Sequela of Chronic Liver DiseaseNCT01633554
ST-2; a Non-invasive Fibrosis Marker for Chronic Hepatitis B
An observational study of Sequela of Chronic Liver Disease, run by Turkiye Yuksek Ihtisas Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
IL-33 is a recently identified number of the IL-1 family. Hepatic over-expression of IL-33 has been recently linked to liver fibrosis. ST-2 exerts pro-inflammatory effects of IL-33. We aimed to determine ability of ST2 to predict fibrosis in chronic hepatitis B. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sequela of Chronic Liver Disease
- How many people
- 95 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2011to Sep 2012
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 25 Healthy Volunteers 45 patients with chronic hepatitis B 25 patients with liver cirrhosis
Who may be able to join
- Clinical diagnosis of chronic hepatitis B or liver cirrhosis
Who cannot join
- Accompanying chronic inflammatory disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Türkiye Yüksek İhtisas Education and research Hospital
Altındağ, Ankara, 06100
İsmail H KALKAN, MD, +90 312 437 67 78, drismailster@gmail.com
İsmail H KALKAN, MD
About this study
Official title: The Ability of Prediction of Fibrosis for ST-2 as a Non-invasive Marker in Chronic Hepatitis B
IL-33 is a recently identified number of the IL-1 family. Hepatic over-expression of IL-33 has been recently linked to liver fibrosis. ST-2 exerts pro-inflammatory effects of IL-33. We aimed to determine ability of ST2 to predict fibrosis in chronic hepatitis B.
Read the detailed description
ST-2 is an IL-1 receptor family member and exists in both a membrane-bound isoform and a soluble (sST2) isoform. It has a functional ligand (Interleukin-33) and via ST-2/IL-33 inflammation and immunity is regulated. Hepatic over-expression of IL-33 has been recently linked to liver fibrosis. ST-2 exerts pro-inflammatory effects of IL-33. We aimed to determine ability of ST2 to predict fibrosis in chronic hepatitis B.
- Conditions
- Sequela of Chronic Liver Disease
- Keywords
- ST-2, IL-33, prediction, fibrosis, hepatitis B
- Medical subject headings
- Fibrosis, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Hepatitis B Group | Patients with chronic hepatitis B | |
| Cirrhosis | Patients with liver cirrhosis | |
| Control Group | Control Group: Healthy Volunteers |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study startJan 2011
- Primary completionJul 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sequela of Chronic Liver DiseaseStudies 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
- Cross-sectional
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turkiye Yuksek Ihtisas Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, İsmail Hakkı KALKAN, Turkiye Yuksek Ihtisas Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633554
- Sponsor's protocol ID
- 24190708
- Other IDs
- IKalkan24190708
- Status last verified
- Jul 2012
- First submitted
- 1 Jul 2012
- Last updated
- 4 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ability of Prediction of Fibrosis for ST-2 as a Non-invasive Marker in Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT01633554
- Acronym / sponsor ID
- 24190708
- Conditions
- Sequela of Chronic Liver Disease
- Keywords
- ST-2, IL-33, prediction, fibrosis, hepatitis B
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Turkiye Yuksek Ihtisas Education and Research HospitalOther government
- Study start
- Jan 2011
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 4 Jul 2012 (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.
IL-33 is a recently identified number of the IL-1 family. Hepatic over-expression of IL-33 has been recently linked to liver fibrosis. ST-2 exerts pro-inflammatory effects of IL-33. We aimed to determine ability of ST2 to predict fibrosis in chronic hepatitis B.
Detailed description
ST-2 is an IL-1 receptor family member and exists in both a membrane-bound isoform and a soluble (sST2) isoform. It has a functional ligand (Interleukin-33) and via ST-2/IL-33 inflammation and immunity is regulated. Hepatic over-expression of IL-33 has been recently linked to liver fibrosis. ST-2 exerts pro-inflammatory effects of IL-33. We aimed to determine ability of ST2 to predict fibrosis in chronic hepatitis B.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chronic Hepatitis B Group | – | –Patients with chronic hepatitis B |
| Cirrhosis | – | –Patients with liver cirrhosis |
| Control Group | – | –Control Group: Healthy Volunteers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 25 Healthy Volunteers 45 patients with chronic hepatitis B 25 patients with liver cirrhosis
Key inclusion criteria (1 listed)
- Clinical diagnosis of chronic hepatitis B or liver cirrhosis
Key exclusion criteria (1 listed)
- Accompanying chronic inflammatory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2012.
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?
An observational study of Sequela of Chronic Liver Disease, run by Turkiye Yuksek Ihtisas Education and Research Hospital at 1 site in Turkey (Türkiye).
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 4 Jul 2012. 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 Turkey (Türkiye). 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 İsmail H KALKAN, MD (+90 312 437 67 78, drismailster@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 Jul 2012.