Clinical trials: Child-Pugh Classification
BCLC Stage C HCC, CP-B Liver Cirrhosis
Sorafenib PK in Patients With Advanced HCC and Child-Pugh B
Sorafenib has proven efficacy in advanced hepatocellular carcinoma (HCC). Most patients with HCC have impaired liver function due to underlying liver cirrhosis.
- Trial name
- SORBE (NCT04051853)
- Testing
- Sorafenib, Midazolam clearance test, CYP cocktail clearance test
- Where
- Netherlands
- Volunteers
- 5 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Hepatocellular Carcinoma by BCLC Stage
Testing Immunotherapy for Patients With Liver Cancer and Moderately Altered Liver Functions
Liver cancer is the third leading cause of cancer-related deaths worldwide. The majority of primary liver cancers occur as hepatocellular carcinoma (HCC), the incidence of which is increasing in many parts of the world.
- Trial name
- HESTIA (NCT05622071)
- Testing
- Tislelizumab
- Where
- 10 sites in France
- Volunteers
- 50 people
- Sponsor
- UNICANCER
Hepatitis C, Compensated Cirrhosis
Study to Investigate Tolerability and Efficacy of MK5172 / MK8742 Without Ribavirin for 12 Weeks in Patients With Chronic HCV G1b Infection With Compensated Cirrhosis
To assess efficacy (SVR rate) of MK5172 / MK8742 for 12 weeks without RBV in G1b patients with compensated cirrhosis (Child-Pugh A5 to A6) previously failing first gen. PI or non responders to PR.
- Trial name
- GECOM (NCT02732405)
- Testing
- MK5172 /MK8742
- Volunteers
- 120 people
- Sponsor
- Istituto Clinico Humanitas
Hepatitis C, Chronic
BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3
To assess the pharmacokenetic characteristics of 600 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of GT1b HCV infected patients with mild hepatic impairment (CPA) (Arm 1) versus 400 mg BID BI 207127 / 120…
- Trial name
- NCT01830127
- Testing
- Ribavirin, BI 207127 high dose, Faldaprevir
- Where
- 19 sites in United States, Germany and 2 more
- Volunteers
- 35 people
- Sponsor
- Boehringer Ingelheim
Hepatic Insufficiency
Pharmacokinetics and Pharmacodynamics of BI 1356 in Subjects With Different Degrees of Liver Impairment as Compared to Healthy Subjects
To investigate the influence of mild, moderate, and severe liver impairment on the pharmacokinetics and pharmacodynamics of linagliptin in comparison with a control group with normal hepatic function after single or multiple oral…
- Trial name
- NCT02183376
- Testing
- BI 1356
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Hepatic Impairment
A Trial to Evaluate the Pharmacokinetics of ABL001 in Healthy and Hepatic Impaired Subjects
The main purpose of this study is to evaluate the effect of varying degrees of impaired hepatic function (by Child-Pugh classification) on the pharmacokinetics (PK) of ABL001 after a single oral dose.
- Trial name
- NCT02857868
- Testing
- ABL001
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Healthy Volunteers, Hepatic Impairment of Moderate Child Pugh Category
HI Study to Assess and Compare the Pharmacokinetic Parameters of MD1003 in Hepatic Impaired Patients and Healthy Subjects
This is a Phase 1, multicentric, open-label,two arms to assess and compare the effect of single oral administration of MD1003 on the pharmacokinetic parameters in hepatic impaired patients and healthy subjects with normal hepatic…
- Trial name
- NCT04252417
- Testing
- MD1003
- Where
- 3 sites in France, Hungary
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- MedDay Pharmaceuticals SA
Hepatocellular Carcinoma (HCC)
Adaptive Dosing of Immune Checkpoint Inhibitors for Hepatocellular Carcinoma
The goal of this clinical trial is to learn if immunotherapy including nivolumab plus ipilimumab is effective and safe in treating hepatocellular carcinoma.
- Trial name
- NCT07689175
- Testing
- Nivolumab, Ipilimumab (3 mg/kg)
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Texas Southwestern Medical Center
HepatoCellular Carcinoma, Unresectable HepatoCellular Carcinoma
Sorafenib and Bavituximab Plus SBRT in Unresectable Hepatocellular Carcinoma
This study involves a course of radiation to up to 5 tumors in the participant's liver followed by systemic therapy. (Treatment using substances that travel through the bloodstream, reaching and affecting cells all over the…
- Conditions
- HepatoCellular Carcinoma, Unresectable HepatoCellular Carcinoma, Liver Cancer
- Trial name
- NCT02989870
- Testing
- Stereotactic Body Radiation Therapy (SBRT), Sorafenib, Bavituximab
- Where
- United States
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Hepatic Failure, Liver Failure
Cardiox Liver Function Test Pivotal Trial
Performance evaluation of LFT Dye Monitor System using ICG - plasma disappearance rate value (PDR) to assess liver function in normal patients as well as in patients with mild to severe hepatic impairment compared to manual Serum…
- Trial name
- LFT-0002 (NCT02552901)
- Testing
- 0.1 mg/kg ICG Dose, 0.5 mg/kg ICG dose
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Cardiox Corporation
Hepatocellular Carcinoma
Electromagnetic Fields Versus Placebo For Child-Pugh A and B Patients With Advanced Hepatocellular Carcinoma
The primary goals of this study are to compare overall survival and quality of life in subjects with Child-Pugh A or B advanced hepatocellular carcinoma when treated with a device emitting radiofrequencies modulated at specific…
- Trial name
- ARTEMIS (NCT04797884)
- Testing
- TheraBionic Device, Quality of Life Assessment
- Where
- 7 sites in United States
- Volunteers
- 166 people
- Sponsor
- THERABIONIC INC.
Asymptomatic Cirrhosis, Clinically Significant Portal Hypertension
Effect of Long-term Carvedilol to Prevent Decompensation or Death in Patients With Asymptomatic Child-Pugh A5 to B8 Cirrhosis and Clinically Significant Portal Hypertension: a Multicenter Double-blind Randomized Control Trial
Decompensation of cirrhosis is a turning point in cirrhosis course, as associated with a marked decrease in life expectancy. Thus, prevention of decompensation is crucial.
- Trial name
- CARVECIR (NCT06263816)
- Testing
- Experimental group: Patients will be treated with carvedilol.
- Where
- 24 sites in France
- Volunteers
- 290 people
- Sponsor
- University Hospital, Tours
Hepatic Impairment
A Study to Investigate the Pharmacokinetics and Safety of Remibrutinib in Participants With Hepatic Impairment Compared With Matched Healthy Participants
This was a Phase 1, open-label study to evaluate the PK, safety, and tolerability after administration of multiple doses of remibrutinib in participants with mild, moderate, or severe hepatic impairment (HI) compared to pooled…
- Trial name
- NCT05753592
- Testing
- Part 1; LOU064 (Remibrutinib), Part 2; LOU064 (Remibrutinib)
- Where
- Hungary
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Cirrhosis, Portal Hypertension
Efficacy of Long-acting Octreotide (Sandostatin LAR) in Reducing Portal Pressure in Patients With Cirrhosis
Octreotide is used to control variceal bleeding. However, octreotide has to be given through the vein and is effective for less than two hours.
- Conditions
- Cirrhosis, Portal Hypertension, Esophageal Varices
- Trial name
- NCT01188733
- Testing
- Long acting octreotide 10mg, Long acting Octreotide 30mg, Saline
- Volunteers
- 39 people
- Sponsor
- Mayo Clinic
Hepatic Impairment
Pharmacokinetics and Safety Study of Siremadlin (HDM201) in Participants With Mild, Moderate and Severe Hepatic Impairment
The main purpose of this study is to evaluate the effect of varying degrees of impaired hepatic function (by Child Pugh classification) on the plasma PK of siremadlin after a single oral dose.
- Trial name
- NCT05599932
- Testing
- Siremadlin
- Where
- 3 sites in United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Liver Cancer
Sorafenib Tosylate With or Without Pravastatin in Treating Patients With Liver Cancer and Cirrhosis
RATIONALE: Sorafenib tosylate and pravastatin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
- Trial name
- NCT01075555
- Testing
- pravastatin sodium, sorafenib tosylate
- Where
- France
- Volunteers
- 323 people
- Sponsor
- Federation Francophone de Cancerologie Digestive
Hepatocellular Carcinoma (HCC)
Study of CT-01 as Monotherapy and Combination Therapy in Subjects With Intermediate or Advanced Hepatocellular Carcinoma
This is a Phase 1, open-label, multicenter, dose-escalation and dose-expansion study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CT-01, administered either as monotherapy or…
- Trial name
- NCT06994572
- Testing
- CT-01, EVEROLIMUS
- Volunteers
- 141 people
- Sponsor
- Captor Therapeutics S.A.
Liver Neoplasms, Colonic Neoplasms
Safety, Efficacy, and Dosing of Stereotactic Radiosurgery for Hepato-cellular Carc/Colo-rectal Liver Metastases
The purpose of this study is to determine a tolerable dose of radiation delivered by the CyberKnife system in two groups of patients with hepatocellular carcinoma (HCC).
- Conditions
- Liver Neoplasms, Colonic Neoplasms, Metastatic Cancer to Liver
- Trial name
- NCT01528878
- Testing
- Stereotactic Radiosurgery using the CyberKnife System.
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center