Autoimmune HepatitisNCT04339621
AIH Risk Stratification With Multiparametric MRI
An observational study of Autoimmune Hepatitis, run by Perspectum at 1 site in United States.
Trial summary
The primary aim of this study is to investigate whether the baseline cT1 can predict those whose condition relapses following treatment withdrawal. The secondary aim is to investigate correlation of cT1 with histology to explore utility as a monitoring tool. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Hepatitis
- What is being tested?
- LiverMultiscan
- Type of treatment
- Medical device
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2020to 15 Apr 2023
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: To assess the utility of cT1 to risk stratify patients with Autoimmune Hepatitis (AIH)
Who may be able to join
- Patients undergoing management for AIH being considered for treatment cessation
- Patients diagnosed with AIH, are treatment naïve, and will be undergoing biopsy as per clinical pathway
- Diagnostic biopsy prior to cessation of treatment (where possible)
- 18+ years of age.
- Ability to give informed consent
Who cannot join
- Any contraindication to MRI scanning
- Any clinically significant medical or psychiatric condition
Trial locations and contacts
1 site in 1 country.
About this study
The primary aim of this study is to investigate whether the baseline cT1 can predict those whose condition relapses following treatment withdrawal.
The secondary aim is to investigate correlation of cT1 with histology to explore utility as a monitoring tool.
A total of 97 patients with AIH will be recruited and divided into 2 arms. 20 of which will be treatment naive and the other 77 will have been on treatment for the past 18-24 months and will be coming in for therapy cessation review.
Read the detailed description
Patients with AIH who have been undergoing immunosuppressive treatment for 18-24 months will be invited for a series of multiparametric MRI (mpMRI) scans to assess the utility of LMS for monitoring characteristics of the disease.
This will be a prospective, cross-sectional, observational study recruiting 97 participants (20 of which will be treatment naïve at recruitment) from those patients scheduled for a liver biopsy for therapy cessation review. They will be consented and invited for a LiverMultiScan.
All patients whose treatment is ended based on histology results will be followed up over the subsequent 12 months, and those that experience a biochemical relapse or 'flare-up' will be invited for a second LiverMultiScan prior to their scheduled liver biopsy.
All participants will attend their planned outpatient hepatology appointment with their doctor, who will document the intended treatment plan for each participant in line with their usual care pathway. Their MRI scan will then be scheduled for the same day as their outpatient appointment or within a 7-day window after their appointment with the consultant.
- Conditions
- Autoimmune Hepatitis
- Being tested
- LiverMultiscan
- Keywords
- Autoimmune hepatitis, LiverMultiscan, MRI, Liver Biopsy
- Medical subject headings
- Hepatitis, Autoimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiverMultiscanDevice
The LiverMultiscan is a quick 15 minute, contrast free MRI scan that provides three metrics on liver health namely fat, iron and fibro-inflammatory scores
| Study group | Role | What they receive |
|---|---|---|
| Treatment Naive | 20 patients with AIH will be recruited that will be treatment naive at the time of recruitment. Receives: Device: LiverMultiscan | |
| Treatment cessation review | 77 AIH patients will be recruited who will have been on treatment for the past 18-24 months and will be coming in to meet their physician to review treatment cessation options Receives: Device: LiverMultiscan |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the utility of cT1 to risk stratify patients with Autoimmune Hepatitis (AIH).
Performance of cT1, as assessed by Area Under the Receiver Operating Curve, for predicting those patients likely to relapse following treatment cessation.
Measured: 36 months
Secondary outcomes (3)
To assess the utility of cT1 to monitor active disease along the clinical pathway
Performance of cT1 to predict active disease, as defined by histology and assessed by Area Under the Receiver Operating Curve, as part of the monitoring pathway
Measured: 36 months
To assess the correlation between cT1 and other clinically relevant outcomes and biomarkers such as blood biomarkers, autoimmune markers, ultrasound, histology and patient-reported outcome measures
Correlation between cT1 and other clinically relevant outcomes and biomarkers used in the AIH pathway (LFTs, autoimmune markers, ultrasound, histology and patient reported outcome measures)
Measured: 36 months
To collect health economic information about adding LMS into standard care pathway
To quantify the potential reduction in patient management costs by reducing unnecessary appointments
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start20 Oct 2020
- Primary completion8 Sep 2021
- Study completion15 Apr 2023
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune HepatitisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perspectum
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04339621
- Sponsor's protocol ID
- EC-88
- Status last verified
- Nov 2023
- First submitted
- 6 Apr 2020
- Last updated
- 22 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AIH Risk Stratification With Multiparametric MRI
- ClinicalTrials.gov ID
- NCT04339621
- Acronym / sponsor ID
- EC-88
- Conditions
- Autoimmune Hepatitis
- Keywords
- Autoimmune hepatitis, LiverMultiscan, MRI, Liver Biopsy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- PerspectumIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 8 Sep 2021 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 9 Apr 2020 (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.
The primary aim of this study is to investigate whether the baseline cT1 can predict those whose condition relapses following treatment withdrawal.
The secondary aim is to investigate correlation of cT1 with histology to explore utility as a monitoring tool.
A total of 97 patients with AIH will be recruited and divided into 2 arms. 20 of which will be treatment naive and the other 77 will have been on treatment for the past 18-24 months and will be coming in for therapy cessation review.
Detailed description
Patients with AIH who have been undergoing immunosuppressive treatment for 18-24 months will be invited for a series of multiparametric MRI (mpMRI) scans to assess the utility of LMS for monitoring characteristics of the disease.
This will be a prospective, cross-sectional, observational study recruiting 97 participants (20 of which will be treatment naïve at recruitment) from those patients scheduled for a liver biopsy for therapy cessation review. They will be consented and invited for a LiverMultiScan.
All patients whose treatment is ended based on histology results will be followed up over the subsequent 12 months, and those that experience a biochemical relapse or 'flare-up' will be invited for a second LiverMultiScan prior to their scheduled liver biopsy.
All participants will attend their planned outpatient hepatology appointment with their doctor, who will document the intended treatment plan for each participant in line with their usual care pathway. Their MRI scan will then be scheduled for the same day as their outpatient appointment or within a 7-day window after their appointment with the consultant.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Naive | – | Device: LiverMultiscan20 patients with AIH will be recruited that will be treatment naive at the time of recruitment. |
| Treatment cessation review | – | Device: LiverMultiscan77 AIH patients will be recruited who will have been on treatment for the past 18-24 months and will be coming in to meet their physician to review treatment cessation options |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- To assess the utility of cT1 to risk stratify patients with Autoimmune Hepatitis (AIH)
Key inclusion criteria (5 listed)
- Patients undergoing management for AIH being considered for treatment cessation
- Patients diagnosed with AIH, are treatment naïve, and will be undergoing biopsy as per clinical pathway
- Diagnostic biopsy prior to cessation of treatment (where possible)
- 18+ years of age.
- Ability to give informed consent
Key exclusion criteria (2 listed)
- Any contraindication to MRI scanning
- Any clinically significant medical or psychiatric condition
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 |
|---|---|---|
| LiverMultiscanThe LiverMultiscan is a quick 15 minute, contrast free MRI scan that provides three metrics on liver health namely fat, iron and fibro-inflammatory scores | Device | Treatment Naive, Treatment cessation review |
Primary outcome
To assess the utility of cT1 to risk stratify patients with Autoimmune Hepatitis (AIH).
Time frame: 36 months
Performance of cT1, as assessed by Area Under the Receiver Operating Curve, for predicting those patients likely to relapse following treatment cessation.
3 secondary outcomes
To assess the utility of cT1 to monitor active disease along the clinical pathway
Time frame: 36 months
To assess the correlation between cT1 and other clinically relevant outcomes and biomarkers such as blood biomarkers, autoimmune markers, ultrasound, histology and patient-reported outcome measures
Time frame: 36 months
To collect health economic information about adding LMS into standard care pathway
Time frame: 36 months
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Hepatitis, run by Perspectum 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 5 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 22 Nov 2023. 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.
Are results available for this study?
The study was stopped early (reason given: Lack of recruitment). 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?
To assess the utility of cT1 to risk stratify patients with Autoimmune Hepatitis (AIH). (time frame: 36 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 22 Nov 2023.