| CTRI Number |
CTRI/2025/03/082856 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
31/08/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Uniform dose of entecavir for all patients with hepatitis B related cirrhosis |
Scientific Title of Study
Modification(s)
|
Multicentric, open label, pragmatic, randomized, controlled trial to compare the clinical outcome with 0.5 versus 1.0 mg entecavir for hepatitis B related decompensated cirrhosis |
| Trial Acronym |
SECOND trial: Single dose of Entecavir for COmpensated aNd Decompensated cirrhosis |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amit Goel |
| Designation |
Professor and Head of Hepatology Department |
| Affiliation |
Sanjay Gandhi Postgraduate Institute of Medical Sciences |
| Address |
Department of Hepatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Raebareilly Road, Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
09936275741 |
| Fax |
|
| Email |
agoel.ag@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amit Goel |
| Designation |
Professor and Head of Hepatology Department |
| Affiliation |
Sanjay Gandhi Postgraduate Institute of Medical Sciences |
| Address |
Department of Hepatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Raebareilly Road, Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
09936275741 |
| Fax |
|
| Email |
agoel.ag@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amit Goel |
| Designation |
Professor and Head of Hepatology Department |
| Affiliation |
Sanjay Gandhi Postgraduate Institute of Medical Sciences |
| Address |
Department of Hepatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Raebareilly Road, Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
09936275741 |
| Fax |
|
| Email |
agoel.ag@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian council of Medical Research (ICMR), V. Ramalingaswami Bhawan,
P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India
|
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911,
Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manash Kumar Panigrahi |
AIIMS Bhubaneshwar |
Department of Gastroenterology,
AIIMS Bhubaneswar,
Orissa, PIN-751019, India
Ori
Khordha
ORISSA |
9861278332
manaskumarpanigrahi@gmail.com |
| Dr Vinod Kumar |
BHUIMS |
Department of Gastroenterology,
Institute of Medical Sciences,
Banaras Hindu University,
Varanasi, India
Varanasi
UTTAR PRADESH
Varanasi
UTTAR PRADESH |
9984719346
drv_inod@yahoo.co.in |
| Professor Vinay Kumar Sachan |
GSVM Kanpur |
Department of
Gastroenterology, Ganesh Shankar Vidhyarthi Medical College, Kanpur
UTTAR PRADESH, India
Kanpur Nagar
UTTAR PRADESH |
8004877113
dr.vinaysachan@gmail.com |
| Professor Sumit Rungta |
KGMU |
Department of
Gastroenterology,
King Georges Medical University,
Lucknow
UTTAR PRADESH
Lucknow
UTTAR PRADESH |
09935537944
drsumitrungta79@gmail.com |
| Dr Amit Goel |
SGPGIMS |
Department of Hepatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Raebareilly Road, Lucknow
Lucknow
UTTAR PRADESH |
09936275741
agoel.ag@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Ethics Committee, GSVM Medical College, Kanpur |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| SGPGI Institute Ethic Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K740||Hepatic fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.5 mg arm |
Participants in this arm will be given 0.5 mg dose of entecavir once daily |
| Comparator Agent |
1.0 mg arm |
Participants in this arm will be given 1.0 mg dose of entecavir once daily |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. HBsAg positive 2. hemodynamic stable 3. liver cirrhosis 4. presenting with first decompensation or Child-Tutcott-Pugh (CTP) score seven or more 5. either treatment naïve or had used antivirals for less than 3 months duration 6. had detectable HBV DNA (over 50 IU/mL) at the time of start of antiviral.
Cirrhosis will be diagnosed with a combination of evidences on clinical, biochemical, radiological, and endoscopic examination.
First decompensation of cirrhosis will be defined according to the most recent definition given by BAVENO VII consensus guideline. It defines first decompensation by occurrence of either overt ascites (or pleural effusion) with increased serum ascites albumin gradient [over 1.1 g/dl], or overt hepatic encephalopathy (West Haven grade II or more) or variceal bleeding |
|
| ExclusionCriteria |
| Details |
a. prior use of antivirals for >3 months
b. suspected or confirmed hepatocellular carcinoma
c. hepatitis C virus viremia
d. HIV coinfection
e. active alcohol intake (>30 g for men and 20 g for women daily)
f. concomitant hepatobiliary disease
g. use of immunosuppressive medication, regardless of dose, indication, and drug
h. present or prior malignancy, regardless of its site, nature, and stage
i. pre-existing chronic kidney disease, regardless of its etiology, with eGFR <50 ml
j. Hepatorenal syndrome
k. acute on chronic liver failure |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare the proportion of participants achieveing a ‘composite primary end point’ (further decompensation or hepatocellular carcinoma or liver related death) in 12 months of follow-up. |
12 months from the time of start of entecavir after inclusion in our study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare the proportion of participants who could achieve complete viral suppression (HBV DNA 50 IU/mL) |
12 months from the time of start of entecavir after inclusion in our study |
| Compare the mean reduction in HBV DNA level |
at 3, 6, 9, & 12 months from the time of start of entecavir after inclusion in our study |
| Proportion of HBeAg positive participants who could seroconvert to HBeAg negative status |
12 months from the time of start of entecavir after inclusion in our study |
|
|
Target Sample Size
|
Total Sample Size="390"
Sample Size from India="390"
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)
|
01/07/2025 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
Modification(s)
|
Chronic HBV infection is treated with 0.5 mg entecavir once daily. However, those with decompensated cirrhosis are treated with 1.0 mg entecavir daily. There is no justification or literature to support 1.0 mg entecavir in treatment naïve decompensated cirrhosis. Our hypothesis is that the entecavir use in a higher dose of 1.0 mg in unlikely to improve the clinical outcomes. In our pilot study, we compared the viral suppression achieved with 0.5 mg versus 1.0 mg doses of entecavir in treatment naïve HBV decompensated cirrhosis and showed that the higher dose of entecavir did not hasten the viral suppression. Our study had limitations of nonrandomized study design, small sample size, short follow up of 24 weeks, and failure to include clinically relevant outcomes. In our proposed multicentric, pragmatic, randomized, controlled, equivalence trial of 390 adult participants with HBV related decompensated cirrhosis, will randomize them in 0.5 or 1.0 mg arms, and follow for 12 months to study the following outcomes. Primary objective is to compare the proportion of participants who reach a composite primary end point further decompensation as defined by EASL or hepatocellular carcinoma or liver related death. Secondary outcomes are to compare the proportion of viremic participants who could achieve complete viral suppression, mean reduction in HBV DNA level at various time point during 12 months of treatment, and proportion of HBeAg positive participants who could lose HBeAg. |