Chronic Hepatitis BPhase 2NCT01143662
Efficacy and Safety of Ypeginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B
A Phase 2 study testing Ypeginterferon alfa-2b and Peginterferon alfa-2a in people with Chronic Hepatitis B, run by Xiamen Amoytop Biotech Co., Ltd. at 39 sites in China.
Trial summary
This study is a multi-center, randomized, open-label and positive controlled Phase II Clinical trial to assess efficacy and safety of Ypeginterferon alfa-2b, once a week, in 3 dose-groups: 90mcg, 135mcg and 180mcg, respectively, for treatment of chronic hepatitis B characterized by HBeAg positivity, with Pegasys… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Ypeginterferon alfa-2b and Peginterferon alfa-2a
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 39 sitesChina
- Study dates
- Jul 2010to Apr 2012
- Phase
- Phase 2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age:18~60 years.
- Pregnancy tests of female patients must be negative. All patients with effective birth control measures during treatment period and 6 months after the cessation of treatment.
- Serum HBsAg positive for at least 6 months.
- Serum HBeAg positive with HBV DNA ≥20,000IU/ml.
- 2×ULN≤ALT≤10×ULN at screening(ULN=upper limit of normal).
Who cannot join
- Pregnant or lactating women.
- Mental disorder or physical disability.
- Interferon treatment history or using nucleos(t)ide analogue for chronic hepatitis B treatment within the previous 6 months.
- WBC<3000/mm3, or ANC <1500/mm3, or PLT <90,000/mm3.
- Co-infection with HAV, HIV, HCV, HDV, HEV.
- Both HBsAg and anti-HBs are positive, or both HBeAg and anti-HBe are positive at screening.
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- Chest X-ray with clinically significant active inflammatory process, history of significant pulmonary disease or any history of interstitial lung disease.
- Evidence of hepatic decompensation.
- History of hypothyroidism or current treatment for thyroid disease.
- Uncontrolled significant chronic medical conditions other than chronic hepatitis B, or other conditions which in the opinion of the investigator preclude enrollment into the study.
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
China39 sites
302 Military Hospital
Beijing
Beijing Youan Hospital, Capital Medical University
Beijing
Beijing Youyi Hospital, Capital Medical University
Beijing
Peking University First Hospital
Beijing
Peking University People's Hospital
Beijing
First Affiliated Hospital of Jilin University
Changchun
Xiangya Hospital, Central-south University
Changsha
Xiangya Second Hospital, Central-south University
Changsha
West China Hospital, Sichuan University
Chengdu
Southwest Hospital
Chongqing
Fuzhou Infectious Disease Hospital
Fuzhou
Guangzhou Eighth People's Hospital
Guangzhou
Nanfang Hospital
Guangzhou
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou
First Affiliated Hospital of Guangxi Medical University
Guilin
First Affiliated Hospital, Zhejiang University
Hangzhou
Second Affiliated Hospital of Harbin Medical University
Harbin
First Affiliated Hospital of Anhui Medical University
Hefei
Jinan Infectious Disease Hospital
Jinan
First Affiliated Hospital of Lanzhou University
Lanzhou
First Affiliated Hospital of Nanchang University
Nanchang
81 Military Hospital
Nanjing
Jiangsu Province Hospital
Nanjing
Second Hospital of Nanjing
Nanjing
85 Militay Hospital
Shanghai
Changhai Hospital
Shanghai
Huashan Hospital
Shanghai
Renji Hospital
Shanghai
Ruijin Hospital
Shanghai
Shanghai Public Health Clinical Center
Shanghai
Shenzhen Third People's Hospital
Shenzhen
Third Affiliated Hospital, Hebei Medical University
Shijiazhuang
First Affiliated Hospital, Shanxi University
Taiyuan
Tianjin Third Central Hospital
Tianjin
First Affiliated Hospital of Wenzhou Medical College
Wenzhou
Tongji Hospital, Huazhong University of Science&Technology
Wuhan
Tangdu Hospital, Fourth Military Medical University
Xi'an
First Affiliated Hospital of Zhengzhou University
Zhengzhou
Henan Provincial People's Hospital
Zhengzhou
About this study
Official title: A Multi-center, Randomized, Open-label and Positive Controlled Phase II Clinical Trial to Assess Efficacy and Safety of Ypeginterferon Alfa-2b in HBeAg Positive Patients With Chronic Hepatitis B
This study is a multi-center, randomized, open-label and positive controlled Phase II Clinical trial to assess efficacy and safety of Ypeginterferon alfa-2b, once a week, in 3 dose-groups: 90mcg, 135mcg and 180mcg, respectively, for treatment of chronic hepatitis B characterized by HBeAg positivity, with Pegasys 180mcg/week as positive control. It is aimed to establish a dose response and safety relationship sufficient to allow the subsequent design and conduct of Phase III trials, and generate pharmacokinetic data of Ypeginterferon alfa-2b in hepatitis B patients to satisfy regulatory requirements.
- Conditions
- Chronic Hepatitis B
- Being tested
- Ypeginterferon alfa-2b, Peginterferon alfa-2a
- Keywords
- peginterferon, interferon, Pegasys, HBV, Hepatitis B, HBeAg positive
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ypeginterferon alfa-2bDrug
sc, qw, for 48 weeks.
Peginterferon alfa-2aDrug
Also called Pegasys
sc, qw, for 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Ypeginterferon alfa-2b 90mcg per week Receives: Drug: Ypeginterferon alfa-2b |
| Group 2 | Experimental | Ypeginterferon alfa-2b 135mcg per week Receives: Drug: Ypeginterferon alfa-2b |
| Group 3 | Experimental | Ypeginterferon alfa-2b 180mcg per week Receives: Drug: Ypeginterferon alfa-2b |
| Group 4 | Active comparator | Pegasys 180mcg per week Receives: Drug: Peginterferon alfa-2a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
- Average of HBV DAN decline level at week 24.
- Proportion of patients with HBeAg undetectable and HBeAg seroconversion at week 24.
Measured: week 24 from treatment start
Secondary outcomes (1)
Efficacy
- Average of HBV DNA decline level at week 12, 48 and 72.
- Proportion of patients with HBV DNA undetectable at week 48 and 72.
- Proportion of patients with HBeAg undetectable and HBeAg seroconversion at week 48 and 72.
- Proportion of patients with HBsAg undetectable and HBsAg seroconversion at week 48 and 72.
- Proportion of patients with ALT normalization at week 24 and 48.
Measured: week 12, 24, 48 from treatment start and week 24 after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionApr 2011
- Study completionApr 2012
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 Xiamen Amoytop Biotech Co., Ltd.The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiamen Amoytop Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking University First Hospital
- Responsible party
- Sponsor
- Investigators
- Wang Guiqiang, MD, PhD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01143662
- Sponsor's protocol ID
- TB1007IFN
- Status last verified
- Jun 2010
- First submitted
- 11 Jun 2010
- Last updated
- 4 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Open-label and Positive Controlled Phase II Clinical Trial to Assess Efficacy and Safety of Ypeginterferon Alfa-2b in HBeAg Positive Patients With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT01143662
- Acronym / sponsor ID
- TB1007IFN
- Conditions
- Chronic Hepatitis B
- Keywords
- peginterferon, interferon, Pegasys, HBV, Hepatitis B, HBeAg positive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Xiamen Amoytop Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Peking University First Hospital
- Study start
- Jul 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 14 Jun 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 study is a multi-center, randomized, open-label and positive controlled Phase II Clinical trial to assess efficacy and safety of Ypeginterferon alfa-2b, once a week, in 3 dose-groups: 90mcg, 135mcg and 180mcg, respectively, for treatment of chronic hepatitis B characterized by HBeAg positivity, with Pegasys 180mcg/week as positive control. It is aimed to establish a dose response and safety relationship sufficient to allow the subsequent design and conduct of Phase III trials, and generate pharmacokinetic data of Ypeginterferon alfa-2b in hepatitis B patients to satisfy regulatory requirements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Ypeginterferon alfa-2bYpeginterferon alfa-2b 90mcg per week |
| Group 2 | Experimental | Drug: Ypeginterferon alfa-2bYpeginterferon alfa-2b 135mcg per week |
| Group 3 | Experimental | Drug: Ypeginterferon alfa-2bYpeginterferon alfa-2b 180mcg per week |
| Group 4 | Active comparator | Drug: Peginterferon alfa-2aPegasys 180mcg per week |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age:18~60 years.
- Pregnancy tests of female patients must be negative. All patients with effective birth control measures during treatment period and 6 months after the cessation of treatment.
- Serum HBsAg positive for at least 6 months.
- Serum HBeAg positive with HBV DNA ≥20,000IU/ml.
- 2×ULN≤ALT≤10×ULN at screening(ULN=upper limit of normal).
Key exclusion criteria (10 listed)
- Pregnant or lactating women.
- Mental disorder or physical disability.
- Interferon treatment history or using nucleos(t)ide analogue for chronic hepatitis B treatment within the previous 6 months.
- WBC<3000/mm3, or ANC <1500/mm3, or PLT <90,000/mm3.
- Co-infection with HAV, HIV, HCV, HDV, HEV.
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 |
|---|---|---|
| Ypeginterferon alfa-2bsc, qw, for 48 weeks. | Drug | Group 1, Group 2, Group 3 |
| Peginterferon alfa-2aAlso: Pegasyssc, qw, for 48 weeks. | Drug | Group 4 |
Primary outcome
Efficacy
Time frame: week 24 from treatment start
* Average of HBV DAN decline level at week 24. * Proportion of patients with HBeAg undetectable and HBeAg seroconversion at week 24.
1 secondary outcome
Efficacy
Time frame: week 12, 24, 48 from treatment start and week 24 after treatment
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 4 Feb 2013.
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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.
Wang Guiqiang, MD, PhD principal investigator
Peking University First Hospital
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ypeginterferon alfa-2b and Peginterferon alfa-2a in people with Chronic Hepatitis B, run by Xiamen Amoytop Biotech Co., Ltd. at 39 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 5 inclusion and 10 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 4 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 (time frame: week 24 from treatment start). 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 Feb 2013.