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NCT03603548
Comparison of Safety and Efficacy of Two Variants of Prolonged - Released Tacrolimus (Advagraf vs. Envarsus ) in Patients After Liver Transplantation : Single Center Randomised Control Trial
NA trial testing Envarsus in Liver Transplant Rejection in 200 participants. Status unknown.
9 July 2023
Quick facts
| Lead sponsor | Medical University of Warsaw |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 200 |
| Start date | 9 July 2018 |
| Primary completion | 9 July 2023 |
| Estimated completion | 9 July 2023 |
| Sites | 1 location across Poland |
Drugs / interventions tested
Conditions studied
- Liver Transplant Rejection — all drugs for Liver Transplant Rejection →
- Immunosuppression — all drugs for Immunosuppression →
Sponsor
Medical University of Warsaw
Who can join
Adults 18 to 70, any sex, with Liver Transplant Rejection or Immunosuppression. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Adult patients after liver transplantation initially treated with traditional Tacrolimus variant- Prograf, switched on day 10 after orthotropic liver transplantation (OLTx) on prolonged released Tacrolimus variant in 1:1 ratio ( Advagraf vs. Envarsus)
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03603548
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Envarsus
Trials testing the same drug.
- NCT05655273 — Conversion of Maintenance Prograf to Envarsus in Liver Transplant Recipients · Phase 4 · enrolling by invitation
- NCT04973982 — ENvarsus for Impaired Glucose Tolerance Post REnal transplAnT · NA · withdrawn
- NCT03823768 — Envarsus Neurotoxicity Burden in Liver Transplant Patients · Phase 4 · completed
- NCT03703154 — Alterations in Cognitive Function and Cerebral Blood Flow After Conversion From Immediate Release Tacrolimus to Slow Rel · completed
- NCT03461445 — Effect of Tacrolimus Formulation on Neurological Side Effects in Older Kidney Transplant Recipients · Phase 4 · completed
Other recruiting trials for Liver Transplant Rejection
Currently open trials in the same condition.
- NCT07053488 — CRISPR-Edited HLA Donor Liver Transplant to Reduce Rejection · Phase 1, PHASE2 · recruiting
- NCT06400771 — Safety of DNP007 in Healthy Subjects · Phase 1 · recruiting
- NCT05325073 — Erythropoietin Therapy to Induce Regulatory T Cells in Liver Transplant Recipients · Phase 4 · active not recruiting
- NCT06153641 — Cytokeratin 18 Non-invasive Biomarker for Rejection in Liver Transplant Patients · active not recruiting
Other Medical University of Warsaw trials
Trials by the same sponsor.
- NCT07515768 — TAVI Without On-Site Cardiac Surgery in Poland: A Randomized Multicenter Trial Protocol · NA · not yet recruiting
- NCT07511907 — Routine Intraoperative White Test for Bile Leak Detection in Liver Resection · NA · not yet recruiting
- NCT07498660 — PRP Injection Into the Sacroiliac Joint After Ipsilateral THA: Effects on Early Recovery and Function (SIJ-THA Randomize · NA · not yet recruiting
- NCT07398898 — Use of Augmented Reality Glasses and Noise-Cancelling Headphones to Reduce Dental Anxiety in Adult Patients · NA · recruiting
- NCT07237204 — 15 vs 45 Minute Pringle Maneuver in Liver Cancer Resection: Randomized Noninferiority Trial · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03603548 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Medical University of Warsaw
- Last refreshed: 27 July 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03603548.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing