Clinical trials: Hepatic Transplantation
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.
Chronic Hepatitis C
A Multicenter Treatment Protocol of Daclatasvir (BMS-790052) in Combination With Sofosbuvir for the Treatment of Post-Liver Transplant Subjects With Chronic Hepatitis C
The primary objective of this program is to provide DCV for 24 weeks to be given in combination with SOF to subjects with chronic hepatitis C with decompensated cirrhosis or post-liver transplant subjects with chronic hepatitis C…
- Trial name
- NCT02161939
- Testing
- Daclatasvir (BMS-790052), Sofosbuvir
- Where
- 20 sites in United States
- Sponsor
- Bristol-Myers Squibb
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
Liver Transplantation
Continued Access Study to Evaluate Performance of the Organ Recovery Systems _LifePort® Liver Transporter System, a Machine Perfusion System, for Liver Transplant (PILOT™_CA)
To provide continued access for the LLT system to provide additional safety data in support of the PILOT pivotal efficacy and safety trial
- Trial name
- PILOT™_CA (NCT05574361)
- Testing
- Hypothermic Machine Perfusion
- Where
- 5 sites in United States
- Volunteers
- 385 people
- Sponsor
- Organ Recovery Systems, Inc.
Cytomegalovirus Infections
An Observational Study of Valcyte (Valganciclovir) in D+/R- Liver Transplant Recipients
This retrospective review will evaluate the efficacy of Valcyte (valganciclovir) in preventing Cytomegalovirus (CMV) disease in D+/R- liver transplant recipients.
- Trial name
- NCT02062294
- Where
- 3 sites in Switzerland
- Volunteers
- 14 people
- Sponsor
- Hoffmann-La Roche
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
Intraoperative Complications
Hydroxyethyl Starch (130/0.4) for Intravascular Volume Therapy in Liver Transplantation
There are no standardized plasma volume replacement protocols during liver transplantation surgery. The current study is designed to compare efficacy, safety, and costs of perioperative volume replacement with Voluven…
- Trial name
- NCT00308100
- Testing
- Hydroxyethylstarch 130/0.4, 5% Albumin
- Where
- China
- Volunteers
- 53 people
- Sponsor
- Fresenius Kabi
Liver Transplantation
Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients
This trial was designed to address important issues that impact recipients of liver allografts as well as clinicians, ie, renal function, reduction or discontinuation of tacrolimus early post-transplantation, and progression rate…
- Trial name
- RAD (NCT00622869)
- Testing
- Tacrolimus (reduced tacrolimus), Tacrolimus (tacrolimus elimination), Tacrolimus (tacrolimus control)
- Where
- 91 sites in United States, Argentina and 17 more
- Volunteers
- 719 people
- Sponsor
- Novartis Pharmaceuticals
Hepatitis B
A Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj.
The purpose of this study is to evaluate the efficacy and safety of undiluted intravenous infusion of I.V.-Hepabig inj. in post-liver transplant patients
- Trial name
- NCT05686759
- Testing
- Undiluted I.V.-Hepabig inj(GC5103), Diluted I.V.-Hepabig inj(GC5103)
- Where
- 8 sites in South Korea
- Volunteers
- 105 people
- Sponsor
- GC Biopharma Corp
Liver Transplant Surgery, Liver Transplantation
Open Label Trial of Deceased Donor Livers Transplanted After DHOPE With eXVIVO LIVER Perfusion
The purpose of this clinical study is to confirm the safety and effectiveness of dual hypothermic oxygenated perfusion (DHOPE) using the Liver Assist to preserve deceased donor livers for transplantation.
- Trial name
- NCT06916325
- Testing
- dual hypothermic oxygenated perfusion (DHOPE)
- Volunteers
- 215 people
- Sponsor
- XVIVO Perfusion
End Stage Liver Disease
Allogenic Hepatocyte Transplantation Into Periduodenal Lymph Nodes
This Phase 2a clinical trial is a dose escalation study of the safety, tolerability, and efficacy of hepatocyte transplantation into lymph nodes via endoscopic ultrasound among subjects with end-stage liver disease.
- Trial name
- NCT04496479
- Testing
- LYG-LIV0001
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- LyGenesis, Inc.
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 Transplantation
Phase 3b Study to Evaluate Advagraf in Combination With Mycophenolate Mofetil and Basiliximab in Liver Transplantation
Comparison of 3 dosing regimens of Advagraf to determine if there is a dosing regimen which may have the potential to cause fewer kidney problems.
- Trial name
- DIAMOND (NCT01011205)
- Testing
- Advagraf, Mycophenolate Mofetil, Basiliximab
- Where
- 72 sites in Argentina, Austria and 21 more
- Volunteers
- 893 people
- Sponsor
- Astellas Pharma Inc
Liver Transplantation
Efficacy, Safety, Tolerability, Pharmacokinetics of Sotrastaurin-tacrolimus vs. Mycophenolic Acid-tacrolimus in de Novo Liver Transplant Patients
This study will assess the safety and efficacy of different doses of sotrastaurin when combined with tacrolimus for the prevention of acute rejection after de novo liver transplantation.
- Trial name
- NCT01128335
- Testing
- MMF(1000mg bid) + tacrolimus + standard of care medications, sotrastaurin (200mg bid) + tacrolimus + standard of care medications, sotrastaurin (300 mg bid) + tacrolimus + standard of care medications
- Where
- 39 sites in United States, Argentina and 10 more
- Volunteers
- 200 people
- Sponsor
- Novartis Pharmaceuticals
Ischemia Reperfusion Injury
YSPSL for Prevention of Ischemic Reperfusion Injury in Patients Undergoing Cadaveric Orthotopic 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
- YSPSL (NCT00876902)
- Testing
- recombinant P-selectin glycoprotein ligand Ig fusion protein, Viaspan® and saline
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Y's Therapeutics, Inc.
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
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.
Liver Transplantation
A Study of a Modified-Release Tacrolimus Based Immunosuppression Regimen in Stable Pediatric Liver Transplant Patients
A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable pediatric liver transplant patients converted from a Prograf® based immunosuppression regimen to a modified release tacrolimus based…
- Trial name
- NCT00282256
- Testing
- tacrolimus modified release (MR), tacrolimus
- Where
- 5 sites in United States
- Volunteers
- 19 people
- Sponsor
- Astellas Pharma Inc
Hepatitis C
Phase III Daclatasvir, Sofosbuvir, and Ribavirin in Cirrhotic Participants and Participants Post-liver Transplant
This trial was open to participants who had received a liver transplant or had cirrhosis due to chronic HCV. All subjects were treated with daclatasvir+sofosbuvir+ribavirin and were followed for 24 weeks post treatment.
- Trial name
- ALLY 1 (NCT02032875)
- Testing
- Daclatasvir, Sofosbuvir, Ribavirin
- Where
- 5 sites in United States
- Volunteers
- 116 people
- Sponsor
- Bristol-Myers Squibb
Cytomegalovirus Infections
Maribavir Versus Oral Ganciclovir For The Prevention of Cytomegalovirus (CMV) Disease in Liver Transplant Recipients
The purpose of this research study is to investigate whether or not oral maribavir is safe and effective compared to oral ganciclovir for preventing CMV disease when administered for up to 14 weeks in patients who have had a…
- Trial name
- NCT00497796
- Testing
- maribavir, ganciclovir
- Where
- 55 sites in United States
- Volunteers
- 307 people
- Sponsor
- Shire