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The Connection Between Liver Disease and Chitinase Proteins

The Connection Between Liver Disease and Chitinase Proteins

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00852293
Enrollment
200
Registered
2009-02-26
Start date
2009-03-31
Completion date
2014-03-31
Last updated
2009-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Disease

Keywords

liver disease, Chitinase 3 like-1 protein

Brief 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. 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: a. 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.

Interventions

OTHERA blood test

A blood test of about 5ml of blood will be taken to determine Chitinase 3 like-1 protein levels.

Sponsors

Hadassah Medical Organization
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Age\<18y. * Pregnancy * Patients with other conditions associated with elevated chitinase 3 like 1 protein (such as asthma and rheumatoid arthritis).

Design outcomes

Primary

MeasureTime frame
Comparison between Chitinase 3 like-1 protein levels and liver disease parameters including disease severity, portal hypertension, reaction to treatment and prognosis.5 years

Countries

Israel

Contacts

Primary ContactArik Tzukert, DMD
arik@hadassah.org.il00 972 2 6776095
Backup ContactHadas Lemberg, PhD
lhadas@hadassah.org.il00 972 2 6777572

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026