., a member of Eurofins Transplant Diagnostics) is a non-invasive blood-based test to assist the clinician in lowering immunosuppression in liver transplant patients. It is the first and only blood-based test that offers biomarker guidance to aid physicians in minimizing immunosuppression in transplant recipients. Unfortunately, achieving the tight control of therapeutic levels of immunosuppression that is required to maintain the balance between "too much" and "too little" can be difficult. TruGraf liver can help clinicians confirm immune "quiescence" prior to, as well as following, immunosuppression reduction in patients with stable graft function, minimizing the risk of overt graft injury due to rejection. The clinical context of use for TruGraf is to provide reassurance to the clinician who is contemplating a preemptive reduction in IS therapy that a patient's immune status is "quiescent" thus reducing the risk of triggering acute rejection with that IS reduction. Having the ability to assess whether the patient's immune status is "quiescent" or activated when considering an increase or decrease in IS therapy allows the clinician greater confidence in decision making.
- Állapot (regiszter)
- Leállítva
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 13 (tényleges)
- Első benyújtás
- 2023. szept. 20.
- Kezdés
- 2024. aug. 1.
- Elsődleges befejezés
- 2025. dec. 3.
- Fő szponzor
- Washington University School of Medicine
- Betegségek
- Primer biliáris cholangitis (PBC)
- NCT-szám
- NCT06061341
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Korábbi kezelés
- Recipients of multi-organ or repeat transplantation
Más betegség
- Grafts from donors with HIV
- Grafts from donors with viremic Hepatitis A, B, C
Életkor
- Recipient <18 years of age
Egyéb
- Inability to meet study requirements
Kiket keres a vizsgálat
- Recipients ≥18 years of age
- Currently waitlisted for liver transplant or recipient of liver transplant within the last 30 days
- Primary indication for transplant due to autoimmune hepatitis (AIH) - Primary Biliary Cirrhosis (PBC) or Primary Sclerosing Cholangitis (PSC) etiologies
- First time, single-organ liver transplant recipient
- Willing and able to undergo protocol required TruGraf serial blood draws
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (2)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Washington University and Barnes Jewish Hospital | St Louis | Egyesült Államok | Ismeretlen állapot |
| Washington University School of Medicine | St Louis | Egyesült Államok | Ismeretlen állapot |
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