Clinical trials: Liver Transplants
Liver Transplantation, Kidney Transplantation
A Study to Evaluate the Safety and Efficacy of a Modigraf® Based Immunosuppression Regimen in De Novo Pediatric Allograft Liver and Kidney Transplantation Recipients
The purpose of this study is to observe the safety and efficacy of Modigraf in de novo pediatric allograft liver and kidney transplantation recipients.
- Trial name
- NCT05153915
- Testing
- Tacrolimus granules
- Where
- 7 sites in China
- Volunteers
- 56 people
- Sponsor
- Astellas Pharma China, Inc.
Hepatitis B
A Confirmatory Study of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients
The purpose of this study is to Evaluate the efficacy and safety of Hepabulin IV (HBIG, a study drug) after liver transplantation.
- Trial name
- NCT01513850
- Testing
- Hepabulin IV
- Where
- South Korea
- Volunteers
- 87 people
- Sponsor
- SK Chemicals Co., Ltd.
Hepatitis C, Chronic
A Study of Pharmacokinetics, Efficacy, Safety, Tolerability, of the Combination of Simeprevir (TMC435), Daclatasvir (BMS-790052), and Ribavirin (RBV) in Patients With Recurrent Chronic Hepatitis C Genotype 1b Infection After Orthotopic Liver Transplantation
The purpose of the study is to evaluate effect of steady-state (when the amount of drug administered (in a given time period is equal to the amount of drug eliminated in that same period) of simeprevir and daclatasvir on the…
- Trial name
- NCT01938625
- Testing
- Simeprevir, Daclatasvir, Ribavirin
- Where
- 6 sites in Germany, Poland and 1 more
- Volunteers
- 35 people
- Sponsor
- Janssen R&D Ireland
Liver Transplantation, Infection
Efficacy and Safety of Basiliximab, Cyclosporine/Cyclosporine Microemulsion, and Steroids in Pediatric de Novo Liver Transplant Recipients Avoiding Intraoperative Steroids
Systemic infection is still a major concern in young children with liver transplantation. The approach of this study is to reduce the risk of systemic infections by avoiding intraoperative steroids (another class of…
- Trial name
- NCT00149890
- Testing
- Basiliximab, Cyclosporine/cyclosporine microemulsion, Steroid
- Where
- Germany
- Volunteers
- 77 people
- Sponsor
- Novartis
Liver Transplantation
A Study to Evaluate the Efficiency of Intravenously Administered Cyclosporine in de Novo Liver Transplant Recipients
The aim of this exploratory study is to evaluate the rejection rate in patients treated with cyclosporine (CsA) preceding oral administration of cyclosporine micro emulsion in de novo liver recipients.
- Trial name
- NCT00332462
- Testing
- Cyclosporine (Sandimmun® i.v.), Cyclosporine (Sandimmun® Optoral)
- Where
- Germany
- Volunteers
- 34 people
- Sponsor
- Novartis Pharmaceuticals
Liver Transplant
Efficacy and Safety of Everolimus Versus Mycophenolate Mofetil in Liver Transplant Recipients.
The purpose of this study is to evaluate the efficacy and safety of CertiroBell® tablet compared with mycophenolate mofetil in primary living donor liver transplant recipients.
- Trial name
- MONTBLANC (NCT04471441)
- Testing
- Everolimus Tab., Mycophenolate mofetil Tab./Cap.
- Where
- South Korea
- Volunteers
- 150 people
- Sponsor
- Chong Kun Dang Pharmaceutical
Hepatitits C
An Efficacy and Safety Study of Simeprevir and Sofosbuvir With and Without Ribavirin in Participants With Recurrent Genotype 1 Hepatitis C Post-Orthotopic Liver Transplant
The purpose of this study is to evaluate sustained virologic response 12 weeks after the end of treatment (SVR12) following 12 weeks of simeprevir plus sofosbuvir with and without ribavirin (RBV) and 24 weeks of simeprevir plus…
- Trial name
- GALAXY (NCT02165189)
- Testing
- Simeprevir, Sofosbuvir, Ribavirin
- Where
- 11 sites in United States
- Volunteers
- 46 people
- Sponsor
- Janssen Scientific Affairs, LLC
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
Chronic Hepatitis B
Rollover Protocol Continued Access to Emtricitabine/Tenofovir Disoproxil Fumarate for Adults in United States
The objective of this study is to provide open label emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for an additional 5 years (240 weeks) to adults completing study GS-US-203-0107.
- Trial name
- NCT00936715
- Testing
- FTC/TDF
- Where
- 4 sites in United States
- Volunteers
- 24 people
- Sponsor
- Gilead Sciences
Transthyretin Amyloidosis, Transthyretin Amyloidosis With Cardiomyopathy
Long-term Safety of Eplontersen Treated aTTR Patients and in Liver Transplant and Severely Hepatic Impaired Subpopulations
The aim of this observational cohort study is to characterise use of eplontersen in patients with prior liver transplant or with pre-existing severe hepatic impairment, as well as to assess long-term safety among all new users of…
- Conditions
- Transthyretin Amyloidosis, Transthyretin Amyloidosis With Cardiomyopathy, Transthyretin Amyloidosis With Polyneuropathy
- Trial name
- sTTRing (NCT07654855)
- Testing
- None ( observational study )
- Where
- 6 sites in United States, Canada and 4 more
- Volunteers
- 320 people
- Sponsor
- AstraZeneca
Liver Transplantation
Pharmacokinetics of Tacrolimus in Liver Transplantation Patients Treated With Prograf and Modified Release Tacrolimus
Tacrolimus pharmacokinetics study in primary living donor liver transplantation patients with Tacrolimus based immunosuppressive regimens.
- Trial name
- NCT00909571
- Testing
- FK506E (modified release tacrolimus), Prograf (tacrolimus)
- Where
- South Korea
- Volunteers
- 10 people
- Sponsor
- Astellas Pharma Inc
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
Liver Transplantation, Hepatitis C, Chronic
Effects of Pegylated Interferon Alfa-2b and Ribavirin After Orthotopic Liver Transplantation in Subjects With Chronic Hepatitis C Recurrence (P04590AM3)(COMPLETED)
This is an exploratory study and is a Phase 3, single-arm, multi-center, open-label study of pegylated interferon alfa-2b, PEG-IFN alpha-2b (PEG-Intron) and ribavirin (RBV) to determine the sustained virologic response (SVR) at…
- Conditions
- Liver Transplantation, Hepatitis C, Chronic, Liver Cirrhosis
- Trial name
- NCT00378599
- Testing
- Combination of (a) pegylated interferon alfa-2b and (b) rebetol
- Volunteers
- 125 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis B Virus Associated Liver Disease
Pilot Study to Assess the Pharmacokinetics of Intravenous Nabi 5% Hepatitis B Immune Globulin (Boca HBVIg) Used in Combination With Lamivudine for Patients With Hepatitis B Virus (HBV) Associated Liver Disease Undergoing Liver Transplantation
The purpose of this study is to find the best monthly dose schedule for the new Hepatitis Immune Globulin (Boca HBVIg, a study drug) when used in combination with an antiviral agent Lamivudine after liver transplantation.
- Trial name
- NCT01421212
- Testing
- Hepatitis B Immune Globulin (Boca HBVIg)
- Where
- 11 sites in United States
- Volunteers
- 30 people
- Sponsor
- Biotest Pharmaceuticals Corporation
Liver Failure
Pharmacokinetics of LCP-Tacro™ Once Daily and Prograf® Twice A Day in Adult De Novo Liver Transplant Patients
The purpose of this study is to demonstrate the pharmacokinetics (PK, measuring the amount of medication in blood samples) and safety of a new medicine, LCP-Tacro™ tablets, and Prograf® capsules, a drug commonly taken by…
- Trial name
- NCT00772148
- Testing
- LCP -Tacro, Prograf
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- Veloxis Pharmaceuticals
Liver Diseases, Liver Dysfunction
Global Utilization And Registry Database for Improved preservAtion of doNor Livers
The objective of this registry is to collect and evaluate various clinical effectiveness parameters in patients with transplanted donor liver that were preserved and transported within the LIVERguard system, as well as…
- Conditions
- Liver Diseases, Liver Dysfunction, Liver Transplant Disorder, Liver Transplant Rejection
- Trial name
- NCT05082077
- Testing
- LIVERguard
- Where
- 15 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- Paragonix Technologies
Cirrhosis
Breath Test to Assess Hepatic Metabolic Reserve and to Predict Hepatic Decompensation in Cirrhotics
The three objectives of this trial are: 1. To demonstrate that a decline in hepatic metabolic function as measured by BreathID will correlate with changes in CTP and MELD scores in patients with cirrhosis. 2.
- Trial name
- NCT00375011
- Where
- 3 sites in United States, Israel
- Volunteers
- 200 people
- Sponsor
- Meridian Bioscience, Inc.
Hepato Cellular Carcinoma (HCC), Liver Resection
Retrospective Clinical Validation of HepatoPredict
HepatoPredict is an innovative prognostic tool to support hepatologists, hepatobiliary surgeons and multidisciplinary teams in deciding on the best therapeutical approach for a patient with Hepatocellular Carcinoma, the most…
- Conditions
- Hepato Cellular Carcinoma (HCC), Liver Resection, Liver Transplantation
- Trial name
- NCT06894524
- Volunteers
- 200 people
- Sponsor
- Ophiomics
Liver Transplant, Kidney Transplant
A 5 Year Follow-up of Patients Who Were Previously Enrolled Into an Advagraf Trial Following a Liver or Kidney Transplant
The purpose of this study is to evaluate the impact of Advagraf, prolonged-release, once daily tacrolimus formulation, on long-term graft survival in kidney and liver allograft recipients.
- Trial name
- ADDRESS (NCT02057484)
- Testing
- Tacrolimus
- Where
- 145 sites in Austria, Belarus and 22 more
- Volunteers
- 2,300 people
- Sponsor
- Astellas Pharma Europe Ltd.
Kidney Transplantation, Liver Transplantation
A Study to Compare the Finger Prick Whole Blood MITRA Assay Method With the Established Venepuncture Whole Blood Method for Quantitative Determination of Tacrolimus Blood Concentrations in Transplant Patients
The purpose of this study is to assess relationship between tacrolimus concentrations determined via whole blood MITRA assay method with those determined using the established and validated whole blood venepuncture method using…
- Trial name
- MITRA (NCT03465969)
- Testing
- tacrolimus
- Where
- 4 sites in France, United Kingdom
- Volunteers
- 80 people
- Sponsor
- Astellas Pharma Europe Ltd.