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Sponsored by: |
Norgine |
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Information provided by: | Norgine |
ClinicalTrials.gov Identifier: | NCT00794482 |
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.
Condition | Intervention | Phase |
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Hepatic Cirrhosis |
Drug: NRL972 |
Phase III |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
Official Title: | A Multi-Centre, Multi-National Open Study in Patients With Heaptic Cirrhosis to Characterise the Association Between the Pharmacokinetics of NRL972 and Disease Severity. |
Estimated Enrollment: | 1200 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects meeting the following conditions will be eligible for enrolment:
Exclusion Criteria:
Subjects of any of the following categories will be excluded from enrolment:
Special restrictions for female patients:
Contact: Grainne O'Neill, BSc | +44 (0) 01895 453688 | goneill@norgine.com |
Germany | |
University Hospital | Recruiting |
Essen, Germany, D-45147 | |
Contact: Waldemar Braun +49 201 89900 wb@ife-europe.com | |
Principal Investigator: Guido Gerken, Prof Dr med |
Responsible Party: | Norgine Ltd ( Vice President, Clinical Development ) |
Study ID Numbers: | NRL972-03/2006 (CIR) |
Study First Received: | November 19, 2008 |
Last Updated: | November 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00794482 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; Italy: Ministry of Health; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Russia: FSI Scientific Center of Expertise of Medical Application; Romania: Ministry of Public Health; Lithuania: State Medicine Control Agency - Ministry of Health; Bulgaria: Bulgarian Drug Agency; Serbia and Montenegro: Agency for Drugs and Medicinal Devices |
Liver Diseases Digestive System Diseases Fibrosis Liver Cirrhosis |
Pathologic Processes |