Clinical trials: Liver Transplants
Hepatitis B, Chronic
Efficacy and Safety of Intramuscular HBIG Grifols for the Prevention of Recurrence After Liver Transplantation
The purpose of this study is to determine if treatment with intramuscular hepatitis B virus immune globulin Grifols, a new specific hepatitis B immune globulin, is effective and safe for the prevention of hepatitis B virus…
- Trial name
- NCT00895713
- Testing
- intramuscular hepatitis B virus immune globulin
- Where
- 2 sites in Italy
- Volunteers
- 18 people
- Sponsor
- Instituto Grifols, S.A.
Hepatitis C Virus Infection
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination Administered in Patients Infected With Chronic Genotype 1 or 4 HCV for Use in the Peri-Operative Liver Transplantation Setting
The primary objective of this study is to evaluate the antiviral efficacy of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) therapy at the time of liver transplantation and through 4 weeks…
- Trial name
- NCT02350569
- Testing
- LDV/SOF
- Where
- 6 sites in United States
- Volunteers
- 17 people
- Sponsor
- Gilead Sciences
Liver Transplantation
Study of the Effect of Everolimus Immunosuppressive Combination Therapies on Renal Function When Used as a Maintenance Treatment for Liver Transplant Patients.
A 24-month multi-center, open-label, randomized, controlled study to evaluate the evolution of renal function in maintenance liver transplant recipients receiving everolimus plus reduced TAC or everolimus plus mycophenolate…
- Trial name
- Prometheus (NCT03596970)
- Testing
- TAC withdrawal, Everolimus with reduced TAC
- Sponsor
- Novartis Pharmaceuticals
Liver Transplant
Efficacy and Safety of CertiroBell® Tablet Plus Tacrolimus in Primary Living Donor Liver Transplant Recipients
To evaluate the efficacy and safety of CertiroBell® tablet plus tacrolimus
- Trial name
- STELLA (NCT04867720)
- Testing
- Everolimus
- Where
- South Korea
- Volunteers
- 112 people
- Sponsor
- Chong Kun Dang Pharmaceutical
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
Ischemia-reperfusion Injury in Liver Transplant, Early Allograft Dysfunction
Pilot Study of Reparixin for Early Allograft Dysfunction Prevention in Liver Transplantation
The objective of the study is to evaluate the efficacy and safety of Reparixin treatment (2.772 mg/kg body weight/hour intravenous continuous infusion for 7 days) based on incidence of early allograft dysfunction within the first…
- Trial name
- NCT03031470
- Testing
- Reparixin, Control
- Where
- 7 sites in Belarus, Russia
- Volunteers
- 40 people
- Sponsor
- Dompé Farmaceutici S.p.A
Alcoholic Liver Cirrhosis
Long-Term Follow-up of Patients With Alcoholic Liver Cirrhosis Treated With Cellgram-LC
The goal of this observational study is to learn about the long-term safety of Cellgram-LC in patients with alcoholic liver cirrhosis who previously received Cellgram-LC in the PMC-P-07 study.
- Trial name
- NCT05093881
- Where
- 14 sites in South Korea
- Volunteers
- 100 people
- Sponsor
- Pharmicell Co., Ltd.
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 Transplantation
A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Liver Transplant Patients
A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable liver transplant patients converted from a tacrolimus (Prograf®) based immunosuppression regimen to a modified release tacrolimus based…
- Trial name
- NCT00282243
- Testing
- tacrolimus modified release (MR), tacrolimus
- Where
- 10 sites in United States
- Volunteers
- 70 people
- Sponsor
- Astellas Pharma Inc
Organ Transplant, Ischemic Reperfusion Injury
PERTRIAL - Perla® Preservation Solution
Perla® is a Cold Preservation Solution, with purpose to wash out, preserve during transport liver and kidney grafts in optimal conditions from the donor to the recipient.
- Trial name
- NCT05194306
- Testing
- Perla® Cold Preservation solution
- Where
- Spain
- Volunteers
- 11 people
- Sponsor
- Advanced Life Solutions
Liver Transplantation
A Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Stable Liver Transplantation Patients
This study aims to evaluate and to compare the efficacy and safety of FK506MR with Prograf® in stable liver transplantation patients.
- Trial name
- NCT00619398
- Testing
- Prograf, FK506MR capsule
- Where
- 6 sites in China
- Volunteers
- 172 people
- Sponsor
- Astellas Pharma Inc
Liver Diseases
YSPSL for Prevention of Delayed Graft Function in Cadaveric Liver Transplantation
The study is designed to assess the feasibility of evaluating YSPSL for the amelioration of ischemia reperfusion injury following liver transplantation by administering YSPSL into the liver graft directly ex vivo via the portal…
- Trial name
- NCT00450398
- Testing
- YSPSL
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Y's Therapeutics, Inc.
Hepatitis C, Liver Transplantation
Comparing Efficacy and Safety of Tacrolimus With Steroids or Monoclonal Anti-IL2R Antibody in Hepatitis C Virus (HCV) Positive Liver Transplant Patients
This is an exploratory study to evaluate the impact of eliminating steroid administration upon viral HCV load at 12 months measured by quantitative serum HCV-RNA determination in patients transplanted for HCV cirrhosis.
- Trial name
- CHASE (NCT00295607)
- Testing
- Tacrolimus, steroids, monoclonal anti-IL2R antibody
- Where
- 17 sites in Czechia, France and 6 more
- Volunteers
- 138 people
- Sponsor
- Astellas Pharma Inc
Liver Transplant
Efficacy and Safety of Cyclosporine Microemulsion in Diabetic Adult Stable Liver Transplant Recipients
The purpose of this study is to determine whether the switch from tacrolimus to cyclosporine microemulsion benefits post-transplant diabetes management (in terms of glycogenic control and insulin dosage) in stable liver…
- Trial name
- NCT00171743
- Testing
- Cyclosporine microemulsion
- Volunteers
- 47 people
- Sponsor
- Novartis
Kidney Transplantation, Liver Transplantation
Conversion Trial From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS) in Stable Transplanted Patients Suffering From Gastrointestinal (GI) Adverse Events While on Mycophenolate Mofetil Therapy (MMF) Therapy
This open, single arm, explorative study aims to investigate the evolution of gastrointestinal adverse events after switch from MMF to EC-MPS in organ transplanted patients suffering from gastrointestinal adverse events while on…
- Trial name
- NCT00149942
- Testing
- Enteric-coated Mycophenolate sodium (EC-MPS)
- Where
- Switzerland
- Volunteers
- 23 people
- Sponsor
- Novartis
Hepatitis C Infection, Viruses
Civacir® Polyclonal Immune Globulin (IgG) to Prevent Hepatitis C Virus (HCV) Recurrence in Liver Transplant Patients.
The purpose of this study is to test the safety and efficacy of Civacir® to prevent the recurrence of Hepatitis C Virus (HCV) after liver transplant.
- Conditions
- Hepatitis C Infection, Viruses, Hepatocellular Carcinoma, Hepatitis, Viral, Human
- Trial name
- NCT01804829
- Testing
- Civacir® 10%
- Where
- 23 sites in United States
- Volunteers
- 80 people
- Sponsor
- Biotest Pharmaceuticals Corporation
Liver Transplant
US National OCS Liver Perfusion (OLP) Registry
This Registry is a sponsor-initiated, multi-center, observational, post-approval registry with an independent academic oversight.
- Trial name
- National OLP (NCT05940857)
- Testing
- OCS Liver
- Where
- 22 sites in United States
- Volunteers
- 100,000 people
- Sponsor
- TransMedics
Hepatitis C, Chronic
PHOENIX Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) Administered After Liver Transplantation for Hepatitis C.
This 2-arm study was designed to evaluate the efficacy, safety, and tolerability of prophylactic PEGASYS plus COPEGUS after liver transplantation for hepatitis C, compared to initiation of antiviral therapy at the time of…
- Trial name
- NCT00087633
- Testing
- peginterferon alfa-2a [Pegasys], Copegus
- Where
- 28 sites in United States
- Volunteers
- 115 people
- Sponsor
- Hoffmann-La Roche
Kidney Transplantation, Heart Transplantation
A Study to Determine Pharmacokinetics of Children Receiving Modigraf (Tacrolimus Granules) Following Solid Organ Transplantation
The purpose of this study is to find out how much of Modigraf is absorbed and used in the body and how fast it leaves the body (Pharmacokinetics).
- Conditions
- Kidney Transplantation, Heart Transplantation, Liver Transplantation
- Trial name
- OPTION (NCT01371331)
- Testing
- Tacrolimus granules
- Where
- 10 sites in Belgium, France and 4 more
- Volunteers
- 52 people
- Sponsor
- Astellas Pharma Europe Ltd.
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