Liver DiseaseNCT00852293
The Connection Between Liver Disease and Chitinase Proteins
An observational study of Liver Disease, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Chitinase and chitinase like proteins are members of the 18-glycosyl-hydrolase family. Several reports have linked the chitinase 3 like 1 protein with colitis, asthma and liver disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Disease
- What is being tested?
- A blood test
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2009to Mar 2014
- 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: The study will include patients with liver disease followed at the liver unit, Hadassah Medical Center, Jerusalem Israel.
Who may be able to join
- Patients with liver disease followed at the liver unit at Hadassah Medical Center.
- Patients who have given their informed consent for participation in the study
Who cannot join
- Age<18y.
- Pregnancy
- Patients with other conditions associated with elevated chitinase 3 like 1 protein (such as asthma and rheumatoid arthritis).
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Medical Organization,
Jerusalem
Arik Tzukert, DMD, : 00 972 2 6776095, arik@hadassah.org.il
Hadas Lemberg, PhD, 00 972 2 6777572, lhadas@hadassah.org.il
About this study
Chitinase and chitinase like proteins are members of the 18-glycosyl-hydrolase family. Several reports have linked the chitinase 3 like 1 protein with colitis, asthma and liver disease.
This study aims to evaluate the correlation of chitinase 3 like 1 protein with clinical parameters such as disease severity, reaction to treatment, portal hypertension and prognosis.
Read the detailed description
Chitin is a poly saccharide, abundant in insects, fungi, crustaceans and other organisms, but not in mammals. Chitinases and chitinase like proteins (which have the ability to bind chitin without enzymatic activity) are members of the 18-glycosyl-hydrolase family. Their function and importance are still not clearly understood. However, several reports have linked the chitinase 3 like 1 protein with colitis and asthma. Furthermore, Johansen et al have reported elevated levels of chitinase 3 like 1 protein in patients with liver disease, mainly those with alcoholic liver disease (ALD) and fibrosis. This report consisted of 51 patients with ALD ,but only 16 and 17 patients with fatty liver and viral hepatitis respectively.
This study aims to evaluate the correlation of chitinase 3 like 1 protein with clinical parameters such as disease severity, reaction to treatment, portal hypertension (when measured) and prognosis.
***Study design:
- Subjects i.The study will include patients with liver disease followed at the liver unit, Hadassah Medical Center, Jerusalem. b. Planned number i.The study is planned to include 200 volunteers. c. Inclusion criteria i.Patients with liver disease followed at the liver unit at Hadassah Medical Center. ii.Patients who have given their informed consent for participation in the study. d. Exclusion criteria i.Age<18y. ii.Pregnancy iii.Patients with other conditions associated with elevated chitinase 3 like 1 protein (such as asthma and rheumatoid arthritis). e. Chitinase 3 like-1 protein levels will be measured by a commercially available kit (Human Chitinase 3-like 1 Quantikine ELISA Kit, catalogue number - DC3L1, Biotest LTD). f. Stopping/modifying criteria i.At subjects' request. g. Trial entry and enrollment i.A consecutive cohort will be recruited form amongst the patients followed at the liver unit in Hadassah medical center. Jerusalem Israel. ii.Consenting patients will have a blood test drawn for chitinase 3 like 1 protein levels. iii.Clinical details of each patient will be obtained form the liver unit. iv.In addition to the routine follow up at the liver unit, follow up will be performed at 1,2 and 5 years. h. Statistical considerations i.Subjects will be grouped according to their clinical properties (disease, treatment, severity, portal hypertension) ii.Chitinase 3 like 1 protein levels will be compared between each group. F. Informed consent i.Each subject will be enrolled and enter the study only after giving an informed consent. G. Adherence to study eligibility i.The study will be conducted in accordance with good clinical practice (GCP) guidelines, and the study protocol. H. Safeguarding of documents i.The privacy of the subjects and all confidentiality issues will be handled in accordance with applicable law and guidelines of the institution and the Helsinki Committee, the Israeli ministry of health, or the other appropriate regulatory authorities.
- Conditions
- Liver Disease
- Being tested
- A blood test
- Keywords
- liver disease, Chitinase 3 like-1 protein
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A blood testOther
A blood test of about 5ml of blood will be taken to determine Chitinase 3 like-1 protein levels.
| Study group | Role | What they receive |
|---|---|---|
| study group | Patients with liver disease followed at the liver unit at Hadassah Medical Center. Receives: Other: A blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between Chitinase 3 like-1 protein levels and liver disease parameters including disease severity, portal hypertension, reaction to treatment and prognosis.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2010 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852293
- Sponsor's protocol ID
- 481132-HMO-CTIL
- Status last verified
- Feb 2009
- First submitted
- 25 Feb 2009
- Last updated
- 26 Feb 2009
- Results posted
- No
Publications
Kawada M, Hachiya Y, Arihiro A, Mizoguchi E. Role of mammalian chitinases in inflammatory conditions. Keio J Med. 2007 Mar;56(1):21-7. doi: 10.2302/kjm.56.21.
PubMed 17392594Chupp GL, Lee CG, Jarjour N, Shim YM, Holm CT, He S, Dziura JD, Reed J, Coyle AJ, Kiener P, Cullen M, Grandsaigne M, Dombret MC, Aubier M, Pretolani M, Elias JA. A chitinase-like protein in the lung and circulation of patients with severe asthma. N Engl J Med. 2007 Nov 15;357(20):2016-27. doi: 10.1056/NEJMoa073600.
PubMed 18003958Johansen JS, Christoffersen P, Moller S, Price PA, Henriksen JH, Garbarsch C, Bendtsen F. Serum YKL-40 is increased in patients with hepatic fibrosis. J Hepatol. 2000 Jun;32(6):911-20. doi: 10.1016/s0168-8278(00)80095-1.
PubMed 10898311
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Connection Between Liver Disease and Chitinase Proteins
- ClinicalTrials.gov ID
- NCT00852293
- Acronym / sponsor ID
- 481132-HMO-CTIL
- Conditions
- Liver Disease
- Keywords
- liver disease, Chitinase 3 like-1 protein
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 26 Feb 2009 (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.
Chitinase and chitinase like proteins are members of the 18-glycosyl-hydrolase family. Several reports have linked the chitinase 3 like 1 protein with colitis, asthma and liver disease.
This study aims to evaluate the correlation of chitinase 3 like 1 protein with clinical parameters such as disease severity, reaction to treatment, portal hypertension and prognosis.
Detailed description
Chitin is a poly saccharide, abundant in insects, fungi, crustaceans and other organisms, but not in mammals. Chitinases and chitinase like proteins (which have the ability to bind chitin without enzymatic activity) are members of the 18-glycosyl-hydrolase family. Their function and importance are still not clearly understood. However, several reports have linked the chitinase 3 like 1 protein with colitis and asthma. Furthermore, Johansen et al have reported elevated levels of chitinase 3 like 1 protein in patients with liver disease, mainly those with alcoholic liver disease (ALD) and fibrosis. This report consisted of 51 patients with ALD ,but only 16 and 17 patients with fatty liver and viral hepatitis respectively.
This study aims to evaluate the correlation of chitinase 3 like 1 protein with clinical parameters such as disease severity, reaction to treatment, portal hypertension (when measured) and prognosis.
***Study design:
- Subjects i.The study will include patients with liver disease followed at the liver unit, Hadassah Medical Center, Jerusalem. b. Planned number i.The study is planned to include 200 volunteers. c. Inclusion criteria i.Patients with liver disease followed at the liver unit at Hadassah Medical Center. ii.Patients who have given their informed consent for participation in the study. d. Exclusion criteria i.Age<18y. ii.Pregnancy iii.Patients with other conditions associated with elevated chitinase 3 like 1 protein (such as asthma and rheumatoid arthritis). e. Chitinase 3 like-1 protein levels will be measured by a commercially available kit (Human Chitinase 3-like 1 Quantikine ELISA Kit, catalogue number - DC3L1, Biotest LTD). f. Stopping/modifying criteria i.At subjects' request. g. Trial entry and enrollment i.A consecutive cohort will be recruited form amongst the patients followed at the liver unit in Hadassah medical center. Jerusalem Israel. ii.Consenting patients will have a blood test drawn for chitinase 3 like 1 protein levels. iii.Clinical details of each patient will be obtained form the liver unit. iv.In addition to the routine follow up at the liver unit, follow up will be performed at 1,2 and 5 years. h. Statistical considerations i.Subjects will be grouped according to their clinical properties (disease, treatment, severity, portal hypertension) ii.Chitinase 3 like 1 protein levels will be compared between each group. F. Informed consent i.Each subject will be enrolled and enter the study only after giving an informed consent. G. Adherence to study eligibility i.The study will be conducted in accordance with good clinical practice (GCP) guidelines, and the study protocol. H. Safeguarding of documents i.The privacy of the subjects and all confidentiality issues will be handled in accordance with applicable law and guidelines of the institution and the Helsinki Committee, the Israeli ministry of health, or the other appropriate regulatory authorities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | Other: A blood testPatients with liver disease followed at the liver unit at Hadassah Medical Center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include patients with liver disease followed at the liver unit, Hadassah Medical Center, Jerusalem Israel.
Key inclusion criteria (2 listed)
- Patients with liver disease followed at the liver unit at Hadassah Medical Center.
- Patients who have given their informed consent for participation in the study
Key exclusion criteria (3 listed)
- Age<18y.
- Pregnancy
- Patients with other conditions associated with elevated chitinase 3 like 1 protein (such as asthma and rheumatoid arthritis).
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 |
|---|---|---|
| A blood testA blood test of about 5ml of blood will be taken to determine Chitinase 3 like-1 protein levels. | Other | study group |
Primary outcome
Comparison between Chitinase 3 like-1 protein levels and liver disease parameters including disease severity, portal hypertension, reaction to treatment and prognosis.
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2009.
- Background: PubMed 17392594Kawada M, Hachiya Y, Arihiro A, Mizoguchi E. Role of mammalian chitinases in inflammatory conditions. Keio J Med. 2007 Mar;56(1):21-7. doi: 10.2302/kjm.56.21.
- Background: PubMed 18003958Chupp GL, Lee CG, Jarjour N, Shim YM, Holm CT, He S, Dziura JD, Reed J, Coyle AJ, Kiener P, Cullen M, Grandsaigne M, Dombret MC, Aubier M, Pretolani M, Elias JA. A chitinase-like protein in the lung and circulation of patients with severe asthma. N Engl J Med. 2007 Nov 15;357(20):2016-27. doi: 10.1056/NEJMoa073600.
- Background: PubMed 10898311Johansen JS, Christoffersen P, Moller S, Price PA, Henriksen JH, Garbarsch C, Bendtsen F. Serum YKL-40 is increased in patients with hepatic fibrosis. J Hepatol. 2000 Jun;32(6):911-20. doi: 10.1016/s0168-8278(00)80095-1.
Related trials for Liver Disease
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
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 Liver Disease, run by Hadassah Medical Organization 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 2 inclusion and 3 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 26 Feb 2009. 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 Arik Tzukert, DMD (00 972 2 6776095, arik@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between Chitinase 3 like-1 protein levels and liver disease parameters including disease severity, portal hypertension, reaction to treatment and prognosis. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00852293, which also lists 3 linked publications.
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 26 Feb 2009.