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Hepatic Insufficiency clinical trials

View clinical trials related to Hepatic Insufficiency.

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NCT ID: NCT01512693 Completed - Clinical trials for Hepatic Insufficiency

Assessment of Pharmacokinetics of Single Dose Odanacatib (MK-0822) in Participants With Moderate Hepatic Insufficiency (MK-0822-070)

Start date: February 23, 2012
Phase: Phase 1
Study type: Interventional

This open-label, non-randomized study was designed to compare pharmacokinetics of a single 50 milligram (mg) dose of MK-0822 in participants with and without moderate hepatic insufficiency (abnormal liver function) in order to determine to what degree hepatic dysfunction may impact therapeutic blood levels of MK-0822. The primary hypothesis is that plasma AUC0-∞ of odanacatib in participants with moderate hepatic insufficiency is similar to that in matched healthy participants following a single 50 mg oral dose.

NCT ID: NCT01475136 Completed - Clinical trials for Hepatic Insufficiency

A Study of LY2140023 in Hepatically-Impaired Participants

Start date: November 2011
Phase: Phase 1
Study type: Interventional

This study will explore how liver impairment affects blood levels of LY2140023 (a prodrug) and its active metabolite (LY404039).

NCT ID: NCT01390428 Completed - Hepatitis C Clinical Trials

Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Grazoprevir (MK-5172-013)

Start date: July 28, 2011
Phase: Phase 1
Study type: Interventional

This study will compare the pharmacokinetics (PK) of grazoprevir (MK-5172) when administered to participants with mild, moderate or severe hepatic insufficiency (assessed by the criteria of the Child-Pugh's scale) with the PK of grazoprevir when administered to healthy participants.

NCT ID: NCT01345565 Withdrawn - Liver Failure Acute Clinical Trials

Hepatocyte Transplantation for Acute Decompensated Liver Failure

Start date: March 2011
Phase: Phase 1
Study type: Interventional

The purpose of this research study is to determine whether liver cell transplantation can provide help for patients with liver failure who are unlikely to survive without some form of liver support. The goal of this research study is to determine if liver cell transplants can be effective until a liver transplant is received or until patients recover from their liver failure.

NCT ID: NCT01335568 Recruiting - Liver Cirrhosis Clinical Trials

Hepatocyte Matrix Implant Study Indonesia

HMIIndo
Start date: April 2011
Phase: Phase 1
Study type: Interventional

This clinical investigation of the hepatocyte matrix implant is an evaluation blinded non-randomized and monocentric pilot study of Phase I, which is conducted as a therapeutic investigation. Randomization is not possible due to ethical and practical reasons. This study has already been approved in Switzerland and has been adapted to Indonesian Law and disease. This new treatment procedure has already been successfully used on the basis of compassionate use in Germany. The hepatocyte matrix implant is a new patented procedure consisting of bio-matrix technology. A formaldehyde-free special matrix consisting of self-dissolving polymers is applied as a carrier substance and is cultivated with human autologous cells using a special technique. Clinically the bio artificial liver replacement tissue for patients with end-stage hepatic disease has been developed as a first application. In this procedure autologous hepatocytic tissue and pancreatic tissue is removed (liver resection and pancreatic biopsy) from the patient in a first surgical procedure. The tissue is sent to a specialized Cell Culture Laboratory. The laboratory is GMP certified for this procedure. The cells are processed according to SOPs in a special perfusion procedure and prepared on several platelets of matrices (platelets of 20 mm diameter and 4mm thickness). After completion of the laboratory process the bio tissues are implanted into the mesentery of the small intestine during a second operation. The cells are growing controlled on the matrix, take on the capillaries of the patient and thus connect to the blood circulation. The implanted cells multiply by a specific factor and independently take over the metabolic function of the original liver after two to four weeks. In the following process the carrier matrix dissolves completely and implanted cells develop into liver cell tissue.

NCT ID: NCT01273493 Completed - Clinical trials for Hepatic Insufficiency

A Pharmacokinetic Study of Trabectedin in Patients With Advanced Malignancies and Hepatic Dysfunction

Start date: December 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to characterize the pharmacokinetics (blood levels) of trabectedin after administration to patients with advanced malignancies and hepatic (liver) dysfunction.

NCT ID: NCT01261923 Completed - Clinical trials for Hepatic Insufficiency

Pharmacokinetics of 9-cis-retinoic Acid (Alitretinoin, Toctino®) in Patients With Hepatic Disease

Start date: December 2010
Phase: Phase 1/Phase 2
Study type: Interventional

This study aims to investigate whether liver patients may tolerate alitretinoin by comparing metabolism in 8 such patients with the metabolism in 8 healthy controls

NCT ID: NCT01201720 Completed - Liver Cirrhosis Clinical Trials

Effects on Plasma Exchange on Functional Capacity of Serum Albumin, Circulatory Dysfunction, Renal and Cerebral Function in Cirrhotic Patients With "Acute-on-chronic Liver Failure"

Start date: March 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effects on plasma exchange with 5% albumin on albumin functional capacity, cardiocirculatory, renal and cerebral function in cirrhotic patients with "acute-on-chronic liver failure".

NCT ID: NCT01186588 Completed - Healthy Clinical Trials

A Study of Canagliflozin in Study Participants With Various Degrees of Impaired Hepatic (Liver) Function

Start date: August 2010
Phase: Phase 1
Study type: Interventional

The purpose of the study is to determine the concentration of canagliflozin in blood and urine samples after the administration of canagliflozin to study participants with mild or moderate hepatic (liver) impairment compared with study participants with normal hepatic function.

NCT ID: NCT01148550 Suspended - Clinical trials for End Stage Liver Disease

Longitudinal Study of Mitochondrial Hepatopathies

MITOHEP
Start date: August 18, 2010
Phase:
Study type: Observational

The specific aims of this study are (1) to determine the clinical phenotypes and natural history of hepatic RC and FAO disorders, (2) to determine the correlation between genotype and phenotype, (3) to determine if circulating biomarkers reflect diagnosis and predict liver disease progression and survival with the native liver, (4) to determine the clinical outcome of these disorders following liver transplantation, and (5) to develop a repository of serum, plasma, urine, tissue and DNA specimens that will be used in ancillary studies. To accomplish these aims, the ChiLDREN investigators at clinical sites (currently 15 sites) will prospectively collect defined data and specimens in a uniform fashion at fixed intervals in a relatively large number of subjects. Clinical information and DNA samples to be collected from subjects and their parents will enhance the potential for meaningful research in these disorders. A biobank of subject specimens and DNA samples will be established for use in ancillary studies to be performed in addition to this study.