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Non-Alcoholic Fatty Liver DiseasePhase 2NCT00794716

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

A Phase 2 study testing NRL972 in people with Non-Alcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis, run by Norgine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
NRL972
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
1 siteUnited States
Study dates
Jun 2008to Nov 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 27Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke University Medical Center

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: Prospective Single-centre, Open-label Study to Assess the Pharmacokinetics of Cholyl-lysl-fluorescein (NRL972) in Patients with Clinical Evidence for NAFLD: Supporting the Disease Staging Into Fatty Liver Disease Versus NASH

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.

Read the 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 biopsy in patients with clinically suspected NAFLD. A particular focus was to separate simple fatty liver disease (non-NASH) from non-alcoholic steatohepatitis (NASH) with or without cirrhosis (defined as advanced fibrosis: ≥F3) in a population likely to present with NAFLD.

The study evaluated the predictive value of NRL972 pharmacokinetics in the diagnosis of NASH using fatty liver disease (non-NASH) as the comparator group in a population of clinically suspected NAFLD patients based on histological evaluation. The sensitivity and specificity of NRL972 pharmacokinetics as a diagnostic was compared to that of results from the standard laboratory tests, clinical features, elastography assessments for liver stiffness and tests of metabolic markers, serum fibrosis markers and established disease scores frequently used in the evaluation of NAFLD.

The study also provided information on the safety and tolerability of i.v. doses of NRL972 under these conditions.

Being tested
NRL972
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NRL972Drug

    Also called cholyl-lysyl-fluorescein

    Single dose of 2 mg NRL972 administered intravenously. Total volume 5mL.

Study groups in NCT00794716
Study groupRoleWhat they receive
NRL972Experimental2 mg NRL972 IV
Receives: Drug: NRL972

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. C(30)/C(10)

    The primary efficacy variable was the NRL972 fractional retention ratio for 10 and 30 minutes post-dose (C30/C10) for different populations with NAFLD.

    Measured: 30 minutes post-dose

  2. Adverse Events

    Primary safety assessment: Incidence of treatment-emergent adverse events

    Measured: Up to 2 hours post-dose

  3. Vital Signs

    Primary safety assessment: continuous monitoring on automated cardiovascular systems

    Measured: Up to 2 hours post-dose

Secondary outcomes (3)

  1. C(60)

    NRL972 fractional retention ratio for 60 minutes post-dose for different populations with NAFLD.

    Measured: 60 minutes post-dose

  2. t1/2

    apparent terminal disposition half-life

    Measured: 60 minutes post-dose

  3. CL

    approximate overall clearance

    Measured: 60 minutes post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionMar 2010
  4. Study completionNov 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00794716
Sponsor's protocol ID
NRL972-01/2007 (FLD)
Status last verified
Sep 2024
First submitted
19 Nov 2008
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes

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.

    PubMed 30411081

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NRL972 in people with Non-Alcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis, run by Norgine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

C(30)/C(10) (time frame: 30 minutes post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00794716, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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