| CTRI Number |
CTRI/2026/03/105288 [Registered on: 03/03/2026] Trial Registered Prospectively |
| Last Modified On: |
02/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment for Chronic hepatitis B patients with low viral load prevents liver damage. |
|
Scientific Title of Study
|
Study to assess the effectiveness of the treatment in chronic hepatitis patients with low viremia and evaluate strategies to optimize intervention |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anindita Banerjee |
| Designation |
Scientist E(Medical) |
| Affiliation |
ICMR-National Institute of Immunohaematology |
| Address |
Department of Transfusion Transmitted Diseases,
13th Floor, NMS Building,
KEM Campus, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9830476354 |
| Fax |
|
| Email |
anny.banerjee@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anindita Banerjee |
| Designation |
Scientist E(Medical) |
| Affiliation |
ICMR-National Institute of Immunohaematology |
| Address |
Department of Transfusion Transmitted Diseases,
13th Floor, NMS Building,
KEM Campus, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9830476354 |
| Fax |
|
| Email |
anny.banerjee@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anindita Banerjee |
| Designation |
Scientist E(Medical) |
| Affiliation |
ICMR-National Institute of Immunohaematology |
| Address |
Department of Transfusion Transmitted Diseases,
13th Floor, NMS Building,
KEM Campus, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9830476354 |
| Fax |
|
| Email |
anny.banerjee@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
13th Floor, NMS Building, KEM Campus, Parel, Mumbai |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Anindita Banerjee |
LTMCH |
OPD No 27, Department of Gastroenterology, LTMCH,Sion, Mumbai
Mumbai
MAHARASHTRA |
9830476354
anny.banerjee@gmail.com |
| Naveen Khargekar |
V B Civil Hospital, Silvassa |
OPD No 33, Superspeciality OPD, Department of Gastroenterology,V B Civil Hospital, Silvassa
Dadra & Nagar Haveli
DADRA & NAGAR HAVELI |
9867191421
naveenkhargekar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ICMR-NATIONAL INSTITUTE OF IMMUNOHAEMATOLOGY |
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 |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Tenofovir |
Dose: 300 mg per day for 1 year to be taken orally. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
HBV DNA 2000 to 20000
Elevated ALT above 30IU in males and 19 IU in females. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria include prior HBV antiviral therapy, HCC, co-infection with HIV/HCV, other liver diseases (e.g., autoimmune hepatitis, Wilson’s disease), pregnancy, lactation, serious comorbidities, or inability to consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the quantitative HbsAg, HbV DNA from baseline to 12 months. |
Change in the quantitative HbsAg, HbV DNA from baseline to 12 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Liver fibrosis |
6, 12 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
13/03/2026 |
| 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="2"
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
|
This is a single arm hybrid Type II effectiveness implementation protocol conducted in two public sector facilities in western India one tertiary hospital and one district hospital serving a predominantly tribal population. Adults aged 18 years and above with chronic hepatitis B defined as HBsAg positive for more than six months HBV DNA between 2000 and 20000 IU per mL and elevated ALT will receive guideline based antiviral therapy with tenofovir or entecavir along with structured adherence support. Participants will be followed for 24 months. The primary effectiveness outcome is change in quantitative HBsAg at 12 and 24 months. Secondary outcomes include HBV DNA suppression ALT normalization fibrosis progression assessed by transient elastography HBeAg seroconversion safety outcomes and health related quality of life measured by EQ 5D. Implementation outcomes guided by Proctor framework include acceptability feasibility adoption fidelity and determinants of treatment initiation and adherence. Quantitative tools include Acceptability of Intervention Measure and Feasibility of Intervention Measure. Qualitative data from interviews and focus group discussions with patients providers and policymakers will be analyzed using the Consolidated Framework for Implementation Research CFIR 2 0. Determinants will be mapped to tailored strategies using the CFIR ERIC matching tool. Mixed methods integration will use joint displays to link biological and implementation findings. |