Fibrosis, LiverNCT05567614
Platelets Indices and Its Role to Predict Liver Fibrosis in Patients With Chronic Hepatitis B Infection
An observational study of Fibrosis, Liver, run by Assiut University at 1 site in Egypt.
Trial summary
Platelets indices and its role to predict liver Fibrosis in patients with chronic hepatitis B infection Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibrosis, Liver
- What is being tested?
- Liver Fibroscan
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2022to 15 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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 -
Who may be able to join
- Age from 18 to 70 years
- without a history of clinical illness
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Platelets indices and its role to predict liver Fibrosis in patients with chronic hepatitis B infection
Read the detailed description
Patients with chronic Hepatitis B infection will be collected and will do liver fibroscan to predict the degree of liver Fibrosis and correlate between the role of platelets count and degree of liver Fibrosis in patients with Chronic hepatitis B virus
- Conditions
- Fibrosis, Liver
- Being tested
- Liver Fibroscan
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver FibroscanRadiation
Also called Elastography and Fibroscan
Patients with CHB virus will do liver fibroscan and correlat between platelets count and degree of liver fibrosis
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Radiation: Liver Fibroscan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start20 Oct 2022 (estimated)
- Primary completion15 Aug 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fibrosis, LiverStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wafaa Adel Abdelghany, Assiut University
- Investigators
- Ahmed AB Maghraby, Professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567614
- Sponsor's protocol ID
- Platelets and liver fibrosis
- Status last verified
- Oct 2022
- First submitted
- 2 Oct 2022
- Last updated
- 5 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the value of platelets count in evaluating the degree of liver fibrosis in patients with chronic hepatits B infecion
Publications
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.
PubMed 32363594Tan 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.
PubMed 28883700
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelets Indices and Its Role to Predict Liver Fibrosis in Patients With Chronic Hepatitis B Infection
- ClinicalTrials.gov ID
- NCT05567614
- Acronym / sponsor ID
- Platelets and liver fibrosis
- Conditions
- Fibrosis, Liver
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Oct 2022 (estimated)
- Primary completion
- 15 Aug 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 5 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Platelets indices and its role to predict liver Fibrosis in patients with chronic hepatitis B infection
Detailed description
Patients with chronic Hepatitis B infection will be collected and will do liver fibroscan to predict the degree of liver Fibrosis and correlate between the role of platelets count and degree of liver Fibrosis in patients with Chronic hepatitis B virus
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 75 | – | Radiation: Liver Fibroscanpatients with chronic hepatitis B infection will be collected and underwill liver fibroscan then corelate between platelets indicies and predict degree of liver fibrosis |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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 -
Key inclusion criteria (2 listed)
- Age from 18 to 70 years
- without a history of clinical illness
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver FibroscanAlso: Elastography and FibroscanPatients with CHB virus will do liver fibroscan and correlat between platelets count and degree of liver fibrosis | Radiation | 75 |
Primary outcome
Platelets indices and its role to predict liver Fibrosis in patients with chronic hepatitis B infection
Time frame: Two years
Correlation between platelets count and degree of liver Fibrosis in patients with chronic hepatitis B virus through liver fibroscan
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
- Background: PubMed 32363594Zhong 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.
- Background: PubMed 28883700Tan 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.
- Individual participant dataSharing planned: No. the value of platelets count in evaluating the degree of liver fibrosis in patients with chronic hepatits B infecion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed AB Maghraby, Professor study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibrosis, Liver, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wafaa Ad Abdelghany, resident DR (01118845248, wafaaadel789@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelets indices and its role to predict liver Fibrosis in patients with chronic hepatitis B infection (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05567614, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2022.