ST-2; a Non-invasive Fibrosis Marker for Chronic Hepatitis B | NCT01633554

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

NCT01633554

Sponsor

Turkiye Yuksek Ihtisas Education and Research Hospital

Status

Unknown status

Last Update Posted

Jul 4, 2012Estimated

Enrollment

95Estimated

Phase

Not provided

Conditions

Sequela of Chronic Liver Disease

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
IKalkan24190708	Registry Identifier	IKalkan24190708

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Jul 2012Estimated

Completion Date

Sep 2012Estimated

First Submitted Date

Jul 1, 2012

First Submission Date that Met QC Criteria

Jul 3, 2012

First Posted Date

Jul 4, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 3, 2012

Last Update Posted Date

Jul 4, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

İsmail Hakkı KALKAN, MD, Turkiye Yuksek Ihtisas Education and Research HospitalPrincipal Investigator

Lead Sponsor

Turkiye Yuksek Ihtisas Education and Research HospitalOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

95Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Chronic Hepatitis B Group		Patients with chronic hepatitis B
Cirrhosis		Patients with liver cirrhosis
Control Group		Control Group: Healthy Volunteers

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of chronic hepatitis B or liver cirrhosis

Exclusion Criteria:

Accompanying chronic inflammatory disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
İsmail H KALKAN, MD	Contact	+90 312 437 67 78		drismailster@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Türkiye Yüksek İhtisas Education and research Hospital	Recruiting	Altındağ	Ankara	06100	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D005355	Fibrosis
D006509	Hepatitis B

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D000086982	Blood-Borne Infections
D003141	Communicable Diseases

Browse Leaves

Not provided

Browse Branches

Not provided