Pharmacokinetic and Pharmacodynamic Study of IDN-6556 in ACLF

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Acute on Chronic Hepatic Failure, Acute Liver Failure, Liver Cirrhosis, Acute Alcoholic Hepatitis

In brief

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.

Key facts

Study ID

NCT01937130

Run by

Conatus Pharmaceuticals Inc.

People needed

23

Starts

2013-09-01

Expected to finish

2015-02-01

Last updated by the study team

2016-04-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Subjects with renal failure (defined as creatinine ≥ 2.0 to ≤ 3.4 mg/dL)
• 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
• 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

You may not qualify if…

• 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
• History or presence of clinically concerning cardiac arrhythmias, or prolongation of Screening (pre-treatment) QT or QTc interval of > 480 milliseconds (msec)

Where it is running

• 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
• University of Washington Harborview Medical Center — Seattle, Washington, United States
• Singleton Hospital — Swansea, Wales, United Kingdom
• Basildon and Thurrock University Hospital — Basildon, United Kingdom
• Blackpool Victoria Hospital — Blackpool, United Kingdom
• Bristol Royal Infirmary — Bristol, United Kingdom
• Ninewells Hospital — Dundee, United Kingdom
• Glasgow Royal Infirmary — Glasgow, United Kingdom
• Leicester Royal Infirmary — Leicester, United Kingdom
• Royal Liverpool University Hospital — Liverpool, United Kingdom
• University College London, Royal Free Hospital — London, United Kingdom
• Royal London Hospital — London, United Kingdom
• Central Manchester University Hospitals NHS Trust — Manchester, United Kingdom
• Freeman Hospital — Newcastle upon Tyne, United Kingdom
• Nottingham University Hospitals NHS Trust — Nottingham, United Kingdom
• Derriford Hospital — Plymouth, United Kingdom

Full record on ClinicalTrials.gov

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