Hepatic FailurePhase 3LFT-0002NCT02552901
Cardiox Liver Function Test Pivotal Trial
A Phase 3 study testing 0.1 mg/kg ICG Dose and 0.5 mg/kg ICG dose in people with Hepatic Failure and Liver Failure, run by Cardiox Corporation at 1 site in United States.
Trial summary
Performance evaluation of LFT Dye Monitor System using ICG - plasma disappearance rate value (PDR) to assess liver function in normal patients as well as in patients with mild to severe hepatic impairment compared to manual Serum ICG PDR. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Failure, Liver Failure
- What is being tested?
- 0.1 mg/kg ICG Dose and 0.5 mg/kg ICG dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to May 2016
- Phase
- Phase 3
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female between 18 to 75 years of age inclusive, at the time of Screening.
- Voluntarily provide written informed consent.
- Female patients are eligible only if all of the following apply:
- Not pregnant (negative urine pregnancy test at the Screening visit);
- Not lactating;
- Not planning to become pregnant within the duration of the study;
Show all 14Show fewer
- Surgically sterile, or at least 2 years postmenopausal, or is practicing an acceptable form of birth control (defined as the use of an intrauterine device, a barrier method with spermicide, condoms, subdermal implant, oral contraceptives, abstinence, or sterilization of monogamous partner) for greater than 60 days prior to Screening and commits to the use of the acceptable form of birth control for the duration of the study.
- If a healthy volunteer; is considered to be in generally good health, in the opinion of the Investigator, at the Screening visit based upon the results of their medical and surgical history, vital signs, physical examination, and clinical laboratory tests.
- Prior to receiving any ICG injections the subject agrees to be fasting for at least eight (8) hours.
- If a subject with liver cirrhosis; is considered to be in general satisfactory health, in the opinion of the Investigator (other than their hepatic impairment) at the Screening visit based upon the results of their medical and surgical history, vital signs, physical examination, and non-hepatic clinical laboratory tests.
- Liver cirrhosis subjects must have a clinical diagnosis of hepatic impairment based on documented evidence of hepatic cirrhosis by medical history, or previous liver biopsy, or hepatic ultrasound; which conforms to the criteria for class A or B or C of the Childs-Pugh classification (Appendix B); and are expected to require an ICG liver function study, such as for liver transplantation, liver resection, liver cirrhosis prognosis evaluation, functional liver cell mass and/or general liver dysfunction evaluations.
- On stable drug therapy that is not expected to change (i.e. in dose, frequency, additions or deletions of agents) for at least 2 weeks before ICG dye injection.
- Must, in the Investigator's opinion, be able to comply with study procedures.
- If the Subject is being enrolled in the fifth group they have a diagnosis of acute liver failure (ALF) as defined by the Principal Investigator.
Who cannot join
- Have any clinically significant condition or unstable current illness that would, in the opinion of the Investigator, preclude study participation or interfere with the assessment of the procedure;
- Known allergy or sensitivity to ICG dye or history of allergy to iodides;
- Actively bleeding associated with acute blood volume changes.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
Official title: A Pivotal, Within Subject, Comparison of the LFT™ Dye Monitor System to the Indocyanine Green Dye (ICG) Serial Blood Plasma Disappearance Rate in Patients With Impaired and Non-Impaired Hepatic Function
Performance evaluation of LFT Dye Monitor System using ICG - plasma disappearance rate value (PDR) to assess liver function in normal patients as well as in patients with mild to severe hepatic impairment compared to manual Serum ICG PDR.
Read the detailed description
Indocyanine green (ICG) is a water-soluble, non-toxic tricarbocyanine dye, extracted principally by hepatic parenchymal cells and excreted almost entirely into the bile without enterohepatic circulation. Clinically, its elimination rate is used primarily to measure hepatic function and liver blood flow. ICG studies are also used in ophthalmic angiography and the determination of cardiac output.
Beginning about 1959, the first human clinical studies were reported wherein an indocyanine green (ICG) bolus was injected into a vein, and then blood samples were withdrawn over a period of time and analyzed for ICG concentrations. This method is referred to hereinafter as the serial blood sampling method. These blood samples are sent to a clinical laboratory for a multi-step process of centrifuging, separation and spectrophotometric measurements of ICG levels. The laboratory-based measured levels of residual ICG levels are then used to determine the ICG clearance rate and R15 value or residual amount of dye remaining after 15 minutes, expressed as a percentage of the initial concentration.
As an alternative to the time- and labor-consuming serial blood sampling method, a non-invasive technique was first reported nearly 20 years ago. In the first published clinical study, Ishigami reported the use of a pulse dye densitometry (PDD) method to transcutaneously detect the rate of clearance of ICG from the bloodstream to be referred to hereinafter as dynamic liver function testing.
PDD expresses ICG elimination in terms of the indocyanine green plasma disappearance rate because only relative ICG concentration changes are assessed. The results of this noninvasive method have been shown to correlate with those obtained by the invasive method used in critically ill patients (hemodynamically unstable and stable), and in patients after liver surgery.
ICG elimination rate after liver transplantation measured by either invasive or noninvasive ICG methods is widely used to evaluate graft function. Studies have shown that ICG elimination, measured on the day of transplantation, reflects graft function and can be used to predict graft viability and the expected survival of the patient. Sequential measurements of ICG elimination between days 0 and 28 of transplantation, have been shown to predict clinical outcome in the early postoperative period after living donor transplantation. All of the studies have shown that the ICG elimination rate is an accurate test for evaluating liver dysfunction, but lacks the ability to differentiate the underlying causes of the hepatic dysfunction.
Unlike all currently existing PDD methods for performing liver function testing, LFT Dye Monitor System employs a more sensitive method for the transcutaneous measurement of ICG concentration level in the blood using NIR fluorescence, with a sensor that is attached loosely to the scaphoid fossa of the ear. Thus, the chemical properties of ICG dye to fluoresce when properly excited are used in the LFT system to enable much lower concentrations of ICG to be detectable.
- Conditions
- Hepatic Failure, Liver Failure
- Being tested
- 0.1 mg/kg ICG Dose, 0.5 mg/kg ICG dose
- Keywords
- hepatic, liver, LFT, hepatic assessment, ICG dye, indocyanine green dye, Diagnostic Green, Pulsion, Akorn, Cardiox, anazen, essence, dye detection monitor, Earpads, flow sensor, scaphoid fossa, liver disease, acute hepatic failure, AHF, NASH
- Medical subject headings
- Liver Failure, Liver Diseases, Liver Failure, Acute, Hepatitis C, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.1 mg/kg ICG DoseDrug
Also called LFT Dose
least efficacious dose
0.5 mg/kg ICG doseDrug
per package insert
| Study group | Role | What they receive |
|---|---|---|
| LFT Dye Detection Monitor | Experimental | Not described Receives: Drug: 0.1 mg/kg ICG Dose; Drug: 0.5 mg/kg ICG dose |
| Serial Blood Draws | Active comparator | Not described Receives: Drug: 0.5 mg/kg ICG dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma disappearance rate
Measured: Study Day 1
Secondary outcomes (3)
physical examinations
Measured: Study Day 1
vital signs
Measured: Study Day 1
adverse events
Measured: Study Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startNov 2015
- Primary completionMay 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiox Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Jopling, MD, Study director, Medical Director, Cardiox Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552901
- Sponsor's protocol ID
- LFT-0002
- Acronym
- LFT-0002
- Status last verified
- Jan 2016
- First submitted
- 15 Sep 2015
- Last updated
- 15 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal, Within Subject, Comparison of the LFT™ Dye Monitor System to the Indocyanine Green Dye (ICG) Serial Blood Plasma Disappearance Rate in Patients With Impaired and Non-Impaired Hepatic Function
- ClinicalTrials.gov ID
- NCT02552901
- Acronym / sponsor ID
- LFT-0002 / LFT-0002
- Conditions
- Hepatic Failure, Liver Failure
- Keywords
- hepatic, liver, LFT, hepatic assessment, ICG dye, indocyanine green dye, Diagnostic Green, Pulsion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cardiox CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 17 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Performance evaluation of LFT Dye Monitor System using ICG - plasma disappearance rate value (PDR) to assess liver function in normal patients as well as in patients with mild to severe hepatic impairment compared to manual Serum ICG PDR.
Detailed description
Indocyanine green (ICG) is a water-soluble, non-toxic tricarbocyanine dye, extracted principally by hepatic parenchymal cells and excreted almost entirely into the bile without enterohepatic circulation. Clinically, its elimination rate is used primarily to measure hepatic function and liver blood flow. ICG studies are also used in ophthalmic angiography and the determination of cardiac output.
Beginning about 1959, the first human clinical studies were reported wherein an indocyanine green (ICG) bolus was injected into a vein, and then blood samples were withdrawn over a period of time and analyzed for ICG concentrations. This method is referred to hereinafter as the serial blood sampling method. These blood samples are sent to a clinical laboratory for a multi-step process of centrifuging, separation and spectrophotometric measurements of ICG levels. The laboratory-based measured levels of residual ICG levels are then used to determine the ICG clearance rate and R15 value or residual amount of dye remaining after 15 minutes, expressed as a percentage of the initial concentration.
As an alternative to the time- and labor-consuming serial blood sampling method, a non-invasive technique was first reported nearly 20 years ago. In the first published clinical study, Ishigami reported the use of a pulse dye densitometry (PDD) method to transcutaneously detect the rate of clearance of ICG from the bloodstream to be referred to hereinafter as dynamic liver function testing.
PDD expresses ICG elimination in terms of the indocyanine green plasma disappearance rate because only relative ICG concentration changes are assessed. The results of this noninvasive method have been shown to correlate with those obtained by the invasive method used in critically ill patients (hemodynamically unstable and stable), and in patients after liver surgery.
ICG elimination rate after liver transplantation measured by either invasive or noninvasive ICG methods is widely used to evaluate graft function. Studies have shown that ICG elimination, measured on the day of transplantation, reflects graft function and can be used to predict graft viability and the expected survival of the patient. Sequential measurements of ICG elimination between days 0 and 28 of transplantation, have been shown to predict clinical outcome in the early postoperative period after living donor transplantation. All of the studies have shown that the ICG elimination rate is an accurate test for evaluating liver dysfunction, but lacks the ability to differentiate the underlying causes of the hepatic dysfunction.
Unlike all currently existing PDD methods for performing liver function testing, LFT Dye Monitor System employs a more sensitive method for the transcutaneous measurement of ICG concentration level in the blood using NIR fluorescence, with a sensor that is attached loosely to the scaphoid fossa of the ear. Thus, the chemical properties of ICG dye to fluoresce when properly excited are used in the LFT system to enable much lower concentrations of ICG to be detectable.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LFT Dye Detection Monitor | Experimental | Drug: 0.1 mg/kg ICG Dose, Drug: 0.5 mg/kg ICG dose |
| Serial Blood Draws | Active comparator | Drug: 0.5 mg/kg ICG dose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female between 18 to 75 years of age inclusive, at the time of Screening.
- Voluntarily provide written informed consent.
- Female patients are eligible only if all of the following apply:
- If a healthy volunteer; is considered to be in generally good health, in the opinion of the Investigator, at the Screening visit based upon the results of their medical and surgical history, vital signs, physical examination, and clinical laboratory tests.
- Prior to receiving any ICG injections the subject agrees to be fasting for at least eight (8) hours.
Key exclusion criteria (3 listed)
- Have any clinically significant condition or unstable current illness that would, in the opinion of the Investigator, preclude study participation or interfere with the assessment of the procedure;
- Known allergy or sensitivity to ICG dye or history of allergy to iodides;
- Actively bleeding associated with acute blood volume changes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.1 mg/kg ICG DoseAlso: LFT Doseleast efficacious dose | Drug | LFT Dye Detection Monitor |
| 0.5 mg/kg ICG doseper package insert | Drug | LFT Dye Detection Monitor, Serial Blood Draws |
Primary outcome
plasma disappearance rate
Time frame: Study Day 1
3 secondary outcomes
physical examinations
Time frame: Study Day 1
vital signs
Time frame: Study Day 1
adverse events
Time frame: Study Day 1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Jopling, MD study director
Medical Director, Cardiox Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 0.1 mg/kg ICG Dose and 0.5 mg/kg ICG dose in people with Hepatic Failure and Liver Failure, run by Cardiox Corporation 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 14 inclusion and 3 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: withdrawn, as of the sponsor's last update on 15 Jan 2016. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
plasma disappearance rate (time frame: Study Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2016.