NCT00915057

Effect of Chronic Viral Hepatitis on the Pharmacokinetics of NRL972.

An Open Study to Investigate the Effects of Chronic Viral Hepatitis B or C on the Pharmacokinetics of Cholyl-lysyl-fluorescein (NRL972) Before, During and After Standard Treatment.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Norgine · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Little is known about the nature and extent of the disturbance in hepatic function and biliary hepatic clearance in chronic viral hepatitis, while the course of this disease, the functional implications and response to treatment are difficult to predict. This study aims to assess this in patients with chronic viral hepatitis B (CHB) and chronic viral hepatitis C (CHC) who are eligible for treatment in accordance with the established consensus guidelines in the involved countries. The pharmacokinetics of NRL972 will be determined at baseline (within one month of starting treatment), at 3-monthly intervals during treatment, for up to 12 months (or at the end of treatment), and at 3 and 6 months after the end on treatment. This will provide a clearer understanding regarding the use of the pharmacokinetics of NRL972 in detecting changes in biliary clearance during and after treatment for CHB and CHC.

Conditions

• Hepatitis, Viral, Human

Interventions

Type	Name	Description
DRUG	NRL972	Single dose of NRL972 administered at baseline, at 3-monthly intervals during treatment for up to 12 months (or the end of treatment) and at 3 and 6 months after the end of treatment.

Timeline

• Start date: 2009-03-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2009-06-05
• Last updated: 2009-12-23

Locations

4 sites across 2 countries: Bulgaria, Romania