Chronic Hepatitis BNCT02589652
Switch or Sequential Combination Therapy of Peginterferon in Hepatitis B Patients With Longterm Entecavir Therapy
An observational study of Chronic Hepatitis B, run by Huashan Hospital at 17 sites in China.
Trial summary
This is a multicenter, prospective cohort study to evaluate the efficacy and safety of sequential combination or switch therapy of pegylated interferon alfa-2a in chronic hepatitis B patients with low HBsAg and HBeAg titers after long-term entecavir therapy, and compared to those who continued on ETV therapy. 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?
- Pegylated interferon alfa-2a, Pegylated interferon alfa-2a plus Entecavir and Entecavir
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 294 participants
- Where
- 17 sitesChina
- Study dates
- Oct 2015to Oct 2017
- Phase
- Observational
- 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
Study population: Chronic Hepatitis B Patients with Low HBsAg and HBeAg Titers after Long-term Entecavir Therapy
Who may be able to join
- Male and female patients > 18 and ≤ 60 years of age;
- Positive HBsAg for more than 6 months;
- Patients receiving previous ETV therapy ≥2 years;
- Patients who have achieved undetectable HBV DNA, HBsAg <1500IU/mL and HBeAg <200S/CO prior to switch or S-C therapy;
- ALT<=10*ULN and TB<2*ULN;
- Patients who have been assigned to treatment with PegIFN (S-C or switch) or continuous ETV after previous ETV therapy
Who cannot join
- Evidence of decompensated cirrhosis or hepatocellular carcinoma;
- Serological evidence of co-infection with HCV, HDV or HIV;
- Pregnant or breast-feeding women;
- Patients with diseases that might contraindicate to PegIFN therapy including severe psychiatric diseases, immunological diseases, severe retinopathy, thyroid dysfunction, leukocytopenia, thrombopenia, etc
- Patients receiving concomitant therapy with telbivudine;
- A history of drug or alcohol abuse;
- Other conditions that investigates consider not suitable for participate
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
China17 sites
Beijing Ditan Hospital
Beijing, Beijing Municipality
Yao Xie, xieyao@public.bta.net.cn
Fuzhou Municipal Infectious Disease Hospital
Fuzhou, Fujian
Minghua Lin, fulmh@yahoo.com.cn
Zhongshan No.2 People's Hospital, Zhongshan, Guangdong
Guangzhou, Guangdong
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang
Xiaowei Xu, xxw69@126.com
The First Affiliated Hospital, Anhui Medical University
Hefei, Anhui
Jiabin Li, lijiabin9441@vip.sohu.com
The Second Affiliated Hospital, Anhui Medical University
Hefei, Anhui
Yufeng Gao, aygyf@126.com
Shandong Provincial Hospital of Shandong University
Jinan, Shandong
Wanhua Ren, ganbingzx@163.com
The Affiliated Hospital of Luzhou Medical College
Luzhou, Sichuan, 646000
Gang Wu, 0830-2292040
The Second Hospital of Yinzhou of Ningbo
Ningbo, Zhejiang, 315040
Guojun Li, 13615880689@163.com
Rui'an People's Hospital
Rui’an, Zhejiang
Liang Hong, 0577-65866555
Shenyang Municipal Infectious Disease Hospital
Shenyang, Liaoning
Mingxiang Zhang, zmx6511@126.com
The third People's Hospital of Shenzhen
Shenzhen, Guangdong
Jing Yuan, 13500054798@139.com
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei
Caiyan Zhao, zhaoy2005@163.com
Sichuan Provincial People's Hospital
Sichuan, Sichuan
Xingxiang Yang, xxyang508@tom.com
Fifth People's Hospital of Suzhou
Suzhou, Jiangsu
Chuanwu Zhu, zhuchw@126.com
The First Affiliated Hospital Medical School of Xi'an Jiaotong University
Xi’an, Shanxi
Yingren Zhao, zhaoyingren@sohu.com
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu
Xuebing Yan, yxbxuzhou@126.com
About this study
Official title: Efficacy of Switch or Sequential Combination Therapy of Pegylated Interferon Alfa-2a in Chronic Hepatitis B Patients With Low HBsAg and HBeAg Titers After Long-term Entecavir Therapy: A Multicenter, Prospective Cohort Study
This is a multicenter, prospective cohort study to evaluate the efficacy and safety of sequential combination or switch therapy of pegylated interferon alfa-2a in chronic hepatitis B patients with low HBsAg and HBeAg titers after long-term entecavir therapy, and compared to those who continued on ETV therapy.
Read the detailed description
Chronic hepatitis B (CHB) infection remains a global health treat. The ideal end point of therapy is HBsAg loss or HBsAg seroconversion, indicating a complete remission of CHB. In patients with HBeAg-positive CHB, sustained HBeAg seroconversion is also a desirable end point. Current therapies include pegylated interferon (PegIFN) finite and nucleos(t)ide analogues (NUCs) longterm therapy. However, only 30-40% of patients may achieve HBeAg seroconversion on PegIFN monotherapy, whereas 15-20% of patients on entecavir (ETV). Recently, accumulating evidence had shown that optimization of switching or combining PegIFN in patients on long-term ETV therapy may increase rate of HBeAg seroconversion and even lead to the complete eradication of HBV. However, these two regimens has not been tested adequately in patients with low HBsAg/HBeAg titers on long-term ETV therapy.
This is a multicenter, prospective cohort study to evaluate the efficacy and safety of sequential combination or switch therapy of pegylated interferon alfa-2a in chronic hepatitis B patients with low HBsAg and HBeAg titers after long-term entecavir therapy, and compared to those who continued on ETV therapy.
- Conditions
- Chronic Hepatitis B
- Being tested
- Pegylated interferon alfa-2a, Pegylated interferon alfa-2a plus Entecavir, Entecavir
- Keywords
- Pegylated interferon, Entecavir
- 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.
Pegylated interferon alfa-2aDrug
Also called PegIFN alpha-2a
ETV 0.5mg oral daily plus PegIFN alfa-2a 180ug subcutaneous injection weekly for 8 weeks and followed by PegIFN alfa-2a 180ug subcutaneous injection weekly for 40 weeks
Pegylated interferon alfa-2a plus EntecavirDrug
Also called PegIFN alpha-2a, ETV
ETV 0.5mg oral daily plus PegIFN alfa-2a 180ug subcutaneous injection weekly for 48 weeks
EntecavirDrug
Also called ETV
ETV 0.5mg oral daily for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| Switch group | Patients who have been assigned to pegylated interferon alfa-2a. Receives: Drug: Pegylated interferon alfa-2a | |
| Sequential combination group (S-C group) | Patients who have been assigned to pegylated interferon alfa-2a plus entecavir. Receives: Drug: Pegylated interferon alfa-2a plus Entecavir | |
| ETV group | Patients who have been assigned to entecavir monotherapy. Receives: Drug: Entecavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of HBeAg seroconversion
Loss of HBeAg and detection of anti-HBe antibodies
Measured: week 72 (24 weeks after 48 weeks of treatment)
Secondary outcomes (5)
Rate of HBsAg loss
HBsAg loss with or without detection of anti-HBs antibodies
Measured: week 72 (24 weeks after 48 weeks of treatment)
Rate of HBV DNA <20IU/mL
Measured: week 72 (24 weeks after 48 weeks of treatment)
Rate of HBsAg seroconversion
Measured: week 72 (24 weeks after 48 weeks of treatment)
Percentage of patients reaching a ≥ 1log10 decline of quantitative HBsAg
Measured: week 72 (24 weeks after 48 weeks of treatment)
Decline of quantitative HBsAg from baseline
Measured: week 72 (24 weeks after 48 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (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 Huashan HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 294 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-hong Zhang, Huashan Hospital
- Investigators
- Wenhong Zhang, MD, PhD, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02589652
- Sponsor's protocol ID
- 81271833
- Status last verified
- Oct 2015
- First submitted
- 25 Oct 2015
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Switch or Sequential Combination Therapy of Pegylated Interferon Alfa-2a in Chronic Hepatitis B Patients With Low HBsAg and HBeAg Titers After Long-term Entecavir Therapy: A Multicenter, Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02589652
- Acronym / sponsor ID
- 81271833
- Conditions
- Chronic Hepatitis B
- Keywords
- Pegylated interferon, Entecavir
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 28 Oct 2015 (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 is a multicenter, prospective cohort study to evaluate the efficacy and safety of sequential combination or switch therapy of pegylated interferon alfa-2a in chronic hepatitis B patients with low HBsAg and HBeAg titers after long-term entecavir therapy, and compared to those who continued on ETV therapy.
Detailed description
Chronic hepatitis B (CHB) infection remains a global health treat. The ideal end point of therapy is HBsAg loss or HBsAg seroconversion, indicating a complete remission of CHB. In patients with HBeAg-positive CHB, sustained HBeAg seroconversion is also a desirable end point. Current therapies include pegylated interferon (PegIFN) finite and nucleos(t)ide analogues (NUCs) longterm therapy. However, only 30-40% of patients may achieve HBeAg seroconversion on PegIFN monotherapy, whereas 15-20% of patients on entecavir (ETV). Recently, accumulating evidence had shown that optimization of switching or combining PegIFN in patients on long-term ETV therapy may increase rate of HBeAg seroconversion and even lead to the complete eradication of HBV. However, these two regimens has not been tested adequately in patients with low HBsAg/HBeAg titers on long-term ETV therapy.
This is a multicenter, prospective cohort study to evaluate the efficacy and safety of sequential combination or switch therapy of pegylated interferon alfa-2a in chronic hepatitis B patients with low HBsAg and HBeAg titers after long-term entecavir therapy, and compared to those who continued on ETV therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Switch group | – | Drug: Pegylated interferon alfa-2aPatients who have been assigned to pegylated interferon alfa-2a. |
| Sequential combination group (S-C group) | – | Drug: Pegylated interferon alfa-2a plus EntecavirPatients who have been assigned to pegylated interferon alfa-2a plus entecavir. |
| ETV group | – | Drug: EntecavirPatients who have been assigned to entecavir monotherapy. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Chronic Hepatitis B Patients with Low HBsAg and HBeAg Titers after Long-term Entecavir Therapy
Key inclusion criteria (6 listed)
- Male and female patients > 18 and ≤ 60 years of age;
- Positive HBsAg for more than 6 months;
- Patients receiving previous ETV therapy ≥2 years;
- Patients who have achieved undetectable HBV DNA, HBsAg <1500IU/mL and HBeAg <200S/CO prior to switch or S-C therapy;
- ALT<=10*ULN and TB<2*ULN;
Key exclusion criteria (7 listed)
- Evidence of decompensated cirrhosis or hepatocellular carcinoma;
- Serological evidence of co-infection with HCV, HDV or HIV;
- Pregnant or breast-feeding women;
- Patients with diseases that might contraindicate to PegIFN therapy including severe psychiatric diseases, immunological diseases, severe retinopathy, thyroid dysfunction, leukocytopenia, thrombopenia, etc
- Patients receiving concomitant therapy with telbivudine;
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 |
|---|---|---|
| Pegylated interferon alfa-2aAlso: PegIFN alpha-2aETV 0.5mg oral daily plus PegIFN alfa-2a 180ug subcutaneous injection weekly for 8 weeks and followed by PegIFN alfa-2a 180ug subcutaneous injection weekly for 40 weeks | Drug | Switch group |
| Pegylated interferon alfa-2a plus EntecavirAlso: PegIFN alpha-2a, ETVETV 0.5mg oral daily plus PegIFN alfa-2a 180ug subcutaneous injection weekly for 48 weeks | Drug | Sequential combination group (S-C group) |
| EntecavirAlso: ETVETV 0.5mg oral daily for 48 weeks | Drug | ETV group |
Primary outcome
Rate of HBeAg seroconversion
Time frame: week 72 (24 weeks after 48 weeks of treatment)
Loss of HBeAg and detection of anti-HBe antibodies
5 secondary outcomes
Rate of HBsAg loss
Time frame: week 72 (24 weeks after 48 weeks of treatment)
Rate of HBV DNA <20IU/mL
Time frame: week 72 (24 weeks after 48 weeks of treatment)
Rate of HBsAg seroconversion
Time frame: week 72 (24 weeks after 48 weeks of treatment)
Percentage of patients reaching a ≥ 1log10 decline of quantitative HBsAg
Time frame: week 72 (24 weeks after 48 weeks of treatment)
Decline of quantitative HBsAg from baseline
Time frame: week 72 (24 weeks after 48 weeks of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
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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.
Wenhong Zhang, MD, PhD principal investigator
Huashan Hospital
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis B, run by Huashan Hospital at 17 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 6 inclusion and 7 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 28 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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.
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 Yiqi Yu, MD (+86 21 52888123 ext. 8123, 07301010205@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of HBeAg seroconversion (time frame: week 72 (24 weeks after 48 weeks of treatment)). 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 28 Oct 2015.