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ST-2; a Non-invasive Fibrosis Marker for Chronic Hepatitis B

This study is currently recruiting participants.
Verified July 2012 by Turkiye Yuksek Ihtisas Education and Research Hospital
Sponsor:
Information provided by (Responsible Party):
İsmail Hakkı KALKAN, Turkiye Yuksek Ihtisas Education and Research Hospital
ClinicalTrials.gov Identifier:
NCT01633554
First received: July 1, 2012
Last updated: July 3, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition
Sequela of Chronic Liver Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: The Ability of Prediction of Fibrosis for ST-2 as a Non-invasive Marker in Chronic Hepatitis B

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Turkiye Yuksek Ihtisas Education and Research Hospital:

Estimated Enrollment: 95
Study Start Date: January 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Chronic Hepatitis B Group
Patients with chronic hepatitis B
Cirrhosis
Patients with liver cirrhosis
Control Group
Control Group: Healthy Volunteers

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

25 Healthy Volunteers 45 patients with chronic hepatitis B 25 patients with liver cirrhosis

Criteria

Inclusion Criteria:

  • Clinical diagnosis of chronic hepatitis B or liver cirrhosis

Exclusion Criteria:

  • Accompanying chronic inflammatory disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01633554

Contacts
Contact: İsmail H KALKAN, MD +90 312 437 67 78 drismailster@gmail.com

Locations
Turkey
Türkiye Yüksek İhtisas Education and research Hospital Recruiting
Altındağ, Ankara, Turkey, 06100
Contact: İsmail H KALKAN, MD     +90 312 437 67 78     drismailster@gmail.com    
Sub-Investigator: İsmail H KALKAN, MD            
Sponsors and Collaborators
Turkiye Yuksek Ihtisas Education and Research Hospital
  More Information

No publications provided

Responsible Party: İsmail Hakkı KALKAN, MD, Turkiye Yuksek Ihtisas Education and Research Hospital
ClinicalTrials.gov Identifier: NCT01633554     History of Changes
Other Study ID Numbers: 24190708, IKalkan24190708
Study First Received: July 1, 2012
Last Updated: July 3, 2012
Health Authority: 'Turkey:Turkish Gastroenterology Organization'

Keywords provided by Turkiye Yuksek Ihtisas Education and Research Hospital:
ST-2, IL-33, prediction, fibrosis, hepatitis B

Additional relevant MeSH terms:
Fibrosis
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Liver Diseases
Hepatitis B, Chronic
Pathologic Processes
 Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on May 22, 2013