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Trial record 4 of 608 for:    Nonalcoholic Fatty Liver | Non-Alcoholic Steatohepatitis

Pharmacokinetics of NRL972 in Patients With Nonalcoholic Steatohepatitis (NASH) and Non-Alcoholic Fatty Liver Disease (NAFLD)

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ClinicalTrials.gov Identifier: NCT00794716
Recruitment Status : Completed
First Posted : November 20, 2008
Last Update Posted : June 10, 2015
Sponsor:
Information provided by (Responsible Party):
Norgine

Tracking Information
First Submitted Date  ICMJE November 19, 2008
First Posted Date  ICMJE November 20, 2008
Last Update Posted Date June 10, 2015
Study Start Date  ICMJE June 2008
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2010)
The primary efficacy variable is the NRL972 fractional retention ratio for 10 and 30 minutes post-dose (C30/C10) for different populations with NAFLD. [ Time Frame: 30 minutes post-dose ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 19, 2008)
The primary efficacy variable is the NRL972 fractional retention ratio for 10 and 30 minutes post-dose (C30/C10) for different poopulations with NAFLD. [ Time Frame: 30 minutes post-dose ]
Change History Complete list of historical versions of study NCT00794716 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2008)
Approximate overall clearance and t½ within 60 minutes of dosing with NRL972. Cmax, AUC(0-∞), and mean residence time derived from a non-compartmental analysis. [ Time Frame: 60 minutes post-dose ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics of NRL972 in Patients With Nonalcoholic Steatohepatitis (NASH) and Non-Alcoholic Fatty Liver Disease (NAFLD)
Official Title  ICMJE Prospective Single-centre, Open-label Study to Assess the Pharmacokinetics of Cholyl-lysl-fluorescein (NRL972) in Patients With Clinical Evidence for Non-alcoholic Fatty Liver Disease (NAFLD): Supporting the Disease Staging Into Fatty Liver Disease Versus Non-alcoholic Steatohepatitis (NASH)
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 specificity of NRL972 pharmacokinetics as a diagnostic tool will be compared to results from the standard laboratory tests, elastography, tests of metabolic markers and serum fibrosis markers frequently used in the evaluation of clinically predicted NAFLD patients. Patients will be included if they have clinical evidence of fatty liver disease and have been referred to the clinic for a diagnostic work-up, including a liver biopsy, blood tests and scans of the liver.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Non-Alcoholic Fatty Liver Disease
  • Nonalcoholic Steatohepatitis
Intervention  ICMJE Drug: NRL972
Single dose of 2 mg NRL972 administered intravenously. Total volume 5mL.
Study Arms Experimental: NRL972
Intervention: Drug: NRL972
Publications * Glass O, Henao R, Patel K, Guy CD, Gruss HJ, Syn WK, Moylan CA, Streilein R, Hall R, Mae Diehl A, Abdelmalek MF. Serum Interleukin-8, Osteopontin, and Monocyte Chemoattractant Protein 1 Are Associated With Hepatic Fibrosis in Patients With Nonalcoholic Fatty Liver Disease. Hepatol Commun. 2018 Sep 21;2(11):1344-1355. doi: 10.1002/hep4.1237. eCollection 2018 Nov.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 9, 2015)
125
Original Estimated Enrollment  ICMJE
 (submitted: November 19, 2008)
110
Actual Study Completion Date November 2011
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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 Criteria:

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00794716
Other Study ID Numbers  ICMJE NRL972-01/2007 (FLD)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Norgine
Study Sponsor  ICMJE Norgine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Manal F Abdelmalek, M.D., MPH Duke University
PRS Account Norgine
Verification Date August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP