Hepatitis B, ChronicPhase 4S-RGTNCT01456312
HBsAg Related Response Guided Therapy
A Phase 4 study testing Peginterferon alfa-2a and Entecavir in people with Hepatitis B, Chronic, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
Primary objective: Compare Pegasys RGT overall response rate (i.e., HBeAg seroconversion rate) with Pegasys mono historical response rate at week 72 (48 week treatment with 24 week follow up) Secondary objective : The changes of HBsAg titer The rate of combined HBeAg seroconversion and HBV DNA < 300 copies/mL The rate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- Peginterferon alfa-2a and Entecavir
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2012to Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Positive HBsAg for more than 6 months, positive HBeAg, detectable HBV DNA(patients must have > 100,000 copies/ml as measured by PCR) and anti-HBs negative
- Elevated serum ALT > 2ULN but ≤ 10 × ULN as determined by two abnormal values taken ≥ 14 days apart during the six months before the first dose of study drug with at least one of the determinations obtained ≤ 35 days prior to the first dose.
Who cannot join
- Patients must not have received antiviral therapy for their chronic hepatitis B. Patients who are expected to need systemic antiviral therapy other than that provided by the study at any time during their participation in the study are also excluded. Exception: patients who have had less than 6 months treatment of NA(Nucleos(t)ide analog) and more than 1 year wash-out period for systemic antiviral therapy and negative results in the NA resistance test at baseline are not excluded.
- Positive test at screening for HAV IgM Ab, HCV-RNA or HCV Ab, HDV Ab or HIV Ab.
- Diagnosed hepatic cellular carcinoma
- Any evidence of decompensated liver disease (Childs B-C)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Shinchon Severance Hospital
Seoul, Seoul, 120742
Sanghoon Ahn, professor, 82-2-2228-1936, ahnsh@yuhs.ac
Sanhoon Ahn, Professor
About this study
Official title: A Multi Center, Phase IIIb Study to Evaluate the Efficacy of Response Guided Therapy Using Quantitative HBsAg Measurement in Patient With HBeAg Positive Chronic Hepatitis B:
Primary objective: Compare Pegasys RGT overall response rate (i.e., HBeAg seroconversion rate) with Pegasys mono historical response rate at week 72 (48 week treatment with 24 week follow up)
Secondary objective :
- The changes of HBsAg titer
- The rate of combined HBeAg seroconversion and HBV DNA < 300 copies/mL
- The rate of serum HBV DNA < 300 copies/mL ⅳ. The rate of ALT normalization
- The rate of HBsAg loss ⅵ. The rate of serum HBV DNA < 10,000 copies/mL
Read the detailed description
After 12w treatment of Pegasys, depends on results of quantitative HBsAg test, Patients will be allocated to one of three groups.
- HBsAg >20,000 : study termination
- Group A :1,500<HBsAg≤ 20,000
- Group B : .HBsAg ≤ 1500 At week 48, according to HbeAg seroconversion, patients will be allocated to one of two sub-groups(A-1, A-2, B-1, B-2) Patients are seen for evaluation at treatment weeks 4,8,12,24,36,48. Post-treatment assessments will be performed at 4,12 and 24 week during off-treatment phase for the assessment of the primary and main secondary endpoints of the study.
- Conditions
- Hepatitis B, Chronic
- Being tested
- Peginterferon alfa-2a, Entecavir
- Keywords
- Peginterferon alfa 2a, Entecavir, Response Guided Therapy, Chronic Hepatitis B
- 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
Also called Pegasys
Duration and combination
EntecavirDrug
Also called Baraclude Tab
combination
| Study group | Role | What they receive |
|---|---|---|
| HBsAg quantification>20,000 IU/ml | Sham comparator | stop peginterferon alfa 2a if patients reach HBsAg quantification>20,000 Iu/ml at 12w Receives: Drug: Peginterferon alfa-2a |
| HBsAg<=1500IU/ml | Sham comparator | extend peginterferon alfa 2a until 48weeks Receives: Drug: Peginterferon alfa-2a |
| HBsAg >1500 <=20,000 IU/ML | Sham comparator | add Entecavir for 12w with peginterferon alfa 2a then, extend peginterferon alfa 2a until 48w Receives: Drug: Peginterferon alfa-2a; Drug: Entecavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBeAg seroconversion
Measured: 24 weeks post treatment follow up
Secondary outcomes (1)
The changes of HBsAg titer
Measured: baseline and 24weeks post treatment follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startSep 2012
- Primary completionFeb 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Principal investigator, Kwan Sik Lee, Gangnam Severance Hospital
- Investigators
- Kwansik Lee, professor, Study chair, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01456312
- Sponsor's protocol ID
- ML25588
- Acronym
- S-RGT
- Status last verified
- Oct 2012
- First submitted
- 15 Oct 2011
- Last updated
- 31 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi Center, Phase IIIb Study to Evaluate the Efficacy of Response Guided Therapy Using Quantitative HBsAg Measurement in Patient With HBeAg Positive Chronic Hepatitis B:
- ClinicalTrials.gov ID
- NCT01456312
- Acronym / sponsor ID
- S-RGT / ML25588
- Conditions
- Hepatitis B, Chronic
- Keywords
- Peginterferon alfa 2a, Entecavir, Response Guided Therapy, Chronic Hepatitis B
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Sep 2012
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 20 Oct 2011 (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.
Primary objective: Compare Pegasys RGT overall response rate (i.e., HBeAg seroconversion rate) with Pegasys mono historical response rate at week 72 (48 week treatment with 24 week follow up)
Secondary objective :
- The changes of HBsAg titer
- The rate of combined HBeAg seroconversion and HBV DNA < 300 copies/mL
- The rate of serum HBV DNA < 300 copies/mL ⅳ. The rate of ALT normalization
- The rate of HBsAg loss ⅵ. The rate of serum HBV DNA < 10,000 copies/mL
Detailed description
After 12w treatment of Pegasys, depends on results of quantitative HBsAg test, Patients will be allocated to one of three groups.
- HBsAg >20,000 : study termination
- Group A :1,500<HBsAg≤ 20,000
- Group B : .HBsAg ≤ 1500 At week 48, according to HbeAg seroconversion, patients will be allocated to one of two sub-groups(A-1, A-2, B-1, B-2) Patients are seen for evaluation at treatment weeks 4,8,12,24,36,48. Post-treatment assessments will be performed at 4,12 and 24 week during off-treatment phase for the assessment of the primary and main secondary endpoints of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HBsAg quantification>20,000 IU/ml | Sham comparator | Drug: Peginterferon alfa-2astop peginterferon alfa 2a if patients reach HBsAg quantification>20,000 Iu/ml at 12w |
| HBsAg<=1500IU/ml | Sham comparator | Drug: Peginterferon alfa-2aextend peginterferon alfa 2a until 48weeks |
| HBsAg >1500 <=20,000 IU/ML | Sham comparator | Drug: Peginterferon alfa-2a, Drug: Entecaviradd Entecavir for 12w with peginterferon alfa 2a then, extend peginterferon alfa 2a until 48w |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Positive HBsAg for more than 6 months, positive HBeAg, detectable HBV DNA(patients must have > 100,000 copies/ml as measured by PCR) and anti-HBs negative
- Elevated serum ALT > 2ULN but ≤ 10 × ULN as determined by two abnormal values taken ≥ 14 days apart during the six months before the first dose of study drug with at least one of the determinations obtained ≤ 35 days prior to the first dose.
Key exclusion criteria (4 listed)
- Patients must not have received antiviral therapy for their chronic hepatitis B. Patients who are expected to need systemic antiviral therapy other than that provided by the study at any time during their participation in the study are also excluded. Exception: patients who have had less than 6 months treatment of NA(Nucleos(t)ide analog) and more than 1 year wash-out period for systemic antiviral therapy and negative results in the NA resistance test at baseline are not excluded.
- Positive test at screening for HAV IgM Ab, HCV-RNA or HCV Ab, HDV 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 |
|---|---|---|
| Peginterferon alfa-2aAlso: PegasysDuration and combination | Drug | HBsAg >1500 <=20,000 IU/ML, HBsAg quantification>20,000 IU/ml, HBsAg<=1500IU/ml |
| EntecavirAlso: Baraclude Tabcombination | Drug | HBsAg >1500 <=20,000 IU/ML |
Primary outcome
HBeAg seroconversion
Time frame: 24 weeks post treatment follow up
1 secondary outcome
The changes of HBsAg titer
Time frame: baseline and 24weeks post treatment follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 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.
Kwansik Lee, professor study chair
Gangnam 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 and Entecavir in people with Hepatitis B, Chronic, run by Gangnam Severance 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 3 inclusion and 4 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 31 Oct 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 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 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 Kwansik Lee, professor (+82 11 9636 9935, leeks519@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBeAg seroconversion (time frame: 24 weeks post treatment follow up). 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 31 Oct 2012.