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Pharmacokinetic and Pharmacodynamic Study of IDN-6556 in ACLF | Clinical Trials | Clareo Health

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Pharmacokinetic and Pharmacodynamic Study of IDN-6556 in ACLF

A Placebo-Controlled, Multicenter, Double-Blind, Randomized, Pharmacokinetic and Pharmacodynamic Trial of IDN-6556 in Subjects With Acute-on-Chronic Liver Failure

NCT01937130•Conatus Pharmaceuticals Inc.

View on ClinicalTrials.gov

Summary

The study will evaluate the pharmacokinetics, pharmacodynamics, safety and preliminary efficacy of IDN-6556 in subjects with cirrhosis of the liver who are hospitalized for more than 24 hours due to acute deterioration of liver function.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female subjects of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and understand and comply with the requirements of the study
•Subjects with a clinical, radiological and/or histological diagnosis of cirrhosis
•Subjects having not required hospital admission within 4 weeks of screening for a complication of cirrhosis
•Subjects with an acute deterioration of liver function
•Subjects who meet one of the following criteria:
•1. Subjects with renal failure (defined as creatinine ≥ 2.0 to ≤ 3.4 mg/dL)
•2. Subjects with other single organ failure with i. Renal impairment (defined as an increase in creatinine of \> 0.3 mg/dL from either an established prior Baseline level or if applicable, upon admission to hospital if prior level is unavailable; for inclusion, the creatinine level must be raised above normal levels), and/or ii. Hepatic encephalopathy grade I or II
•3. Subjects with two organ failures
•If a subject received steroids for alcohol-induced acute liver failure, he/she must be unresponsive to steroid therapy. Responsiveness is based on investigator discretion.
•Willingness to utilize two reliable forms of contraception (for both males and females of childbearing potential) from screening to one month after the last dose of study drug

Exclusion Criteria

•Known infection with HIV
•Subjects with cirrhosis who develop decompensation at any time in the postoperative period following partial hepatectomy
•Subjects with evidence of uncontrolled infection defined as persistent bacterial culture positivity despite adequate antibiotic therapy
•Subjects with clinical evidence of disseminated intravascular coagulation
•Subjects with chronic and/or pre-existing kidney disease defined as eGFR (estimated glomerular filtration rate) of less than 30 mL/min for 3 months or longer
•Subjects who are hypotensive (defined as mean arterial pressure \<70 mmHg) or require the use of inotropic support
•Subjects with evidence of significant and/or uncontrolled bleeding
•Subjects requiring mechanical ventilation
•Subjects with active or history of malignancies other than hepatocellular carcinoma (HCC) within Milan criteria or curatively treated skin cancer (basal cell or squamous cell carcinomas), unless adequately treated or in complete remission for five or more years
•Subjects previously exposed to IDN-6556
+1 more criteria

Locations (26)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Scripps Clinic

La Jolla, California, United States

VA San Diego Healthcare System

San Diego, California, United States

Sutter Pacific Medical Foundation

San Francisco, California, United States

Georgetown University Hospital

Washington D.C., District of Columbia, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Univerisity of Louisville Liver Research Center

Louisville, Kentucky, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Montefiore Medical Center

The Bronx, New York, United States

University of Utah

Salt Lake City, Utah, United States

Key Dates

Start Date

September 1, 2013

Primary Completion Date

January 1, 2015

Completion Date

February 1, 2015

Last Updated

April 11, 2016

Enrollment

ACTUAL participants

Conditions

Acute on Chronic Hepatic FailureAcute Liver FailureLiver CirrhosisAcute Alcoholic Hepatitis

Interventions

IDN-6556

DRUG

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 11, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Pharmacokinetic and Pharmacodynamic Study of IDN-6556 in ACLF

Inclusion Criteria

Exclusion Criteria

ALSS - DPMAS and Therapeutic Plasma Exchange (TPE), Its Effect on Primary Coagulation, Inflammation and the Function of Vital Organs in ALF or ACLF

Standard Volume vs. High Volume Plasma Exchange in Pediatric Acute Liver Failure

Verification of Risk Factors of Thrombohemorrhagic Complications in Recipients After Related Liver Transplantation

Analysis of Methylomic Features and Prognostic Risk Prediction in Patients With Hepatitis B-related Acute-on-chronic Liver Failure

Validation of New Prognostic Biomarkers in Patients With Decompensated Cirrhosis

Stop of Proton-pump Inhibitor Treatment in Patients With Liver Cirrhosis - a Double-blind, Placebo-controlled Trial