Clinical trials: Liver Function
Hepatitis C Viral, Chronic Kidney Disease stage3
A Study for G1b CHC Patients With CKD-3 Treated With Grazoprevir Plus Elbasvir
The regimen using grazoprevir plus elbasvir treatment is promising in Japan, because it may safely be used for the elderly patients with renal dysfunction.
- Trial name
- NCT03144635
- Testing
- Grazoprevir plus Elbasvir
- Where
- Japan
- Volunteers
- 80 people
- Sponsor
- Kyushu University
Liver Transplantation
REnal Function in Liver Transplantation: Everolimus With Calcineurin Inhibitor (CNI)-Sparing sTrategy
The purpose of this study was, starting from the Italian clinical practice in liver transplantation, to optimize the immunosuppressive therapy, considering specific patient characteristics as alcoholic cirrhosis, hepatitis C…
- Trial name
- REFLECT (NCT02115113)
- Testing
- Everolimus, Tacrolimus
- Where
- 14 sites in Italy
- Volunteers
- 78 people
- Sponsor
- Novartis Pharmaceuticals
Immunosuppression, Renal Failure
Conversion to Everolimus From Calcineurin Inhibitor With Mycophenolic Acid: Impact on Long Term Renal Function in Liver Transplantation.
This study will examine the renal sparing impact of implementing a strategy of conversion to everolimus from a calcineurin inhibitor based immunosuppressive protocol at 3 months post liver transplant
- Trial name
- NCT01936519
- Testing
- Arm A: Everolimus, Calcineurin Inhibitor
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Milton S. Hershey Medical Center
Congenital Heart Disease
Acute Effects of Inhaled Treprostinil in Fontan Patients
In this pilot study investigators propose to explore the effects of a locally delivered inhaled pulmonary vasodilator (inhaled treprostinil) on exercise performance, pulmonary blood flow, venous pressure response and vascular…
- Trial name
- NCT02769624
- Testing
- Treprostinil
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Hepatic Insufficiency
A Study to Investigate the Effect of Impaired Hepatic Function on the Pharmacokinetics of Entrectinib in Volunteers With Different Levels of Hepatic Function
This is a non-randomized, open-label, one treatment, four group, parallel group study to investigate the effect of impaired hepatic function on the pharmacokinetics of entrectinib in participants with different levels of hepatic…
- Trial name
- NCT04226833
- Testing
- entrectinib
- Where
- 3 sites in Czechia, Hungary and 1 more
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Liver Transplantation
Low Dose Thymoglobulin to Protect Kidney Function After Liver Transplant
This study will evaluate the use of a drug called Thymoglobulin, combined with a delayed start of the anti-rejection drugs (10 days after liver transplant), compared to the current approach of starting anti-rejection drugs called…
- Trial name
- NCT00970073
- Testing
- Thymoglobulin 3mg total, Thymoglobulin 4.5mg total, Mycophenolate mofetil
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- The Cleveland Clinic
Hepatitis C
Pharmacokinetic and Safety Study of Daclatasvir in Patients With Renal Impairment
The purpose of this study is to assess the effect of renal function impairment on the single dose pharmacokinetics of Daclatasvir.
- Trial name
- NCT01830205
- Testing
- Daclatasvir
- Where
- 2 sites in United States
- Volunteers
- 58 people
- Sponsor
- Bristol-Myers Squibb
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
Liver Transplant
A Multicentre, Randomised, Open-label, Controlled, 12-month Follow-up Study to Assess Impact on Renal Function of an Immunosuppression Regimen Based on Tacrolimus Minimisation in Association With Everolimus in de Novo Liver Transplant Recipients.
Assuming greater efficacy in the prevention of acute rejection in the EVR arm with minimisation of TAC levels, the hypothesis of the present trial was that the introduction of EVR in combination with the minimisation of TAC…
- Trial name
- REDUCE (NCT02040584)
- Testing
- Minimisation of TAC, TAC + MMF + corticosteroids
- Where
- 20 sites in Spain
- Volunteers
- 217 people
- Sponsor
- Novartis Pharmaceuticals
Hepatic Impairment
A Phase 1 Open-Label Evaluation of the Pharmacokinetics and Safety of a Single Dose of Apraglutide in Subjects With Normal and Impaired Hepatic Function
The primary objective is to assess the pharmacokinetics (PK) of apraglutide in subjects with hepatic impairment compared with matched control subjects with normal hepatic function following single subcutaneous (SC) dose…
- Trial name
- NCT05706623
- Testing
- Apraglutide
- Where
- 2 sites in Germany, Slovakia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- VectivBio AG
Advanced Solid Tumors, Relapsed/Refractory Lymphoma
Pharmacokinetics of Alisertib in Adults With Advanced Solid Tumors or Relapsed/Refractory Lymphoma With Varying Degrees of Hepatic Function
The purpose of this study is to evaluate the effect of moderate or severe hepatic impairment on the single-dose pharmacokinetics of alisertib in adult participants with cancer.
- Trial name
- NCT02214147
- Testing
- Alisertib
- Where
- 7 sites in United States
- Volunteers
- 36 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
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
Hepatic Steatosis, Bariatric Surgery Candidate
Hepatic Mitochondrial Function in Youth
Assess the impact of bariatric surgery on hepatic energy metabolism and glucose and insulin dynamics in obese youth
- Conditions
- Hepatic Steatosis, Bariatric Surgery Candidate, Adolescent Obesity, Obesity
- Trial name
- MANGO (NCT03587727)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Colorado, Denver
Known or Suspected Focal Liver Lesions, Severe Renal Impairment
Safety and Diagnostic Efficacy of Mangoral in Participants With Focal Liver Lesions and Reduced Kidney Function
The overall objective of this study is to evaluate the safety and diagnostic efficacy of Mangoral in liver MRI in participants with known or suspected focal liver lesions and severe renal impairment.
- Trial name
- SPARKLE (NCT04119843)
- Testing
- Mangoral
- Where
- 60 sites in United States, Argentina and 8 more
- Volunteers
- 87 people
- Sponsor
- Ascelia Pharma AB
Drug Induced Liver Injury
Acetaminophen Adduct Formation in Non-Drinkers Taking Therapeutic Doses of Acetaminophen for Ten Consecutive Days
Acetaminophen is commonly used to treat fever or pain. Your body clears acetaminophen by processing it in the liver. During the processing, some of the acetaminophen may bind to proteins in the liver.
- Trial name
- Non-Drinker (NCT00616018)
- Testing
- acetaminophen
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Kennon Heard
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
Nonalcoholic Steatohepatitis (NASH), Primary Sclerosing Cholangitis (PSC)
Pharmacokinetics and Pharmacodynamics of Cilofexor in Adults With Normal and Impaired Hepatic Function
The primary objective of this study is to evaluate the single-dose pharmacokinetics of cilofexor in adults with impaired hepatic function relative to matched, healthy controls with normal hepatic function.
- Trial name
- NCT02808312
- Testing
- Cilofexor
- Where
- 5 sites in United States, New Zealand
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Hepatitis C Virus
Study to Evaluate the Pharmacokinetics of Velpatasvir in Participants With Normal Renal Function and Severe Renal Impairment
The primary objective of the study is to evaluate the single-dose pharmacokinetics (PK) of velpatasvir (formerly GS-5816) in participants with severe renal impairment using matched healthy participants as a control group.
- Trial name
- NCT02002767
- Testing
- Velpatasvir
- Where
- 5 sites in United States, New Zealand
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Asses Immunosuppression Modulation on Renal Recovery Post LT
Examination of Immunosuppression Adjustment Impact on Kidney Function in Liver Transplant
This is a study to help understand how well new combinations of immunosuppressive medications (medications that weaken your immune system to prevent your body from rejecting the transplanted liver) work compared to standard…
- Trial name
- NCT04104438
- Testing
- Basiliximab 20 MG
- Where
- United States
- Volunteers
- 71 people
- Sponsor
- Fady M Kaldas, M.D., F.A.C.S.
Hepatitis C
Pharmacokinetics and Safety of BI 201335 in Patients With Mild to Severe Renal Impairment
The main objective of this study is to investigate the influence of mild, moderate and severe renal impairment on the pharmacokinetics and safety of BI 201335 in comparison to a control group with normal renal function after…
- Trial name
- NCT01580306
- Testing
- BI 201335
- Where
- Germany
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim