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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NRL972 | Drug | Single dose of 2 mg NRL972 administered intravenously. Total volume 5 mL. |
| Measure | Description | Time Frame |
|---|---|---|
| Influence of CTP staging on the pharmacokinetics of NRL972 in patients with cirrhosis. | Single dose, 2-5 day follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Inter-subject relationship between the pharmacokinetics of NRL972 and other parameters used to define the severity of hepatic cirrhosis | 2-5 days | |
| To assess the safety and tolerability of 2mg NRL972 administered by intravenous injection to patients with hepatic cirrhosis |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Essen | D-45147 | Germany |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C000601594 | NRL972 |
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| 2-5 days |
| D013568 |
| Pathological Conditions, Signs and Symptoms |