Hepatic FailureNCT02516319
Liver Function Assessment - Feasibility and Dosing Study
A study testing ICG Dye in people with Hepatic Failure, run by Cardiox Corporation.
Trial summary
The purpose of this study is to 1) determine the feasibility of using Cardiox Liver Function Assessment System (LFA) to measure indocyanine green (ICG) clearance; 2) determine an adequate dose based on LFA technology and 3) determine an adequate time period for LFA determination. 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
- What is being tested?
- ICG Dye
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Jan 2016
- Phase
- Interventional
- 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 subjects, aged 18 to 75 years, inclusive
- Informed consent documentation understood and signed.
Who cannot join
- Known allergy or sensitivity to the ICG or to iodide contrast dye
- Pregnant women or those nursing babies
About this study
Official title: A Feasibility Study to Determine an Adequate Dose of ICG for the Liver Function Assessment System in Healthy Volunteers
The purpose of this study is to 1) determine the feasibility of using Cardiox Liver Function Assessment System (LFA) to measure indocyanine green (ICG) clearance; 2) determine an adequate dose based on LFA technology and 3) determine an adequate time period for LFA determination.
Read the detailed description
Four cohorts of subjects will be enrolled. The fist two cohorts will receive fixed doses of ICG dye (2.5 mg, 5.0 mg, 7.5 mg, 10.0 mg) followed by 20 minutes of LFT monitoring. The final two cohorts will receive weight based doses of ICG dye (0.1 mg/kg, 0.5 mg/kg) followed by 20 minutes of LFT monitoring. Additionally the final two cohorts will have serial blood draws before the ICG dose and at 5, 10, 15 and 20 minutes post ICG dose.
- Conditions
- Hepatic Failure
- Being tested
- ICG Dye
- Medical subject headings
- Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICG DyeDrug
| Study group | Role | What they receive |
|---|---|---|
| Serial Blood Draws | Active comparator | Cohorts 3 and 4 - weight based doses of ICG dye followed by serial blood draws at 5, 10, 15 and 20 minutes post ICG injection. Receives: Drug: ICG Dye |
| Liver Funtion Test Dye Detection Monitor | Experimental | All cohorts receive continuous LFT monitoring post ICG injection. Receives: Drug: ICG Dye |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICG dye detection using the LFT system compared to serial blood sampling ethods.
Determination of an adequate dose for the Cardiox Liver Functioning Assessment LFA system to produce liver function assessments consistent with serial blood sampling methods.
Measured: 20 minutes post ICG dose
Secondary outcomes (2)
ICG fluorescence detection at the scaphoid fossa of the ears
Measured: 20 minutes post ICG dose
Repeatability of the Cardiox LFA system to detect the ICG fluorescence in the same subjects over time.
Measured: 20 minutes post ICG dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2015 (estimated)
- Study startSep 2012
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: Business decision to discontinue product development.
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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiox Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael W Jopling, M.D, Principal investigator, Cardiox Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02516319
- Sponsor's protocol ID
- LFA-0001
- Status last verified
- Jan 2016
- First submitted
- 21 Jul 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 Feasibility Study to Determine an Adequate Dose of ICG for the Liver Function Assessment System in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02516319
- Acronym / sponsor ID
- LFA-0001
- Conditions
- Hepatic Failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision to discontinue product development.
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Cardiox CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 5 Aug 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.
The purpose of this study is to 1) determine the feasibility of using Cardiox Liver Function Assessment System (LFA) to measure indocyanine green (ICG) clearance; 2) determine an adequate dose based on LFA technology and 3) determine an adequate time period for LFA determination.
Detailed description
Four cohorts of subjects will be enrolled. The fist two cohorts will receive fixed doses of ICG dye (2.5 mg, 5.0 mg, 7.5 mg, 10.0 mg) followed by 20 minutes of LFT monitoring. The final two cohorts will receive weight based doses of ICG dye (0.1 mg/kg, 0.5 mg/kg) followed by 20 minutes of LFT monitoring. Additionally the final two cohorts will have serial blood draws before the ICG dose and at 5, 10, 15 and 20 minutes post ICG dose.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serial Blood Draws | Active comparator | Drug: ICG DyeCohorts 3 and 4 - weight based doses of ICG dye followed by serial blood draws at 5, 10, 15 and 20 minutes post ICG injection. |
| Liver Funtion Test Dye Detection Monitor | Experimental | Drug: ICG DyeAll cohorts receive continuous LFT monitoring post ICG injection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female subjects, aged 18 to 75 years, inclusive
- Informed consent documentation understood and signed.
Key exclusion criteria (2 listed)
- Known allergy or sensitivity to the ICG or to iodide contrast dye
- Pregnant women or those nursing babies
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 |
|---|---|---|
| ICG Dye | Drug | Liver Funtion Test Dye Detection Monitor, Serial Blood Draws |
Primary outcome
ICG dye detection using the LFT system compared to serial blood sampling ethods.
Time frame: 20 minutes post ICG dose
Determination of an adequate dose for the Cardiox Liver Functioning Assessment LFA system to produce liver function assessments consistent with serial blood sampling methods.
2 secondary outcomes
ICG fluorescence detection at the scaphoid fossa of the ears
Time frame: 20 minutes post ICG dose
Repeatability of the Cardiox LFA system to detect the ICG fluorescence in the same subjects over time.
Time frame: 20 minutes post ICG dose
Results and safety
The study was stopped early (reason given: Business decision to discontinue product development.). Results are not available in the source record.
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 W Jopling, M.D principal investigator
Cardiox Corporation
Questions about this trial
What is this clinical trial studying?
A study testing ICG Dye in people with Hepatic Failure, run by Cardiox Corporation.
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 2 inclusion and 2 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: stopped early, 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.
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.
Are results available for this study?
The study was stopped early (reason given: Business decision to discontinue product development.). Results are not available in the source record.
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?
ICG dye detection using the LFT system compared to serial blood sampling ethods. (time frame: 20 minutes post ICG dose). 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.