Clinical trials: Transplant, Liver
Biliary Stricture
WallFlex Biliary Fully Covered (FC) Benign Stricture Study
The purpose of this study is to evaluate the safety and performance of the WallFlex® Biliary RX Fully Covered Stent as a treatment of biliary obstruction resulting from benign bile duct strictures.
- Trial name
- NCT01014390
- Testing
- WallFlex Biliary RX Fully Covered Stent System
- Where
- 13 sites in Australia, Austria and 9 more
- Volunteers
- 187 people
- Sponsor
- Boston Scientific Corporation
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
Hepatitis B
Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Pre-liver Transplant Patients 18 Years of Age
The purpose of this study is to enroll pre-liver transplant patients who will be vaccinated with either the novel adjuvanted HBV vaccine or double doses of Engerix™-B.
- Trial name
- NCT00697554
- Testing
- HBV-MPL vaccine 208129, Engerix™-B
- Volunteers
- 93 people
- Sponsor
- GlaxoSmithKline
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.
Coagulation Defect; Bleeding
Quantra QStat Sample Type Comparison
This is a single center prospective observational study to compare QStat parameter measurements in arterial and venous blood samples collected in parallel from patients undergoing liver transplantation.
- Trial name
- NCT06025708
- Testing
- Diagnostic Test: Quantra QStat Cartridge
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- HemoSonics LLC
Hepatitis C Virus (HCV)
A Study of of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection
A Phase 3b, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir/pibrentasvir for an 8- or 12-week treatment duration in participants with chronic hepatitis C virus (HCV) genotype (GT) 5 or 6…
- Trial name
- ENDURANCE-5 6 (NCT02966795)
- Testing
- Glecaprevir/Pibrentasvir
- Where
- 25 sites in United States, Australia and 7 more
- Volunteers
- 84 people
- Sponsor
- AbbVie
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
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.
Recurrent Chronic Hepatitis C Virus, Post Liver Transplant
Safety and Efficacy of Sofosbuvir and Ribavirin in Adults With Recurrent Chronic Hepatitis C Virus (HCV) Post Liver Transplant
This is an open-label, single-arm study of sofosbuvir (GS-7977) and ribavirin (RBV) in adults who have had a liver transplant which has become re-infected with hepatitis C.
- Trial name
- NCT01687270
- Testing
- Sofosbuvir, RBV
- Where
- 12 sites in United States, France and 3 more
- Volunteers
- 40 people
- Sponsor
- Gilead Sciences
Liver Transplant
Cyclosporine A C-2h Monitoring Versus Tacrolimus C-0h Monitoring in de Novo Liver Transplant Recipients
The purpose of this study is to determine whether cyclosporine A (in a micro emulsion formulation) monitored by sample taken 2 hour after oral dose (C-2h) will show equivalent or superior efficacy compared to tacrolimus monitored…
- Trial name
- NCT00149994
- Testing
- Cyclosporine A, Tacrolimus, Basiliximab
- Where
- Switzerland
- Volunteers
- 171 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Hepatitis C Genotype 1b
Efficacy and Safety of All-Oral Combination of Narlaprevir/Ritonavir and Daclatasvir in Treatment-Naїve Patients With Chronic Hepatitis C Genotype 1b
The purpose of this study is to confirm that combination of Narlaprevir, Ritonavir and Daclatasvir is safe and highly effective regimen in treatment-naїve patients with chronic hepatitis C (HCV) genotype 1b infection.
- Trial name
- NCT03485846
- Testing
- Narlaprevir, Ritonavir, Daclatasvir
- Where
- 4 sites in Russia
- Volunteers
- 105 people
- Sponsor
- R-Pharm
Intestine Transplantation, Kidney Transplantation
Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf®
Parts A \& B: Conversion of stable pediatric allograft recipients from Prograf® immunosuppression to Advagraf® immunosuppression to compare exposure and one year follow-up for safety and efficacy.
- Conditions
- Intestine Transplantation, Kidney Transplantation, Lung Transplantation, Liver Transplantation
- Trial name
- NCT01294020
- Testing
- Tacrolimus, Tacrolimus prolonged release
- Where
- 16 sites in Belgium, Czechia and 5 more
- Volunteers
- 81 people
- Sponsor
- Astellas Pharma Europe Ltd.
Liver Transplantation, Transplantation Immunology
A Randomized Study to Assess the Safety and Efficacy of Prograf vs Prograf-XL in de Novo Liver Transplant Recipients.
The purpose of this study is to compare the efficacy and safety of Prograf extended release(XL) plus MMF with Prograf plus MMF and steroid withdrawal in de novo Liver transplant recipients
- Conditions
- Liver Transplantation, Transplantation Immunology, Host vs Graft Reaction
- Trial name
- NCT00720408
- Testing
- Prograf-XL, Prograf, MMF
- Where
- 4 sites in Taiwan
- Volunteers
- 48 people
- Sponsor
- Astellas Pharma Inc
Hemorrhage, Trauma
Quantra QStat in Trauma and Liver Transplant
This is a multi-center prospective, observational study of the Quantra System with the QStat Cartridge in trauma patients and patients undergoing liver transplant.
- Conditions
- Hemorrhage, Trauma, Liver Transplant
- Trial name
- NCT04312958
- Testing
- Quantra System
- Where
- 10 sites in United States
- Volunteers
- 397 people
- Sponsor
- HemoSonics LLC
Heart Transplantation, Kidney Transplantation
A Paediatric, Open, Follow up Study With Modigraf Examining Safety and Efficacy in de Novo Allograft Recipients
The purpose of this study, a follow up to study FG506-CL-0403, is to see how safe and effective Modigraf® is (Part A) and to see how safe and effective it is to change your child's medication from Modigraf® to Prograf® (Part B).
- Conditions
- Heart Transplantation, Kidney Transplantation, Liver Transplantation
- Trial name
- PROGRESSION (NCT01371344)
- Testing
- Tacrolimus granules, Tacrolimus capsules
- Where
- 12 sites in Belgium, France and 4 more
- Volunteers
- 47 people
- Sponsor
- Astellas Pharma Europe Ltd.
Hepatitis C, Chronic
Safety Study of Regimens of Sofosbuvir, GS-0938, and Ribavirin in Patients With Chronic Hepatitis C Infection
This study was designed to assess the safety and efficacy of multiple interferon-free treatment regimens of sofosbuvir (Sovaldi™; GS-7977; PSI-7977) and GS-0938 (PSI-352938) alone and in combination, with and without ribavirin…
- Trial name
- QUANTUM (NCT01435044)
- Testing
- Sofosbuvir, GS-0938, RBV
- Where
- 44 sites in United States, Puerto Rico
- Volunteers
- 239 people
- Sponsor
- Gilead Sciences
Acute Liver Failure, Acute-On-Chronic Liver Failure
Study to Evaluate Safety and Efficacy of LifeLiver in Acute or Acute-on-Chronic Liver Failure Patients
This is a prospective, comparative, open label, phase 2b study designed to investigate the safety and efficacy of LifeLiver (an Extracorporeal Bio Artificial Liver).
- Trial name
- NCT03882346
- Testing
- LifeLiver
- Where
- South Korea
- Volunteers
- 40 people
- Sponsor
- HLB Cell Co., Ltd.
Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease
An Open-label Study to Investigate ECUR-506 in Male Babies Less Than 9 Months of Age With Neonatal Onset OTC Deficiency
Ornithine Transcarbamylase (OTC) deficiency, the most common urea cycle disorder, is an inherited metabolic disorder caused by a genetic defect in a liver enzyme responsible for detoxifying of ammonia.
- Conditions
- Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease, Ornithine Carbamoyltransferase Deficiency (Disorder), Urea Cycle Disorders, Inborn
- Trial name
- NCT06255782
- Testing
- ECUR-506
- Where
- 12 sites in United States, Australia and 2 more
- Volunteers
- 20 people
- Sponsor
- iECURE, Inc.
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
Maintenance Liver Transplant Patients With New Onset Diabetes
Conversion From Tacrolimus to Cyclosporine Microemulsion in Liver Transplant Patients With New Onset Diabetes After the 3rd Month Post-transplant
The trial is conducted in patients who have received a liver transplant, were prescribed tacrolimus to prevent organ rejection and developed diabetes from 3 month post-transplantation onwards.
- Trial name
- NCT00171717
- Testing
- Cyclosporine - cyclosporine microemulsion
- Volunteers
- 39 people
- Sponsor
- Novartis