Clinical trials: Child-Pugh Classification
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
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
Cirrhosis
OCR002-SP103 - Oral Immediate Release Study
This is an open-label Phase 1, 2-part, crossover study in approximately 33 adult subjects (12 subjects in Part 1 and 21 subjects in Part 2), with varying degrees of cirrhosis with analysis of pharmacokinetic (PK) data after Part…
- Trial name
- NCT03846843
- Testing
- OCR-002 IR Oral Tablet, OCR-002 Oral Solution, OCR-002 IV Solution
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Ocera Therapeutics, Inc.
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
Leiomyoma
Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1002670 (Vilaprisan)
Evaluate the potential effect of hepatic impairment on the pharmacokinetics, safety and tolerability of BAY1002670 (vilaprisan)
- Trial name
- NCT03092999
- Testing
- Vilaprisan (BAY1002670)
- Where
- 2 sites in Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Bayer
Chronic Kidney Disease
Study of the Influence of Liver Function on Blood Concentrations of Runcaciguat in Participants With Different Degrees of Liver Impairment
Researchers are looking for a better way to treat people with chronic kidney diseases. Before a treatment can be approved for patients to take, researchers do clinical studies to better understand its safety and what happens to…
- Trial name
- NCT04820621
- Testing
- Runcaciguat (BAY1101042)
- Where
- Germany
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Bayer
Heart Failure
A Trial to Learn How Safe Vericiguat (BAY1021189) is and the Way the Body Absorbs, Distributes and Gets Rid of Vericiguat in Participants With Liver Disease and in Age-, Weight- and Gender-matched Healthy Participants
Vericiguat (BAY1021189) is under development to treat heart failure, a condition in in which the heart has trouble pumping blood through the body.
- Trial name
- NCT04722562
- Testing
- Vericiguat (BAY1021189)
- Where
- Germany
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Bayer
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
Hepatocellular Carcinoma
A Study to Evaluate the Safety, Tolerability and Efficacy of Cabozantinib in Patients With Hepatocellular Carcinoma and Impaired Liver Function
This is an prospective, interventional, non-randomized multicenter phase II study to evaluate the safety, tolerability and efficacy of Cabozantinib as a second-line therapy (after one prior systemic therapy) in patients with…
- Trial name
- CaboCHILD (NCT04454762)
- Testing
- Cabozantinib
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- Johannes Gutenberg University Mainz
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.
Healthy
Pharmacokinetics of Nilotinib in Subjects With Impaired Hepatic Function and Healthy Subjects With Normal Hepatic Function
This study will be a formal assessment of the impact of hepatic function impairment on the pharmacokinetics of nilotinib
- Trial name
- NCT00418626
- Testing
- Nilotinib
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
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.
Cirrhosis
Impact on Morbidity and Mortality of Prophylactic Dosing of Low Molecular Heparin in Child-Pugh B Cirrhotic Patients
Thrombosis occurring in the small intrahepatic, as well as in the large vessels is involved in the progression of cirrhosis. Anticoagulation could reduce morbidity and mortality in cirrhotic patients
- Trial name
- Childbenox (NCT02271295)
- Testing
- Enoxaparine
- Where
- France
- Volunteers
- 16 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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
Pharmacology, Clinical
Study on the Safety of Neladenoson Bialanate, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Dug Given as a Single Oral Dose in Participants With Liver Impairment and Healthy Participants Matched for Age-, Gender-, and Weight
Neladenoson bialanate is currently under clinical development for a condition in which the heart has trouble pumping blood through the body (chronic heart failure).
- Trial name
- NCT04322253
- Testing
- Neladenoson bialanate (BAY 1067197)
- Where
- Germany
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Bayer
Alcoholic or Viral C Compensated Cirrhosis
Influence of ABO Blood Group on the Risk of Complications in Alcoholic or Viral C Cirrhosis?
The non-O blood group is a risk factor of deep vein thrombosis and recurrence of thromboembolic events, especially when associated with Factor 5 Leiden or prothrombin G20210A mutations.
- Trial name
- ABOCIRRALVIR (NCT03342170)
- Testing
- G20210A prothrombin gene mutation and Factor 5 Leiden mutation
- Where
- France
- Volunteers
- 1,500 people
- Sponsor
- University Hospital, Caen
Hepatocellular Carcinoma
Study of Milciclib in Patients With Unresectable/Metastatic Hepatocellular Carcinoma
The primary aim of this exploratory study is to test the safety and tolerability of milciclib when administered orally at 100 mg in patients with recurrent or metastatic Hepatocellular Carcinoma.
- Trial name
- NCT03109886
- Testing
- Milciclib maleate
- Where
- 14 sites in Greece, Israel and 1 more
- Volunteers
- 31 people
- Sponsor
- Tiziana Life Sciences LTD
Human Immunodeficiency Virus, Hepatitis C
Pharmacokinetic Study of Raltegravir in Human Immunodeficiency Virus/Hepatitis C Virus (HIV/VHC) Coinfected Patients With Advanced (Child-Pugh C) Hepatic Cirrhosis
Raltegravir is the first integrase inhibitor used in humans. It has been shown to be highly efficacious and well tolerated in phase III clinical trials in multidrug experienced human immunodeficiency virus(HIV)-infected patients…
- Trial name
- LIVERAL (NCT01289951)
- Testing
- Raltegravir 400 mg/12hours
- Where
- Spain
- Volunteers
- 10 people
- Sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal