Clinical trials: Liver Transplant Disorder
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
Hepatic Veno-Occlusive Disease
European VOD Registry
Following the licencing of a new drug, Defitelio®, indicated for the treatment of severe Veno-Occlusive Disease of the liver (sVOD), a rare but serious complication of haematopoietic stem cell transplantation (HSCT), as a…
- Trial name
- NCT03032016
- Where
- 53 sites in France, Italy and 2 more
- Volunteers
- 176 people
- Sponsor
- Jazz Pharmaceuticals
End Stage Liver DIsease, Liver Failure
Bridge to HOPE: Hypothermic Oxygenated Perfusion Versus Cold Storage Prior to Liver Transplantation
This is a prospective, multi-center, controlled, randomized, pivotal study to evaluate the safety and effectiveness of the VitaSmart™ Liver Machine Perfusion System by comparing clinical outcomes in patients undergoing liver…
- Trial name
- NCT05045794
- Testing
- VitaSmart™Liver Machine Perfusion System, Static cold storage
- Where
- 15 sites in United States
- Volunteers
- 228 people
- Sponsor
- Bridge to Life Ltd.
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.
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.
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
Coagulopathy, Endstage Liver Disease
Evaluation of the Safety of Octaplas™ Versus Plasma in Patients Undergoing Orthotopic Liver Transplantation
Post-Marketing Requirement study to evaluate the safety of octaplas™ versus plasma in patients undergoing orthotopic liver transplantation (OLT).
- Trial name
- NCT02037373
- Testing
- Octaplas™, Plasma
- Where
- 4 sites in United States
- Volunteers
- 43 people
- Sponsor
- Octapharma
Cancer Metastatic to the Liver, Hepatocellular Carcinoma
A Study to Assess PV-10 Chemoablation of Cancer of the Liver
This open-label study will evaluate the safety, tolerability, pharmacokinetics and effect on tumor growth following a single intralesional injection of PV-10 in subjects with either (a) hepatocellular carcinoma (HCC) that is not…
- Conditions
- Cancer Metastatic to the Liver, Hepatocellular Carcinoma, Metastatic Melanoma, Metastatic Ocular Melanoma
- Trial name
- NCT00986661
- Testing
- PV-10 (10% rose bengal disodium)
- Where
- 5 sites in United States
- Volunteers
- 78 people
- Sponsor
- Provectus Biopharmaceuticals, Inc.
Portopulmonary Hypertension, Pulmonary Arterial Hypertension
A Study to Assess the Safety and Efficacy of Treprostinil to Facilitate Liver Transplantation in Patients With Portopulmonary Hypertension
This was a multicenter, prospective, observational, open-label study. Patients meeting inclusion/exclusion criteria received treatment with treprostinil as recommended by their treating physicians and were followed according to…
- Conditions
- Portopulmonary Hypertension, Pulmonary Arterial Hypertension, Pulmonary Hypertension
- Trial name
- NCT01028651
- Testing
- Treprostinil
- Where
- 4 sites in United States
- Volunteers
- 13 people
- Sponsor
- United Therapeutics
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
Chronic Hepatitis B
Efficacy and Safety of Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF)-Containing Regimens in Participants With Chronic Hepatitis B Virus (HBV) Infection and Stage 2 or Greater Chronic Kidney Disease Who Have Received a Liver Transplant
The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF)-containing regimens at Week 24 in participants with chronic…
- Trial name
- NCT02862548
- Testing
- TAF, TDF, Other approved antivirals
- Where
- New Zealand
- Volunteers
- 51 people
- Sponsor
- Gilead Sciences
Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases
The Mycophenolate Pregnancy Registry
The Mycophenolate Pregnancy Registry is designed as a prospective, observational registry collecting data regarding mycophenolate exposure during pregnancy, and pregnancy outcomes, fetal and infant outcomes after exposure.
- Trial name
- NCT01733082
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- Genentech, Inc.
Hepatitis C, Chronic
PHOENIX Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) Administered After Liver Transplantation for Hepatitis C.
This 2-arm study was designed to evaluate the efficacy, safety, and tolerability of prophylactic PEGASYS plus COPEGUS after liver transplantation for hepatitis C, compared to initiation of antiviral therapy at the time of…
- Trial name
- NCT00087633
- Testing
- peginterferon alfa-2a [Pegasys], Copegus
- Where
- 28 sites in United States
- Volunteers
- 115 people
- Sponsor
- Hoffmann-La Roche
Portal Hypertension, TIPS
The BD Liverty™ TIPS Stent Graft Study
The objective of the study is to assess the safety and effectiveness of the BD Liverty™ TIPS Stent Graft for the treatment of the complications of portal hypertension from cirrhosis.
- Trial name
- ARCH (NCT05711316)
- Testing
- BD Liverty™ TIPS Stent Graft
- Where
- 26 sites in United States, France and 1 more
- Volunteers
- 177 people
- Sponsor
- C. R. Bard
Hepatitis C Virus Infection
Safety and Efficacy of SOF/VEL/VOX FDC for 12 Weeks and SOF/VEL for 12 Weeks in DAA-Experienced Adults With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor
The primary objectives of the study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks and of…
- Trial name
- POLARIS-4 (NCT02639247)
- Testing
- SOF/VEL/VOX, SOF/VEL
- Where
- 78 sites in United States, Australia and 6 more
- Volunteers
- 333 people
- Sponsor
- Gilead Sciences
Acquired Bleeding Disorder, Bleeding During/Following Surgery
Safety and Efficacy of Activated Recombinant Human Factor VII in Patients Undergoing Orthotopic Liver Transplantation
This trial is conducted in Europe, North America and Oceania. The aim of this trial is to evaluate the haemostatic efficacy of activated recombinant human factor VII in subjects undergoing orthotopic liver transplantation surgery.
- Trial name
- NCT01563458
- Testing
- activated recombinant human factor VII
- Where
- 18 sites in Australia, Canada and 5 more
- Volunteers
- 208 people
- Sponsor
- Novo Nordisk A/S
Recurrent Hepatocellular Carcinoma
A Study of LioCyx in Patient With Recurrent HBV-related HCC Post Liver Transplantation
Hepatocellular carcinoma (HCC) represent approximately 70-85% of liver cancer, in which Hepatitis B virus (HBV) is the major etiologic agent accounting for at least 80% of HCC in Asian countries.
- Trial name
- NCT03634683
- Testing
- LioCyx
- Where
- 3 sites in China, Singapore
- Sponsor
- Lion TCR Pte. Ltd.
Hepatitis B, Chronic Hepatitis B Atypical
Safety, Tolerability, Pharmacokinetics and Antiviral Activity of IONIS-HBVRx in Treatment-Naïve Patients With Chronic HBV Infection
To examine the safety and tolerability of IONIS-HBVRx administration to treatment-naive patients with chronic hepatitis B virus infection
- Trial name
- NCT02981602
- Testing
- IONIS-HBVRx
- Where
- 7 sites in Hong Kong, South Korea
- Volunteers
- 31 people
- Sponsor
- GlaxoSmithKline
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
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