Hepatitis BPhase 4NCT07816094
Comparison of Viral Suppression With 0.5 mg and 1.0 mg Daily Doses of Entecavir in Decompensated HBV Cirrhosis of Liver
A Phase 4 study testing Entecavir in people with Hepatitis B, run by Bangladesh Medical University at 1 site in Bangladesh.
Trial summary
This is a prospective, randomized, open-label clinical trial designed to compare the antiviral efficacy and safety of entecavir 0.5 mg once daily versus entecavir 1.0 mg once daily in adult patients with hepatitis B virus (HBV)-related decompensated liver cirrhosis. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Entecavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Jan 2026to 19 Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 years or older.
- HBV-related decompensated cirrhosis of liver based on clinical, biochemical and radiological evidence.
- Detectable level of HBV DNA irrespective of HBeAg status.
Who cannot join
- Clinical, biochemical, or radiological evidence of hepatocellular carcinoma.
- Coinfection with HCV.
- Patient is ongoing antiviral treatment.
- Cirrhosis due to other causes.
- Acute-on-chronic liver failure, defined according to the criteria established by APASL.
- Pregnancy.
- Patients with known hypersensitivity or allergy to Entecavir.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site, 1 recruiting
- Recruiting
Bangladesh Medical university
Dhaka, Dhaka Division, 1000
Hanif Uddin, MBBS, +8801710099830, mdhanifuddin173@gmail.com
About this study
This is a prospective, randomized, open-label clinical trial designed to compare the antiviral efficacy and safety of entecavir 0.5 mg once daily versus entecavir 1.0 mg once daily in adult patients with hepatitis B virus (HBV)-related decompensated liver cirrhosis. A total of 48 participants will be randomized equally to the two treatment groups and followed for 24 weeks. The primary outcome is the reduction in serum HBV DNA at week 24. Secondary outcomes include changes in Child-Pugh and MELD scores, HBeAg seroconversion, development or worsening of hepatic decompensation, occurrence of hepatocellular carcinoma, and safety of treatment.
- Conditions
- Hepatitis B
- Being tested
- Entecavir
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EntecavirDrug
Participants receive oral Entecavir once daily. The dose is either 0.5 mg or 1.0 mg, according to randomized treatment assignment, 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Entecavir 0.5 mg | Active comparator | Participants receive Entecavir 0.5 mg orally once daily for 24 weeks. Receives: Drug: Entecavir |
| Entecavir 1.0 mg | Active comparator | Participants receive Entecavir 1.0 mg orally once daily for 24 weeks. Receives: Drug: Entecavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum HBV DNA levels
Comparison of the reduction in serum HBV DNA (IU/mL) from baseline to 24 weeks between receiving Entecavir 0.5 mg/day and 1.0 mg/day.
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start1 Jan 2026
- Primary completion19 Jan 2027 (estimated)
- Study completion19 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangladesh Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanif Uddin, Bangladesh Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816094
- Sponsor's protocol ID
- 5933
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Viral Suppression With 0.5 mg and 1.0 mg Daily Doses of Entecavir in Decompensated HBV Cirrhosis of Liver
- ClinicalTrials.gov ID
- NCT07816094
- Acronym / sponsor ID
- 5933
- Conditions
- Hepatitis B
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Bangladesh Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 19 Jan 2027 (estimated)
- Study completion
- 19 Jan 2027 (estimated)
- First posted
- 11 Sep 2026 (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.
This is a prospective, randomized, open-label clinical trial designed to compare the antiviral efficacy and safety of entecavir 0.5 mg once daily versus entecavir 1.0 mg once daily in adult patients with hepatitis B virus (HBV)-related decompensated liver cirrhosis. A total of 48 participants will be randomized equally to the two treatment groups and followed for 24 weeks. The primary outcome is the reduction in serum HBV DNA at week 24. Secondary outcomes include changes in Child-Pugh and MELD scores, HBeAg seroconversion, development or worsening of hepatic decompensation, occurrence of hepatocellular carcinoma, and safety of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Entecavir 0.5 mg | Active comparator | Drug: EntecavirParticipants receive Entecavir 0.5 mg orally once daily for 24 weeks. |
| Entecavir 1.0 mg | Active comparator | Drug: EntecavirParticipants receive Entecavir 1.0 mg orally once daily for 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 18 years or older.
- HBV-related decompensated cirrhosis of liver based on clinical, biochemical and radiological evidence.
- Detectable level of HBV DNA irrespective of HBeAg status.
Key exclusion criteria (7 listed)
- Clinical, biochemical, or radiological evidence of hepatocellular carcinoma.
- Coinfection with HCV.
- Patient is ongoing antiviral treatment.
- Cirrhosis due to other causes.
- Acute-on-chronic liver failure, defined according to the criteria established by APASL.
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 |
|---|---|---|
| EntecavirParticipants receive oral Entecavir once daily. The dose is either 0.5 mg or 1.0 mg, according to randomized treatment assignment, 24 weeks. | Drug | Entecavir 0.5 mg, Entecavir 1.0 mg |
Primary outcome
Change in Serum HBV DNA levels
Time frame: Baseline to Week 24
Comparison of the reduction in serum HBV DNA (IU/mL) from baseline to 24 weeks between receiving Entecavir 0.5 mg/day and 1.0 mg/day.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Entecavir in people with Hepatitis B, run by Bangladesh Medical University at 1 site in Bangladesh.
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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 11 Sep 2026. 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 Bangladesh. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hanif Uddin, MBBS (+8801710099830, mdhanifuddin173@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum HBV DNA levels (time frame: Baseline to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2026.