Clinical trials: Hepatic
Hepatitis C, Chronic
A Study of the Pharmacokinetics of Uprifosbuvir (MK-3682) and Ruzasvir (MK-8408) in Participants With Moderate and Severe Hepatic Insufficiency (MK-3682-029)
This is a non-randomized, open-label, single-dose study to evaluate the pharmacokinetics (PK) of uprifosbuvir (MK-3682), the M5 and M6 metabolites of uprifosbuvir, and ruzasvir (MK-8408), in participants with moderate hepatic…
- Trial name
- NCT02666352
- Testing
- Uprifosbuvir, Ruzasvir
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hepatic Cirrhosis, Liver Fibrosis
A Study of Experimental Medication BMS-986263 in Adults With Advanced Hepatic Fibrosis After Cure of Hepatitis C
This is a study of experimental medication BMS-986263 in adult patients with advanced hepatic fibrosis (scar tissue in the liver caused by inflammation that is far on in progress) after the patient is cured of hepatitis C (an…
- Trial name
- NCT03420768
- Testing
- BMS-986263
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Bristol-Myers Squibb
Erythropoietic Protoporphyria
Multicentre Phase III Erythropoietic Protoporphyria Study
This was a phase III, multicentre, randomised, double-blind, placebo-controlled study, to evaluate the safety and efficacy of subcutaneous bioresorbable afamelanotide implants in patients with Erythropoietic Protoporphyria (EPP).
- Trial name
- NCT04053270
- Testing
- Afamelanotide
- Volunteers
- 100 people
- Sponsor
- Clinuvel Pharmaceuticals Limited
Colorectal Cancer, Liver Neoplasms
Safety & Efficacy of NV1020 in Colorectal Cancer Metastatic to the Liver
This study is an open-label study. It has two stages. Stage 1 is a dose escalation phase of the study to determine and evaluate the safety and tolerability of repeated treatments with a genetically engineered herpes simplex virus…
- Trial name
- NCT00149396
- Testing
- NV1020
- Where
- 5 sites in United States
- Volunteers
- 32 people
- Sponsor
- MediGene
Cirrhosis
A Trial of OPC-41061 in Patients With Hepatic Edema - Investigation of the Safety of Treatment at 7.5 mg Beyond 7 Days and of the Effect of Dose Escalation to 15 mg
OPC-41061 will be orally administered at 7.5 mg/day for 7 days to cirrhosis patients with ascites despite having received conventional diuretic therapy.
- Trial name
- NCT01048788
- Testing
- OPC-41061
- Where
- 6 sites in Japan
- Volunteers
- 51 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Hepatic Encephalopathy
Safety and Tolerability Study of Rifaximin in Participants With a History of Hepatic Encephalopathy
This study will look at the safety of a drug used in participants who have had hepatic encephalopathy (HE) in the past.
- Trial name
- NCT00686920
- Testing
- Rifaximin
- Where
- 35 sites in United States, Canada
- Volunteers
- 322 people
- Sponsor
- Bausch Health Americas, Inc.
Bleeding (Oozing) in Hepatic Resection
Fibrin Sealant VH S/D 500 S-apr in Hepatic Resection
The purpose of the study is to compare safety and efficacy of Fibrin Sealant (FS) Vapor Heated (VH) S/D 500 s-apr with manual compression as a supportive treatment of local bleeding (i.e.
- Trial name
- NCT01244425
- Testing
- Fibrin Sealant (FS) VH S/D 500 s-apr, Manual compression
- Where
- 7 sites in Germany
- Volunteers
- 70 people
- Sponsor
- Baxter Healthcare Corporation
Hepatitis B
Comparison of Entecavir to Adefovir in Chronic Hepatitis B Virus (HBV) Patients With Hepatic Decompensation
This is a phase IIIb comparative study of entecavir 1.0 mg once daily (QD) vs. adefovir 10 mg QD in patients who have chronic hepatitis B infection and hepatic decompensation.
- Trial name
- NCT00065507
- Testing
- Entecavir (ETV), Adefovir (ADV)
- Where
- 61 sites in United States, Brazil and 15 more
- Volunteers
- 195 people
- Sponsor
- Bristol-Myers Squibb
Hepatic Cirrhosis, Liver Fibrosis
A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Liver Cirrhosis
This is a study of experimental medication BMS-986036 given to adults with Nonalcoholic Steatohepatitis (NASH; the buildup of fat and inflammation in the liver that is not caused by alcohol) and liver cirrhosis (liver damage…
- Conditions
- Hepatic Cirrhosis, Liver Fibrosis, Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis
- Trial name
- FALCON 2 (NCT03486912)
- Testing
- BMS-986036
- Where
- 91 sites in United States, Japan
- Volunteers
- 155 people
- Sponsor
- Bristol-Myers Squibb
Hepatic Impairment
Study to Evaluate a Dose of Telotristat Etiprate in Male and Female With Mild, Moderate and Severe Hepatic Insufficiency and Matched Healthy Subjects
The purpose of the protocol is to assess the pharmacokinetics, safety and tolerability of a single dose of telotristat etiprate in subjects with various stages of hepatic impairment compared to healthy control subjects.
- Trial name
- NCT02683577
- Testing
- telotristat etiprate
- Where
- 2 sites in Moldova, Romania
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Ipsen
Liver Fibrosis, Hepatic Fibrosis
A Trial of IDN-6556 in Post Orthotopic Liver Transplant for Chronic HCV
This is a double-blind, multicenter study involving patients with chronic HCV infection who had a liver transplantation; developed HCV-related liver fibrosis and/or incomplete cirrhosis; achieved a sustained virologic response…
- Conditions
- Liver Fibrosis, Hepatic Fibrosis, Liver Cirrhosis, Hepatic Cirrhosis
- Trial name
- POLT-HCV-SVR (NCT02138253)
- Testing
- IDN-6556
- Where
- 35 sites in United States
- Volunteers
- 64 people
- Sponsor
- Conatus Pharmaceuticals Inc.
Chronic Hepatitis B
Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Alafenamide (TAF) From Tenofovir Disoproxil Fumarate (TDF) and/or Other Oral Antiviral Treatment (OAV)
The primary objective of this study is to evaluate the safety and tolerability and virologic response of tenofovir alafenamide (TAF) in virologically suppressed chronic hepatitis B participants with renal and/or hepatic…
- Trial name
- NCT03180619
- Testing
- TAF
- Where
- 30 sites in United States, Canada and 6 more
- Volunteers
- 124 people
- Sponsor
- Gilead Sciences
Portal Hypertension
Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension
The primary purpose of this study is to determine the efficacy and safety of cobiprostone (at two dose levels) as compared to placebo for lowering portal hypertension.
- Trial name
- NCT00737594
- Testing
- Cobiprostone
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Sucampo Pharma Americas, LLC
Hepatic Impairment
Study of PF-05221304 in Subjects With Varying Degrees of Hepatic Impairment
Hepatic impairment PK study
- Trial name
- NCT03309202
- Testing
- PF-05221304
- Where
- 6 sites in United States, Belgium and 2 more
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Diabetes
Mechanisms of Glucose Lowering Effect of Colesevelam HCl
The mechanism by which colesevelam HCl lowers glucose is not known. Knowledge of the potential mechanism of action is important for defining the role of the drug among oral antidiabetic agents available for use in subjects with…
- Trial name
- NCT00596427
- Testing
- Colesevelam HCL
- Where
- 3 sites in United States
- Volunteers
- 60 people
- Sponsor
- Carine Beysen
Liver Failure
Pharmacokinetics of LCP-Tacro in Stable Liver Transplant Patients
A three sequence, open-label, multi-center, prospective, study in stable liver transplant patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of LCP-Tacro (tacrolimus) tablets versus Prograf…
- Trial name
- NCT00608244
- Testing
- LCP Tacro, Prograf
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- Veloxis Pharmaceuticals
Hepatic Encephalopathy
A Retrospective, Open-label, Uncontrolled Cohort Study to Assess the Effectiveness and Safety of Lactulose Retention Enema in the Treatment of Cirrhotic Patients With Grade 3 or 4 (West Haven Criteria) Hepatic Encephalopathy (HE) [The RETRO Study]
This is a retrospective study in adult patients with cirrhosis and grade 3 or 4 HE (West Haven Criteria) to evaluate the effectiveness and safety of lactulose retention enema in the treatment of deep grade HE (West Haven…
- Trial name
- NCT02377947
- Where
- 3 sites in India
- Volunteers
- 50 people
- Sponsor
- Abbott
Advanced Hepatocellular Carcinoma, Liver Cancer
CS1008- in Combination With Sorafenib Compared to Sorafenib Alone in Subjects With Advanced Liver Cancer
The purpose of this study is to determine the safety and efficacy of CS-1008 in combination with sorafenib to sorafenib alone for treating liver cancer.
- Conditions
- Advanced Hepatocellular Carcinoma, Liver Cancer, Hepatic Cancer, Liver Neoplasms
- Trial name
- NCT01033240
- Testing
- CS-1008 2 mg/kg, Sorafenib, CS-1008 6/2 mg/kg
- Where
- 28 sites in United States, Japan and 2 more
- Volunteers
- 172 people
- Sponsor
- Daiichi Sankyo
Type2 Diabetes Mellitus
Safety and Efficacy of Bexagliflozin in Subjects With Moderate Hepatic Impairment
The purpose of this study is to examine the drug exposure and drug effects on subjects with moderate hepatic impairment after a single oral dose of bexagliflozin tablets, 20mg.
- Trial name
- NCT03557658
- Testing
- Bexagliflozin
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Theracos
Chronic Hepatitis C
Study of Efficacy and Safety of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Chronic Hepatitis C Participants With Child-Pugh (CP)-B Hepatic Insufficiency (MK-5172-059)
This study is being done to evaluate the efficacy and safety of the drug combination grazoprevir (GZR; MK-5172) + elbasvir (EBR; MK-8742) in participants with chronic hepatitis C virus (HCV) genotype (GT) 1, 4, or 6 infection and…
- Trial name
- NCT02115321
- Testing
- Grazoprevir, Elbasvir, MK-5172A
- Volunteers
- 40 people
- Sponsor
- Merck Sharp & Dohme LLC