Pharmacokinetic and Pharmacodynamic Study of IDN-6556 in ACLF
NCT ID: NCT01937130
Last Updated: 2016-04-11
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
23 participants
INTERVENTIONAL
2013-09-30
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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IDN-6556 5 mg
Dosed twice daily
IDN-6556
IDN-6556 25 mg
Dosed twice daily
IDN-6556
IDN-6556 50 mg
Dosed twice daily
IDN-6556
Placebo
Dosed twice daily
Placebo
Interventions
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IDN-6556
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Conatus Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Stephen Ryder, Dr.
Role: PRINCIPAL_INVESTIGATOR
Nottingham University Hospital NHS Trust
Locations
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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
Queen Alexandra Hospital
Portsmouth, , United Kingdom
Countries
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Other Identifiers
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IDN-6556-02
Identifier Type: -
Identifier Source: org_study_id
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