Reproducibility of Child-Turcotte-Pugh (CTP) Rating and NRL972 Pharmacokinetics in Patients With Cirrhosis

NCT00896597 | Completed Phase 1

• 1 other identifier: NRL972-11/2008 (PAIR)
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open, randomized study in patients with different severity stages of hepatic cirrhosis, in which rater pairs will be used for the assessment of the intra- and inter-rater reproducibility of NRL972 pharmacokinetics and CTP sum score. Rating will be performed by 32 to 40 pairs of raters. The raters will perform the required assessments in the capacity of sub-investigators of the phase I (co-ordinating) unit. Up to 240 patients with clinically established hepatic cirrhosis without confounding end-stage co-morbidity (stable disease) will be studied. Within 30 days of confirmation of eligibility, Visit 1 will take place to determine the investigational parameters (NRL972 pharmacokinetics, clinical laboratory tests, and determination of CTP sum score). At approximate intervals of one week, Visits 2, 3 and 4 will occur, and the investigational parameters will again be assessed.

Conditions

Hepatic Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Comparison of the reproducibility of the CTP sum score with the reproducibility of the pharmacokinetics of NRL972, both assessed by a rater pair, in patients with stable hepatic cirrhosis.

  Up to 6 weeks

Study Arms (1)

NRL972

EXPERIMENTAL

A single dose of 2 mg NRL972 will be administered on four occasions over a period of up to 6 weeks.

Drug: NRL972

Interventions

NRL972 DRUG

2 mg NRL972 in 5 mL solution for injection administered as a 15-second intravenous injection on each of four occasions.

NRL972

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to give written Informed Consent.
• Gender: male and female (non-childbearing potential = postmenopausal or medically adequate contraception).
• Ethnicity: Any.
• Age: 18 to 80 years of age.
• Patient volunteers with a diagnosis of clinically stable hepatic cirrhosis with a CTP class A, B and C but excluding patient volunteers 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 enrollment.
• No previous transjugular intrahepatic portosystemic shunt (TIPS) or portocaval anastomosis (PCA).
• Medically fit to undergo the protocol-defined procedures without undue risk and discomfort.
• No previous participation in a study with an investigational product within 90 days prior to enrolment except epidemiologic or observational studies.

You may not qualify if:

• Previous participation in this trial (except for scheduled re-testing in relation to technical difficulties with initial test or rescreening).
• Donation of blood during the last 60 days or a history of excessive blood loss within the last 3 months, assessed using clinical judgement.
• Any donation of germ cells, blood, organs or bone marrow during the course of the study.
• History of any clinically relevant allergy (including hypersensitivity to the IMP).
• Presence of clinical relevant acute or chronic infection (other than chronic viral hepatitis, if applicable).
• Presence of hepatic encephalopathy at grades 3 or 4
• Unstable clinical presentation of hepatic cirrhosis (not allowing completion of participation in the study within 6 weeks).
• Use of confounding concomitant medication (see Section 7.5.7).
• Presence or history of any end-stage (co-)morbidity (excluding the effects of hepatic cirrhosis) such as: malignancy and clinically relevant systemic diseases.
• Presence of primary and/or hepatic malignancy.
• Suspicion or evidence that the patient volunteer is not trustworthy and reliable.
• Suspicion or evidence that the patient volunteer is not able to make a free consent or to understand the information in this regard.
• Primary biliary cirrhosis and primary sclerosing cholangitis.
• Cystic fibrosis.
• Patient volunteers who are employees at the investigational site, relatives or spouses of the investigator.

Sponsors & Collaborators

• Norgine: lead

Study Sites (1)

IFE Romania

Timișoara, 300244, Romania

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

NRL972

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hans-Jürgen Gruss, MD

  Norgine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 8, 2009
• First Posted: May 11, 2009
• Study Start: April 1, 2009
• Primary Completion: December 1, 2009
• Last Updated: August 9, 2010

Record last verified: 2010-08

Locations

RO (1)