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

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ClinicalTrials.gov Identifier: NCT01633554
Recruitment Status : Unknown
Verified July 2012 by İsmail Hakkı KALKAN, Turkiye Yuksek Ihtisas Education and Research Hospital.
Recruitment status was:  Recruiting
First Posted : July 4, 2012
Last Update Posted : July 4, 2012
Sponsor:
Information provided by (Responsible Party):
İsmail Hakkı KALKAN, Turkiye Yuksek Ihtisas Education and Research Hospital

Tracking Information
First Submitted Date July 1, 2012
First Posted Date July 4, 2012
Last Update Posted Date July 4, 2012
Study Start Date January 2011
Estimated Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title ST-2; a Non-invasive Fibrosis Marker for Chronic Hepatitis B
Official Title The Ability of Prediction of Fibrosis for ST-2 as a Non-invasive Marker in Chronic Hepatitis B
Brief 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.
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 25 Healthy Volunteers 45 patients with chronic hepatitis B 25 patients with liver cirrhosis
Condition Sequela of Chronic Liver Disease
Intervention Not Provided
Study Groups/Cohorts
  • Chronic Hepatitis B Group
    Patients with chronic hepatitis B
  • Cirrhosis
    Patients with liver cirrhosis
  • Control Group
    Control Group: Healthy Volunteers
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July¬†3,¬†2012)
95
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2012
Estimated Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Clinical diagnosis of chronic hepatitis B or liver cirrhosis

Exclusion Criteria:

  • Accompanying chronic inflammatory disease
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT01633554
Other Study ID Numbers 24190708
IKalkan24190708 ( Registry Identifier: IKalkan24190708 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party İsmail Hakkı KALKAN, Turkiye Yuksek Ihtisas Education and Research Hospital
Study Sponsor Turkiye Yuksek Ihtisas Education and Research Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Turkiye Yuksek Ihtisas Education and Research Hospital
Verification Date July 2012