Clinical trials: Child-Pugh Classification
Hepatitis B
Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment
This is a Phase 1, open-label, parallel-group study to evaluate the pharmacokinetics of GSK3228836 in participants with Child-Pugh B (CP-B) cirrhosis (moderate hepatic impairment), Child-Pugh A (CP-A) cirrhosis (mild hepatic…
- Trial name
- NCT04971928
- Testing
- GSK3228836
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Volunteers, Hepatic Impairment
GP681 in Volunteers With Hepatic Impairment Compared With Healthy Volunteers
The primary objective of this study is to test whether mild (Child-Pugh A, score 5-6) and moderate (Child-Pugh B, score 7-9) hepatic impairment affects pharmacokinetics, safety and tolerability of GP681, compared with a control…
- Trial name
- NCT05814926
- Testing
- GP681
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Sever Aplastic Anaemia
A Trial of Hetrombopag in Healthy and Hepatic Impairment Subjects
This is a single-dose, open-label, phase I clinical study evaluating the PK of hetrombopag in subjects with mild hepatic impairment (Child-Pugh Class A), subjects with moderate hepatic impairment (Child-Pugh Class B), as well as…
- Trial name
- NCT05088642
- Testing
- Hetrombopag Olamine Tablet
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Hepatic Insufficiency
A Study to Test How BI 1584862 is Taken up in the Blood of People With and Without Liver Problems
This study is open to adults between 18 and 80 years of age. People with a body mass index (BMI) between 18 and 42 kg/m2 can take part.
- Trial name
- NCT06957756
- Testing
- BI 1584862
- Where
- 3 sites in United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Hepatocellular Carcinoma (HCC)
A Study to Assess the Adverse Events and How Intravenously Infused Livmoniplimab in Combination With Budigalimab Moves Through the Bodies of Adult Chinese Participants With Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC)
Hepatocellular carcinoma (HCC) is a common cancer worldwide and a leading cause of cancer-related death. The majority of participants first presenting with HCC have advanced unresectable or metastatic disease.
- Trial name
- NCT06487559
- Testing
- Livmoniplimab, Budigalimab
- Where
- 11 sites in China
- Volunteers
- 3 people
- Sponsor
- AbbVie
Hepatocellular Carcinoma
A Study Evaluating Atezolizumab, With or Without Bevacizumab, in Participants With Unresectable Hepatocellular Carcinoma and Child-pugh B7 and B8 Cirrhosis
The purpose of this study is to assess the safety of atezolizumab and bevacizumab, or atezolizumab alone, as first-line treatment in participants with unresectable, locally advanced or metastatic hepatocellular carcinoma (HCC)…
- Trial name
- Kirros (NCT06096779)
- Testing
- Atezolizumab, Bevacizumab
- Where
- 54 sites in United States, Puerto Rico
- Volunteers
- 30 people
- Sponsor
- Genentech, Inc.
Hepatic Impairment
A Single and Repeat Dose Trial in Participants With Hepatic Impairment
This study is a a single (open-label) and repeat dose (randomised, placebo controlled) trial to assess the safety, tolerability and pharmacokinetics of GB1211 (Gal-3 inhibitor) in participants with hepatic impairment (Child Pugh…
- Trial name
- NCT05009680
- Testing
- GB1211
- Where
- 4 sites in Bulgaria
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Galecto Biotech AB
Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men
A Study to Learn How Different Levels of Decreased Liver Function Influence Blood Levels of Elinzanetant Compared to Normal Liver Function in Male and Female Participants
Researchers are looking for a better way to treat people who have symptoms caused by hormonal changes, like those that happen in women during menopause. These symptoms can include vasomotor symptoms.
- Trial name
- NCT04903821
- Testing
- BAY3427080
- Where
- 2 sites in Germany
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Bayer
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.
Liver Diseases, Healthy
A Study to Test How Zongertinib is Taken up in the Blood of People With and Without Liver Problems
This study is open to adults between 18 and 80 years of age. People with a body mass index (BMI) between 18 and 42 kg/m^2 can take part. Women can only participate if they cannot get pregnant.
- Trial name
- NCT06692322
- Testing
- Zongertinib (BI 1810631)
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Boehringer Ingelheim
Chronic Kidney Disease, Hepatic Impairment
A Study to Learn About How BAY 3283142 Moves Into, Through, and Out of the Body After a Single Dose in Participants With Reduced Liver Function Compared to Participants With Normal Liver Function
Researchers are looking for a better way to treat people who have chronic kidney disease (CKD). CKD is a condition in which the kidneys' ability to work properly gradually decreases over time.
- Trial name
- NCT06402721
- Testing
- BAY3283142
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Bayer
NASH, Cirrhosis, Liver
A Phase 3 Study to Evaluate the Effect of Resmetirom on Clinical Outcomes in Patients With Well-compensated NASH Cirrhosis (MAESTRO-NASH-OUTCOMES)
This study will determine the effect of oral 80 mg resmetirom administered once daily on participants with well-compensated non-alcoholic steatohepatitis (NASH) cirrhosis by measuring the time to experiencing a Composite Clinical…
- Trial name
- NCT05500222
- Testing
- Resmetirom
- Where
- 141 sites in United States, Belgium and 7 more
- Volunteers
- 845 people
- Sponsor
- Madrigal Pharmaceuticals, Inc.
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
Small Cell Lung Carcinoma
A Phase 1 Study to Evaluate the Pharmacokinetics of JDQ443 in Participants With Hepatic Impairment Compared to Matched Healthy Control Participants.
The purpose of this study is to evaluate the effect of hepatic impairment on the systemic pharmacokinetics (PK), safety, and tolerability of JDQ443 in participants with varying degrees of hepatic impairment.
- Trial name
- NCT05329623
- Testing
- JDQ443
- Where
- 2 sites in United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Advanced Hepatocellular Carcinoma
Durvalumab and Tremelimumab as First Line Treatment in Participants With Advanced Hepatocellular Carcinoma (HCC)
This study will assess the safety and efficacy of Single Tremelimumab Regular Interval Durvalumab (STRIDE) as first-line therapy in participants with advanced unresectable HCC.
- Trial name
- SIERRA (NCT05883644)
- Testing
- Durvalumab, Tremelimumab
- Where
- 40 sites in United States, France and 8 more
- Volunteers
- 111 people
- Sponsor
- AstraZeneca
Hepatic Impairment
Effect of Mild Hepatic Impairment on the Pharmacokinetics of Istradefylline
The purpose of this study is to test whether mild liver impairment affects blood levels of istradefylline in humans. Decreased liver function could possibly increase istradefylline levels.
- Trial name
- NCT02256033
- Testing
- Istradefylline
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Kyowa Kirin Co., Ltd.
Hepatic Impairment
A Study to Assess Safety and Pharmacokinetics of Telaprevir in Patients With Hepatic Impairment
The purpose of this study is to determine whether the pharmacokinetic (what the body does to the drug) parameters of telaprevir are altered in patients with moderate hepatic impairment, compared to the pharmacokinetic parameters…
- Trial name
- NCT01600976
- Testing
- telaprevir
- Where
- 2 sites in Czechia, Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Janssen Infectious Diseases BVBA
Myelofibrosis
To Evaluate the Pharmacokinetics and Safety of TQ05105 Tablet in Hepatic Impairment Subjects
This is an open, open-label, parallel, single-dose, phase I clinical study designed to evaluate the pharmacokinetic (PK) profile of TQ05105 tablet in patients with hepatic impairment after a single dose, and to evaluate the…
- Trial name
- NCT07480824
- Testing
- TQ05105
- Where
- 2 sites in China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Liver Diseases, Healthy
A Study to Test How BI 690517 is Taken up in the Body of People With and Without Liver Problems
The main objective of this trial is to assess the effect of mild and moderate hepatic impairment (Child-Pugh classification A and B) on the pharmacokinetics, safety, and tolerability of BI 690517 in comparison with a control…
- Trial name
- NCT05731908
- Testing
- BI 690517
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim