Study Stopped
Data needs met
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
1 other identifier
interventional
23
2 countries
26
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2013
Shorter than P25 for phase_2
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 4, 2013
CompletedFirst Posted
Study publicly available on registry
September 9, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedResults Posted
Study results publicly available
April 11, 2016
CompletedApril 11, 2016
March 1, 2016
1.3 years
September 4, 2013
February 26, 2016
March 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Area Under the Curve (AUC)
Primary endpoints for AUC\_0-8, AUC\_0 last, AUC\_0-inf on Day 1 and Day 4 for the active treatment arms were analyzed.
28 days
Cmax
Primary endpoints forCmax on Day 1 and Day 4 for the active treatment arms were analyzed.
28 Days
Tmax & t1/2 Parameters
Primary endpoints for tmax \& t1/2 on Day 1 and Day 4 for the active treatment arms were analyzed.
28 Days
Secondary Outcomes (3)
Levels of CK18/M30
Baseline, Day 2, Day 4, Day 7, Day 14, Day 21, and Day 28
Levels of CK18/M65
Baseline, Day 2, Day 4, Day 7, Day 14, Day 21, and Day 28
Levels of Caspase 3/7 RLU
Baseline, Day 2, Day 4, Day 7, Day 14, Day 21, and Day 28
Study Arms (4)
IDN-6556 5 mg
EXPERIMENTALDosed twice daily
IDN-6556 25 mg
EXPERIMENTALDosed twice daily
IDN-6556 50 mg
EXPERIMENTALDosed twice daily
Placebo
PLACEBO COMPARATORDosed twice daily
Interventions
Eligibility Criteria
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 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Scripps Clinic
La Jolla, California, 92037, United States
VA San Diego Healthcare System
San Diego, California, 92161, United States
Sutter Pacific Medical Foundation
San Francisco, California, 94115, United States
Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Univerisity of Louisville Liver Research Center
Louisville, Kentucky, 40202, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
University of Utah
Salt Lake City, Utah, 84132, United States
University of Washington Harborview Medical Center
Seattle, Washington, 98104, United States
Singleton Hospital
Swansea, Wales, SA2 8QA, United Kingdom
Basildon and Thurrock University Hospital
Basildon, SS16 5NL, United Kingdom
Blackpool Victoria Hospital
Blackpool, FY3 8NR, United Kingdom
Bristol Royal Infirmary
Bristol, BS2 8HW, United Kingdom
Ninewells Hospital
Dundee, DD1 9SY, United Kingdom
Glasgow Royal Infirmary
Glasgow, United Kingdom
Leicester Royal Infirmary
Leicester, LE1 5WW, United Kingdom
Royal Liverpool University Hospital
Liverpool, L7 8XP, United Kingdom
University College London, Royal Free Hospital
London, NW3 2PF, United Kingdom
Royal London Hospital
London, United Kingdom
Central Manchester University Hospitals NHS Trust
Manchester, M13 9WL, United Kingdom
Freeman Hospital
Newcastle upon Tyne, NE7 7DN, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
Queen Alexandra Hospital
Portsmouth, PO6 3LY, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Study was terminated early.
Results Point of Contact
- Title
- Jean L. Chan, MD
- Organization
- Conatus Pharmaceuticals
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Ryder, Dr.
Nottingham University Hospital NHS Trust
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2013
First Posted
September 9, 2013
Study Start
September 1, 2013
Primary Completion
January 1, 2015
Study Completion
February 1, 2015
Last Updated
April 11, 2016
Results First Posted
April 11, 2016
Record last verified: 2016-03