NCT01633554

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
95

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 4, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

July 4, 2012

Status Verified

July 1, 2012

Enrollment Period

1.5 years

First QC Date

July 1, 2012

Last Update Submit

July 3, 2012

Conditions

Sequela of Chronic Liver Disease

Keywords

ST-2, IL-33, prediction, fibrosis, hepatitis B

Study Arms (3)

Chronic Hepatitis B Group

Patients with chronic hepatitis B

Cirrhosis

Patients with liver cirrhosis

Control Group

Control Group: Healthy Volunteers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Clinical diagnosis of chronic hepatitis B or liver cirrhosis

You may not qualify if:

  • Accompanying chronic inflammatory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Türkiye Yüksek İhtisas Education and research Hospital

Altındağ, Ankara, 06100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

FibrosisHepatitis B

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Central Study Contacts

İsmail H KALKAN, MD

CONTACT

+90 312 437 67 78drismailster@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 1, 2012

First Posted

July 4, 2012

Study Start

January 1, 2011

Primary Completion

July 1, 2012

Study Completion

September 1, 2012

Last Updated

July 4, 2012

Record last verified: 2012-07

Locations

TU(1)