Clinical trials: Child-Pugh Classification
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
Healthy Study Participants, Impaired Hepatic Function
A Pharmacokinetic Study of Padsevonil in Study Participants With Either Normal or Moderately Impaired Hepatic Function
The purpose of the study is to evaluate the plasma pharmacokinetic (PK), safety and tolerability of padsevonil (PSL) in hepatically impaired and non-hepatically impaired study participants.
- Trial name
- NCT04136444
- Testing
- Padsevonil
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- UCB Biopharma S.P.R.L.
Carcinoma, Hepatocellular
c-Met Second-Line Hepatocellular Carcinoma
This is a Phase 1b/2, multicenter, single arm trial to assess the efficacy, safety, and pharmacokinetics (PK) of MSC2156119J as monotherapy in subjects with MET+ advanced hepatocellular carcinoma (HCC) with child Pugh Class A…
- Trial name
- NCT02115373
- Testing
- Tepotinib
- Where
- Germany
- Volunteers
- 66 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Hepatic Insufficiency
Nintedanib in Volunteers With Hepatic Impairment Compared With Healthy Volunteers
The primary objective of this study is to investigate the effect of mild (Child-Pugh A, score 5-6) and moderate (Child-Pugh B, score 7-9) hepatic impairment on the pharmacokinetics, safety and tolerability of nintedanib, in…
- Trial name
- NCT02191865
- Testing
- Nintedanib
- Where
- Germany
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Carcinoma, Hepatocellular
Efficacy, Safety, and Pharmacokinetic of MSC2156119J in Asian Participants With Hepatocellular Carcinoma
This is an open-label, integrated, Phase 1b/2 trial to determine the recommended Phase 2 dose (RP2D) and to evaluate the efficacy, safety, and pharmacokinetic of MSC2156119J as first-line treatment versus sorafenib in subjects…
- Trial name
- NCT01988493
- Testing
- Tepotinib 300 mg, Tepotinib 500 mg, Tepotinib 1000 mg
- Where
- 43 sites in China, South Korea and 1 more
- Volunteers
- 117 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Hepatic Insufficiency, Healthy
Pharmacokinetics of Empagliflozin (BI 10773) in Patients With Impaired Liver Function
The main objective of this study is to assess the effect of mild, moderate and severe hepatic impairment on the pharmacokinetics, safety and tolerability of BI 10773 following oral administration of BI 10773 as a single dose.
- Trial name
- NCT01111318
- Testing
- BI 10773
- Where
- Romania
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Advanced Adult Hepatocellular Carcinoma, Child-Pugh Class A
Sorafenib Tosylate and Pembrolizumab in Treating Patients With Advanced or Metastatic Liver Cancer
This phase Ib/II trial studies how well sorafenib tosylate and pembrolizumab work in treating patients with liver cancer that has spread to other parts of the body.
- Conditions
- Advanced Adult Hepatocellular Carcinoma, Child-Pugh Class A, Stage III Hepatocellular Carcinoma, Stage IIIA Hepatocellular Carcinoma
- Trial name
- NCT03211416
- Testing
- Laboratory Biomarker Analysis, Pembrolizumab, Sorafenib Tosylate
- Where
- 2 sites in United States
- Volunteers
- 37 people
- Sponsor
- Roswell Park Cancer Institute
Hepatocellular Carcinoma
A Study of Dovitinib Versus Sorafenib in Adult Patients With Hepatocellular Carcinoma (HCC) as a First Line Treatment
The purpose of this open-label, randomized, phase II study is to compare the safety and efficacy of dovitinib versus sorafenib as first-line treatment in adult patients with advanced Hepatocellular Carcinoma (HCC).
- Trial name
- NCT01232296
- Testing
- dovitinib, sorafenib
- Where
- 24 sites in China, Hong Kong and 5 more
- Volunteers
- 162 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Hepatitis C Infection, Compensated Cirrhosis
A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267; (ABT-267 Also Known as Ombitasvir) and ABT-333 (Also Known as Dasabuvir) Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis
The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir)…
- Trial name
- TURQUOISE-II (NCT01704755)
- Testing
- ABT-450/r/ABT-267, ABT-333, Ribavirin (RBV)
- Volunteers
- 381 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Hepatitis C Virus (HCV)
A Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Pediatric Subjects With Genotypes 1-6 Chronic Hepatitis C Virus (HCV) Infection
The objectives of this study are to assess the pharmacokinetics, safety, and efficacy of glecaprevir/pibrentasvir adult formulation in adolescents ages 12 to 17 years and a pediatric formulation of glecaprevir and pibrentasvir in…
- Trial name
- DORA (NCT03067129)
- Testing
- Glecaprevir/Pibrentasvir Adult Formulation, Glecaprevir + Pibrentasvir Pediatric Formulation
- Where
- 38 sites in United States, Belgium and 7 more
- Volunteers
- 129 people
- Sponsor
- AbbVie
Infections, Bacterial
Pharmacokinetics (PK) Study of Gepotidacin (GSK2140944) in Adult Subjects With Varying Degrees of Hepatic Impairment and in Matched Control Subjects With Normal Hepatic Function
This is a two-part study which will evaluate the PK, safety, and tolerability of a single 1500 milligram (mg) oral dose of gepotidacin in subjects with normal hepatic function and in subjects with mild, moderate, and severe…
- Trial name
- NCT03562117
- Testing
- Gepotidacin
- Where
- 2 sites in United States
- Volunteers
- 25 people
- Sponsor
- GlaxoSmithKline
Advanced Adult Hepatocellular Carcinoma
Cabozantinib in Patients With Advanced Hepatocellular Carcinoma With Child Pugh Class B Cirrhosis After First-Line Therapy
The aim of this study is to determine the safety and efficacy of cabozantinib in the management of unresectable or metastatic hepatocellular carcinoma (HCC) with underlying Child-Pugh class B cirrhosis.
- Trial name
- NCT04497038
- Testing
- Cabozantinib
- Where
- 4 sites in United States
- Volunteers
- 3 people
- Sponsor
- University of Michigan Rogel Cancer Center
Chronic Hepatitis C
A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, Odalasvir, and Simeprevir
The purpose of this study is to evaluate the safety and tolerability of AL-335 in combination with odalasvir (ODV) with or without simeprevir (SMV) in participants with genotype (GT)1 or GT2 or GT3 chronic hepatitis C (CHC)…
- Trial name
- NCT02569710
- Testing
- AL-335, Odalasvir (ODV), Simeprevir (SMV)
- Where
- 11 sites in Mauritius, Moldova and 2 more
- Volunteers
- 161 people
- Sponsor
- Alios Biopharma Inc.
Chronic Hepatitis C, Decompensated Cirrhosis
A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Ribavirin in Adults With Genotype 1 and Ombitasvir/Paritaprevir/Ritonavir With Ribavirin in Adults With Genotype 4 Chronic Hepatitis C Virus Infection and Decompensated Cirrhosis
The primary objectives of this study are to assess the safety and the SVR12 rate of ombitasvir/paritaprevir/ritonavir and dasabuvir with RBV in GT1-infected participants with decompensated cirrhosis.
- Conditions
- Chronic Hepatitis C, Decompensated Cirrhosis, Hepatitis C Virus
- Trial name
- TURQUOISE-CPB (NCT02219477)
- Testing
- ombitasvir/paritaprevir/ritonavir, dasabuvir, ribavirin
- Volunteers
- 36 people
- Sponsor
- AbbVie
Hepatitis C Virus Infection
Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 Weeks in Participants With Chronic HCV Infection and Child-Pugh-Turcotte Class C Cirrhosis
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir velpatasvir (SOF/VEL) fixed-dose combination (FDC) with ribavirin (RBV) for 12 weeks in participants…
- Trial name
- NCT02994056
- Testing
- SOF/VEL, RBV
- Where
- 12 sites in United States, France
- Volunteers
- 32 people
- Sponsor
- Gilead Sciences
Unresectable Hepatocellular Carcinoma
A Study of Atezolizumab and Bevacizumab in Hepatocellular Carcinoma
This will be a nonrandomized, single arm feasibility study with the primary goal of evaluating the safety profile of the combination of atezolizumab and bevacizumab in patients with advanced/metastatic HCC with Child-Pugh B7 and…
- Trial name
- AB7 (NCT04829383)
- Testing
- Atezolizumab, Bevacizumab
- Where
- 7 sites in United States
- Volunteers
- 6 people
- Sponsor
- Howard S Hochster
Chronic Hepatitis C Infection, Compensated Cirrhosis
A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis
The purpose of this study was to evaluate the safety and efficacy of ombitasvir/ paritaprevir/ ritonavir and dasabuvir in adults with genotype 1b chronic hepatitis C virus (HCV) infection and cirrhosis.
- Trial name
- TURQUOISE-III (NCT02219503)
- Testing
- Ombitasvir/Paritaprevir/Ritonavir, Dasabuvir
- Volunteers
- 60 people
- Sponsor
- AbbVie
Hepatic Failure, Hepatic Impairment
Single Dose Pharmacokinetics of Suboxone Study in Hepatic Impaired Subjects
The objective was to determine if hepatitis C virus (HCV) infection or mild to severe hepatic impairment (Child-Pugh Classes A, B, and C) altered the PK of buprenorphine, norbuprenorphine, or naloxone.
- Conditions
- Hepatic Failure, Hepatic Impairment, Chronic Hepatitis C Infection With Hepatic Coma
- Trial name
- NCT01846455
- Testing
- 2.0mg Buprenorphine/0.5mg Naloxone, Promethazine
- Where
- 3 sites in United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Indivior Inc.
Cancer
Study Of Eribulin (E7389) In Patients With Advanced Solid Tumors And Normal Or Reduced Hepatic Function As Per Child-Pugh System
This is an open-label, three-parallel group pharmacokinetic study. Patients with advanced solid tumors will be assigned to one of three groups to receive I.V. doses of eribulin (E7389).
- Trial name
- NCT00706095
- Testing
- E7389
- Where
- 2 sites in Netherlands
- Volunteers
- 18 people
- Sponsor
- Eisai Inc.
Child-Pugh Class A, Child-Pugh Class B
Transarterial Chemoembolization Compared With Stereotactic Body Radiation Therapy or Stereotactic Ablative Radiation Therapy in Treating Patients With Residual or Recurrent Liver Cancer Undergone Initial Transarterial Chemoembolization
This randomized phase III trial studies how well transarterial chemoembolization (TACE) works compared to stereotactic body radiation therapy (SBRT) or stereotactic ablative radiation therapy (SABR) in patients with liver cancer…
- Conditions
- Child-Pugh Class A, Child-Pugh Class B, Recurrent Hepatocellular Carcinoma
- Trial name
- NCT02762266
- Testing
- Stereotactic Body Radiation Therapy, Transarterial Chemoembolization, embolic agent
- Where
- 2 sites in United States, Japan
- Volunteers
- 13 people
- Sponsor
- Stanford University