Status:
COMPLETED
PK of NRL972 in Patients with Nonalcoholic Steatohepatitis (NASH) and Non-Alcoholic Fatty Liver Disease (NAFLD)
Lead Sponsor:
Norgine
Conditions:
Non-Alcoholic Fatty Liver Disease
Nonalcoholic Steatohepatitis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This study is to evaluate the predictive value of NRL972 pharmacokinetics in the diagnosis of steatohepatitis using fatty liver disease as the comparator group. In addition, the sensitivity and specif...
Detailed Description
The study was conducted to describe and compare the plasma pharmacokinetics of NRL972 after a 15-second intravenous (i.v.) injection of 2 mg NRL972 against the diagnostic assessment based on liver bio...
Eligibility Criteria
Inclusion
- Subjects meeting the following conditions will be eligible for enrollment:
- Males or females (females of non-child-bearing potential or of child-bearing potential while taking medically appropriate contraception)
- Any ethnicity
- Age: 18 to 80 years of age
- Clinical evidence of non-alcoholic liver disease requiring the conduct of a liver biopsy for the diagnosis of NAFLD and/or staging of disease severity
- Willing and able to provide informed consent
Exclusion
- Subjects fulfilling any of the following criteria will be excluded from enrollment:
- General - all subjects
- Presence of acute or chronic viral hepatitis confirmed by serology
- Clinical signs of significant cholestasis
- Liver impairment due to space-occupying processes (e.g. carcinoma)
- Liver transplant recipient or patient scheduled for liver transplantation
- Clinically evident rapidly deteriorating hepatic function
- Significant bleeding diathesis
- Esophageal bleeding within the 8 weeks prior to study entry
- Presence of any contraindications for the conduct of the planned liver biopsy (e.g. allergy to lidocaine, coagulopathy with \<100 x109/L thrombocytes and/or INR \>1.3
- History of any allergic reaction to fluorescein
- Presence of any acute infection
- Previous participation in this trial
- Having received any investigational drug or treatment within 30 days prior to study entry or requiring a concurrent treatment with any other experimental drug or treatment
- Uncontrolled hypo- or hypertension (treated or untreated) with resting systolic blood pressure \>160 or \< 90 mmHg, diastolic blood pressure \>95 or \< 50 mmHg
- Clinically relevant abnormal laboratory values indicating end-stage renal, pulmonary or cardiac disease
- Known HIV infection
- Concurrent alcohol use of more than 14 drinks (140g ethanol) for men and 7 drinks (70g ethanol) for women per week (each drink is counted as 10g ethanol)
- History of drug or alcohol abuse within 2 months prior to dosing
- Use of prohibited medication (section 4.8)
- Donation of blood during the last 60 days or a history of blood loss exceeding 300 mL within the last 3 months
- Suspicion or evidence that the subject is not trustworthy and reliable
- Suspicion or evidence that the subject is not able to make a free consent or to understand the information in this regard
- Significant side effects prior to the liver biopsy (e.g. anxiety requiring pre-medication) or after the biopsy (e.g. pain requiring i.v. pain medication, bleeding re-quiring medical intervention)
- General - all females
- Positive pregnancy test
- Pre-menopausal women not using appropriate contraception
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT00794716
Start Date
June 1 2008
End Date
November 1 2011
Last Update
September 19 2024
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710