Clinical trials: Liver Transplants
Liver Transplantation
A Study to Assess the Pharmacokinetics, Safety and Efficacy of Advagraf and Prograf in de Novo Liver Transplantation
The purpose of this study is to investigate and compare the pharmacokinetic parameters of tacrolimus from Advagraf and Prograf in de nove living donor liver transplant recipients.
- Trial name
- MAIN (NCT01339468)
- Testing
- Advagraf, Prograf
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Astellas Pharma Inc
Recurrent Chronic Hepatitis C Virus, Post Liver Transplant
Safety and Efficacy of Sofosbuvir and Ribavirin in Adults With Recurrent Chronic Hepatitis C Virus (HCV) Post Liver Transplant
This is an open-label, single-arm study of sofosbuvir (GS-7977) and ribavirin (RBV) in adults who have had a liver transplant which has become re-infected with hepatitis C.
- Trial name
- NCT01687270
- Testing
- Sofosbuvir, RBV
- Where
- 12 sites in United States, France and 3 more
- Volunteers
- 40 people
- Sponsor
- Gilead Sciences
Recurrent Hepatocellular Carcinoma
A Study of LioCyx in Patient With Recurrent HBV-related HCC Post Liver Transplantation
Hepatocellular carcinoma (HCC) represent approximately 70-85% of liver cancer, in which Hepatitis B virus (HBV) is the major etiologic agent accounting for at least 80% of HCC in Asian countries.
- Trial name
- NCT03634683
- Testing
- LioCyx
- Where
- 3 sites in China, Singapore
- Sponsor
- Lion TCR Pte. Ltd.
Liver Transplantation, Mycoses
Liver Transplant European Study Into the Prevention of Fungal Infection
Prevention of invasive fungal infection in high risk patients following liver transplant.
- Trial name
- TENPIN (NCT01058174)
- Testing
- micafungin, fluconazole, liposomal amphotericin B
- Where
- 36 sites in Austria, Belgium and 12 more
- Volunteers
- 350 people
- Sponsor
- Astellas Pharma Inc
Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases
The Mycophenolate Pregnancy Registry
The Mycophenolate Pregnancy Registry is designed as a prospective, observational registry collecting data regarding mycophenolate exposure during pregnancy, and pregnancy outcomes, fetal and infant outcomes after exposure.
- Trial name
- NCT01733082
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- Genentech, Inc.
Transthyretin (TTR)-Mediated Amyloidosis, Familial Amyloidotic Polyneuropathy (FAP)
The Study of an Investigational Drug, Revusiran (ALN-TTRSC), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis in Patients Whose Disease Has Continued to Worsen Following Liver Transplant
The purpose of this study was to evaluate the safety and effectiveness of revusiran (ALN-TTRSC) in adults with transthyretin-mediated amyloidosis (ATTR), whose disease has continued to worsen after liver transplantation.
- Conditions
- Transthyretin (TTR)-Mediated Amyloidosis, Familial Amyloidotic Polyneuropathy (FAP), ATTR Amyloidosis, Familial Amyloid Neuropathies
- Trial name
- NCT02595983
- Testing
- Revusiran
- Where
- 6 sites in France, Germany and 4 more
- Volunteers
- 12 people
- Sponsor
- Alnylam Pharmaceuticals
Liver Transplantation
A Study of TCD601 in the Induction of Tolerance in de Novo Liver Transplantation
The purpose of this study is to evaluate if treatment with a siplizumab-based regimen can induce allogeneic tolerance in liver transplant recipients.
- Trial name
- NCT06019507
- Testing
- TCD601, Cyclophosphamide, TAC
- Where
- Sweden
- Volunteers
- 12 people
- Sponsor
- ITB-Med LLC
Hepatitis B, Liver Transplantation
HepeX-B in Post Hepatic Allografts for Treatment of End Stage Liver Disease Due to Hepatitis B Infection
The purpose of this study is to compare the use of HepeX-B versus HBIg, two anti-viral drugs, in patients who have received liver transplants due to liver failure caused by Hepatitis B infection.
- Trial name
- NCT00228592
- Testing
- HepeX-B, Hepatitis B Immune Globulin (HBIg)
- Where
- 20 sites in United States, France and 5 more
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Liver Transplantation
A Multicenter Study Evaluating the Safety and Tolerability of Intravenous rhMBL in Liver Transplant Recipients.
This is a multicenter, open-label, randomized, Phase 1B study evaluating liver transplant recipients receiving rhMBL (2 cohorts) or without rhMBL (1 cohort).
- Trial name
- NCT00415311
- Testing
- Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)
- Where
- 4 sites in United States
- Volunteers
- 24 people
- Sponsor
- Enzon Pharmaceuticals, Inc.
Tacrolimus-associated Abnormal Glucose Metabolism in Kidney and Liver Transplant Recipients
Safety and Efficacy of Converting Maintenance Kidney and Liver Transplant Recipients With Abnormal Glucose Metabolism From Tacrolimus to Cyclosporine Micro-emulsion
New onset diabetes mellitus (NODM) post- transplantation decreases patient and graft survival. Some immunosuppressive agents are associated with a higher incidence of NODM.
- Trial name
- NCT00150085
- Testing
- cyclosporine micro-emulsion
- Volunteers
- 50 people
- Sponsor
- Novartis
Hepatitis B
Registry Study for Patients With Chronic HBV Receiving Nucleotide Therapy
This registry will remain open for approximately 5 years (4 years of enrollment + 1 year of follow up). Subjects will be followed until Orthotopic Liver Transplant (OLT), resolution of liver decompensation, death, or conclusion…
- Trial name
- NCT01590615
- Testing
- Anti-HBV nucleoside/nucleotide therapy
- Where
- 27 sites in United States, Canada
- Volunteers
- 54 people
- Sponsor
- Gilead Sciences
Liver Transplantation
A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Liver Transplant Patients.
This 2 arm study will compare the efficacy and safety of two CellCept-containing treatment regimens in de novo liver transplant patients.
- Trial name
- NCT00545402
- Testing
- Mycophenolate mofetil, adjusted dose, Tacrolimus, Corticosteroids, IV
- Where
- 16 sites in France
- Volunteers
- 180 people
- Sponsor
- Hoffmann-La Roche
Hemorrhage
PeproStat Haemostat Study in Subjects Undergoing Liver Surgery
The purpose of this First in Man study is to evaluate the safety and tolerability, as well as to explore efficacy of PeproStat, a new peptide based coagulant (haemostat), when used in patients undergoing open liver resection…
- Trial name
- NCT02204930
- Testing
- PeproStat
- Where
- 4 sites in United Kingdom
- Volunteers
- 20 people
- Sponsor
- Haemostatix Ltd
Liver Transplantation
Study Evaluating of Calcineurin Inhibitor and Sirolimus (Rapamune) Treatment in Liver Transplant Recipients
The purpose of this study is to evaluate the sirolimus conversion regimen as compared with the calcineurin inhibitor continuation regimen with regards to renal function in stable liver transplant subjects.
- Trial name
- NCT00086346
- Testing
- Sirolimus (Rapamune), Cyclosporine or Tacrolimus
- Where
- 42 sites in United States, Belgium and 10 more
- Volunteers
- 607 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Liver Failure
Assessment of the Pharmacokinetic Profile of Tacrolimus Medications and Their Relation to Effectiveness and Safety in Liver Transplant Patients
The goal of this observational study is oo compare the pharmacokinetic parameters of different tacrolimus containing medications in liver transplant patients.
- Trial name
- LTA (NCT05744635)
- Testing
- Tacrolimus
- Where
- 2 sites in Hungary, Slovenia
- Volunteers
- 110 people
- Sponsor
- Chiesi Hungary Ltd.
Liver Transplant
A Multicentre, Randomised, Open-label, Controlled, 12-month Follow-up Study to Assess Impact on Renal Function of an Immunosuppression Regimen Based on Tacrolimus Minimisation in Association With Everolimus in de Novo Liver Transplant Recipients.
Assuming greater efficacy in the prevention of acute rejection in the EVR arm with minimisation of TAC levels, the hypothesis of the present trial was that the introduction of EVR in combination with the minimisation of TAC…
- Trial name
- REDUCE (NCT02040584)
- Testing
- Minimisation of TAC, TAC + MMF + corticosteroids
- Where
- 20 sites in Spain
- Volunteers
- 217 people
- Sponsor
- Novartis Pharmaceuticals
Hepatitis B
PK Study of Tacrolimus and Cyclosporine When Co-Administered With Adefovir Dipivoxil in Post-Liver Transplant Patients
Open-label pharmacokinetic drug interaction study.
- Trial name
- NCT00644761
- Testing
- Adefovir Dipivoxil
- Where
- 11 sites in United States
- Volunteers
- 16 people
- Sponsor
- Gilead Sciences
Liver Diseases
Drug Use Investigation for IMURAN (Azathioprine) Tablet (Hepatic Transplantation)
This post-marketing surveillance (PMS) study is designed to investigate the efficacy and safety of azathioprine tablets in Japanese subjects whom liver transplantation is performed.
- Trial name
- NCT01390766
- Testing
- Azathioprine
- Volunteers
- 41 people
- Sponsor
- GlaxoSmithKline
Hepatitis B, Chronic
Nabi-HB Administered Subcutaneously in Patients With Hepatitis B Virus Post Liver Transplantation
A phase 3, multicenter, open label study to assess the safety and efficacy of Nabi-HB, administered subcutaneously in patients with Hepatitis B Virus Associated Liver Disease who underwent liver transplantation.
- Trial name
- Nabi-HB-SC (NCT00800787)
- Testing
- Nabi-HB
- Sponsor
- Biotest Pharmaceuticals Corporation
Liver Transplant Rejection
Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Liver Transplant Recipients With Additional 12-month Follow-up and Long-term Extension
This was a multicenter, open-label, active-controlled study to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of two CFZ533 maintenance doses in de novo liver transplant recipients.
- Trial name
- CONTRAIL I (NCT03781414)
- Testing
- CFZ533, Tacrolimus - MMF - corticosteroids
- Where
- 29 sites in United States, Argentina and 8 more
- Volunteers
- 129 people
- Sponsor
- Novartis Pharmaceuticals