InflammationNCT03358420
Inflammation and Steatosis: the Role of Alpha-defensin
An observational study of Inflammation and Fatty Liver, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The aim of this study is to examine the correlation between the severity of non-alcoholic steatohepatitis/non alcoholic fatty liver disease (NASH/NAFLD) in naïve and hepatitis C (HCV) positive patients and the amplitude of alpha-defensin immunohistochemical staining in liver biopsy. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Inflammation, Fatty Liver
- What is being tested?
- Immunohistochemical staining
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2017to Jul 2018
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients attending our liver unit who underwent a liver biopsy with proven fatty liver disease
Who may be able to join
- Fatty liver disease patients with liver biopsy
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hille Yaffe Medical Center
Hadera, 38100
Rami Abu Fanne, MD, 972-503573694, ramia@hadassah.org.il
About this study
The aim of this study is to examine the correlation between the severity of non-alcoholic steatohepatitis/non alcoholic fatty liver disease (NASH/NAFLD) in naïve and hepatitis C (HCV) positive patients and the amplitude of alpha-defensin immunohistochemical staining in liver biopsy.
- Conditions
- Inflammation, Fatty Liver
- Being tested
- Immunohistochemical staining
- Medical subject headings
- Inflammation, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunohistochemical stainingDiagnostic test
Pathological liver slides to be immunohistochemically stained for alpha-defensin
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplitude of immunohistochemical stain
The amplitude of each slide will be graded from 1-4
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study startDec 2017 (estimated)
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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 only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Rami Abu Fanne, MD, Study director, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358420
- Sponsor's protocol ID
- HYMC-103-16
- Status last verified
- Nov 2017
- First submitted
- 27 Nov 2017
- Last updated
- 30 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammation and Steatosis: the Role of Alpha-defensin
- ClinicalTrials.gov ID
- NCT03358420
- Acronym / sponsor ID
- HYMC-103-16
- Conditions
- Inflammation, Fatty Liver
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Dec 2017 (estimated)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 30 Nov 2017 (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 aim of this study is to examine the correlation between the severity of non-alcoholic steatohepatitis/non alcoholic fatty liver disease (NASH/NAFLD) in naïve and hepatitis C (HCV) positive patients and the amplitude of alpha-defensin immunohistochemical staining in liver biopsy.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients attending our liver unit who underwent a liver biopsy with proven fatty liver disease
Key inclusion criteria (1 listed)
- Fatty liver disease patients with liver biopsy
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Immunohistochemical stainingPathological liver slides to be immunohistochemically stained for alpha-defensin | Diagnostic test | – |
Primary outcome
Amplitude of immunohistochemical stain
Time frame: Six months
The amplitude of each slide will be graded from 1-4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
- Individual participant dataSharing planned: No
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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.
Rami Abu Fanne, MD study director
Hillel Yaffe Medical Center
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 Inflammation and Fatty Liver, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 1 inclusion and 1 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 30 Nov 2017. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rami Abu Fanne, MD (972-50-3573694, ramia@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amplitude of immunohistochemical stain (time frame: Six 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 30 Nov 2017.