Multi-national Cirrhosis Study to Characterise the Association Between the Pharmacokinetics of NRL972 and Disease Severity.

Hepatic Cirrhosis Clinical Trial

Official title:

A Multi-centre, Multi-national Open Study in Patients With Hepatic Cirrhosis to Characterise the Association Between the Pharmacokinetics of NRL972 and Disease Severity.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00794482
• Other study ID #: NRL972-03/2006 (CIR)
• Status: Completed
• Phase: Phase 3
• First received: November 19, 2008
• Last updated: October 7, 2009
• Start date: March 2008
• Est. completion date: June 2009

Study information

• Verified date: October 2009
• Source: Norgine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesItaly: Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRussia: FSI Scientific Center of Expertise of Medical ApplicationRomania: Ministry of Public HealthLithuania: State Medicine Control Agency - Ministry of HealthBulgaria: Bulgarian Drug AgencySerbia and Montenegro: Agency for Drugs and Medicinal Devices
• Study type: Interventional

Clinical Trial Summary

This is a multi-centre, multi-national, open study to assess the pharmacokinetics of NRL972 in patients with hepatic cirrhosis CTP-classes A, B, and C (histologically confirmed by liver biopsy). The pharmacokinetics of NRL972 will be referenced to a Clinical Staging Matrix obtained during a clinical work-up of patients with hepatic cirrhosis. Patients to be studied will have histologically established hepatic cirrhosis or confirmed hepatic cirrhosis by an objective imaging study without confounding end-stage co-morbidity. Within 14 days of confirming eligibility, the investigations will be conducted over 2-5 days with the test procedures (clinical laboratory tests, ultrasound (US)-investigations, gastroscopy, NRL972- and MEGX'-test). Up to one week after the NRL972-test, a follow-up telephone call will be made.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

Subjects meeting the following conditions will be eligible for enrolment:

• Patient has given his or her written informed consent to the study participation, prior to study specific procedures

• Male and female (non-child-bearing potential = post-menopausal or medically adequate contraception)

• Ethnicity: any

• Age: 18 to 80 years of age

• Patients with histologically established diagnosis of hepatic cirrhosis and available histological material for review by the central histopathologist or a CTP score greater than or equal to 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

• Medically fit to undergo the protocol-defined procedures without undue risk and discomfort

• Predicted life-expectancy greater than or equal to 6 months by clinical judgement

Exclusion Criteria:

Subjects of any of the following categories will be excluded from enrolment:

• Previous participation in this trial (except for scheduled re-testing in relation to technical difficulties with initial test)

• Participant in any other trial during the last 90 days

• Donation of blood during the last 60 days or a history of blood loss exceeding 300 mL within the last 3 months

• 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 trial medications)

• Presence of clinical relevant acute or chronic infection (other than chronic viral hepatitis, if applicable)

• Use of confounding concomitant medication

• Presence or history of any end-stage (co-)morbidity (excluding the effects of hepatic cirrhosis) such as: malignancy and clinically relevant systemic diseases

• Suspicion or evidence that the subject is not trustworthy and reliable

• Suspicion or evidence that the subject 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

• Previous liver transplantation or intended liver transplantation within 6 months after enrolment

• Patients having undergone previous transjugular intrahepatic portosystemic shunt (TIPS) or portocaval anastomosis (PCA)

• Patients who are employees at the investigational site, relatives or spouses of the investigator

• Current drug, or medication abuse

Special restrictions for female patients:

• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation.

• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, unless they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels greater than 40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy or hysterectomy or are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation, vasectomy), hormonal contraception (implantable, patch, oral), and double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hepatic Cirrhosis
• Liver Cirrhosis

Intervention

Drug:
• NRL972
Single dose of 2 mg NRL972 administered intravenously. Total volume 5 mL.

Locations

Country	Name	City	State
Germany	University Hospital	Essen

Sponsors (1)

Lead Sponsor	Collaborator
Norgine

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Influence of CTP staging on the pharmacokinetics of NRL972 in patients with cirrhosis.		Single dose, 2-5 day follow-up	No
Secondary	Inter-subject relationship between the pharmacokinetics of NRL972 and other parameters used to define the severity of hepatic cirrhosis		2-5 days	No
Secondary	To assess the safety and tolerability of 2mg NRL972 administered by intravenous injection to patients with hepatic cirrhosis		2-5 days	No