CTRI/2025/03/083590 [Registered on: 27/03/2025] Trial Registered Prospectively
Last Modified On:
10/11/2025
Post Graduate Thesis
No
Type of Trial
Observational
Type of Study
Follow Up Study
Study Design
Other
Public Title of Study
Long-term follow-up study to evaluate response in previous bepirovirsen study participants.
Scientific Title of Study
A prospective, multi-centre study (B-Sure) to evaluate long-term durability of treatment response in chronic hepatitis B participants with and without nucleos(t)ide therapy who have participated in a previous bepirovirsen treatment study
Trial Acronym
B-Sure
Secondary IDs if Any
Secondary ID
Identifier
2023-506867-33
EudraCT
206882 Protocol Amendment 3_04 Apr 2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Syneos Health India Private Limited
4th and 5th Floor, Block-2, DLF Downtown,
Commercial Site, Block-V, DLF City, Phase III, Sector-25A,
Gurugram – 122002
Gurgaon HARYANA 122002 India
Phone
9560453771
Fax
Email
sumit.gupta@gmail.com
Details of Contact Person Public Query
Name
Ataur Rahman
Designation
Manager, Clinical Operations
Affiliation
Syneos Health India Private Limited
Address
Syneos Health India Private Limited
4th and 5th Floor, Block-2, DLF Downtown,
Commercial Site, Block-V, DLF City, Phase III, Sector-25A,
Gurugram – 122002
Gurgaon HARYANA 122002 India
Phone
8532011805
Fax
Email
ataur.rahman@syneoshealth.com
Source of Monetary or Material Support
GlaxoSmithKline Research & Development Limited
980 Great West Road, Brentford, Middlesex, TW8 9GS,
UK
Primary Sponsor
Name
GlaxoSmithKline Research & Development Limited
Address
980 Great West Road, Brentford, Middlesex, TW8 9GS,
UK
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
Syneos Health India Private Limited
4th and 5th Floor, Block-2, DLF Downtown,
Commercial Site, Block-V, DLF City, Phase III, Sector-25A,
Gurugram – 122002
Countries of Recruitment
Taiwan Argentina Australia Brazil Bulgaria Canada China France Germany Greece Hong Kong Hungary India Italy Japan Malaysia New Zealand Panama Philippines Poland Republic of Korea Romania Russian Federation Singapore South Africa Spain Thailand United Kingdom United States of America
Amrita Institute of Medical Sciences &Research Centre AIMS,
Ponekkara (P.O.), Kochi, Kerala, 68204l,India Ernakulam KERALA
9497556339
Shines1560@aims.amrita.edu
Dr Ganesh Subramanian
Apollo Cancer Centre
No. 320, Padma Complex, Anna Salai, Chennai-600 035,
Tamil Nadu, India.
Chennai TAMIL NADU
9841098434
ganeshgastro@gmail.com
Dr Jatin Yegurla
Apollo Hospitals
Jubilee Hills Hyderabad
Telangana, pincode -500096 India Hyderabad TELANGANA
9550007809
drjatin.y@gmail.com
Dr Pravin Motilal Rathi
B.Y.L Nair Ch. Hospital and T.N Medical College,
Opp Building 7th Floor, Department of Gasteroenterology, Room no. 714/715, Dr A L Nair Road, Mumbai Central 400008, India Mumbai MAHARASHTRA
9322406438
rathipmpp@gmail.com
Dr Ameetkumar Mandot
Gleneagles hospital Super Speciality & Transplant Centre,
A Unit of Cedntre for Digestive and Kidney Diseases(India) Pvt. Ltd. 35, Dr. E. Borges Road, hospital Avenue.
Opposite Shirodkar high school, Parel, Mumbai
400012, Maharashtra. Mumbai MAHARASHTRA
9819622291
ameetmandot@yahoo.co.in
Dr Pai Nitin Vikas
Grant Medical Foundation Ruby Hall Clinic
40, Sassoon Road, Pune - 411001,
Maharashtra, India
Pune MAHARASHTRA
9822008682
drnitinpai@gmail.com
Dr Praveen Sharma
Institute of Gastroenterology & Pancreatico Biliary Sciences, Sir Ganga Ram Hospital
Sir Ganga Ram Hospital Marg, Rajinder Nagar, New Delhi 110060, India. New Delhi DELHI
9810365151
Drpraveen_sharma@yahoo.com
Shiv Kumar Sarin
Institute of Liver and Biliary Sciences,
D-1, Vasant ,Kjnu New Delhi-110070 New Delhi DELHI
9540947000
shivsarin@gmail.com
Dr Santosh Dhanajay Hajare
KLES Dr Prabhakar Kore Hospital & Medical Research Centre,
Nehrunagar, Belagavi- 590010, Karnataka, India Belgaum KARNATAKA
9448111913
drsantoshhajare@gmail.com
Dr Sanjay Chandnani
Lokmanya Tilak Municipal Medical College & General Hospital.
College Building, 1st Floor, Room no. 2, Gastroenterology office,Lokmanya Tilak Muncipal Medical College & General Hospital, Sion-400022, Mumbai, India Mumbai MAHARASHTRA
9049708800
Sanjy.med@gmail.com
Dr Aejaz Habeeb Mohammad
Origin hospital,
A Unit of C.LRD,: 2-5-36/CLRD/1. Chintalmetmet X road. Near Pillar No. 177, PVNR Expressway, Attapur, Hyderabad. Hyderabad TELANGANA
9848034860
aejazhabeeb@hotmail.com
Dr Akash Shukla
Seth GS Medical College Kem Hospital-Mumbai-India
Department Of Gastroenterology, Ward 32A, 9th Floor, M.S Building, Seth G.S. Medical College KEM Hospital, Parel, Mumbai-400012 Mumbai MAHARASHTRA
9869256376
drakashshukla@yahoo.com
Dr Rajiv Mehta
SIDS Hospital and Research Centre
A unit of SIDS Healthcare Private Limited.
Off Ring Road, Near Shell petrol Pump, Ring Road – Sosyo circle lane, Surat-395002, Gujarat, India. Surat GUJARAT
9879863510
rmgastro@yahoo.com
Dr V G Mohanprasad
VGM Hospital
2100, Trichy Road, Rajalakshmi mill stop, Coimbatore-641005 Coimbatore TAMIL NADU
9842204995
drvgm@rediffmail.com
Dr Nagalingeswaran Kumarasamy
VHS Infectious Diseases Medical Centre,
CART Clinical Research Site, Voluntary Health Services Rajiv Gandhi Salai, Taramani Chennai 600113 Chennai TAMIL NADU
9176912007
kumarasamyn@gmail.com
Dr Dharmesh Kapoor
Yashoda Hospitals
S.P, Road, Alexander Road, Secunderabad, Hyderabad, Telangana, India-500003 Hyderabad TELANGANA
Ethics Committee: Institutional Ethics Committee, Origin Hospital. 2-5-36CLRD 1, - Chintalmetmet Xroad, Near Pillar No .177, PVNR Expressway, Attapur, Hyderabad.
Approved
ICMR-NIIH Institutional Ethics Committee ICMR-National Institute Of Immunohaematology 13th Floor, King Edward Memorial Hospital, Parel, Mumbai 400012 Mumbai Mumbai City Maharashtra
Submittted/Under Review
Institutional Ethics Committee Amrita Institute of Medical Sciences and Research Centre AlMS-Ponekkara Kochi Edappally Ernakulam Kerala - 682041 India.
Institutional Ethics Committee Poona Medical Research Foundation ,E4C to E4F, 4th floor, Fifth Avenue Condominium Dhole Patel Road, Pune 4110001 Maharashtra India
Approved
Institutional Ethics Committee The Voluntary Health Services Multi-Speciality Hospital &Research Centre Rajiv Gandhi Salai, Adyar, Chennai Tamil Nadu -600113 India
Submittted/Under Review
Institutional Ethics Committee TNMC NAIR HOSPITAL Topiwala National Medical College Nair Hospital Dr A L Nair Road Mumbai Central, Mumbai City Maharashtra - 400008 India
Institutional Ethics Committee, Gleneagles Hospital,Room No.222, 35, Dr E.Borges Road, hospital Avenue, Opposite Shirodkar High School, Parel, Mumbai-400012, Maharashtra, India
Approved
Institutional Ethics Committee, Institute of Liver and Biliary Sciences, D-1, Vasant ,Kunj New Delhi-110070
Submittted/Under Review
Institutional Ethics Committee, KLES Dr Prabhakar Kore Hospital & Medical Research Centre, Nehrunagar, Belagavi- 590010, Karnataka, India
Submittted/Under Review
Institutional Ethics Committee, Yashoda Academy of Medical Education & Research, Yashoda Hospitals, S.P, Road, Alexander Road, Secunderabad, Hyderabad, Telangana, India-500003
Submittted/Under Review
Institutional Ethics Committee-Clinical Studies APOLLO HOSPITALS ENTERPRISE LIMITED
Approved
Institutional Ethics Committee-Clinical studies, No. 21, Greams Lane, Off Greams Road, Thousand lights, Chennai-600 006, Tamil Nadu, India.
Submittted/Under Review
Sir Ganga Ram Hospital Ethics Committee, Sir Ganga Ram Hospital, Old Rajinder Nagar, New Delhi-110060, India
Submittted/Under Review
Surat Institute of Digestive Science Ethics Committee,Surat Institute of digestive sciences A Unit Of SIDS Healthcare Pvt Ltd Off Ring Road Near Shell Petrol Pump Ring Road Sosyo Circle Lane Surat Surat Gujarat - 395002 India
Approved
Regulatory Clearance Status from DCGI
Status
Notified
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: K928||Other specified diseases of the digestive system,
Intervention / Comparator Agent
Type
Name
Details
Intervention
N/A
N/A
Comparator Agent
N/A
N/A
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
Participants are eligible to be included in the study only if all the following criteria apply:
1. Participants who enter the study on stable NA are willing and able to cease their NA
treatment in accordance with the NA cessation schedule.
2. Capable of giving informed consent as described in Section 10.1 which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
ExclusionCriteria
Details
Participants are excluded from the study if any of the following criteria apply:
1. Participants who have participated in / are currently participating in another interventional clinical study exploring HBV treatment since completing their treatment with bepirovirsen.
2. Any condition which, in the opinion of the investigator or Medical Monitor,
contraindicates their participant in this study.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
A prospective, multi-centre study (B-Sure) to evaluate long term durability of
treatment response in chronic hepatitis B participants with and without nucleos(t)ide
therapy who have participated in a previous bepirovirsen treatment studyâ€
132 Weeks
Secondary Outcome
Outcome
TimePoints
To describe changes in
disease following NA cessation (in
either parent study or B-Sure), as
measured by time to HBsAg reversion,
time to virologic relapse, time to clinical
relapse and time to NA retreatment in
on-NA/NA-cessated participants, who
achieved PSPO.
Time from NA cessation to the first occurrence of HBsAg reversion or first use of any rescue medication.
Time from NA cessation to the first occurrence of virologic relapse or first use of any rescue medication.
Time from NA cessation to the first occurrence of clinical relapse or first use of any rescue medication.
Time from NA cessation to NA retreatment.
Target Sample Size
Total Sample Size="450" Sample Size from India="17" 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)
08/04/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
14/12/2021
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="5" Months="0" Days="0"
Recruitment Status of Trial (Global)
Open to Recruitment
Recruitment Status of Trial (India)
Open to Recruitment
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 Phase 2b, global, multi-centre, long-term follow-up study designed to assess
durability of treatment response from the parent study. Follow-up will be over a period of
up to 5 years, in participants who demonstrated a complete or partial response in a
previous bepirovirsen treatment study.
No further treatment with bepirovirsen will be administered in this study. Non-cirrhotic
participants who are controlled on stable NA therapy on study entry will be asked to