Chronic Hepatitis BNCT01243281
Pegylated Interferon Alpha-2b Monotherapy Versus Combination With Entecavir in HBeAg-negative Chronic Hepatitis B
A study testing PEG-IFN and entecavir in people with Chronic Hepatitis B, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
The outcome of treatment of chronic hepatitis B is determined by viral and host interaction, thus the combination therapy of immunomodulator (PEG-IFN) and potent antiviral drug (entecavir) should improve the response rate. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- PEG-IFN and entecavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2011to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women 18 to 65 years of age
- Patients with HBeAg-negative chronic hepatitis B
- Positive for HBsAg for at least 6 months, negative for anti-HBs and HBeAg
- Serum HBV DNA levels ≥ 2,000 IU/mL at screening
- Increased alanine aminotransferase (ALT) levels [greater than the upper limit of normal (ULN) and less than 10xULN}
- No signs or symptoms of advanced liver disease
- Patient has had a liver biopsy within 1 year of screening
Who cannot join
- Patient had previous treatment with IFN, peg-IFN, and/or entecavir
- Patient has evidence or history of chronic hepatitis not caused by HBV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis
- Patient has co-infection with hepatitis C virus and/or human immunodeficiency virus
- Patients with liver cancer
- Female patient is pregnant, lactating, expecting to conceive or donate eggs, or is of childbearing potential throughout treatment.
- Patient has any other condition that is contraindicated for treatment with PEG-IFN or entecavir
- Patient has any condition or pre-study laboratory abnormality, or history of any illness, which in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drug
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Chulalongkorn University
Bangkok, 10330
Pisit Tangkijvanich, M.D., +662-256-4482, pisittkvn@yahoo.com
Pisit Tangkijvanich, M.D.
About this study
Official title: A Randomized Design Study to Compare the Efficacy of Pegylated Interferon Alpha-2b Monotherapy Versus Combination With Entecavir in HBeAg-negative Chronic Hepatitis B: Role of Host and Viral Factors Associated With Treatment Response
The outcome of treatment of chronic hepatitis B is determined by viral and host interaction, thus the combination therapy of immunomodulator (PEG-IFN) and potent antiviral drug (entecavir) should improve the response rate. In addition, the simultaneous assessment of viral and host genetic factors associated with SVR may help to identify predictors of treatment outcomes, which will in turn significant reduce the cost/effect of therapy
- Conditions
- Chronic Hepatitis B
- Being tested
- PEG-IFN and entecavir
- Keywords
- hepatitis B, HBeAg, pegylated interferon, entecavir
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-IFN and entecavirDrug
Also called pegintron, baraclude
The patients will be randomized in approximately 1:1 ratio into one of 2 treatment regimens; to receive PEG-IFN alpha-2b (1.5 microgram/kg/week) plus entecavir (0.5 mg/day) or PEG-IFN alpha-2b (1.5 microgram/kg/week) alone for 48 weeks by using pre-generated randomization schedule.
| Study group | Role | What they receive |
|---|---|---|
| drug combination | Active comparator | Not described Receives: Drug: PEG-IFN and entecavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether a combination of PEG-IFN and entecavir improves the rate of sustained response and HBsAg clearance in patients with HBeAg-negative chronic hepatitis B
Measured: 24 weeks post treatment
Secondary outcomes (1)
To determine host factors and viral factors associated with response to PEG-IFN alone or PEG-IFN plus entecavir treatment
Measured: 24 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2010 (estimated)
- Study startMar 2011
- Primary completionMay 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Investigators
- Pisit Tangkijvanich, M.D., Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01243281
- Sponsor's protocol ID
- Biochem2010/01
- Status last verified
- Jun 2011
- First submitted
- 17 Nov 2010
- Last updated
- 28 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Design Study to Compare the Efficacy of Pegylated Interferon Alpha-2b Monotherapy Versus Combination With Entecavir in HBeAg-negative Chronic Hepatitis B: Role of Host and Viral Factors Associated With Treatment Response
- ClinicalTrials.gov ID
- NCT01243281
- Acronym / sponsor ID
- Biochem2010/01
- Conditions
- Chronic Hepatitis B
- Keywords
- hepatitis B, HBeAg, pegylated interferon, entecavir
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- May 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 18 Nov 2010 (estimated)
- 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.
The outcome of treatment of chronic hepatitis B is determined by viral and host interaction, thus the combination therapy of immunomodulator (PEG-IFN) and potent antiviral drug (entecavir) should improve the response rate. In addition, the simultaneous assessment of viral and host genetic factors associated with SVR may help to identify predictors of treatment outcomes, which will in turn significant reduce the cost/effect of therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| drug combination | Active comparator | Drug: PEG-IFN and entecavir |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women 18 to 65 years of age
- Patients with HBeAg-negative chronic hepatitis B
- Positive for HBsAg for at least 6 months, negative for anti-HBs and HBeAg
- Serum HBV DNA levels ≥ 2,000 IU/mL at screening
- Increased alanine aminotransferase (ALT) levels [greater than the upper limit of normal (ULN) and less than 10xULN}
Key exclusion criteria (7 listed)
- Patient had previous treatment with IFN, peg-IFN, and/or entecavir
- Patient has evidence or history of chronic hepatitis not caused by HBV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis
- Patient has co-infection with hepatitis C virus and/or human immunodeficiency virus
- Patients with liver cancer
- Female patient is pregnant, lactating, expecting to conceive or donate eggs, or is of childbearing potential throughout treatment.
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 |
|---|---|---|
| PEG-IFN and entecavirAlso: pegintron, baracludeThe patients will be randomized in approximately 1:1 ratio into one of 2 treatment regimens; to receive PEG-IFN alpha-2b (1.5 microgram/kg/week) plus entecavir (0.5 mg/day) or PEG-IFN alpha-2b (1.5 microgram/kg/week) alone for 48 weeks by using pre-generated randomization schedule. | Drug | drug combination |
Primary outcome
To determine whether a combination of PEG-IFN and entecavir improves the rate of sustained response and HBsAg clearance in patients with HBeAg-negative chronic hepatitis B
Time frame: 24 weeks post treatment
1 secondary outcome
To determine host factors and viral factors associated with response to PEG-IFN alone or PEG-IFN plus entecavir treatment
Time frame: 24 weeks post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2011.
Related trials for Chronic Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingPhase 2
A Study of HT-101 and HT-102 in Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
Active, not recruitingPhase 4
Effectiveness of TAF in Reducing Clinical Events in CHB Patients Beyond Treatment Indications by Current Guidelines
Chronic Hepatitis b
Active, not recruitingPhase 4
Effectiveness of Antiviral Treatment in Cirrhotic Patients With Low-level Hepatitis B Virus DNA Levels
Hepatitis B, Chronic
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. This study is not recruiting at the moment.
Pisit Tangkijvanich, M.D. principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEG-IFN and entecavir in people with Chronic Hepatitis B, run by Chulalongkorn University at 1 site in Thailand.
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 7 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: status not confirmed, as of the sponsor's last update on 28 Jun 2011. 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 Thailand. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pisit Tangkijvanich, M.D. (+662-256-4482, pisittkvn@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine whether a combination of PEG-IFN and entecavir improves the rate of sustained response and HBsAg clearance in patients with HBeAg-negative chronic hepatitis B (time frame: 24 weeks post treatment). 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 28 Jun 2011; AzTrials last refreshed its copy on 6 Nov 2026.