Clinical trials: Liver Transplant Recipients
Liver Transplant Rejection
Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Liver Transplant Recipients With Additional 12-month Follow-up and Long-term Extension
This was a multicenter, open-label, active-controlled study to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of two CFZ533 maintenance doses in de novo liver transplant recipients.
- Trial name
- CONTRAIL I (NCT03781414)
- Testing
- CFZ533, Tacrolimus - MMF - corticosteroids
- Where
- 29 sites in United States, Argentina and 8 more
- Volunteers
- 129 people
- Sponsor
- Novartis Pharmaceuticals
Hepatitis C
A Study of the Use of Hepatitis C Positive Donors for Hepatitis C Negative Lung Transplant Recipients With Post-transplant Treatment With Mavyret
Patients who are Hepatitis C Negative (HCV negative) and are on the waiting list for a lung transplant at NYULH who consent to participate in this study will receive a lung transplant from a deceased donor that is HCV positive.
- Trial name
- NCT03523871
- Testing
- Mavyret
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- NYU Langone Health
Liver Failure, Carcinoma, Hepatocellular
Remote Ischemic Conditioning (RIC) in Recipients of Brain Death Donor Livers - A Feasibility and Safety Study
This study will assess the feasibility of lower limb-ischemia induced Remote Ischemic Conditioning (RIC) in the perioperative period before, during, and after Orthotopic Liver Transplantation (OLT).
- Trial name
- NCT02635347
- Testing
- Remote Ischemic Conditioning (RIC), Pneumatic tourniquet
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Rutgers, The State University of New Jersey
Heart Transplantation, Liver Transplantation
Study to Ascertain if Prolonged Release Tacrolimus (FK506E - MR4) is Safe and Effective When Used in the Long Term and in Combination With Other Immunosuppressive Drugs in Patients Who Have Received a Transplant
The purpose of this study was to offer patients who had participated in one of the phase II PK or phase III studies on FK506E (MR4) the possibility to continue FK506E (MR4) until commercial availability of the drug and to record…
- Conditions
- Heart Transplantation, Liver Transplantation, Kidney Transplantation
- Trial name
- NCT02118896
- Testing
- FK506E
- Where
- 105 sites in United States, Australia and 21 more
- Volunteers
- 850 people
- Sponsor
- Astellas Pharma Europe Ltd.
Liver Transplantation
RESCUE Study - Everolimus in Liver Transplantation Recipients With Renal Insufficiency
The purpose of the study is to assess the effect of everolimus initiation together with reduction or discontinuation of calcineurin inhibitor (CNI) on renal function in maintenance liver transplant recipients with CNI-related…
- Trial name
- NCT00267189
- Testing
- Everolimus, Calcineurin inhibitors (CNI), Mycophenolate acid (MPA)/ Azathioprine (AZA)
- Where
- 2 sites in Germany, Switzerland
- Volunteers
- 145 people
- Sponsor
- Novartis Pharmaceuticals
Liver Transplant Recipient
Extension Study to Evaluate the Long-term Efficacy and Safety of Everolimus in Liver Transplant Recipients
The reason for this extension is to evaluate the long-term safety and efficacy of two concentration-controlled everolimus regimen in de novo liver transplant recipients.
- Trial name
- NCT01150097
- Testing
- Tacrolimus (reduced tacrolimus), Everolimus (reduced tacrolimus), Tacrolimus (tacrolimus elimination)
- Where
- 57 sites in United States, Argentina and 14 more
- Volunteers
- 284 people
- Sponsor
- Novartis Pharmaceuticals
Immunosuppression
Conversion of CellCept to Myfortic: A Prospective Study in Liver Transplant Recipients
The objective of this study is to determine the tolerability and safety of Myfortic in liver transplant patients. Patients receiving CellCept who have GI side effects will have CellCept discontinued and changed to Myfortic…
- Trial name
- NCT00336895
- Testing
- Myfortic
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- University of Pittsburgh
Liver Transplantation
Measurement of Gastrointestinal (GI) and Health-related Quality of Life (HRQL) Outcomes in Liver Transplant Recipients
Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients.
- Trial name
- NCT00405652
- Testing
- Enteric-coated Mycophenolate sodium (EC-MPS)
- Where
- Germany
- Volunteers
- 34 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplant Recipients, Liver Transplant Recipients
COVID Protection After Transplant-Immunosuppression Reduction
This study will enroll individuals who have: Completed primary series of mRNA COVID-19 vaccine, and An antibody response ≤ 2500 U/mL measured at least 30 days after the last dose of vaccine.
- Trial name
- CPAT-ISR (NCT05077254)
- Testing
- Pfizer-BioNTech COVID-19 Vaccine 2023-2024, Moderna COVID-19 Vaccine 2023-2024, SOC IS Regimen
- Where
- 15 sites in United States
- Volunteers
- 48 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Liver Transplantation
Efficacy of Low Dose, SubQ Interleukin-2 (IL-2) to Expand Endogenous Regulatory T-Cells in Liver Transplant Recipients
The purpose of this investigation is to study if very low dose IL-2, given to liver transplant patients by subcutaneous (under the skin) injections, over a 4 week period of time, will cause an increase in the number of Treg cells…
- Trial name
- NCT02739412
- Testing
- Interleukin-2
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Beth Israel Deaconess Medical Center
Liver Transplantation
A National Multi-center Randomized, Open Label Study to Evaluate Efficacy and Safety of Everolimus With EC-MPS Compared to Standard Treatment Combination Tacrolimus and EC-MPS in de Novo Liver Transplant Recipients
The aims of the study was to evaluate the safety and efficacy of early introduction one month post-transplantation of everolimus associated to EC-MPS with tacrolimus discontinuation in de novo liver transplant recipients and to…
- Trial name
- SIMCER (NCT01625377)
- Testing
- tacrolimus, everolimus, Basiliximab
- Where
- 14 sites in France
- Volunteers
- 188 people
- Sponsor
- Novartis Pharmaceuticals
Medication Adherence, Liver Transplantation
A Study of mDOT for Immunosuppressant Adherence in Solid Organ Transplant Recipients
In solid organ transplant recipients, poor adherence to immunosuppressant medications carries the risk of graft rejection (needing a new transplant), post-transplant complications, and increased healthcare costs.
- Conditions
- Medication Adherence, Liver Transplantation, Kidney Transplantation
- Trial name
- NCT04587024
- Testing
- mHealth intervention, standard of care
- Where
- 2 sites in United States
- Volunteers
- 75 people
- Sponsor
- Johns Hopkins University
Recurrent Hepatitis C
Efficacy of Everolimus as Inhibitor of Fibrosis Progression in Liver Transplant Patients With Recurrence of Hepatitis C Viral Infection
This study will assess the efficacy of everolimus as an inhibitor of fibrosis progression in liver transplant patients who have a recurrence of hepatitis C viral infection in the transplant
- Trial name
- REVERT (NCT00582738)
- Testing
- CsA-TAC (standard Treatment), Everolimus
- Where
- Argentina
- Volunteers
- 43 people
- Sponsor
- Novartis 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, 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
Immunosuppression
A Prospective Study on the Tolerability and Efficacy of the de Novo Use of Myfortic in Liver Transplant Recipients
The objective of this study is to compare the safety and efficacy of Myfortic with CellCept in liver transplant patients. Myfortic and CellCept are both immunosuppressive (anti-rejection) drugs.
- Trial name
- NCT00336817
- Testing
- Myfortic, CellCept
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Pittsburgh
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
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
Kidney Transplant, Hepatitis C
Utilization of Hepatitis C Positive Kidneys in Negative Recipients
To evaluate the safety and feasibility of transplanting kidneys from Hepatitis C virus (HCV) infected donors into recipients without HCV infection
- Conditions
- Kidney Transplant, Hepatitis C, HCV
- Trial name
- NCT03801707
- Testing
- Sofosbuvir / Velpatasvir Oral Tablet [Epclusa], Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet [MAVYRET]
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- Ohio State University
Cervical Cancer, Hpv
Does the HPV Vaccine Cause the Same Response in Adolescent Kidney and Liver Transplant Patients as in Healthy Controls?
The purpose of the study is to understand if children with liver and kidney transplants develop the antibodies from the Gardasil vaccine.
- Conditions
- Cervical Cancer, Hpv, Warts
- Trial name
- NCT01101750
- Testing
- Quadrivalent HPV for types 6, 11, 16 and 18
- Where
- 2 sites in United States
- Volunteers
- 25 people
- Sponsor
- Medstar Health Research Institute