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35 active trials for Hepatic Impairment

Hepatic Impairment Study of Encorafenib in Combination With Binimetinib in BRAF Melanoma

Encorafenib in combination with binimetinib have been approved in USA, Europe, Australia, Japan and Switzerland for the treatment of adult patients with unresectable or metastatic melanoma with BRAF V600 mutation. The main objective of this study is to find a safe and effective dose of encorafenib in combination with binimetinib for patients who have BRAF-mutant metastatic or unresectable melanoma with hepatic dysfunction (i.e. moderate or severe impairment).

Start: February 2021

A Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Hepatic Impairment

A single oral dose study to investigate the PK and safety of olorofim in mild and moderately hepatically impaired subjects compared to subjects with normal hepatic function.

Start: February 2021

Open-Label Study to Evaluate the Safety, Tolerability, and PK of Aramchol in Subjects With Hepatic Impairment

Phase 1, multicenter, open-label, 2-part, single- and multiple-dose study designed to assess the effect of hepatic insufficiency on the PK of aramchol

Start: January 2020

Pharmacokinetics, Pharmacodynamics and Safety of SHR4640 in Patients With Hepatic Impairment

Study to evaluate pharmacokinetics, pharmacodynamics and safety of SHR4640 in patients with mild, moderate hepatic impairment and normal liver function in phase I clinical study.

Start: August 2020

Safety and Pharmacokinetics of Fluzoparib in Healthy Subjects and Those With Impaired Liver Function

This study is designed to evaluate the safety and pharmacokinetics of Fluzoparib in subjects with impaired liver function in comparison with healthy subjects ,to develop dose recommendations for patients with hepatic impairment.

Start: November 2020

Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Multiple Oral Doses of MGL-3196 in Subjects With Varying Degrees of Hepatic Impairment and Healthy Matched Control Subjects

The purpose of this study is to directly characterize the pharmacokinetic (PK) profiles of MGL-3196 and its major metabolite (MGL-3623) following administration of multiple oral doses (QD x 6 days) in subjects with varying degrees of hepatic impairment (HI) compared to healthy matched control subjects with normal hepatic function, including a subset of NASH subjects.

Start: October 2018

A Pharmacokinetics and Tolerability Study of Fedratinib in Subjects With Moderate and Severe Hepatic Impairment

This is a Phase 1, multicenter, nonrandomized, open-label, single oral dose study to assess the PK of fedratinib in subjects with moderate and severe hepatic impairment, and in matched subjects with normal hepatic function. Degrees of hepatic impairment will be determined during screening by the subject's score according to Pugh's Modification of Child's Classification of Severity of Liver Disease.

Start: July 2019

An Investigational Study of SHR6390 in Participants With Mild to Moderate Liver Impairment and Healthy Participants

The purpose of this study is to investigate SHR6390 in participants with different levels of liver function

Start: December 2020

An Investigational Study of SHR3680 in Participants With Mild to Moderate Liver Impairment and Healthy Participants

The purpose of this study is to investigate SHR3680 in participants with different levels of liver function

Start: December 2020

A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls

The main purpose of this study is to compare the pharmacokinetic and safety of tegoprazan following single oral dose in subjects with hepatic impairment versus healthy control.

Start: September 2020

Nalbuphine ER Effects of Liver Disease on Pharmacokinetics and Itch

This research study will evaluate the effect of liver disease on the pharmacokinetics (the breakdown of the drug in the body) of parallel-group, multiple oral doses nalbuphine extended release (NAL ER), tablets in people with liver disease (mild, moderate and severe), compared to people with normal liver function. The study will also test the safety and tolerability of the NAL ER, when it is given to subjects with mild, moderate and severe liver disease, compared to subjects with normal liver function. This protocol will also study the effects of this drug on itching in liver disease subjects if they report some itching prior to taking part in this study.

Start: October 2018

A STUDY TO COMPARE THE PHARMACOKINETICS OF PF-06835919 IN PARTICIPANTS WITH AND WITHOUT HEPATIC IMPAIRMENT

The study is proposed to characterize the effect of varying degrees of hepatic impairment on the plasma PK of PF-06835919

Start: January 2020

To Evaluate the Pharmacokinetics and Safety of Yimitasvir Phosphate Capsules in Subjects With Moderate and Severe Liver Function Impairment and in Healthy Subjects

To evaluate the pharmacokinetics and safety of Yimitasvir phosphate capsules in subjects with moderate and severe liver function impairment and healthy subjects in a single-center, non-randomized, open, single-dose administration

Start: September 2020

Pharmacokinetics and Safety of SHR0302 in Patients With Hepatic Impairment

Study to Evaluate Pharmacokinetics and Safety of SHR0302 in Patients With Mild, Moderate Hepatic Impairment and Normal Liver Function in Phase I Clinical Study

Start: May 2020

PVB Versus TAP in Hepatic Patients Undergoing Laparoscopic Cholecystectomy

The Era of using ultrasound guided blocks provides an attractive and more or less safe alternative to other techniques. Among these blocks is ultrasound-guided transverse abdominis plane block (USG-TAP block) that controls pain by local anesthetic injection into the neurofascial plane of the abdominal muscles. Ultrasound-guided thoracic paravertebral block (USG-TPVB) is another technique in which local anesthetic is injected nearby the thoracic vertebra where spinal nerve emerges from the intervertebral foramina. It provides ipsilateral somatic and sympathetic blockade in many dermatomes around the injection site. The aim of this study is to verify which technique is more efficient in reducing the intra- and postoperative analgesic requirements in hepatic patients.

Start: December 2019