Clinical trials: Transplantation, Liver
Liver Preservation
Trial of the TransMedics Organ Care System™ Liver For Preserving and Assessing Donor Livers for Transplantation
A prospective, single-center controlled trial to evaluate the safety and performance of the portable Organ Care System (OCS) Liver for preservation and assessment of donor livers for transplantation.
- Trial name
- REVIVE (NCT02449694)
- Testing
- OCS Liver
- Where
- United Kingdom
- Volunteers
- 25 people
- Sponsor
- TransMedics
Hepatitis B, Liver Transplantation
Evaluation of HepaGam B® in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients
The purpose of the study is to assess the pharmacokinetics, safety and efficacy of HepaGam B in combination with antiviral therapy for the prevention of hepatitis B virus (HBV) recurrence following HBV-related orthotopic liver…
- Trial name
- NCT00722332
- Testing
- HepaGam B
- Where
- 16 sites in United States, Canada
- Volunteers
- 9 people
- Sponsor
- Cangene Corporation
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
Liver Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Sirolimus in Recipients of a Liver Transplant
This two-arm study will assess the efficacy and safety of a long-term calcineurin inhibitor-free maintenance regimen with CellCept and sirolimus in recipients of an orthotropic liver transplant.
- Trial name
- NCT00118742
- Testing
- mycophenolate mofetil [CellCept], Tacrolimus, Cyclosporine
- Where
- 46 sites in United States, Canada
- Volunteers
- 293 people
- Sponsor
- Hoffmann-La Roche
Liver Transplantation
Comparing Efficacy & Safety of Tacrolimus With/Without MMF or Monoclonal Anti-IL2R Antibody in Liver Transplantation.
To compare the efficacy and safety of two regimens containing tacrolimus and minimal steroids together with either monoclonal anti-IL2R antibodies (daclizumab) or mycophenolate mofetil.
- Trial name
- MARSILEA (NCT00295594)
- Testing
- tacrolimus
- Where
- 41 sites in Belgium, Denmark and 9 more
- Volunteers
- 627 people
- Sponsor
- Astellas Pharma Inc
Hemorrhage
TachoSil® Versus Surgicel® Original for the Secondary Treatment of Local Bleeding in Adult and Pediatric Patients Undergoing Hepatic Resection Surgery
The efficacy and safety of TachoSil® as secondary hemostatic treatment in hepatic resection surgery will be compared to the standard USA licensed hemostatic agent, Surgicel® Original.
- Trial name
- NCT01192022
- Testing
- TachoSil®, Surgicel® Original
- Where
- 17 sites in United States
- Volunteers
- 253 people
- Sponsor
- Takeda
Evidence of Liver Transplantation
The Study to Evaluate Efficacy and Safety of MY-REPT Capsule in Primary, Liver Transplantation Recipients (MYLT1)
Efficacy and safety of MY-REPT capsule in primary, liver transplantation recipients
- Trial name
- NCT01766518
- Testing
- Mycophenolate mofetil
- Where
- 3 sites in South Korea
- Volunteers
- 120 people
- Sponsor
- Chong Kun Dang Pharmaceutical
Intestine Transplantation, Kidney Transplantation
Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf®
Parts A \& B: Conversion of stable pediatric allograft recipients from Prograf® immunosuppression to Advagraf® immunosuppression to compare exposure and one year follow-up for safety and efficacy.
- Conditions
- Intestine Transplantation, Kidney Transplantation, Lung Transplantation, Liver Transplantation
- Trial name
- NCT01294020
- Testing
- Tacrolimus, Tacrolimus prolonged release
- Where
- 16 sites in Belgium, Czechia and 5 more
- Volunteers
- 81 people
- Sponsor
- Astellas Pharma Europe Ltd.
Hepatitis C
Follow-up Study of Patients Who Experienced Thromboembolic Events in the ENABLE Studies
The objective of this observational study is to characterize long-term (5 years post event) clinical outcomes in patients who experienced a thromboembolic event (TEE) during participation in the GSK ENABLE clinical trials.
- Trial name
- NCT01715779
- Testing
- Eltrombopag
- Volunteers
- 22 people
- Sponsor
- Novartis
Chronic Hepatitis B
Truvada Versus Truvada Plus Hepatitis B Immunoglobulin (HBIg) in Prevention of Chronic Hepatitis B Recurrence Post Liver Transplant
The objective of this 96-week study was to evaluate the safety and antiviral efficacy of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF, coformulated; Truvada®) with or without hepatitis B immunoglobulin (HBIg) in…
- Trial name
- NCT00507689
- Testing
- FTC/TDF, Hepatitis B Immunoglobulin (HBIg)
- Where
- 7 sites in United States
- Volunteers
- 40 people
- Sponsor
- Gilead Sciences
Chronic HCV Infection
Ledipasvir/Sofosbuvir Fixed-Dose Combination Plus Ribavirin in Participants With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant
This study will evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) in participants with advanced liver disease or posttransplant and chronic genotype 1 or 4 hepatitis C virus (HCV)…
- Trial name
- NCT02010255
- Testing
- LDV/SOF, RBV
- Where
- 34 sites in Australia, Austria and 10 more
- Volunteers
- 334 people
- Sponsor
- Gilead Sciences
Liver Transplantation
A Multicenter Study in Liver Transplant Patients Converted From Prograf® to Advagraf® During the First Post-transplantation Year
A study in which two groups of patients will be analysed; patients converted from Prograf to Advagraf within the first 3 months after transplantation and patients converted from Prograf to Advagraf between 3 months and 1 year…
- Trial name
- COBALT (NCT02143479)
- Testing
- Tacrolimus
- Where
- 18 sites in France
- Volunteers
- 398 people
- Sponsor
- Astellas Pharma S.A.S.
Hepatitis
Study to Evaluate the Safety and Efficacy of Larsucosterol in Participants With Alcohol-associated Hepatitis (AH)
The primary purpose of this study is to evaluate the safety and efficacy of larsucosterol, as determined by transplant-free survival through Day 90 in participants with severe alcohol-associated hepatitis (AH) with pre-treatment…
- Trial name
- NCT07428538
- Testing
- Larsucosterol
- Where
- 92 sites in United States
- Volunteers
- 350 people
- Sponsor
- Bausch Health Americas, Inc.
Liver Transplant
Efficacy and Safety of Once-Daily Tacrolimus in Liver Transplant Recipients (SOUL)
The purpose of this study is to evaluate the efficacy and safety of conversion to TacroBell slow-release cap.(Once-daily Tacrolimus) in patients undergoing maintenance therapy with Twice-Daily Tacrolimus after liver…
- Trial name
- NCT04069065
- Testing
- Conversion to Once-daily Tacrolimus
- Where
- South Korea
- Volunteers
- 146 people
- Sponsor
- Chong Kun Dang Pharmaceutical
Hepatocellular Carcinoma
Clemizole HCl for Subjects With Hepatocellular Carcinoma
This study is a phase IIa open label pilot study of up to six months treatment with clemizole hydrochloride (200 mg vs. 300 mg vs. 400 vs.
- Trial name
- NCT03069508
- Testing
- Clemizole Hydrochloride
- Where
- Turkey (Türkiye)
- Volunteers
- 12 people
- Sponsor
- Eiger Group International, 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
Chronic Hepatitis C, HCV
A Study to Evaluate the Safety and Efficacy of ABT-493/ABT-530 in Adult Post-Liver or Post-Renal Transplant Recipients With Chronic Hepatitis C Virus (MAGELLAN-2)
The purpose of this study is to assess the safety and efficacy of 12 weeks of treatment of ABT-493/ABT-530 (glecaprevir/pibrentasvir) in adults who are post primary orthotopic liver or renal transplant with chronic hepatitis C…
- Conditions
- Chronic Hepatitis C, HCV, Hepatitis C Virus
- Trial name
- NCT02692703
- Testing
- glecaprevir/pibrentasvir
- Volunteers
- 100 people
- Sponsor
- AbbVie
Liver Transplantation
A Study of CellCept (Mycophenolate Mofetil) Combined With Calcineurin Inhibitors in Liver Transplant Patients.
This 2 arm study will compare the efficacy and safety of switching to CellCept combined with different regimens of reduced calcineurin inhibitors (CNI) in patients with liver transplants.
- Trial name
- NCT00717314
- Testing
- Mycophenolate mofetil, CNI (50%), CNI (≥75%)
- Where
- 11 sites in China
- Volunteers
- 87 people
- Sponsor
- Hoffmann-La Roche
Acute-graft-versus-host Disease, Steroid Refractory Acute Graft Versus Host Disease
Early Access Program Using Alpha 1 Antitrypsin Infusion for Patients With Steroid Refractory Acute GvHD After Hematopoietic Stem Cell Transplantation (HSCT)
An Early Access Program for patients with steroid refractory acute GvHD after hematopoietic stem cell transplantation. This Program is available for female and male who are recipients of allogenic HSCT and who have been newly…
- Conditions
- Acute-graft-versus-host Disease, Steroid Refractory Acute Graft Versus Host Disease, Graft-versus-host-disease, Graft Vs Host Disease
- Trial name
- NCT03172455
- Testing
- Glassia
- Sponsor
- Impatients N.V. trading as myTomorrows
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