Clinical trials: Transplantation, Liver
Hepatitis C Virus Infection
Sofosbuvir/Velpatasvir Fixed-Dose Combination in HCV-Infected Adults Who Are Undergoing Liver Transplantation
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in hepatitis C virus (HCV)-infected adults who are undergoing…
- Trial name
- NCT02728206
- Testing
- SOF/VEL
- Where
- New Zealand
- Volunteers
- 9 people
- Sponsor
- Gilead Sciences
Obesity, Liver Cirrhosis
Endoscopic Intragastric Balloon Placement for Weight Loss in Liver Transplant Waitlist Candidates
The purpose of this study is to determine whether the Orbera Intragastric Balloon is a safe and effective means for weight loss and improved metabolic disease in patients with cirrhosis requiring liver transplantation.
- Trial name
- NCT02556138
- Testing
- ORBERA Intragastric Balloon
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Mayo Clinic
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
Liver Transplant, Liver Transplantation
Evaluation of Donor Specific Immune Senescence and Exhaustion as Biomarkers of Tolerance Post Liver Transplantation
The primary aim of this study is to determine whether a peripheral blood or graft lymphocyte phenotype of immune senescence or exhaustion is different between operationally tolerant and non-tolerant liver allograft recipients.
- Trial name
- OPTIMAL (NCT02533180)
- Testing
- Immunosuppression withdrawal
- Where
- 7 sites in United States
- Volunteers
- 100 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Liver Transplantation
Biomarkers Predicting Successful Tacrolimus Withdrawal and Everolimus (Zortress) Monotherapy Early After Liver Transplantation
Most patients who get a liver transplant must take immunosuppressants for the rest of their lives. However, this has occurred at the expense of chronic CNI toxicity, e.g.
- Trial name
- NCT02736227
- Testing
- Tacrolimus Withdrawal and Everolimus Monotherapy
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Northwestern University
Liver Failure
A Randomized Controlled Clinical Trial of Thymoglobulin® After Liver Transplantation
This is a 24-month, Phase II, multi-center, two-arm, randomized controlled study of adult patients receiving a single organ liver transplant from a deceased donor; the purpose being to determine the efficacy of Thymoglobulin®…
- Trial name
- NCT02544113
- Testing
- Thymoglobulin
- Where
- 4 sites in United States
- Volunteers
- 110 people
- Sponsor
- The Cleveland Clinic
Acute Cellular Graft Rejection, New Onset Diabetes After Transplant
Budesonide for Liver Transplant Immune Suppression
This is a pilot study that investigates the efficacy and safety of budesonide as an immune suppressing agent for liver transplant recipients in the early post-transplant period.
- Trial name
- NCT03304626
- Testing
- Budesonide 3Mg Capsule, Standard of Care Prednisone
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Cincinnati
Liver Transplantation, Liver Preservation for Transplant
OCS Liver PROTECT Trial: Preserving and Assessing Donor Livers for Transplantation
A prospective, phased-pivotal, international randomized trial to evaluate the effectiveness of the OCS™ Liver to preserve and assess donor livers intended for transplantation.
- Trial name
- PROTECT (NCT02522871)
- Testing
- OCS™ Liver System, Control
- Where
- 20 sites in United States
- Volunteers
- 300 people
- Sponsor
- TransMedics
Common Bile Duct Stricture
Covered Metallic Stents for First-Line Treatment of Benign Bile Duct Strictures
The current standard of care for benign bile duct strictures involves placement of multiple plastic stents under endoscopic and fluoroscopic guidance to progressively dilate or stretch it open.
- Trial name
- NCT01221311
- Testing
- Fully covered Metallic Stent, Plastic Stent
- Where
- 8 sites in United States, United Kingdom
- Volunteers
- 112 people
- Sponsor
- Medical University of South Carolina
Liver Transplant
OCS Liver DCD Trial
Evaluate the safety and effectiveness of the OCS Liver System to preserve, optimize the condition, and assess levers from DCD donors.
- Trial name
- NCT04194437
- Testing
- OCS Liver System
- Where
- 4 sites in United States
- Volunteers
- 9 people
- Sponsor
- TransMedics
Hepatitis C
Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation
The purpose of this study is to evaluate the effect of cyclosporine, an anti-rejection drug, on the clearance of the hepatitis C virus in liver transplant subjects being treated with peg-interferon and ribavirin.
- Trial name
- NCT00821587
- Testing
- Cyclosporine, Tacrolimus
- Volunteers
- 39 people
- Sponsor
- University of Florida
Living Donor Liver Transplantation
DCreg in Living Donor Liver Transplantation
Phase I/II, single center, prospective, open-label, non-controlled, non-randomized, interventional, cohort study in which low risk living donor liver transplant (LDLT) recipients will receive a single infusion of donor-derived…
- Trial name
- NCT03164265
- Testing
- Regulatory Donor-Derived Dendritic Cell infusion
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Angus W. Thomson PhD DSc
Liver Transplant
OCS Liver PROTECT Continued Access Protocol
Continued Access Protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers.
- Trial name
- NCT04186221
- Testing
- OCS Liver System
- Where
- 17 sites in United States
- Volunteers
- 74 people
- Sponsor
- TransMedics
Reperfusion Injury, Liver Injury
Study to Evaluate if Inhaled Nitric Oxide Improves Liver Function After Transplantation
This blinded, placebo-controlled study will administer inhaled nitric oxide to patients undergoing liver transplantation. The purpose of the study is to test if inhaled nitric oxide prevents liver injury associated with the…
- Trial name
- NCT00582010
- Testing
- inhaled nitric oxide, nitrogen gas
- Where
- 2 sites in United States
- Volunteers
- 80 people
- Sponsor
- University of Alabama at Birmingham
Liver Transplant, Liver Steatosis
Controlled Attenuation Parameter (CAP) in Liver Allografts
The primary aim is to determine the accuracy of CAP in the quantification of liver steatosis using liver biopsies as reference. Secondarily, investigators will correlate transient elastography (TE) and CAP results, analyze…
- Conditions
- Liver Transplant, Liver Steatosis, Liver Disease, Primary Non-function
- Trial name
- NCT02798861
- Testing
- Fibroscan 402/530
- Where
- 3 sites in United States
- Volunteers
- 160 people
- Sponsor
- Andres Duarte-Rojo
Liver Transplant Recipients, Liver Transplantation
Immunosuppression Withdrawal for Stable Pediatric Liver Transplant Recipients
The primary objective of this study is to assess the efficacy of immunosuppression withdrawal (ISW) in pediatric liver transplant (tx) recipients.
- Conditions
- Liver Transplant Recipients, Liver Transplantation, Immunosuppression
- Trial name
- iWITH (NCT01638559)
- Testing
- Immunosuppression withdrawal
- Where
- 12 sites in United States, Canada
- Volunteers
- 161 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Hepatitis C, Transplantation Disease Transmission
Prevention of De Novo HCV With Antiviral HCV Therapy Post-Liver and Post-Kidney Transplant
In this study, subjects that do not have Hepatitis C virus (HCV) will be transplanted with livers or kidneys from donors who do have HCV.
- Trial name
- PRO-ACT: (NCT03619837)
- Testing
- Sofosbuvir/Velpatasvir, Sofosbuvir/Velpatasvir/Voxilaprevir
- Where
- 6 sites in United States
- Volunteers
- 122 people
- Sponsor
- University of California, San Francisco
Liver Cirrhosis
Human Fetal Liver Cell Transplantation in Chronic Liver Failure
The herein study consists in the transplantation of liver progenitor cells isolated from human fetal liver tissue with the aim of improving conventional liver therapy and broadening therapeutical options other than liver…
- Trial name
- hFLCTx (NCT01013194)
- Testing
- Human Fetal Liver Cell Transplantation
- Where
- Italy
- Volunteers
- 25 people
- Sponsor
- The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Kidney Failure
Everolimus Plus Mycophenolic Acid for Kidney Preservation in Liver Transplant Recipients With Impaired Kidney Function
Tacrolimus is the standard immunosuppressive drug used to prevent organ rejection post liver transplant. One side effect of Tacrolimus is nephrotoxicity. Everolimus does not have the nephrotoxicity side effects of Tacrolimus.
- Trial name
- NCT04258423
- Testing
- Tacrolimus, Everolimus
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Indiana University
Liver Transplantation
Donor-Alloantigen-Reactive Regulatory T Cell (darTregs) in Liver Transplantation
The purpose of this study is look at the safety of: Taking a specific combination of immunosuppressant drugs after liver transplantation Receiving one of three different doses of donor-alloantigen-reactive regulatory T cells…
- Trial name
- deLTa (NCT02188719)
- Testing
- Anti-Thymocyte Globulin - Rabbit, darTreg Infusion, Everolimus
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)