NCT05567614

Brief Summary

Platelets indices and its role to predict liver Fibrosis in patients with chronic hepatitis B infection

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
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2022

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

First Submitted

Initial submission to the registry

October 2, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 5, 2022

Completed
15 days until next milestone

Study Start

First participant enrolled

October 20, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

October 5, 2022

Status Verified

October 1, 2022

Enrollment Period

10 months

First QC Date

October 2, 2022

Last Update Submit

October 2, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Platelets indices and its role to predict liver Fibrosis in patients with chronic hepatitis B infection

    Correlation between platelets count and degree of liver Fibrosis in patients with chronic hepatitis B virus through liver fibroscan

    Two years

Study Arms (1)

75

patients with chronic hepatitis B infection will be collected and underwill liver fibroscan then corelate between platelets indicies and predict degree of liver fibrosis

Radiation: Liver Fibroscan

Interventions

Patients with CHB virus will do liver fibroscan and correlat between platelets count and degree of liver fibrosis

Also known as: Elastography and Fibroscan
75

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients at Age from 18 to 70 years with chronic hepatits B infection will do liver fibroscan and correlate between platelets indicies and degree of liver fibrosis \-

You may qualify if:

  • Age from 18 to 70 years
  • without a history of clinical illness

You may not qualify if:

  • with other hepatitis virus infection; (b) with alcoholic liver disease; (c) with any disease related to fibrosis (such as connective tissue diseases, chronic obstructive pulmonary disease, kidney failure, tumors, and so on); (d) have received any anti-fibrosis therapy; and (e) pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AssiutU

Asyut, Egypt

Location

Related Publications (2)

  • Zhong LK, Zhang G, Luo SY, Yin W, Song HY. The value of platelet count in evaluating the degree of liver fibrosis in patients with chronic hepatitis B. J Clin Lab Anal. 2020 Jul;34(7):e23270. doi: 10.1002/jcla.23270. Epub 2020 May 4.

    PMID: 32363594BACKGROUND
  • Tan YW, Zhou XB, Ye Y, He C, Ge GH. Diagnostic value of FIB-4, aspartate aminotransferase-to-platelet ratio index and liver stiffness measurement in hepatitis B virus-infected patients with persistently normal alanine aminotransferase. World J Gastroenterol. 2017 Aug 21;23(31):5746-5754. doi: 10.3748/wjg.v23.i31.5746.

    PMID: 28883700BACKGROUND

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ahmed AB Maghraby, Professor

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Wafaa Ad Abdelghany, resident DR

CONTACT

Osama AH Ibrahim

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Platelets indices and its role to predict liver Fibrosis in patients with chronic hepatitis B infection

Study Record Dates

First Submitted

October 2, 2022

First Posted

October 5, 2022

Study Start

October 20, 2022

Primary Completion

August 15, 2023

Study Completion

December 15, 2023

Last Updated

October 5, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

the value of platelets count in evaluating the degree of liver fibrosis in patients with chronic hepatits B infecion

Locations