NASH With FibrosisEarly Phase 1AGEDDXNCT06348563
AGED Diagnostics Liver Disease Assessment
A Early Phase 1 study testing AGED Multiple Target Assay in NAFLD Participants and AGED Multiple Target Assay in Fibrosis Participants in people with NASH With Fibrosis and NAFLD, run by Active Genomes Expressed Diagnostics, Corp at 1 site in United States.
Trial summary
Continue development of previously established methods to further validate candidate biomarkers that can discriminate steatosis from NASH and separately stage fibrosis from blood. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- NASH With Fibrosis, NAFLD, Healthy
- What is being tested?
- AGED Multiple Target Assay in NAFLD Participants and AGED Multiple Target Assay in Fibrosis Participants
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2024to 15 Sep 2025
- Phase
- Early Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant with liver biopsy over the past 1-2 years are permissible for study inclusion.
- Participant is considered to be a "Healthy Subject" relative to any form of liver disease OR
- Participant is suspected of having one of the following diagnoses: metabolic syndrome, NAFLD, fibrosis/cirrhosis, cardiovascular disease, chronic kidney disease.
Who cannot join
- Participant is known to have HIV, Hepatitis B or Hepatitis C
- Participant has any other known form of chronic liver disease (aside from NAFLD/liver fibrosis)
- Participant has excess alcohol intake, excess alcohol is defined as participants that exceed an average 20g of alcohol daily for females (140g weekly intake) and average 30g of alcohol daily for males (210g weekly intake)
- Participant has had a bone marrow transplant at any time
- Participant is on anti-coagulation or anti-platelet therapy
- Participant is known to be pregnant
- Participant is unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
AGED Diagnostics
Bethesda, Maryland, 20002
Rachel Zayas, 617-777-7971, rachel@ageddiagnostics.com
About this study
Official title: AGED Diagnostics Epigenetic Modifications of Liver Disease Assessment
Continue development of previously established methods to further validate candidate biomarkers that can discriminate steatosis from NASH and separately stage fibrosis from blood. The first assessment is to conduct test method verification to expand sample size to several hundred samples through whole genome sequencing methods. The second assessment is focused on biomarker validation by comparing targeted sequencing from patient plasma. Several sub- assessments will be conducted to support overall biomarker development efforts.
Read the detailed description
Aim 1: Test Method Verification, Whole genome bisulfite sequencing assessment for liver tissue and plasma Conduct whole genome bisulfite sequencing in patient liver tissue and patient plasma to identified candidate biomarkers that can discriminate between steatosis and NASH, and separately conduct a comparative analysis of patient liver tissue and patient plasma samples to assess NASH encompassing NASH with mild fibrosis, NASH with significant fibrosis and NASH with advanced fibrosis. The purpose of each is to identify a set of markers that have biological relevance on the liver and then identify epigenetic biomarkers in plasma derived from liver tissue. Note: both a subset of NASH specific biomarkers and fibrosis specific biomarkers have been previously reported for technical feasibility.
Aim 2: Biomarker Validation, Targeted Epigenetic Sequencing Assessment Select top NASH specific biomarkers and top fibrosis specific biomarkers and design, develop and test probes to assess overall performance of each candidate biomarker in plasma. Conduct comparative analysis between various targeted sequencing and PCR based modalities. Candidate biomarker performance will be evaluated based on sensitivity, specificity, AUROC and reproducibility, among several other assessments.
- Conditions
- NASH With Fibrosis, NAFLD, Healthy
- Being tested
- AGED Multiple Target Assay in Healthy Controls, AGED Multiple Target Assay in NAFLD Participants, AGED Multiple Target Assay in Fibrosis Participants
- 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.
AGED Multiple Target Assay in Healthy ControlsDiagnostic test
Analysis of blood based cfDNA/cfRNA biomarkers found at defined concentrations in participant samples that correlates to healthy controls
AGED Multiple Target Assay in NAFLD ParticipantsDiagnostic test
Analysis of blood based cfDNA/cfRNA biomarkers found at defined concentrations in participant samples that correlates to NAFLD participants (defined as simple steatosis through NASH)
AGED Multiple Target Assay in Fibrosis ParticipantsDiagnostic test
Analysis of blood based cfDNA/cfRNA biomarkers found at defined concentrations in participant samples that correlates to liver fibrosis stage (F0-F4)
| Study group | Role | What they receive |
|---|---|---|
| Health controls | Other | Diagnostic assessment Receives: Diagnostic Test: AGED Multiple Target Assay in Healthy Controls |
| NAFLD | Other | Diagnostic assessment. confirmation of diagnosis from liver biopsy is required.
* NASH Diagnosis is on histological assessment from NASH CRN score:
* NASH CRN score of ≤ 3 is classified as steatosis.
* NASH CRN score of ≥ 5 is classified as NASH.
* Participant samples can be subsequently diagnosed with CAP or MRI-PDFF to rule out NASH (or in rule in simple steatosis) but cannot be used to rule in NASH (as biopsy is required for confirmation).
* All diagnostic criteria for participant at time of visit is requested. Receives: Diagnostic Test: AGED Multiple Target Assay in NAFLD Participants |
| Liver Fibrosis | Other | Diagnostic assessment, For fibrosis diagnosis and analysis, diagnostic tools can constitute zero or mild fibrosis (F0-F1), significant fibrosis (F2), and advanced fibrosis (F3-F4) in the presence or absence of NASH.
* Participant samples can be diagnosed through non-invasive modalities such as but not limited to FIB4, ELF, PROC3, and/or imaging modalities such as but not limited to vibration controlled transient elastography (VCTE), magnetic resonance elastography (MRE), acoustic radiation force impulse (AFRI) or multiparameter imaging assessments.
* All diagnostic criteria for participant at time of visit is requested. Receives: Diagnostic Test: AGED Multiple Target Assay in Fibrosis Participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test Method Verification, Whole genome bisulfite sequencing assessment for liver tissue and plasma
Conduct whole genome bisulfite sequencing in patient liver tissue and patient plasma to identified candidate biomarkers that can discriminate between steatosis and NASH, and a separate assessment that can stage liver fibrosis.
Measured: 6-9 months
Secondary outcomes (1)
Biomarker Validation, Targeted Epigenetic Sequencing Assessment
Select top NASH specific biomarkers and top fibrosis specific biomarkers and design, develop and test probes to assess overall performance of each candidate biomarker in plasma through multiple targeted sequencing and PCR based modalities.
Measured: 6-9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start15 May 2024 (estimated)
- Primary completion15 May 2025 (estimated)
- Study completion15 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASH With FibrosisStudies 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Active Genomes Expressed Diagnostics, Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Arizona Clinical Trials, Walter Reed National Military Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348563
- Sponsor's protocol ID
- 7437787981
- Acronym
- AGEDDX
- Status last verified
- Apr 2024
- First submitted
- 1 Apr 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AGED Diagnostics Epigenetic Modifications of Liver Disease Assessment
- ClinicalTrials.gov ID
- NCT06348563
- Acronym / sponsor ID
- AGEDDX / 7437787981
- Conditions
- NASH With Fibrosis, NAFLD, Healthy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Active Genomes Expressed Diagnostics, CorpIndustry (pharma, biotech, devices)
- Collaborators
- Arizona Clinical Trials, Walter Reed National Military Medical Center
- Study start
- 15 May 2024 (estimated)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 4 Apr 2024 (actual)
- 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.
Continue development of previously established methods to further validate candidate biomarkers that can discriminate steatosis from NASH and separately stage fibrosis from blood. The first assessment is to conduct test method verification to expand sample size to several hundred samples through whole genome sequencing methods. The second assessment is focused on biomarker validation by comparing targeted sequencing from patient plasma. Several sub- assessments will be conducted to support overall biomarker development efforts.
Detailed description
Aim 1: Test Method Verification, Whole genome bisulfite sequencing assessment for liver tissue and plasma Conduct whole genome bisulfite sequencing in patient liver tissue and patient plasma to identified candidate biomarkers that can discriminate between steatosis and NASH, and separately conduct a comparative analysis of patient liver tissue and patient plasma samples to assess NASH encompassing NASH with mild fibrosis, NASH with significant fibrosis and NASH with advanced fibrosis. The purpose of each is to identify a set of markers that have biological relevance on the liver and then identify epigenetic biomarkers in plasma derived from liver tissue. Note: both a subset of NASH specific biomarkers and fibrosis specific biomarkers have been previously reported for technical feasibility.
Aim 2: Biomarker Validation, Targeted Epigenetic Sequencing Assessment Select top NASH specific biomarkers and top fibrosis specific biomarkers and design, develop and test probes to assess overall performance of each candidate biomarker in plasma. Conduct comparative analysis between various targeted sequencing and PCR based modalities. Candidate biomarker performance will be evaluated based on sensitivity, specificity, AUROC and reproducibility, among several other assessments.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Health controls | Other | Diagnostic Test: AGED Multiple Target Assay in Healthy ControlsDiagnostic assessment |
| NAFLD | Other | Diagnostic Test: AGED Multiple Target Assay in NAFLD ParticipantsDiagnostic assessment. confirmation of diagnosis from liver biopsy is required. * NASH Diagnosis is on histological assessment from NASH CRN score: * NASH CRN score of ≤ 3 is classified as steatosis. * NASH CRN score of ≥ 5 is classified as NASH. * Participant samples can be subsequently diagnosed with CAP or MRI-PDFF to rule out NASH (or in rule in simple steatosis) but cannot be used to rule in NASH (as biopsy is required for confirmation). * All diagnostic criteria for participant at time of visit is requested. |
| Liver Fibrosis | Other | Diagnostic Test: AGED Multiple Target Assay in Fibrosis ParticipantsDiagnostic assessment, For fibrosis diagnosis and analysis, diagnostic tools can constitute zero or mild fibrosis (F0-F1), significant fibrosis (F2), and advanced fibrosis (F3-F4) in the presence or absence of NASH. * Participant samples can be diagnosed through non-invasive modalities such as but not limited to FIB4, ELF, PROC3, and/or imaging modalities such as but not limited to vibration controlled transient elastography (VCTE), magnetic resonance elastography (MRE), acoustic radiation force impulse (AFRI) or multiparameter imaging assessments. * All diagnostic criteria for participant at time of visit is requested. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant with liver biopsy over the past 1-2 years are permissible for study inclusion.
- Participant is considered to be a "Healthy Subject" relative to any form of liver disease OR
- Participant is suspected of having one of the following diagnoses: metabolic syndrome, NAFLD, fibrosis/cirrhosis, cardiovascular disease, chronic kidney disease.
Key exclusion criteria (7 listed)
- Participant is known to have HIV, Hepatitis B or Hepatitis C
- Participant has any other known form of chronic liver disease (aside from NAFLD/liver fibrosis)
- Participant has excess alcohol intake, excess alcohol is defined as participants that exceed an average 20g of alcohol daily for females (140g weekly intake) and average 30g of alcohol daily for males (210g weekly intake)
- Participant has had a bone marrow transplant at any time
- Participant is on anti-coagulation or anti-platelet therapy
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 |
|---|---|---|
| AGED Multiple Target Assay in Healthy ControlsAnalysis of blood based cfDNA/cfRNA biomarkers found at defined concentrations in participant samples that correlates to healthy controls | Diagnostic test | Health controls |
| AGED Multiple Target Assay in NAFLD ParticipantsAnalysis of blood based cfDNA/cfRNA biomarkers found at defined concentrations in participant samples that correlates to NAFLD participants (defined as simple steatosis through NASH) | Diagnostic test | NAFLD |
| AGED Multiple Target Assay in Fibrosis ParticipantsAnalysis of blood based cfDNA/cfRNA biomarkers found at defined concentrations in participant samples that correlates to liver fibrosis stage (F0-F4) | Diagnostic test | Liver Fibrosis |
Primary outcome
Test Method Verification, Whole genome bisulfite sequencing assessment for liver tissue and plasma
Time frame: 6-9 months
Conduct whole genome bisulfite sequencing in patient liver tissue and patient plasma to identified candidate biomarkers that can discriminate between steatosis and NASH, and a separate assessment that can stage liver fibrosis.
1 secondary outcome
Biomarker Validation, Targeted Epigenetic Sequencing Assessment
Time frame: 6-9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: Undecided. Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing AGED Multiple Target Assay in NAFLD Participants and AGED Multiple Target Assay in Fibrosis Participants in people with NASH With Fibrosis and NAFLD, run by Active Genomes Expressed Diagnostics, Corp 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 4 Apr 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test Method Verification, Whole genome bisulfite sequencing assessment for liver tissue and plasma (time frame: 6-9 months). 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 4 Apr 2024.