Chronic Hepatitis BPhase 3NCT01769833
HBsAg Decline After Pegylated-interferon-α in e Antigen Positive Chronic Hepatitis B With Nucleoside Maintenance
A Phase 3 study testing PEG-interferon-Alfa-2A and Nucleosides in people with Chronic Hepatitis B, run by Pusan National University Hospital at 1 site in South Korea.
Trial summary
This study proposes to compare the effect of 48 weeks exposure to pegylated interferon alpha vs. nucleoside analogue (NA) on hepatitis B e antigen (HBeAg) seroconversion and HBsAg levels in nucleoside analogue controlled HBeAg-positive chronic hepatitis B (CHB) patients who have an undetectable hepatitis B virus (HBV)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- PEG-interferon-Alfa-2A and Nucleosides
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2013to May 2016
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent
- Age over 20 years
- HBeAg-positive CHB patients
- Patients treated with all available nucleoside analogue monotherapy or combination in Korea except telbivudine ( e.g.entecavir monotherapy or lamivudine/adefovir combination , lamivudine, adefovir monotherapy) for ≥ 18months and patients who have undetectable HBV viral load at least one year HBV DNA undetectable (≤ 400 copies/ml ) Serum alanine transferase: ≤ 10 X upper limit of normal (ULN) Baseline HBsAg: ≥ 102 IU/ml
- Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug. Additionally, all fertile males with partners of childbearing age and females must be using reliable contraception during the study and for 3 months after treatment completion.
- Obtaining written informed consent form
Who cannot join
- Decompensated cirrhosis or other contraindications to interferon alfa 2a therapy following local label.
- Concomitant or prior use of telbivudine.
- Positive test at screening for hepatitis A virus immunoglobulin M Ab, Hepatitis C virus-RNA or hepatitis C virus Ab, hepatitis delta virus Ab or HIV Ab.
- Diagnosed hepatic cellular carcinoma
- Any evidence of decompensated liver disease (Childs B-C)
- History or other evidence of a medical condition associated with chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures, thalassemia).
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- Women with ongoing pregnancy or who are breast feeding.
- Evidence of alcohol and/or drug abuse within one year of entry.
- History of major organ transplantation with an existing functional graft.
- Inability or unwillingness to provide informed consent or abide by the requirements of the study.
- History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study.
- Patients with a value of alpha-fetoprotein >100 ng/mL are excluded, unless stability (less than 10% increase) has been documented over at least the previous 3 months.
- patients having hypersensitivities for peginterferon alfa-2a or NAs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HBsAg Decline and HBeAg Seroconversion Following 48 Weeks Peg-interferon-α Treatment in Patients With e Antigen Positive Chronic Hepatitis B After Nucleoside Analogue Maintenance Therapy Compared to Continuing Nucleoside Analogue Treatment
This study proposes to compare the effect of 48 weeks exposure to pegylated interferon alpha vs. nucleoside analogue (NA) on hepatitis B e antigen (HBeAg) seroconversion and HBsAg levels in nucleoside analogue controlled HBeAg-positive chronic hepatitis B (CHB) patients who have an undetectable hepatitis B virus (HBV) viral load at least 1 years.
Read the detailed description
Pegylated interferon after long term NA therapy will potentiate the antiviral efficacy directly via its effect on broad antiviral activities and indirectly via activation of innate and adaptive immune responses leading to HBeAg seroconversion and eventually HBsAg loss and/or seroconversion.
This study proposes to compare the effect of 48 weeks exposure to pegylated interferon alpha vs. NA on HBeAg seroconversion and HBsAg levels in NA controlled HBeAg-positive CHB patients who have an undetectable HBV viral load at least 1 years.
- Conditions
- Chronic Hepatitis B
- Being tested
- PEG-interferon-Alfa-2A, Nucleosides
- Keywords
- HBsAg, Chronic hepatitis B, PEGinterferon Alfa-2A
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-interferon-Alfa-2ADrug
Also called Pegasys (PEG-interferon-Alfa-2A)
Pegasys ( PEG-interferon-Alfa-2A) 180mcg / subcutaneous / once-weekly
NucleosidesDrug
| Study group | Role | What they receive |
|---|---|---|
| PEG-interferon-alfa 2A | Active comparator | PEG-interferon-alfa 2A Receives: Drug: PEG-interferon-Alfa-2A |
| Nucleosides | Placebo comparator | Nucleosides Receives: Drug: Nucleosides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in log10 HBsAg titer during antiviral therapy
To evaluate whether pegylated-IFNα2a treatment lowers HBsAg levels and eventually leads to HBsAg loss in patients after long term NA therapy compared to continuing NA treatment.
Measured: 48 week
Secondary outcomes (5)
HBV DNA undetectability and below 400 IU/mL during antiviral therapy and follow-up
Measured: 48 week, 96 week
HBeAg seroconversion and loss during antiviral therapy and at end of treatment and 1 and 2 years following end of treatment
Measured: 48 week, 96 week
HBsAg loss and HBsAg seroconversion at end of treatment and 1 and 2 years following end of treatment
Measured: 48 week, 96 week
Change in log10 HBsAg titer during follow-up
Measured: 48 week, 96 week
Mean change in log10 HBsAg titre over time, as estimated from the area between the baseline value and the curve of log10 HBsAg titre divided by the duration of treatment
Measured: 48 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2015 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeong Heo, Dr, Principal investigator, Pusan National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769833
- Sponsor's protocol ID
- ML25659
- Status last verified
- Nov 2014
- First submitted
- 15 Jan 2013
- Last updated
- 4 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Woo HY, Heo J, Tak WY, Lee HJ, Chung WJ, Park JG, Park SY, Park YJ, Lee YR, Hwang JS, Kweon YO. Effect of switching from nucleos(t)ide maintenance therapy to PegIFN alfa-2a in patients with HBeAg-positive chronic hepatitis B: A randomized trial. PLoS One. 2022 Jul 22;17(7):e0270716. doi: 10.1371/journal.pone.0270716. eCollection 2022.
PubMed 35867702
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HBsAg Decline and HBeAg Seroconversion Following 48 Weeks Peg-interferon-α Treatment in Patients With e Antigen Positive Chronic Hepatitis B After Nucleoside Analogue Maintenance Therapy Compared to Continuing Nucleoside Analogue Treatment
- ClinicalTrials.gov ID
- NCT01769833
- Acronym / sponsor ID
- ML25659
- Conditions
- Chronic Hepatitis B
- Keywords
- HBsAg, Chronic hepatitis B, PEGinterferon Alfa-2A
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 17 Jan 2013 (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.
This study proposes to compare the effect of 48 weeks exposure to pegylated interferon alpha vs. nucleoside analogue (NA) on hepatitis B e antigen (HBeAg) seroconversion and HBsAg levels in nucleoside analogue controlled HBeAg-positive chronic hepatitis B (CHB) patients who have an undetectable hepatitis B virus (HBV) viral load at least 1 years.
Detailed description
Pegylated interferon after long term NA therapy will potentiate the antiviral efficacy directly via its effect on broad antiviral activities and indirectly via activation of innate and adaptive immune responses leading to HBeAg seroconversion and eventually HBsAg loss and/or seroconversion.
This study proposes to compare the effect of 48 weeks exposure to pegylated interferon alpha vs. NA on HBeAg seroconversion and HBsAg levels in NA controlled HBeAg-positive CHB patients who have an undetectable HBV viral load at least 1 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG-interferon-alfa 2A | Active comparator | Drug: PEG-interferon-Alfa-2APEG-interferon-alfa 2A |
| Nucleosides | Placebo comparator | Drug: NucleosidesNucleosides |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed consent
- Age over 20 years
- HBeAg-positive CHB patients
- Patients treated with all available nucleoside analogue monotherapy or combination in Korea except telbivudine ( e.g.entecavir monotherapy or lamivudine/adefovir combination , lamivudine, adefovir monotherapy) for ≥ 18months and patients who have undetectable HBV viral load at least one year HBV DNA undetectable (≤ 400 copies/ml ) Serum alanine transferase: ≤ 10 X upper limit of normal (ULN) Baseline HBsAg: ≥ 102 IU/ml
- Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug. Additionally, all fertile males with partners of childbearing age and females must be using reliable contraception during the study and for 3 months after treatment completion.
Key exclusion criteria (13 listed)
- Decompensated cirrhosis or other contraindications to interferon alfa 2a therapy following local label.
- Concomitant or prior use of telbivudine.
- Positive test at screening for hepatitis A virus immunoglobulin M Ab, Hepatitis C virus-RNA or hepatitis C virus Ab, hepatitis delta virus Ab or HIV Ab.
- Diagnosed hepatic cellular carcinoma
- Any evidence of decompensated liver disease (Childs B-C)
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-interferon-Alfa-2AAlso: Pegasys (PEG-interferon-Alfa-2A)Pegasys ( PEG-interferon-Alfa-2A) 180mcg / subcutaneous / once-weekly | Drug | PEG-interferon-alfa 2A |
| Nucleosides | Drug | Nucleosides |
Primary outcome
Change in log10 HBsAg titer during antiviral therapy
Time frame: 48 week
To evaluate whether pegylated-IFNα2a treatment lowers HBsAg levels and eventually leads to HBsAg loss in patients after long term NA therapy compared to continuing NA treatment.
5 secondary outcomes
HBV DNA undetectability and below 400 IU/mL during antiviral therapy and follow-up
Time frame: 48 week, 96 week
HBeAg seroconversion and loss during antiviral therapy and at end of treatment and 1 and 2 years following end of treatment
Time frame: 48 week, 96 week
HBsAg loss and HBsAg seroconversion at end of treatment and 1 and 2 years following end of treatment
Time frame: 48 week, 96 week
Change in log10 HBsAg titer during follow-up
Time frame: 48 week, 96 week
Mean change in log10 HBsAg titre over time, as estimated from the area between the baseline value and the curve of log10 HBsAg titre divided by the duration of treatment
Time frame: 48 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2014.
- Derived from this study: PubMed 35867702Woo HY, Heo J, Tak WY, Lee HJ, Chung WJ, Park JG, Park SY, Park YJ, Lee YR, Hwang JS, Kweon YO. Effect of switching from nucleos(t)ide maintenance therapy to PegIFN alfa-2a in patients with HBeAg-positive chronic hepatitis B: A randomized trial. PLoS One. 2022 Jul 22;17(7):e0270716. doi: 10.1371/journal.pone.0270716. eCollection 2022.
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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.
Jeong Heo, Dr principal investigator
Pusan National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PEG-interferon-Alfa-2A and Nucleosides in people with Chronic Hepatitis B, run by Pusan National University Hospital at 1 site in South Korea.
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 6 inclusion and 13 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 4 Nov 2014. 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 South Korea. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in log10 HBsAg titer during antiviral therapy (time frame: 48 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01769833, which also lists 1 linked publication.
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 4 Nov 2014.