Clinical trials: Child-Pugh Classification
Hepatic; Functional Disturbance
Open-label Study to Assess the Pharmacokinetics of NKTR-118 in Patients With Impaired Hepatic Function
The purpose of this study is to assess the pharmacokinetics of NKTR-118 in patients with impaired hepatic function versus subjects with normal hepatic function.
- Trial name
- NCT01392807
- Testing
- NKTR-118
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
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
Hepatocellular Carcinoma
Safety and Tolerability of I.V. Infusion of MB07133 in Patients With Unresectable Hepatocellular Carcinoma
Hepatocellular carcinoma (HCC) is the most common primary cancer of the liver. MB07133 is being developed for the treatment of inoperable HCC, using a platform technology known as HepDirectTM, which enables drugs to be targeted…
- Trial name
- NCT00073736
- Testing
- MB07133 300mg/m2/day, MB07133 600 mg/m2/day, MB07133 1200 mg/m2/day
- Where
- 4 sites in United States, Hong Kong and 1 more
- Volunteers
- 28 people
- Sponsor
- Ligand Pharmaceuticals
Hepatic Impairment (Mild and Moderate, Child-Pugh Class A and B), Hepatic Insufficiency (MeSH ID: D048550)
Pharmacokinetics and Safety of MDR-001 in Mild and Moderate Hepatic Impairment
This is a Phase I, single-center, open-label, parallel-group study. A single oral dose of MDR-001, a GLP-1 receptor agonist, will be administered to participants with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic…
- Trial name
- NCT07550634
- Testing
- MDR-001
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- MindRank AI Ltd
Advanced Hepatocellular Carcinoma
Phase 1 Study of SF1126 in Combination With Nivolumab in Patients With Advanced Hepatocellular Carcinoma
Primary Objectives: 1. To determine the maximum tolerated dose (MTD) or maximum recommended dose of SF1126 in combination with nivolumab in adult patients with advanced (unresectable or metastatic) HCC and Child-Pugh A or…
- Trial name
- NCT03059147
- Testing
- SF1126, Nivolumab
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- SignalRX Pharmaceuticals, Inc.
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
Solid Tumour, Advanced Solid Malignancies
A Phase I Study of AZD1480 in Patients With Advanced Solid Malignancies and Advanced Hepatocellular Carcinoma in the Escalation Phase,Non-Small Cell Lung Cancer(NSCLC) and Non-smokers With Lung Metastasis and Gastric Cancer and Solid Tumour in the Expansion Phase.
This is Phase I, open-label and dose escalation study to evaluate the safety and tolerability of AZD1480(JAK2 inhibitor) in Asian patients with advanced solid tumors (Part A and C) and in patients with advanced HCC (Part B) in…
- Conditions
- Solid Tumour, Advanced Solid Malignancies, Child-Pugh A to B7 Advanced Hepatocellular Carcinoma, EGFR and/or ROS Mutant NSCLC
- Trial name
- NCT01219543
- Testing
- AZD1480 Daily, AZD1480 BID
- Where
- South Korea
- Volunteers
- 47 people
- Sponsor
- AstraZeneca
Influenza Type A, Influenza Type B
To Compare the Safety and PK/ PD Characteristics of ADC189 Between Hepatic Impairment and Normal Hepatic Function Subjects
This study aims to evaluate the pharmacokinetics, pharmacodynamics, safety, and tolerability of ADC189 in subjects with hepatic impairment compared with subjects with normal hepatic function.
- Trial name
- NCT06485401
- Testing
- ADC189
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Jiaxing AnDiCon Biotech Co.,Ltd
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)
Hepatic Impairment
A Single Dose Study of Oral Vadadustat in Subjects With Normal and Impaired Hepatic Function
This is a Phase I open-label study to evaluate the pharmacokinetic (PK) profile of a single oral dose of vadadustat in subjects with hepatic impairment(HI) compared to healthy matched control subjects with normal hepatic function.
- Trial name
- NCT03799848
- Testing
- Vadadustat
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Akebia Therapeutics
Healthy, Liver Diseases
A Study to Test How Avenciguat (BI 685509) is Taken up in the Body of People With and Without Liver Problems
This study is open to people with and without severe liver problems. People can join the study if they are 18 to 80 years of age and have a body mass index (BMI) between 18.5 and 42 kg/m2.
- Trial name
- NCT06272058
- Testing
- Avenciguat (BI 685509)
- Where
- 2 sites in United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Participants, Participants With Mild Hepatic Impairment
A Phase I Clinical Trial to Evaluate the Pharmacokinetic and Safety of Ammoxetine Hydrochloride Enteric-Coated Tablets in Participants With Mild Hepatic Impairment, Moderate Hepatic Impairment, and Normal Liver Function
Use these resources to provide understandable information about this study to patients, families, and health care providers:This study is a multi-center, non-randomized, open-label, parallel-group, multiple-dose Phase I clinical…
- Conditions
- Healthy Participants, Participants With Mild Hepatic Impairment, Participants With Moderate Hepatic Impairment
- Trial name
- NCT07694843
- Testing
- ammoxetine hydrochloride enteric-coated tablets
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Hepatic Impairment (HI)
Pharmacokinetic Study of Vorolanib Tablets in Trial Participants With Hepatic Impairment
This is a single-center, non-randomized, open-label, parallel-group, single-dose study designed to evaluate the safety and pharmacokinetic (PK) profile of vorolanib tablets in participants with hepatic impairment.
- Trial name
- NCT07809802
- Testing
- vorolanib
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Unresectable or Metastatic Hepatocellular Carcinoma, Child-Pugh A Hepatocellular Carcinoma
Visugromab, Nivolumab and Lenvatinib Compared to Double Placebo and Lenvatinib in Unresectable or Metastatic Hepatocellular Carcinoma Post Anti-PD-(L)1 Failure
This is a Phase 2b, randomized, blinded clinical trial investigating the efficacy and safety of visugromab in combination with nivolumab and Lenvatinib compared to double placebo and Lenvatinib in participants with unresectable…
- Conditions
- Unresectable or Metastatic Hepatocellular Carcinoma, Child-Pugh A Hepatocellular Carcinoma, Failure of First-Line Treatment That Included an Approved Anti PD-(L)1 Compound
- Trial name
- GDFATHERHCC01 (NCT07219459)
- Testing
- Visugromab RDE (recommended dose for expansion), Nivolumab, Lenvatinib
- Where
- 23 sites in United States, France and 4 more
- Volunteers
- 104 people
- Sponsor
- CatalYm GmbH
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
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.
Hepatic Failure
Pharmacokinetic Study of Icenticaftor in Participants With Hepatic Impairment
The primary purpose of this study is to evaluate the effect of hepatic impairment on the systemic pharmacokinetics, safety, and tolerability of icenticaftor in participants with varying degrees of hepatic impairment.
- Trial name
- NCT04587622
- Testing
- Icenticaftor
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals