Pharmacokinetic and Pharmacodynamic Study of IDN-6556 in ACLF

NCT01937130 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2016-04-11

Study results available
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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.

Conditions

  • Acute on Chronic Hepatic Failure
  • Acute Liver Failure
  • Liver Cirrhosis
  • Acute Alcoholic Hepatitis

Interventions

DRUG

IDN-6556

OTHER

Placebo

Sponsors & Collaborators

  • Conatus Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Stephen Ryder, Dr. · Nottingham University Hospital NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-01-31
Completion
2015-02-28

Countries

  • United States
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01937130 on ClinicalTrials.gov