Clinical trials: Transplantation, Liver
de Novo Liver Transplant Subjects
A Study to Evaluate the Effect of Advagraf Conversion From Prograf in Liver Transplant Subjects
The objective of this study is to compare the efficacy and safety between a group that has been on Prograf twice daily therapy but converted to Advagraf once daily therapy and a group that maintained Prograf twice daily therapy.
- Trial name
- Maple (NCT01882322)
- Testing
- Prograf, Advagraf
- Where
- South Korea
- Volunteers
- 36 people
- Sponsor
- Astellas Pharma Korea, Inc.
Hepatitis B
A Clinical Trial of Zutectra in Patients Who Recently Received a Liver Transplant
Patients who receive liver transplantation for hepatitis B virus (HBV) induced liver failure require longterm therapy to prevent HBV reinfection of the transplanted liver.
- Trial name
- ZEUS (NCT01856413)
- Testing
- Zutectra
- Where
- 16 sites in France, Italy and 2 more
- Volunteers
- 49 people
- Sponsor
- Biotest
Evidence of Liver Transplantation
Evaluate the Efficacy and Safety of the ADVAGRAF®
The primary objective of this study is to evaluate the efficacy of 6-month treatment with Advagraf® converted from 12-month treatment with tacrolimus in stable liver transplant recipients.
- Trial name
- STABLE (NCT04763096)
- Testing
- Advagraf
- Where
- South Korea
- Volunteers
- 101 people
- Sponsor
- Linical Korea
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
Hepatitis B
A Confirmatory Study of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients
The purpose of this study is to Evaluate the efficacy and safety of Hepabulin IV (HBIG, a study drug) after liver transplantation.
- Trial name
- NCT01513850
- Testing
- Hepabulin IV
- Where
- South Korea
- Volunteers
- 87 people
- Sponsor
- SK Chemicals Co., Ltd.
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 Infection
HBV-associated Liver Transplant(LT) Patients by IV Injecting GC1102
This is a clinical study for GC1102 to demonstrate preventing the recurrence of hepatitis B virus (HBV) infection following liver transplantation and a dose-finding study to determine its optional dose.
- Trial name
- NCT03519113
- Testing
- GC1102 80,000 IU, GC1102 100,000 IU, I.V HBIG
- Where
- South Korea
- Volunteers
- 186 people
- Sponsor
- Green Cross Corporation
Liver Transplantation
OrganOx Metra® New Enrollment PAS
The objective of the OrganOx metra® New Enrollment Post-Approval Study is to collect data on the post-transplant clinical outcomes of DBD and DCD donor livers preserved and assessed on the OrganOx according to the current…
- Trial name
- NCT05526326
- Testing
- Transplant with normothermic machine perfused (NMP) donor liver
- Where
- 10 sites in United States
- Volunteers
- 315 people
- Sponsor
- OrganOx Ltd.
Amatoxin Poisoning, Amanita Poisoning
Intravenous Milk Thistle (Silibinin-Legalon) for Hepatic Failure Induced by Amatoxin/Amanita Mushroom Poisoning
Legalon® SIL will be administered to patients with amatoxin poisoning diagnosed by history, gastrointestinal symptoms, elevated liver enzymes, and/or diagnostic assay (should one become available).
- Conditions
- Amatoxin Poisoning, Amanita Poisoning, Mushroom Poisoning, Liver Failure
- Trial name
- NCT00915681
- Testing
- Silibinin
- Where
- 2 sites in United States
- Volunteers
- 148 people
- Sponsor
- Mylan Specialty, LP
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
Liver Transplantation, Mycoses
Liver Transplant European Study Into the Prevention of Fungal Infection
Prevention of invasive fungal infection in high risk patients following liver transplant.
- Trial name
- TENPIN (NCT01058174)
- Testing
- micafungin, fluconazole, liposomal amphotericin B
- Where
- 36 sites in Austria, Belgium and 12 more
- Volunteers
- 350 people
- Sponsor
- Astellas Pharma Inc
Autoimmune Diseases, Inflammation
Prospective Study of White Blood Cells
The purpose of this study is to investigate white blood cells from volunteering donors to support the development of engineered regulatory T cell therapies.
- Conditions
- Autoimmune Diseases, Inflammation, Rejection; Transplant, Liver
- Trial name
- NCT04838171
- Testing
- White blood cell and blood collection
- Where
- United Kingdom
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Quell Therapeutics Limited
Anastomotic Biliary Stricture Post Orthotopic Liver Transplant
WallFlex Biliary Post Liver Transplant IDE Pilot
The primary objective of this study is to demonstrate effectiveness of the WallFlex Biliary RX Fully Covered Stent for anastomotic biliary strictures in post-orthotopic liver transplant (OLT) patients.
- Trial name
- NCT01151280
- Testing
- WallFlex Biliary Fully Covered Stent
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Boston Scientific Corporation
Chronic Hepatitis B
Study Comparing Tenofovir Disoproxil Fumarate (TDF), Emtricitabine (FTC)/TDF, and Entecavir (ETV) in the Treatment of Chronic HBV in Subjects With Decompensated Liver Disease.
This study was designed to evaluate and compare the safety and tolerability of tenofovir disoproxil fumarate (TDF), emtricitabine (FTC)/TDF, and entecavir (ETV) in the treatment of hepatitis B patients with decompensated liver…
- Trial name
- NCT00298363
- Testing
- Tenofovir disoproxil fumarate (tenofovir DF; TDF), Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), Entecavir (ETV)
- Where
- 38 sites in United States, Canada and 9 more
- Volunteers
- 112 people
- Sponsor
- Gilead Sciences
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
A Study to Compare Safety and Efficacy of Prograf + Myfortic and Advagraf + Myfortic in Liver Transplantation Patients
To compare the safety and efficacy of Prograf® with Myfortic® to Advagraf® extended release tacrolimus with Myfortic® in de novo liver transplant recipients.
- Trial name
- NCT01018914
- Testing
- Prograf, Advagraf, Myfortic
- Where
- 3 sites in Taiwan
- Volunteers
- 44 people
- Sponsor
- Astellas Pharma Inc
Liver Diseases
Drug Use Investigation for IMURAN (Azathioprine) Tablet (Hepatic Transplantation)
This post-marketing surveillance (PMS) study is designed to investigate the efficacy and safety of azathioprine tablets in Japanese subjects whom liver transplantation is performed.
- Trial name
- NCT01390766
- Testing
- Azathioprine
- Volunteers
- 41 people
- Sponsor
- GlaxoSmithKline
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
Chronic Hepatitis C Infection
A Study to Evaluate Chronic Hepatitis C Infection in Adult Transplant Recipients
The purpose of this study is to evaluate the safety and efficacy of ABT-450/r/ABT-267 with or without ABT-333 and with or without ribavirin (RBV) in adult liver or renal transplant recipients with hepatitis C virus (HCV) genotype…
- Trial name
- CORAL-I (NCT01782495)
- Testing
- ombitasvir/paritaprevir/ritonavir and dasabuvir, ombitasvir/paritaprevir/ritonavir, ribavirin
- Volunteers
- 129 people
- Sponsor
- AbbVie
Liver Transplantation
A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in ABO-Incompatible Liver Transplantation
The purpose of this study is to evaluate the efficacy and safety of LIV-GAMMA SN Inj. administered for consecutive 3 days in adult subjects to prevent biliary complications after ABO incompatible adult to adult living donor liver…
- Trial name
- NCT05666453
- Testing
- LIV-GAMMA SN Inj., No intervention
- Where
- 5 sites in South Korea
- Volunteers
- 59 people
- Sponsor
- SK Plasma Co., Ltd.