Chronic Hepatitis BPhase 4NCT02822547
Study on Treatment of Pegylated Interferon Alfa 2a(Pegasys®) in the Korean Chronic Hepatitis B(CHB) Adults
A Phase 4 study testing Peginterferon alfa-2a in people with Chronic Hepatitis B, run by Yonsei University at 1 site in South Korea.
Trial summary
Patients will receive Peginterferon alfa-2a according to the standard medical practice but the observation period is 12 weeks Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Peginterferon alfa-2a
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 253 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2015to Dec 2016
- Phase
- Phase 4
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of HBsAg positive for more than 6 months
- HBeAg-positive or HBeAg-negative within 8 weeks
- Serum AST or ALT ≥ 80 IU/L
- HBe-Ag positive patients: Serum HBV DNA ≥ 1.0 X 10^5 copies/mL (or 20,000 IU/mL)
- HBeAg-negative patients: serum HBV DNA ≥ 1.0 X 10^4 copies/mL(or 2,000 IU/mL)
Who cannot join
- History of antiviral therapy for Chronic hepatitis B within 6 months of study enrollment
- Prior treatment of interferon
- Presence of viral coinfections (hepatitis C, hepatitis delta, or human immunodeficiency virus)
- Other chronic liver disease or decompensated liver disease
- platelet<90,000/mm3 or absolute neutrophil count < 1,500 mm3
- Pregnant or lactating woman
- History of Organ transplantation
- Treatment with immunosuppressive/immunomodulatory agents within 6 months prior to study entry
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital
Seoul, Seoul, 120-752
Sang Hoon Ahn, M.D.Ph.D, +82-11-419-8087, ahnsh@yuhs.ac
Jun Yong Park, M.D, +82-10-8353-0670, drpjy@yuhs.ac
About this study
Official title: Study to Identify Eligible Subjects Using Response Guided Therapy-Stopping Rule for Treatment of Pegylated Interferon Alfa 2a(Pegasys®) in the Korean Chronic Hepatitis B(CHB) Adults.
Patients will receive Peginterferon alfa-2a according to the standard medical practice but the observation period is 12 weeks
- Conditions
- Chronic Hepatitis B
- Being tested
- 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.
Peginterferon alfa-2aDrug
Patients will receive Peginterferon alfa-2a according to the standard medical practice
| Study group | Role | What they receive |
|---|---|---|
| Peginterferon alfa-2a | Experimental | Not described Receives: Drug: Peginterferon alfa-2a |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion subjects with HBsAg ≤ 20,000 IU/mL at 12 week treatment of PEG-IFN in HBeAg-positive Chronic Hepatitis B
Measured: 12 week from baseline
The proportion subjects with any decline of HBsAg and/or HBV DNA decline more than 2 log copies/ml at 12 week treatment of PEG-IFN in HBeAg-negative CHB
Measured: 12 week from baseline
Secondary outcomes (4)
The change of HBV DNA at Week 12 from baseline
Measured: 12 week from baseline
The change of HBsAg at Week 4, 8, 12 from baseline
Measured: 4, 8, 12 week from baseline
The change of ALT at week 4, 8, 12 from baseline
Measured: 4, 8, 12 week from baseline
The proportion of HBV DNA undetectable level (< 60 IU/mL, approximately 300 copies/mL) at week 12
Measured: 12 week from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study startMar 2015
- Primary completionSep 2016 (estimated)
- Study completionDec 2016 (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 Yonsei 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 253 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Principal investigator, Sang Hoon Ahn, Yonsei University
- Investigators
- Sang Hoon Ahn, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02822547
- Sponsor's protocol ID
- ML29378
- Status last verified
- Jun 2016
- First submitted
- 30 Jun 2016
- Last updated
- 4 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Identify Eligible Subjects Using Response Guided Therapy-Stopping Rule for Treatment of Pegylated Interferon Alfa 2a(Pegasys®) in the Korean Chronic Hepatitis B(CHB) Adults.
- ClinicalTrials.gov ID
- NCT02822547
- Acronym / sponsor ID
- ML29378
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 253 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Mar 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 4 Jul 2016 (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.
Patients will receive Peginterferon alfa-2a according to the standard medical practice but the observation period is 12 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peginterferon alfa-2a | Experimental | Drug: Peginterferon alfa-2a |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- History of HBsAg positive for more than 6 months
- HBeAg-positive or HBeAg-negative within 8 weeks
- Serum AST or ALT ≥ 80 IU/L
- HBe-Ag positive patients: Serum HBV DNA ≥ 1.0 X 10^5 copies/mL (or 20,000 IU/mL)
- HBeAg-negative patients: serum HBV DNA ≥ 1.0 X 10^4 copies/mL(or 2,000 IU/mL)
Key exclusion criteria (8 listed)
- History of antiviral therapy for Chronic hepatitis B within 6 months of study enrollment
- Prior treatment of interferon
- Presence of viral coinfections (hepatitis C, hepatitis delta, or human immunodeficiency virus)
- Other chronic liver disease or decompensated liver disease
- platelet<90,000/mm3 or absolute neutrophil count < 1,500 mm3
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 |
|---|---|---|
| Peginterferon alfa-2aPatients will receive Peginterferon alfa-2a according to the standard medical practice | Drug | Peginterferon alfa-2a |
Primary outcome
The proportion subjects with HBsAg ≤ 20,000 IU/mL at 12 week treatment of PEG-IFN in HBeAg-positive Chronic Hepatitis B
Time frame: 12 week from baseline
The proportion subjects with any decline of HBsAg and/or HBV DNA decline more than 2 log copies/ml at 12 week treatment of PEG-IFN in HBeAg-negative CHB
Time frame: 12 week from baseline
4 secondary outcomes
The change of HBV DNA at Week 12 from baseline
Time frame: 12 week from baseline
The change of HBsAg at Week 4, 8, 12 from baseline
Time frame: 4, 8, 12 week from baseline
The change of ALT at week 4, 8, 12 from baseline
Time frame: 4, 8, 12 week from baseline
The proportion of HBV DNA undetectable level (< 60 IU/mL, approximately 300 copies/mL) at week 12
Time frame: 12 week from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2016.
- Individual participant dataSharing planned: No
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Chronic Hepatitis B
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.
Sang Hoon Ahn principal investigator
Severance Hospital
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 Peginterferon alfa-2a in people with Chronic Hepatitis B, run by Yonsei University 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 5 inclusion and 8 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 Jul 2016. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sang Hoon Ahn (82-2-2228-1936, ahnsh@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion subjects with HBsAg ≤ 20,000 IU/mL at 12 week treatment of PEG-IFN in HBeAg-positive Chronic Hepatitis B (time frame: 12 week from baseline). The study lists 2 primary outcomes in all. 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 4 Jul 2016.