Clinical trials: Liver Transplant Infection
Hepatitis C Virus Infection
Safety and Efficacy of SOF/VEL/VOX FDC for 8 Weeks and SOF/VEL for 12 Weeks in Adults Chronic Genotype 3 HCV Infection and Cirrhosis
The primary objective of this study is to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 8 weeks and of treatment with…
- Trial name
- POLARIS-3 (NCT02639338)
- Testing
- SOF/VEL/VOX, SOF/VEL
- Where
- 70 sites in United States, Australia and 6 more
- Volunteers
- 220 people
- Sponsor
- Gilead Sciences
Liver Transplant, Hepatitis C
Liver Fibrosis in Patients Transplanted for Hepatitis C Receiving Either Cyclosporine Microemulsion or Tacrolimus
Following a transplant for hepatitis C cirrhosis, the infection comes back in 70-90% of cases and over time causes fibrosis and eventually cirrhosis of the new liver.
- Trial name
- NCT00260208
- Testing
- Cyclosporine A, Tacrolimus
- Where
- 2 sites in United States, Switzerland
- Volunteers
- 361 people
- Sponsor
- Novartis Pharmaceuticals
Healthy
A Drug Interaction Study to Assess the Pharmacokinetics of Narlaprevir and Antiretroviral Drugs
The study purpose is to evaluate the potential for a pharmacokinetic drug-drug interaction, safety and tolerability when Narlaprevir, Ritonavir (used as a metabolic inhibitor) and Tenofovir disoproxil fumarate (part 1) and…
- Trial name
- NCT03537404
- Testing
- Narlaprevir, Ritonavir, Tenofovir Disoproxil Fumarate
- Where
- Russia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- R-Pharm
Cytomegalovirus (CMV) Infections Among Children and Adult Liver Transplantation Patients in China
A Study of Cytomegalovirus Disease Epidemiology in Pediatric and Adult Liver Transplant Recipients in China
The goal of this observational study is to learn about cytomegalovirus disease epidemiology in pediatric and adult liver transplant recipients in China.
- Trial name
- NCT05958186
- Where
- China
- Volunteers
- 800 people
- Sponsor
- Lin Zhong
Liver Transplant, Hepatitis C
The Use of Hepatitis C Positive Livers in Hepatitis C Negative Liver Transplant Recipients
This is an open-label, pilot trial to test the safety and efficacy of transplantation of livers from Hepatitis C seropositive non-viremic (HCV Ab+/NAT-) and HCV seropositive viremic (HCV Ab+/NAT+) donors to HCV seronegative…
- Trial name
- NCT03819322
- Testing
- sofosbuvir/velpatasvir
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Fernanda P Silveira, MD, MS
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
Hepatitis C, Hepatocellular Carcinoma
Efficacy of Sofosbuvir With Ribavirin Administered Pre-Transplant in Preventing Hepatitis C Virus (HCV) Recurrence Post-Transplant
The primary objective is to determine if the administration of a combination of sofosbuvir (SOF; GS-7977; PSI-7977) and ribavirin (RBV) to HCV-infected adults with hepatocellular carcinoma (HCC) meeting the MILAN criteria prior…
- Trial name
- NCT01559844
- Testing
- Sofosbuvir, Ribavirin
- Where
- 15 sites in United States, New Zealand and 1 more
- Volunteers
- 61 people
- Sponsor
- Gilead Sciences
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
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
Chronic Hepatitis B
Rollover Protocol Continued Access to Emtricitabine/Tenofovir Disoproxil Fumarate for Adults in United States
The objective of this study is to provide open label emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for an additional 5 years (240 weeks) to adults completing study GS-US-203-0107.
- Trial name
- NCT00936715
- Testing
- FTC/TDF
- Where
- 4 sites in United States
- Volunteers
- 24 people
- Sponsor
- Gilead Sciences
Liver Transplantation, Surgical Site Infection
Surgical Site Infections After Liver Transplantation Based on Perioperative Antibiotics
This study will be to prospectively determine differences in Surgical Site Infection (SSI) if a prolonged course of post-operative antibiotics are used following liver transplantation.
- Trial name
- NCT02717273
- Testing
- standard, extended, liver transplant
- Volunteers
- 102 people
- Sponsor
- University of Virginia
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
Sequelae of Viral Hepatitis, Transplantation Infection
Randomized Phase II Study of Hepatitis C Immune Globulin Intravenous (Human), Civacir(TM), in Liver Transplantation
A Phase 2 study to evaluate safety, pharmacokinetics and efficacy of Hepatitis C Immune Globulin Intravenous (human) [Civacir(TM)] for preventing or reducing the impact of recurrent HCV infection following liver transplantation.
- Conditions
- Sequelae of Viral Hepatitis, Transplantation Infection, Evidence of Liver Transplantation
- Trial name
- NCT00473824
- Testing
- Hepatitis C Immune Globulin Intravenous (Human) 5%
- Where
- 3 sites in United States
- Volunteers
- 7 people
- Sponsor
- ADMA Biologics, Inc.
Hepatitis C
Study of Sirolimus Versus Mycophenolate Liver Transplant Recipients With Recurrent Hepatitis C Virus (HCV)
Different immunosuppressive drugs used in transplantation may reduce the body's defences against infection differently. It is known that patients with Hepatitis C virus, known as HCV, who switched from azathioprine to…
- Trial name
- NCT01134952
- Testing
- Mycophenolate to sirolimus switch
- Where
- Canada
- Volunteers
- 11 people
- Sponsor
- London Health Sciences Centre
Hepatitis C Infection
Open Label Study of the Efficacy and Safety of MBL-HCV1 in Combination With Oral Direct-Acting Antivirals in Patients Undergoing Liver Transplantation for Hepatitis C
The purpose of this study is to assess efficacy of a human monoclonal antibody against Hepatitis C (MBL-HCV1) combined with telaprevir [part 1: an HCV protease inhibitor] or sofosbuvir [part 2: an Hepatitis C virus NS5B…
- Trial name
- MBL-HCV1 (NCT01532908)
- Testing
- MBL-HCV1, Telaprevir (Part 1), Sofosbuvir (Part 2)
- Where
- 5 sites in United States
- Volunteers
- 11 people
- Sponsor
- MassBiologics
Hepatitis C, Chronic, Lung Transplant
Lung Transplantation in Chronic HCV Infection With Post Transplant EPCLUSA Treatment
The purpose of this study is to evaluate whether treatment with Epclusa (sofosbuvir/velpatasvir) after lung transplantation in individuals with chronic hepatitis C infection is feasible, safe and effective at curing HCV.
- Trial name
- NCT03207399
- Testing
- Epclusa
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Duke University
End Stage Heart Disease, Hepatitis C
DAA Treatment in Donor HCV-positive to Recipient HCV-negative Heart Transplant
This is a proof of concept, single center study for the donation of HCV-positive hearts to HCV negative recipient patients, with preemptive, interventional treatment with 12 weeks of commercially available DAA therapy to prevent…
- Trial name
- NCT03208244
- Testing
- Clinically prescribed direct acting antiviral
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Massachusetts General Hospital
Hepatitis C Virus Infection
Sofosbuvir/Velpatasvir Fixed Dose Combination in Participants With Chronic Hepatitis C Virus Infection Who Have Received a Liver Transplant
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir /velpatasvir (SOF/VEL) fixed-dose combination (FDC) in participants with chronic hepatitis C virus (HCV) who have received…
- Trial name
- NCT02781571
- Testing
- SOF/VEL
- Where
- 15 sites in Spain, Switzerland and 1 more
- Volunteers
- 79 people
- Sponsor
- Gilead Sciences
Hepatitis C Virus Infection
Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination (FDC) for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic HCV Infection
This study will evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) for 12 or 24 weeks in adults with chronic genotype 1 or genotype 4 hepatitis C virus (HCV)…
- Trial name
- NCT02251717
- Testing
- LDV/SOF
- Where
- 5 sites in Austria, France and 2 more
- Volunteers
- 114 people
- Sponsor
- Gilead Sciences
Cancer
Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain
This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual spray as a treatment for breakthrough cancer pain.
- Trial name
- NCT00538850
- Testing
- Fentanyl sublingual spray
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- INSYS Therapeutics Inc