Hepatitis BNCT01599130
Efficacy of Peg-interferon α-2a in Hepatitis B Patients Treated by Entecavir Without HBeAg Loss
A study testing Entecavir and Peginterferon alfa-2a in people with Hepatitis B, run by Sun Yat-sen University at 1 site in China.
Trial summary
For HBeAg (+) hepatitis B patients who have been treated by entecavir for 48 weeks but without HBeAg loss, switching to peg-interferon may increase the response rate. In the investigators study, patients were divided into two groups. In Group A, patients continued entecavir for another 72 weeks. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Entecavir and Peginterferon alfa-2a
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jul 2012to Apr 2014
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 50 years old
- HBsAg(+) and HBeAg(+) for over 6 months before entecavir treatment
- Treated by entacavir for 48 weeks with HBeAg seroconversion
Who cannot join
- Pregnant women
- Decompensated liver disease
- Combination infection of HCV, HAV, or HEV
- Combination infection of HIV
- Any contraindication of interferon α
Trial locations and contacts
1 site in 1 country.
China1 site
The Third Affliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
Yufeng Zhang, master, +862085253333, zhanlianh@163.com
+862085253333
About this study
Official title: The Efficacy of Peg-interferon α-2a in HBeAg (+) Chronic Hepatitis B Patients Who Have Been Treated by Entecavir for 48 Weeks But Without HBeAg Loss
For HBeAg (+) hepatitis B patients who have been treated by entecavir for 48 weeks but without HBeAg loss, switching to peg-interferon may increase the response rate. In the investigators study, patients were divided into two groups. In Group A, patients continued entecavir for another 72 weeks. In Group B, patients switched to peg-interferon-2a monotherapy for 48 weeks, then followed up 24 weeks.
Read the detailed description
For HBeAg positive hepatitis B patients who have been treated by entecavir for 48 weeks but without HBeAg loss, switching to peg-interferon may increase the response rate. In our study, patients without HBeAg loss to 48 weeks entecavir treatment were divided into two groups. In Group A, patients continued entecavir for another 72 weeks. In Group B, patients switched to peg-interferon-2a monotherapy for 48 weeks, then followed up 24 weeks.
- Conditions
- Hepatitis B
- Being tested
- Entecavir, Peginterferon alfa-2a
- Keywords
- Hepatitis B, sequential peg-interferon-2a to 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
Also called Baraclude
entecavir 0.5mg per day
Peginterferon alfa-2aDrug
Also called Pagasys
Peginterferon alfa-2a 180ug per week
| Study group | Role | What they receive |
|---|---|---|
| entecavir | Active comparator | patients continue to use entecavir Receives: Drug: Entecavir |
| peg-interferon | Experimental | patients switch to sequential peg-interferon α-2a Receives: Drug: Peginterferon alfa-2a |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBeAg sericonversion rate
Measured: 72 weeks
Secondary outcomes (6)
HBeAg loss rate
Measured: 72 weeks
HBeAg quantification dynamic change
Measured: 72 weeks
HBsAg loss rate
Measured: 72 weeks
HBsAg seroconversion rate
Measured: 72 weeks
HBsAg quantification dynamic change
Measured: 72 weeks
ALT normalization rate
Measured: 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startJul 2012
- Primary completionApr 2014 (estimated)
- Study completionApr 2014 (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.
- More trials run by Sun Yat-sen 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao zhiliang, Sun Yat-sen University
- Investigators
- Zhiliang Gao, Principal investigator, The Third Affliated Hospital of Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599130
- Sponsor's protocol ID
- Zhangyufeng
- Status last verified
- May 2012
- First submitted
- 8 May 2012
- Last updated
- 15 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Peg-interferon α-2a in HBeAg (+) Chronic Hepatitis B Patients Who Have Been Treated by Entecavir for 48 Weeks But Without HBeAg Loss
- ClinicalTrials.gov ID
- NCT01599130
- Acronym / sponsor ID
- Zhangyufeng
- Conditions
- Hepatitis B
- Keywords
- Hepatitis B, sequential peg-interferon-2a to entecavir
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 15 May 2012 (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.
For HBeAg (+) hepatitis B patients who have been treated by entecavir for 48 weeks but without HBeAg loss, switching to peg-interferon may increase the response rate. In the investigators study, patients were divided into two groups. In Group A, patients continued entecavir for another 72 weeks. In Group B, patients switched to peg-interferon-2a monotherapy for 48 weeks, then followed up 24 weeks.
Detailed description
For HBeAg positive hepatitis B patients who have been treated by entecavir for 48 weeks but without HBeAg loss, switching to peg-interferon may increase the response rate. In our study, patients without HBeAg loss to 48 weeks entecavir treatment were divided into two groups. In Group A, patients continued entecavir for another 72 weeks. In Group B, patients switched to peg-interferon-2a monotherapy for 48 weeks, then followed up 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| entecavir | Active comparator | Drug: Entecavirpatients continue to use entecavir |
| peg-interferon | Experimental | Drug: Peginterferon alfa-2apatients switch to sequential peg-interferon α-2a |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18 and 50 years old
- HBsAg(+) and HBeAg(+) for over 6 months before entecavir treatment
- Treated by entacavir for 48 weeks with HBeAg seroconversion
Key exclusion criteria (5 listed)
- Pregnant women
- Decompensated liver disease
- Combination infection of HCV, HAV, or HEV
- Combination infection of HIV
- Any contraindication of interferon α
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 |
|---|---|---|
| EntecavirAlso: Baracludeentecavir 0.5mg per day | Drug | entecavir |
| Peginterferon alfa-2aAlso: PagasysPeginterferon alfa-2a 180ug per week | Drug | peg-interferon |
Primary outcome
HBeAg sericonversion rate
Time frame: 72 weeks
6 secondary outcomes
HBeAg loss rate
Time frame: 72 weeks
HBeAg quantification dynamic change
Time frame: 72 weeks
HBsAg loss rate
Time frame: 72 weeks
HBsAg seroconversion rate
Time frame: 72 weeks
HBsAg quantification dynamic change
Time frame: 72 weeks
ALT normalization rate
Time frame: 72 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2012.
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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. This study is not recruiting at the moment.
The Third Affliated Hospital of Sun Yat-sen University
Guangzhou, China
Zhiliang Gao principal investigator
The Third Affliated Hospital of Sun Yat-sen 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 Entecavir and Peginterferon alfa-2a in people with Hepatitis B, run by Sun Yat-sen University at 1 site in China.
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 5 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 15 May 2012. 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 China. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBeAg sericonversion rate (time frame: 72 weeks). 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 15 May 2012.