Effect of Chronic Viral Hepatitis on the Pharmacokinetics of NRL972.

NCT00915057 | Completed Phase 2

• 1 other identifier: NRL972-09/2008 (CHBC)
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 4

Brief 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

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics of NRL972

  Up to one hour post-dosing

Study Arms (1)

NRL972

EXPERIMENTAL

Single 2mg intravenous dose of NRL972, administered on up to seven occasions

Drug: NRL972

Interventions

NRL972 DRUG

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.

NRL972

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic viral hepatitis B
• Adult, male or female, age ≥ 18 years and \< 65 years
• Body weight (BW) : 45 - 110 kg
• Body mass index (BMI) : 18 - 30 kg.m-2
• HBV Serology: HBsAg+ for ≥ 6 months (at the time of application for treatment)
• Serum ALT ≥ 1.5 times ULN ≥ 6 months (at the time of application for treatment)
• Positive liver biopsy within 24 months before screening visit
• Positive biopsy with signs of active disease (any level of activity by Knodell, METAVIR or ISHAK)
• HBV DNA counts determined by quantitative PCR: ≥ 20,000 IU/mL ALT \< 10 times ULN
• HIV-Ab negative
• Non-cirrhotic liver disease (on histology within 24 months before screening visit)
• Not having been treated for chronic viral hepatitis previously ("de novo" i.e. "naïve")
• Eligible for treatment of chronic viral hepatitis in accordance with the national consensus guidelines pertinent to the country and site of conduct of the trial
• Willing and able to provide informed consent
• Chronic viral hepatitis C

You may not qualify if:

• Trial specific criteria: CHB, CHC \& CHB+CHC
• Previous participation in the trial
• Participation in any other clinical trial within 30 days of entry to this protocol
• Treatment with any investigational drug within 30 days of entry to this protocol
• Non-response to previous treatment for chronic viral hepatitis
• Relapse after previous treatment for chronic viral hepatitis
• Any other known cause of liver disease other than chronic viral hepatitis B and/or C, including but not limited to hepatitis D, haemochromatosis, alpha1-antitrypsin deficiency, Wilson's disease, autoimmune hepatitis, drug-related liver disease
• Evidence of advanced liver disease, such as history or presence of ascites, bleeding varices, encephalopathy
• Patients with organ transplants
• Hypersensitivity to prospective standard treatment
• Any relevant co-morbidity, for instance, but not limited to:
• Limiting uncompensated psychiatric condition (e.g. severe depression, or a history of severe psychiatric disorder)
• CNS trauma or seizure disorder requiring medication
• Significant cardiovascular dysfunction within the past 6 months (e.g. angina, congestive cardiac failure, recent myocardial infarction, severe hypertension or significant arrhythmia)
• Patients with an ECG showing clinically significant abnormalities

Sponsors & Collaborators

• Norgine: lead

Study Sites (4)

MHAT Sveti Ivan Rilski EAD

Sofia, Bulgaria

Location

Clinical Institute Fundeni

Bucharest, Romania

Location

Emergency Country Hospital Cluj

Cluj-Napoca, Romania

Location

Private Clinic Algomed SRL

Timișoara, Romania

Location

MeSH Terms

Conditions

Hepatitis, Viral, Human

Interventions

NRL972

Condition Hierarchy (Ancestors)

Virus Diseases; Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Hans-Jürgen Gruss, MD

  Norgine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 3, 2009
• First Posted: June 5, 2009
• Study Start: March 1, 2009
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: December 23, 2009

Record last verified: 2009-12

Locations

RO (3); BU (1)