Hepatitis B, ChronicPhase 4NCT01086085
A Study of Peginterferon Alfa-2a [PEGASYS] in Patients With Chronic Hepatitis B Who Are HBeAg Positive
A Phase 4 study testing Adefovir and peginterferon alfa-2a [PEGASYS] in people with Hepatitis B, Chronic, run by Hoffmann-La Roche at 11 sites in China.
Trial summary
This open-label, multi-center study will evaluate the effect on the quantitative HBsAg reduction of peginterferon alfa-2a [PEGASYS] in patients with HBeAg positive chronic hepatitis B. Patients will receive PEGASYS 180 mcg sc once weekly. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- Adefovir and peginterferon alfa-2a [PEGASYS]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 265 participants
- Where
- 11 sitesChina
- Study dates
- Apr 2010to Mar 2013
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients >/=18 years of age
- HBeAg positive chronic hepatitis B
- Compensated liver disease
Who cannot join
- Patients who had previously received treatment of drugs with activity against HBV within 6 months prior to study start
- Antiviral, anti-neoplastic or immunomodulatory treatment
- Co-infection with active hepatitis A, hepatitis C, hepatitis D, or HIV
- Evidence of decompensated liver disease
- Chronic liver disease other than viral hepatitis
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites
Study site
Beijing, 100011
Study site
Beijing, 100034
Study site
Beijing, 100044
Study site
Beijing, 100050
Study site
Changchun, 130021
Study site
Guangzhou, 510515
Study site
Shanghai, 200025
Study site
Shanghai, 200040
Study site
Shanghai, 200433
Study site
Wuhan, 430030
Study site
Xi'an, 710038
About this study
Official title: A Study on Optimizing the Treatment in HBeAg Positive CHB Patients With Response Guide Treatment (RGT) Method.
This open-label, multi-center study will evaluate the effect on the quantitative HBsAg reduction of peginterferon alfa-2a [PEGASYS] in patients with HBeAg positive chronic hepatitis B. Patients will receive PEGASYS 180 mcg sc once weekly. After 24 weeks of treatment, rapid responders will receive another 24 weeks of treatment. After 24 weeks of treatment, slow responders will be randomized to another 24 or 72 weeks of PEGASYS monotherapy, or to 72 weeks PEGASYS plus 36 weeks adefovir (10 mg, po once daily, starting from week 29 of PEGASYS treatment). The anticipated time on study drug is >2 years.
- Conditions
- Hepatitis B, Chronic
- Being tested
- Adefovir, peginterferon alfa-2a [PEGASYS]
- 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.
AdefovirDrug
Adefovir 10 mg po once daily for 36 weeks
peginterferon alfa-2a [PEGASYS]Drug
Early responders: PEGASYS 180 mcg sc once weekly for 48 weeks
peginterferon alfa-2a [PEGASYS]Drug
Non-early responders: PEGASYS 180 mcg sc once weekly for 48 weeks
peginterferon alfa-2a [PEGASYS]Drug
Non-early responders: PEGASYS 180 mcg sc once weekly for 96 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: peginterferon alfa-2a [PEGASYS] |
| B | Experimental | Not described Receives: Drug: peginterferon alfa-2a [PEGASYS] |
| C | Experimental | Not described Receives: Drug: peginterferon alfa-2a [PEGASYS] |
| D | Experimental | Not described Receives: Drug: Adefovir; Drug: peginterferon alfa-2a [PEGASYS] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Quantitative HBsAG reduction (proportion of patients with HBsAG reduction)
Measured: Weeks 72, 96, 120
Secondary outcomes (2)
Proportion of patients achieving HBeAG seroconversion and HBV DNA </=100000 copies/ml
Measured: Weeks 24, 48, 72, 96, 120
Safety: Adverse Events
Measured: From baseline to Week 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionMar 2013
- Study completionMar 2013
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 Hepatitis B, ChronicStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Major Science and Technology Special Project of China Eleventh Five-year
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01086085
- Sponsor's protocol ID
- ML22266
- Status last verified
- Nov 2016
- First submitted
- 11 Mar 2010
- Last updated
- 2 Nov 2016
- Results posted
- No
Publications
Sun J, Ma H, Xie Q, Xie Y, Sun Y, Wang H, Shi G, Wan M, Niu J, Ning Q, Yu Y, Zhou H, Cheng J, Kang W, Xie Y, Fan R, Wei L, Zhuang H, Jia J, Hou J. Response-guided peginterferon therapy in patients with HBeAg-positive chronic hepatitis B: A randomized controlled study. J Hepatol. 2016 Oct;65(4):674-682. doi: 10.1016/j.jhep.2016.05.024. Epub 2016 May 26.
PubMed 27238752
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Optimizing the Treatment in HBeAg Positive CHB Patients With Response Guide Treatment (RGT) Method.
- ClinicalTrials.gov ID
- NCT01086085
- Acronym / sponsor ID
- ML22266
- Conditions
- Hepatitis B, Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Collaborators
- Major Science and Technology Special Project of China Eleventh Five-year
- Study start
- Apr 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 12 Mar 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.
This open-label, multi-center study will evaluate the effect on the quantitative HBsAg reduction of peginterferon alfa-2a [PEGASYS] in patients with HBeAg positive chronic hepatitis B. Patients will receive PEGASYS 180 mcg sc once weekly. After 24 weeks of treatment, rapid responders will receive another 24 weeks of treatment. After 24 weeks of treatment, slow responders will be randomized to another 24 or 72 weeks of PEGASYS monotherapy, or to 72 weeks PEGASYS plus 36 weeks adefovir (10 mg, po once daily, starting from week 29 of PEGASYS treatment). The anticipated time on study drug is >2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: peginterferon alfa-2a [PEGASYS] |
| B | Experimental | Drug: peginterferon alfa-2a [PEGASYS] |
| C | Experimental | Drug: peginterferon alfa-2a [PEGASYS] |
| D | Experimental | Drug: Adefovir, Drug: peginterferon alfa-2a [PEGASYS] |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients >/=18 years of age
- HBeAg positive chronic hepatitis B
- Compensated liver disease
Key exclusion criteria (5 listed)
- Patients who had previously received treatment of drugs with activity against HBV within 6 months prior to study start
- Antiviral, anti-neoplastic or immunomodulatory treatment
- Co-infection with active hepatitis A, hepatitis C, hepatitis D, or HIV
- Evidence of decompensated liver disease
- Chronic liver disease other than viral hepatitis
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 |
|---|---|---|
| AdefovirAdefovir 10 mg po once daily for 36 weeks | Drug | D |
| peginterferon alfa-2a [PEGASYS]Early responders: PEGASYS 180 mcg sc once weekly for 48 weeks | Drug | A |
| peginterferon alfa-2a [PEGASYS]Non-early responders: PEGASYS 180 mcg sc once weekly for 48 weeks | Drug | B |
| peginterferon alfa-2a [PEGASYS]Non-early responders: PEGASYS 180 mcg sc once weekly for 96 weeks | Drug | C, D |
Primary outcome
Efficacy: Quantitative HBsAG reduction (proportion of patients with HBsAG reduction)
Time frame: Weeks 72, 96, 120
2 secondary outcomes
Proportion of patients achieving HBeAG seroconversion and HBV DNA </=100000 copies/ml
Time frame: Weeks 24, 48, 72, 96, 120
Safety: Adverse Events
Time frame: From baseline to Week 120
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Derived from this study: PubMed 27238752Sun J, Ma H, Xie Q, Xie Y, Sun Y, Wang H, Shi G, Wan M, Niu J, Ning Q, Yu Y, Zhou H, Cheng J, Kang W, Xie Y, Fan R, Wei L, Zhuang H, Jia J, Hou J. Response-guided peginterferon therapy in patients with HBeAg-positive chronic hepatitis B: A randomized controlled study. J Hepatol. 2016 Oct;65(4):674-682. doi: 10.1016/j.jhep.2016.05.024. Epub 2016 May 26.
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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.
Clinical Trials study director
Hoffmann-La Roche
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adefovir and peginterferon alfa-2a [PEGASYS] in people with Hepatitis B, Chronic, run by Hoffmann-La Roche at 11 sites 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: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy: Quantitative HBsAG reduction (proportion of patients with HBsAG reduction) (time frame: Weeks 72, 96, 120). 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 NCT01086085, 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 2 Nov 2016.