Chronic Hepatitis BPhase 4NCT02745704
The Optimizing Treatment of PegIFN Alfa in HBeAg-negative CHB Patients With Low Level HBsAg
A Phase 4 study testing Peginterferon alfa in people with Chronic Hepatitis B, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
As HBsAg clearance is uncommon in chronic hepatitis B (CHB) patients on nucleoside analogues (NAs) therapy. The purpose of this study is to optimize HBsAg clearance in CHB Patients with sequential treatment of pegylated interferon alpha and NAs. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Peginterferon alfa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to Apr 2019
- 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
- CHB patients who had received NAs for more than 12 months.
- Hepatitis B e antigen (HBeAg)-negative and anti-HBeAg positive.
- Hepatitis B surface antigen (HBsAg) positive and <1500 IU/mL.
- Hepatitis B virus DNA not detectable(Roche Cobas).
Who cannot join
- Patients with liver cirrhosis, Hepatocellular Carcinoma or other malignancies.
- Patients with other factors causing liver diseases.
- Pregnant and lactating women.
- Patients with concomitant HIV infection or congenital immune deficiency diseases.
- Patients with diabetes, autoimmune diseases.
- Patients with important organ dysfunctions.
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- Patients with serious complications (e.g., infection, hepatic encephalopathy, hepatorenal syndrome, gastrointestinal bleeding.)
- Patients who receive antineoplastic or immunomodulatory therapy in the past 12 months.
- Patients who can't come back to clinic for follow-up on schedule.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The third affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Xiang Zhu, Doctor, 13826452564, 0628zhuxiang@163.com
About this study
Official title: The Optimizing Treatment of PegIFN Alfa in HBeAg-negative Chronic Hepatitis B Patients With Low Level HBsAg
As HBsAg clearance is uncommon in chronic hepatitis B (CHB) patients on nucleoside analogues (NAs) therapy. The purpose of this study is to optimize HBsAg clearance in CHB Patients with sequential treatment of pegylated interferon alpha and NAs.
Read the detailed description
In order to optimize HBsAg clearance in CHB patients with low level HBsAg, the investigators enrolled patients who had received, and responded to, NAs for more than 12 months(see the inclusion criteria), and patients are switched to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for 48 weeks and follow up for 24 weeks.
- Conditions
- Chronic Hepatitis B
- Being tested
- Peginterferon alfa
- Keywords
- chronic hepatitis B, peginterferon alfa
- 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 alfaDrug
peginterferon alfa-2b 80 micrograms/week or peginterferon alfa-2a 180 micrograms/week
| Study group | Role | What they receive |
|---|---|---|
| PEG-IFN group | Experimental | Hepatitis B e antigen (HBeAg)-negative CHB patients who had received NAs for more than 12 months, with HBsAg <1500 IU/ mL and Hepatitis B virus DNA not detectable, are to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for 48 weeks. Receives: Drug: Peginterferon alfa |
| NAs group | No intervention | Patients do not need to change their NAs treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBsAg Clearance
Percentage of Participants with HBsAg negative.
Measured: 72 weeks
HBsAg Seroconversion
Percentage of Participants with HBsAg negative and anti-HBsAg positive.
Measured: 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2019 (estimated)
- Study completionApr 2019 (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.
- 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
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University, Huazhong University of Science and Technology, Nanchang University, Huizhou Municipal Central Hospital, First People's Hospital, Shunde China, Shenzhen Third People's Hospital, First People's Hospital of Foshan, Tang-Du Hospital, First Affiliated Hospital of Kunming Medical University, Yuebei People's Hospital
- Responsible party
- Principal investigator, Zhiliang Gao, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745704
- Sponsor's protocol ID
- 3rd-SYSU-I-Cure
- Status last verified
- Jan 2019
- First submitted
- 11 Apr 2016
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimizing Treatment of PegIFN Alfa in HBeAg-negative Chronic Hepatitis B Patients With Low Level HBsAg
- ClinicalTrials.gov ID
- NCT02745704
- Acronym / sponsor ID
- 3rd-SYSU-I-Cure
- Conditions
- Chronic Hepatitis B
- Keywords
- chronic hepatitis B, peginterferon alfa
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Peking University, Huazhong University of Science and Technology, Nanchang University, Huizhou Municipal Central Hospital, First People's Hospital, Shunde China, Shenzhen Third People's Hospital, First People's Hospital of Foshan, Tang-Du Hospital, First Affiliated Hospital of Kunming Medical University, Yuebei People's Hospital
- Study start
- Apr 2016
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 20 Apr 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.
As HBsAg clearance is uncommon in chronic hepatitis B (CHB) patients on nucleoside analogues (NAs) therapy. The purpose of this study is to optimize HBsAg clearance in CHB Patients with sequential treatment of pegylated interferon alpha and NAs.
Detailed description
In order to optimize HBsAg clearance in CHB patients with low level HBsAg, the investigators enrolled patients who had received, and responded to, NAs for more than 12 months(see the inclusion criteria), and patients are switched to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for 48 weeks and follow up for 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG-IFN group | Experimental | Drug: Peginterferon alfaHepatitis B e antigen (HBeAg)-negative CHB patients who had received NAs for more than 12 months, with HBsAg <1500 IU/ mL and Hepatitis B virus DNA not detectable, are to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for 48 weeks. |
| NAs group | No intervention | –Patients do not need to change their NAs treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- CHB patients who had received NAs for more than 12 months.
- Hepatitis B e antigen (HBeAg)-negative and anti-HBeAg positive.
- Hepatitis B surface antigen (HBsAg) positive and <1500 IU/mL.
- Hepatitis B virus DNA not detectable(Roche Cobas).
Key exclusion criteria (9 listed)
- Patients with liver cirrhosis, Hepatocellular Carcinoma or other malignancies.
- Patients with other factors causing liver diseases.
- Pregnant and lactating women.
- Patients with concomitant HIV infection or congenital immune deficiency diseases.
- Patients with diabetes, autoimmune diseases.
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 alfapeginterferon alfa-2b 80 micrograms/week or peginterferon alfa-2a 180 micrograms/week | Drug | PEG-IFN group |
Primary outcome
HBsAg Clearance
Time frame: 72 weeks
Percentage of Participants with HBsAg negative.
HBsAg Seroconversion
Time frame: 72 weeks
Percentage of Participants with HBsAg negative and anti-HBsAg positive.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Individual participant dataSharing planned: Undecided
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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.
The third affiliated hospital of Sun Yat-sen University
Guangzhou, China
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 in people with Chronic Hepatitis B, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site 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 4 inclusion and 9 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 15 Jan 2019. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBsAg Clearance (time frame: 72 weeks). 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 15 Jan 2019.