NCT01937130
Terminated
Phase 2
A Placebo-Controlled, Multicenter, Double-Blind, Randomized, Pharmacokinetic and Pharmacodynamic Trial of IDN-6556 in Subjects With Acute-on-Chronic Liver Failure
ConditionsAcute on Chronic Hepatic FailureAcute Liver FailureLiver CirrhosisAcute Alcoholic Hepatitis
DrugsIDN-6556
Overview
- Phase
- Phase 2
- Intervention
- IDN-6556
- Conditions
- Acute on Chronic Hepatic Failure
- Sponsor
- Conatus Pharmaceuticals Inc.
- Enrollment
- 23
- Locations
- 26
- Primary Endpoint
- Area Under the Curve (AUC)
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
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:
- •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
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
Arms & Interventions
IDN-6556 5 mg
Dosed twice daily
Intervention: IDN-6556
IDN-6556 25 mg
Dosed twice daily
Intervention: IDN-6556
IDN-6556 50 mg
Dosed twice daily
Intervention: IDN-6556
Placebo
Dosed twice daily
Intervention: Placebo
Outcomes
Primary Outcomes
Area Under the Curve (AUC)
Time Frame: 28 days
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.
Tmax & t1/2 Parameters
Time Frame: 28 Days
Primary endpoints for tmax \& t1/2 on Day 1 and Day 4 for the active treatment arms were analyzed.
Cmax
Time Frame: 28 Days
Primary endpoints forCmax on Day 1 and Day 4 for the active treatment arms were analyzed.
Secondary Outcomes
- 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 Sites (26)
Loading locations...
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