Clinical trials: Child-Pugh Classification
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
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.
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
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
Endometriosis Related Pain, Overactive Bladder
Study on the Safety of BAY1817080, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Drug in Participants With Impaired Liver Function or Normal Liver Function
BAY1817080 is currently under clinical development to treat pain related to unexplained chronic cough or chronic cough not affected by a treatment (refractory and/or unexplained chronic cough, RUCC), or a condition where the…
- Conditions
- Endometriosis Related Pain, Overactive Bladder, Diabetic Neuropathic Pain, Refractory or Unexplained Chronic Cough
- Trial name
- NCT04454424
- Testing
- BAY1817080, Midazolam
- Where
- 2 sites in United States
- Volunteers
- 37 people
- Sponsor
- Bayer
Worsening Chronic Heart Failure, Diabetic Nephropathy
A Study to Learn How Finerenone (BAY94-8862) Moves Into, Through and Out of the Body, How it Affects the Body, and How Safe it is in Adult Participants With Different Degrees of Reduced Liver Function and in Healthy Participants With Similar Age, Weight and Gender Distribution
Researchers are looking for a better way to treat people who have worsening of chronic heart failure, a long-term condition where the heart does not pump blood as well as it should, as well as to treat patients who have diabetic…
- Trial name
- NCT04881994
- Testing
- Finerenone (BAY94-8862)
- Where
- Germany
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Bayer
Solid Tumors, Hepatic Impairment
Pharmacokinetics (PK) of TKI258 in Cancer Patients With Normal and Impaired Hepatic Function
This is a multi-center, open label study to assess pharmacokinetics (PK) of TKI258 at single-dose and steady state in adult cancer patients either with mild, moderate or severe hepatic impairment or with normal hepatic function.
- Trial name
- NCT01443481
- Testing
- Dovitinib
- Where
- 12 sites in United States, Belgium and 4 more
- Volunteers
- 38 people
- Sponsor
- Novartis Pharmaceuticals
Hepatocellular Carcinoma
Phase 2, Randomized, Double-Blind, Placebo-Controlled of the Efficacy and Safety of CF102 in Hepatocellular Carcinoma (HCC)
This is a multicenter, randomized, double-blind, placebo-controlled clinical trial in subjects with advanced HCC and CPB cirrhosis whose disease has progressed while taking 1 prior systemic drug therapy for HCC.
- Trial name
- NCT02128958
- Testing
- CF102
- Where
- 21 sites in United States, Bulgaria and 3 more
- Volunteers
- 78 people
- Sponsor
- Can-Fite BioPharma
Chronic Hepatitis C, Hepatitis C Virus
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-administration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects With HCV Genotype 1, 4, 5, and 6 Infection
The purpose of this Phase 2, open-label, 2-part, multicenter study was to evaluate the efficacy, safety, and pharmacokinetics of co-administration of ABT-493 and ABT-530 with and without ribavirin (RBV) at different doses in…
- Conditions
- Chronic Hepatitis C, Hepatitis C Virus, HCV
- Trial name
- NCT02243280
- Testing
- ABT-493, ABT-530
- Volunteers
- 174 people
- Sponsor
- AbbVie
Hepatitis C Virus Infection
Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection and Child-Pugh Class B Cirrhosis
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) with and without ribavirin (RBV) for 12 weeks and SOF/VEL FDC for 24…
- Trial name
- ASTRAL-4 (NCT02201901)
- Testing
- SOF/VEL, RBV
- Where
- 50 sites in United States, Puerto Rico
- Volunteers
- 268 people
- Sponsor
- Gilead Sciences
Hepatic Insufficiency
A Study to Test How Iclepertin is Taken up in the Blood of People With and Without Liver Problems
This study is open to people with and without liver problems. People can join the study if they are 18 to 79 years of age and have a body mass index (BMI) between 18.5 and 35 kg/m2.
- Trial name
- NCT05731895
- Testing
- Iclepertin
- Where
- Germany
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Hepatocellular Carcinoma, Cirrhosis
Namodenoson in the Treatment of Advanced Hepatocellular Carcinoma in Patients With Child-Pugh Class B7 Cirrhosis
This is a clinical trial in patients with advanced hepatocellular carcinoma (HCC) and Child-Pugh Class B7 (CPB7) cirrhosis whose disease has progressed on at least 1st-line therapy.
- Trial name
- LIVERATION (NCT05201404)
- Testing
- Namodenoson
- Where
- 32 sites in United States, Bosnia and Herzegovina and 7 more
- Volunteers
- 471 people
- Sponsor
- Can-Fite BioPharma