| CTRI Number |
CTRI/2023/12/060743 [Registered on: 26/12/2023] Trial Registered Prospectively |
| Last Modified On: |
20/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical, biochemical and liver tissue changes in Hepatitis-B Gray zone patients and determine eligibility for treatment thereof. |
|
Scientific Title of Study
|
Phenotype, clinical profile and treatment eligibility of Hepatitis-B infected patients lying in gray zone in a tertiary care center of Eastern India - an observational study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sk Mahiuddin Ahammed |
| Designation |
Associate Professor Hepatology |
| Affiliation |
IPGMEr and SSKM hospital, Kolkata |
| Address |
SDLD office
School of digestive and Liver disease
Ronald Ross building - 4th floor
IPGMER and SSKM Hospital
242, AJC Bose road
Kolkata - 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9051157404 |
| Fax |
|
| Email |
skmahiuddinahammed@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abdullah Md Hasan |
| Designation |
Post Doctoral Trainee |
| Affiliation |
IPGMER and SSKM hospital, Kolkata |
| Address |
SDLD office
School of digestive and Liver disease
Ronald Ross building - 4th floor
IPGMER and SSKM Hospital
242, AJC Bose road
Kolkata - 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9474174717 |
| Fax |
|
| Email |
abdullah86alamin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abdullah Md Hasan |
| Designation |
Post Doctoral Trainee |
| Affiliation |
IPGMER and SSKM hospital, Kolkata |
| Address |
SDLD office
School of digestive and Liver disease
Ronald Ross building - 4th floor
IPGMER and SSKM Hospital
242, AJC Bose road
Kolkata - 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9474174717 |
| Fax |
|
| Email |
abdullah86alamin@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPGMER and SSKM Hospital ( Government Medical college)
242 AJC Bose Road
Kolkata - 700020
West Bengal |
|
|
Primary Sponsor
|
| Name |
I.P.G.M.R, Kolkata |
| Address |
IPGMER and SSKM Hospital Kolkata
242 AJC Bose Road
Kolkata - 700020 , West Bengal |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sk Mahiuddin Ahammed |
School of digestive and Liver disease |
IPGMER and SSKM Hospital
242, AJC Bose Road
Kolkata 700020
West Bengal
Kolkata
WEST BENGAL |
9051157404
skmahiuddinahammed@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMER (Institute of Post-graduate Medical education and research) - Research Oversight Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B181||Chronic viral hepatitis B withoutdelta-agent, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Hepatitis B patients
1. Age > 18 years
2. Fulfilling Gray zone criteria
a) Grey zone A (GZ- A): HBeAg positive, normal ALT levels and serum HBV DNA <106 IU/ml;
b) Grey zone B (GZ- B): HBeAg positive, elevated ALT levels and serum HBV DNA <2 × 104 IU/ml;
c) Grey zone C (GZ- C): HBeAg negative, normal ALT levels and serum HBV DNA <2 × 10 3 IU/ml;
d) Grey zone D (GZ- D): HBeAg negative, elevated ALT levels and serum HBV DNA>2 × 10 3 IU/ml.
|
|
| ExclusionCriteria |
| Details |
1. subjects unwilling to give consent
2. subjects on treatment or features of Cirrhosis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Liver stiffness measure and histopathological changes (Liver Biopsy) |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="350"
Sample Size from India="350"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/12/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
EASL has described 4 well defined stages of hepatitis B infection pertaining to well characterised immunological states – based on HBV DNA levels and ALT levels as biochemical surrogate for necro-inflammation. There however remain states in between where there is in- congruity between viral dynamics (HBV DNa levels and Hepatitis B e antigen status) and ALT levels – these are known as grey zones. Individuals in the grey zone can be up to 1/3rd of all treatment naïve new CHB patients These patient populations have not been properly characterised– especially since increasing Volume of literature suggest grey zones of hepatitis B are not benign and not always quiescent – there are ongoing disease activity even progressing to higher levels of Liver fibrosis. This study aims to characterise these grey zone population – including and up to histopathological evidence of disease activity and liver fibrosis. It aims to explore the hypothesis that significant underlying liver disease activity might be present in clinical grey zones and also describe the distribution of these baseline and further characteristics among grey zone subgroups.
|