A multi-centre, multi-national open study in patients with hepatic cirrhosis to characterise the association between the pharmacokinetics of NRL972 and disease severity - NRL972 in hepatic cirrhosis

• Conditions: Patients with histologically established diagnosis of Hepatic cirrhosis; MedDRA version: 9.1Level: LLTClassification code 10009211Term: Cirrhosis liver

• Registration Number: EUCTR2007-002404-18-IT
• Lead Sponsor: ORGINE LIMITED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

Patients with histologically established diagnosis of hepatic
cirrhosis and available histological material for review by the
central histopathologist or a CTP score ≥ 10 points plus an
objective imaging study (CT or NMR scan) within 3 months of the
screening visit with a confirmation of hepatic cirrhosis (scans are
collected and reviewed), but excluding patients with the diagnosis
of primary biliary cirrhosis, primary sclerosing cholangitis and
cystic fibrosis-associated liver disease
Present CTP-class A, B or C
NO previous liver transplantation or intended liver transplantation
within the next 6 months after enrolment
NO previous transjugular intrahepatic portosystemic shunt (TIPS)
or portocaval anastomosis (PCA)
Medically fit to undergo the protocol-defined procedures without
undue risk and discomfort
Predicted life-expectancy ≥ 6 months based on clinical judgement
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

patients with the diagnosis of primary biliary cirrhosis, primary sclerosing cholangitis and cystic fibrosis-associated liver disease NO previous liver transplantation or intended liver Transplantation within the next 6 months after enrolment NO previous transjugular intrahepatic portosystemic shunt (TIPS) or portocaval anastomosis (PCA)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified