Chronic Hepatitis BNCT05451420
Inactive HBsAg Carriers (IHCs) Treated With Pegylated Interferon α2b Based Intervention Therapy
A study testing PegIFN α- 2b in people with Chronic Hepatitis B, run by Henan Provincial People's Hospital at 1 site in China.
Trial summary
A single center, randomized controlled trial design was used to select patients with chronic hepatitis B in the immune control period (HBsAg positive, HBeAg negative, normal ALT, HBsAg ≤ 1500iu/ml, HBV DNA ≤ 2000iu/ml) to enter the study, and to compare the feasibility, effectiveness and safety of pegylate combined… 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?
- PegIFN α- 2b
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2017to 31 Dec 2021
- Phase
- Interventional
- 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
- age 18 to 65 years;
- HBsAg seropositive status for more than 6 months prior to enrollment;
- never received treatment with any form of nucleos(t)ide analogues (NAs) or interferon before enrollment;
- Serum HBsAg ≤1500 IU/mL;
- HBeAg negative with or without HBeAb positive;
- Serum HBV DNA ≤2000IU/ml IU/mL;
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- normal ALT levels;
- normal white blood cell and platelet counts;
- abdominal computed tomography or B-ultrasound showed no cirrhosis, splenomegaly or ascites.
Who cannot join
- Participants with other hepatotropic viruses or human immunodeficiency virus co-infection
- other chronic non-viral liver diseases or decompensated liver diseases
- tumours
- drug abuse
- severe psychiatric disease
- uncontrolled thyroid disease or diabetes
- pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy and Safety of Inactive Hepatitis B Surface Antigen (HBsAg) Carriers (IHCs) Treated With Pegylated Interferon α2b Based Intervention Therapy(HBsAg Positive, HBeAg Negative, ALT Normal, HBsAg ≤ 1500IU/ml, HBV DNA ≤ 2000IU/ml)
A single center, randomized controlled trial design was used to select patients with chronic hepatitis B in the immune control period (HBsAg positive, HBeAg negative, normal ALT, HBsAg ≤ 1500iu/ml, HBV DNA ≤ 2000iu/ml) to enter the study, and to compare the feasibility, effectiveness and safety of pegylate combined with Granulocyte-macrophage colony stimulating factor, high-dose hepatitis B vaccine and pegylate monotherapy in the treatment of patients with chronic hepatitis B in the immune control period
Read the detailed description
Explore the efficacy, safety and related influencing factors of intervention therapy based on PegIFN α- 2b in inactive hepatis B surface antigen (HBsAg) carriers (IHCs), and compare pegifn α- 2b combined with granulocyte macrophage stimulating factor (GM-CSF), high-dose hepatitis B vaccine and pegifn α- 2B feasibility, efficacy and safety of monotherapy for IHCs.The IHCs patients were randomly divided into two groups (group A: pegifn α- 2b single drug group, group B: pegifn α- 2b combined with GM-CSF and high-dose hepatitis B vaccine group). To start applying pegifn α- 2B was the baseline, treatment for 68 weeks, followed up for 24 weeks after drug withdrawal. Patients in group B used GM-CSF and vaccine introduction for 16 weeks before baseline.The HBsAg clearance rate and related influencing factors of the two groups at 68 weeks were analyzed.
- Conditions
- Chronic Hepatitis B
- Being tested
- PegIFN α- 2b
- Keywords
- inactive hepatitis B virus carriers, HBsAg clearance, peginterferon alpha 2b, Intervention treatment
- 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.
PegIFN α- 2bDrug
Also called pegbin ® 180μg，produced by Xiamen Tebao Bioengineering Co., Ltd.
Adjuvant immunotherapy with GM-CSF and Hepatitis B vaccine
；GM-CSF（100 μg/ piece, produced by Xiamen Tebao Bioengineering Co., Ltd）；Hepatitis B vaccine（Each 1.0ml/HBsAg60 μ g. Shenzhen Kangtai Biological Products Co., Ltd）
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | PegIFN α- 2b monotherapy, 180 μg/ week, 68 weeks of treatment, 24 weeks of follow-up after drug withdrawal Receives: Drug: PegIFN α- 2b |
| Group B | Active comparator | Patients had a lead-in period of 16 weeks before baseline, pegifn α- 2b single drug treatment for 24 weeks, 4 weeks after drug withdrawal, 16 weeks of introduction period, pegifn α- 2b was followed up for 24 weeks. The plan of the induction period is as follows: 1) from the first day of the induction period, GM-CSF is injected subcutaneously ® one hundred μg/ piece, produced by Xiamen Tebao Bioengineering Co., Ltd.), 100 μg/ day, 5 consecutive days, one cycle every 4 weeks, 4 consecutive cycles. 2) On the third day of the induction period, recombinant hepatitis B vaccine (Saccharomyces cerevisiae) (1.0ml/HBsAg 60 per dose) was injected subcutaneously μg. Shenzhen Kangtai Biological Products Co., Ltd.), 60 μ g. Once every 4 weeks for 4 consecutive cycles, the course of treatment was 68 weeks, and the patients were followed up for 24 weeks. Receives: Drug: PegIFN α- 2b |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBsAg clearance at the end of 68 weeks of treatment
To determine the response rate will be evaluated by HBsAg loss defined as HBsAg level lower than 0.05 IU/ml after 48 week treatment, compared with control group.
Measured: 68 weeks of treatment
Secondary outcomes (2)
HBsAg level and the decreasing extent of HBsAg level
To assessment the decreasing level and difference of HBsAg levels in different treatment groups
Measured: baseline，12 weeks, 24 weeks, 44 weeks，56 weeks， 68weeks，80 weeks，92weeks of treatment
HBsAg seroconversion rate
To assessment the HBsAg seroconversion rate in different treatment groups
Measured: 68 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 posted11 Jul 2022
- Study start1 Dec 2017
- Primary completion30 Jun 2020
- Study completion31 Dec 2021
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xiamen Amoytop Biotech Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Jia Shang, Study chair, Henan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05451420
- Sponsor's protocol ID
- HenanPPHGRK
- Status last verified
- Jun 2022
- First submitted
- 23 Jun 2022
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication
Publications
Ning H, Li K, Peng Z, Jin H, Zhao H, Shang J. The efficacy and safety of pegylated interferon alpha-2b-based immunotherapy for inactive hepatitis B surface antigen carriers. Eur J Gastroenterol Hepatol. 2023 Oct 1;35(10):1216-1223. doi: 10.1097/MEG.0000000000002627. Epub 2023 Aug 14.
PubMed 37577817
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Inactive Hepatitis B Surface Antigen (HBsAg) Carriers (IHCs) Treated With Pegylated Interferon α2b Based Intervention Therapy(HBsAg Positive, HBeAg Negative, ALT Normal, HBsAg ≤ 1500IU/ml, HBV DNA ≤ 2000IU/ml)
- ClinicalTrials.gov ID
- NCT05451420
- Acronym / sponsor ID
- HenanPPHGRK
- Conditions
- Chronic Hepatitis B
- Keywords
- inactive hepatitis B virus carriers, HBsAg clearance, peginterferon alpha 2b, Intervention treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Henan Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Xiamen Amoytop Biotech Co., Ltd.
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 11 Jul 2022 (actual)
- 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.
A single center, randomized controlled trial design was used to select patients with chronic hepatitis B in the immune control period (HBsAg positive, HBeAg negative, normal ALT, HBsAg ≤ 1500iu/ml, HBV DNA ≤ 2000iu/ml) to enter the study, and to compare the feasibility, effectiveness and safety of pegylate combined with Granulocyte-macrophage colony stimulating factor, high-dose hepatitis B vaccine and pegylate monotherapy in the treatment of patients with chronic hepatitis B in the immune control period
Detailed description
Explore the efficacy, safety and related influencing factors of intervention therapy based on PegIFN α- 2b in inactive hepatis B surface antigen (HBsAg) carriers (IHCs), and compare pegifn α- 2b combined with granulocyte macrophage stimulating factor (GM-CSF), high-dose hepatitis B vaccine and pegifn α- 2B feasibility, efficacy and safety of monotherapy for IHCs.The IHCs patients were randomly divided into two groups (group A: pegifn α- 2b single drug group, group B: pegifn α- 2b combined with GM-CSF and high-dose hepatitis B vaccine group). To start applying pegifn α- 2B was the baseline, treatment for 68 weeks, followed up for 24 weeks after drug withdrawal. Patients in group B used GM-CSF and vaccine introduction for 16 weeks before baseline.The HBsAg clearance rate and related influencing factors of the two groups at 68 weeks were analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: PegIFN α- 2bPegIFN α- 2b monotherapy, 180 μg/ week, 68 weeks of treatment, 24 weeks of follow-up after drug withdrawal |
| Group B | Active comparator | Drug: PegIFN α- 2bPatients had a lead-in period of 16 weeks before baseline, pegifn α- 2b single drug treatment for 24 weeks, 4 weeks after drug withdrawal, 16 weeks of introduction period, pegifn α- 2b was followed up for 24 weeks. The plan of the induction period is as follows: 1) from the first day of the induction period, GM-CSF is injected subcutaneously ® one hundred μg/ piece, produced by Xiamen Tebao Bioengineering Co., Ltd.), 100 μg/ day, 5 consecutive days, one cycle every 4 weeks, 4 consecutive cycles. 2) On the third day of the induction period, recombinant hepatitis B vaccine (Saccharomyces cerevisiae) (1.0ml/HBsAg 60 per dose) was injected subcutaneously μg. Shenzhen Kangtai Biological Products Co., Ltd.), 60 μ g. Once every 4 weeks for 4 consecutive cycles, the course of treatment was 68 weeks, and the patients were followed up for 24 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- age 18 to 65 years;
- HBsAg seropositive status for more than 6 months prior to enrollment;
- never received treatment with any form of nucleos(t)ide analogues (NAs) or interferon before enrollment;
- Serum HBsAg ≤1500 IU/mL;
- HBeAg negative with or without HBeAb positive;
Key exclusion criteria (7 listed)
- Participants with other hepatotropic viruses or human immunodeficiency virus co-infection
- other chronic non-viral liver diseases or decompensated liver diseases
- tumours
- drug abuse
- severe psychiatric disease
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 |
|---|---|---|
| PegIFN α- 2bAlso: pegbin ® 180μg，produced by Xiamen Tebao Bioengineering Co., Ltd.Adjuvant immunotherapy with GM-CSF and Hepatitis B vaccine ；GM-CSF（100 μg/ piece, produced by Xiamen Tebao Bioengineering Co., Ltd）；Hepatitis B vaccine（Each 1.0ml/HBsAg60 μ g. Shenzhen Kangtai Biological Products Co., Ltd） | Drug | Group A, Group B |
Primary outcome
HBsAg clearance at the end of 68 weeks of treatment
Time frame: 68 weeks of treatment
To determine the response rate will be evaluated by HBsAg loss defined as HBsAg level lower than 0.05 IU/ml after 48 week treatment, compared with control group.
2 secondary outcomes
HBsAg level and the decreasing extent of HBsAg level
Time frame: baseline，12 weeks, 24 weeks, 44 weeks，56 weeks， 68weeks，80 weeks，92weeks of treatment
HBsAg seroconversion rate
Time frame: 68 weeks of 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 13 Jul 2022.
- Derived from this study: PubMed 37577817Ning H, Li K, Peng Z, Jin H, Zhao H, Shang J. The efficacy and safety of pegylated interferon alpha-2b-based immunotherapy for inactive hepatitis B surface antigen carriers. Eur J Gastroenterol Hepatol. 2023 Oct 1;35(10):1216-1223. doi: 10.1097/MEG.0000000000002627. Epub 2023 Aug 14.
- Individual participant dataSharing planned: Yes. After publication
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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.
Jia Shang study chair
Henan Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PegIFN α- 2b in people with Chronic Hepatitis B, run by Henan Provincial People's Hospital 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 9 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: finished, as of the sponsor's last update on 13 Jul 2022. 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.
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?
HBsAg clearance at the end of 68 weeks of treatment (time frame: 68 weeks of treatment). 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 NCT05451420, 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 13 Jul 2022.