Multi-national Cirrhosis Study to Characterise the Association Between the Pharmacokinetics of NRL972 and Disease Severity.
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|ClinicalTrials.gov Identifier: NCT00794482|
Recruitment Status : Completed
First Posted : November 20, 2008
Last Update Posted : October 8, 2009
|Condition or disease||Intervention/treatment||Phase|
|Hepatic Cirrhosis||Drug: NRL972||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
- Drug: NRL972
Single dose of 2 mg NRL972 administered intravenously. Total volume 5 mL.
- Influence of CTP staging on the pharmacokinetics of NRL972 in patients with cirrhosis. [ Time Frame: Single dose, 2-5 day follow-up ]
- Inter-subject relationship between the pharmacokinetics of NRL972 and other parameters used to define the severity of hepatic cirrhosis [ Time Frame: 2-5 days ]
- To assess the safety and tolerability of 2mg NRL972 administered by intravenous injection to patients with hepatic cirrhosis [ Time Frame: 2-5 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00794482
|Essen, Germany, D-45147|