Hepatitis B, ChronicEarly Phase 1EPCPNCT05922306
Efficacy of NA Combined With PEG-IFN-α2b in the Continuous Versus Pulsed Treatment of Patients With Chronic Hepatitis B
A Early Phase 1 study testing PEGylated recombinant human interferon alpha-2b injection in people with Hepatitis B, Chronic, run by Anhui Medical University at 1 site in China.
Trial summary
Previous studies have shown that there are alterations in the number and affinity of interferon receptors during interferon therapy and that such alterations recover to varying degrees some time after the end of treatment. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- PEGylated recombinant human interferon alpha-2b injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,084 participants
- Where
- 1 siteChina
- Study dates
- Jul 2023to Dec 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 to 60 years, both sexes (both 18 and 60 years)
- HBsAg positive for more than 6 months;
- NAs treated patients on continuous NA therapy for more than 6 months with HBsAg ≥ 1500 IU/ml and HBV-DNA < 500 IU/ml at enrolment;
- Primary treated patients with surface antigen >1500 IU, unlimited E antigen and unlimited HBV DNA at enrolment, meeting the treatment indications of the 2019 edition of the guidelines for the prevention and treatment of chronic hepatitis B.
- negative urine or serum pregnancy test within 24 hours prior to the first dose (for women of childbearing age)
Who cannot join
- Combined active hepatitis A, C, D, E and/or HIV infection;
- Patients who are on future and intend to continue to use tibivudine
- methaemoglobin greater than 100ng/ml at screening; or methaemoglobin that has not remained stable for 3 months prior to the trial and/or liver imaging suggestive of liver tumours;
- decompensated liver disease (Child-Pugh score ≥ 7), meaning that patients will be excluded if one of the following is met: prolonged prothrombin time ≥ 3 seconds, serum bilirubin > 34umol/L, history of hepatic encephalopathy, history of oesophageal variceal bleeding, ascites;
- pregnant or lactating women or patients with planned pregnancy during the study period and unwilling to use contraception
- Neutrophil count < 1.5 x 10^9/L or platelet count < 90 x 10^9/L and creatinine > 1.5 ULN
Show all 13Show fewer
- History of severe psychiatric illness, especially depression. Major psychosis defined as major depressive disorder or psychosis, suicide attempts, hospitalisation for psychosis or incapacity for a period of time due to psychosis;
- history of immune-mediated disease (e.g. inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune haemolytic anaemia, scleroderma, severe psoriasis, rheumatoid arthritis) or abnormally elevated levels of autoimmune antibodies
- Patients with severe combined diseases of the heart, lungs, kidneys, brain, blood and other vital organs, combined with other malignancies
- History of severe epilepsy or current treatment with anti-epileptic drugs. Unstable control of diabetes mellitus, hypertension, thyroid disease, etc. Patients with a history of severe retinopathy or as indicated by other evidence of retinopathy;
- History of any organ transplantation and existing functional grafts (except corneal or hair transplants);
- Patients who are allergic to interferon and its drug components and who, in the judgment of the investigator, are unsuitable for interferon application
- Patients who, in the opinion of the investigator, are not suitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 23000
Yufeng Gao, MD, 1395693032, aygyf@ahmu.edu.cn
About this study
Official title: A Multicenter, Prospective Cohort Study: Efficacy of NA Combined With PEG-IFN-α2b Continuous Versus Pulsed Therapy for 96 Weeks in Patients With Chronic Hepatitis B.
Previous studies have shown that there are alterations in the number and affinity of interferon receptors during interferon therapy and that such alterations recover to varying degrees some time after the end of treatment. It can be conjectured that the rest period of pulsed therapy facilitates the recovery of type I interferon receptors and thus the next round of IFN therapy compared to a continuous regimen of interferon.
Read the detailed description
A large-sample, multicenter, prospective, real-world study using NAs in combination with PEG-IFN-α-2b for the treatment of CHB patients with continuous or pulsed combination therapy over a course of up to 96 weeks is proposed to compare the differences in clinical cure rates and E antigen conversion rates between groups. Multiple novel markers of hepatitis B infection, including HBV pgRNA, HBcrAg and anti-HBcAb quantification, were dynamically measured at baseline, 12, 24, 48, 72 and 96 weeks to explore the appropriate strategy for achieving clinical cure rates in CHB patients treated with NAs in combination with PEG-IFN-α-2b.
- Conditions
- Hepatitis B, Chronic
- Being tested
- PEGylated recombinant human interferon alpha-2b injection
- 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 recombinant human interferon alpha-2b injectionDrug
Also called Nucleotide analogues
Continuous combination therapy: pegylated interferon alpha-2b 180µg, subcutaneously once a week for 96 weeks, combined with NAs throughout the treatment period.
PEGylated recombinant human interferon alpha-2b injectionDrug
Also called Nucleotide analogues
Pulsed combination therapy: pegylated interferon alpha-2b 180µg once weekly by subcutaneous injection for 8 weeks with 4 weeks off for a total treatment duration of 96 weeks, combined with NAs throughout the treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Combination Therapy Cohort | Active comparator | Patients with primary CHB with HBsAg ≥ 1500 IU/ml and HBV-DNA < 500 IU/ml and patients with CHB after treatment with NAs will be enrolled. After fully informed consent, pegylated interferon alpha-2b 180µg will be administered by subcutaneous injection once a week for up to 96 weeks. Receives: Drug: PEGylated recombinant human interferon alpha-2b injection |
| Pulsed Combination Therapy Cohort | Experimental | Patients with primary CHB with HBsAg ≥ 1500 IU/ml and HBV-DNA < 500 IU/ml and patients with CHB after treatment with NAs will be enrolled. After fully informed consent, pegylated interferon alpha-2b 180µg will be administered by subcutaneous injection once weekly for 8 weeks of treatment and discontinued for 4 weeks up to 96 weeks. Receives: Drug: PEGylated recombinant human interferon alpha-2b injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBsAg negative conversion rate after 96 weeks of treatment
After 96 weeks of treatment, 5 ml of blood will be drawn from the patient, serum will be extracted, and HBsAg values will be quantified by chemiluminescence assay; samples less than 0.5 ng/ml will be judged as negative.
Measured: 96 weeks
HBsAb conversion rate after 96 weeks of treatment
After 96 weeks of treatment, 5 ml of blood will be drawn from the patient, serum will be extracted, and HBsAb values will be quantified by chemiluminescence; samples greater than 10 miu/ml 0.5 will be judged as positive.
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study startJul 2023 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,084 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital, University of Science and Technology of China, The Second Hospital of Anhui Medical University, Chaohu Hospital of Anhui Medical University, The First Affiliated Hospital of Bengbu Medical University
- Responsible party
- Principal investigator, Yufeng Gao, Anhui Medical University
- Investigators
- Jiabing Li, MD, Study chair, The First Affiliated Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922306
- Sponsor's protocol ID
- LCYJ2021ZD006
- Acronym
- EPCP
- Status last verified
- Jun 2023
- First submitted
- 2 Jun 2023
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective Cohort Study: Efficacy of NA Combined With PEG-IFN-α2b Continuous Versus Pulsed Therapy for 96 Weeks in Patients With Chronic Hepatitis B.
- ClinicalTrials.gov ID
- NCT05922306
- Acronym / sponsor ID
- EPCP / LCYJ2021ZD006
- Conditions
- Hepatitis B, Chronic
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,084 participants (estimated)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital, University of Science and Technology of China, The Second Hospital of Anhui Medical University, Chaohu Hospital of Anhui Medical University, The First Affiliated Hospital of Bengbu Medical University
- Study start
- Jul 2023 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 Jun 2023 (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.
Previous studies have shown that there are alterations in the number and affinity of interferon receptors during interferon therapy and that such alterations recover to varying degrees some time after the end of treatment. It can be conjectured that the rest period of pulsed therapy facilitates the recovery of type I interferon receptors and thus the next round of IFN therapy compared to a continuous regimen of interferon.
Detailed description
A large-sample, multicenter, prospective, real-world study using NAs in combination with PEG-IFN-α-2b for the treatment of CHB patients with continuous or pulsed combination therapy over a course of up to 96 weeks is proposed to compare the differences in clinical cure rates and E antigen conversion rates between groups. Multiple novel markers of hepatitis B infection, including HBV pgRNA, HBcrAg and anti-HBcAb quantification, were dynamically measured at baseline, 12, 24, 48, 72 and 96 weeks to explore the appropriate strategy for achieving clinical cure rates in CHB patients treated with NAs in combination with PEG-IFN-α-2b.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Combination Therapy Cohort | Active comparator | Drug: PEGylated recombinant human interferon alpha-2b injectionPatients with primary CHB with HBsAg ≥ 1500 IU/ml and HBV-DNA < 500 IU/ml and patients with CHB after treatment with NAs will be enrolled. After fully informed consent, pegylated interferon alpha-2b 180µg will be administered by subcutaneous injection once a week for up to 96 weeks. |
| Pulsed Combination Therapy Cohort | Experimental | Drug: PEGylated recombinant human interferon alpha-2b injectionPatients with primary CHB with HBsAg ≥ 1500 IU/ml and HBV-DNA < 500 IU/ml and patients with CHB after treatment with NAs will be enrolled. After fully informed consent, pegylated interferon alpha-2b 180µg will be administered by subcutaneous injection once weekly for 8 weeks of treatment and discontinued for 4 weeks up to 96 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18 to 60 years, both sexes (both 18 and 60 years)
- HBsAg positive for more than 6 months;
- NAs treated patients on continuous NA therapy for more than 6 months with HBsAg ≥ 1500 IU/ml and HBV-DNA < 500 IU/ml at enrolment;
- Primary treated patients with surface antigen >1500 IU, unlimited E antigen and unlimited HBV DNA at enrolment, meeting the treatment indications of the 2019 edition of the guidelines for the prevention and treatment of chronic hepatitis B.
- negative urine or serum pregnancy test within 24 hours prior to the first dose (for women of childbearing age)
Key exclusion criteria (13 listed)
- Combined active hepatitis A, C, D, E and/or HIV infection;
- Patients who are on future and intend to continue to use tibivudine
- methaemoglobin greater than 100ng/ml at screening; or methaemoglobin that has not remained stable for 3 months prior to the trial and/or liver imaging suggestive of liver tumours;
- decompensated liver disease (Child-Pugh score ≥ 7), meaning that patients will be excluded if one of the following is met: prolonged prothrombin time ≥ 3 seconds, serum bilirubin > 34umol/L, history of hepatic encephalopathy, history of oesophageal variceal bleeding, ascites;
- pregnant or lactating women or patients with planned pregnancy during the study period and unwilling to use contraception
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 recombinant human interferon alpha-2b injectionAlso: Nucleotide analoguesContinuous combination therapy: pegylated interferon alpha-2b 180µg, subcutaneously once a week for 96 weeks, combined with NAs throughout the treatment period. | Drug | Continuous Combination Therapy Cohort |
| PEGylated recombinant human interferon alpha-2b injectionAlso: Nucleotide analoguesPulsed combination therapy: pegylated interferon alpha-2b 180µg once weekly by subcutaneous injection for 8 weeks with 4 weeks off for a total treatment duration of 96 weeks, combined with NAs throughout the treatment period. | Drug | Pulsed Combination Therapy Cohort |
Primary outcome
HBsAg negative conversion rate after 96 weeks of treatment
Time frame: 96 weeks
After 96 weeks of treatment, 5 ml of blood will be drawn from the patient, serum will be extracted, and HBsAg values will be quantified by chemiluminescence assay; samples less than 0.5 ng/ml will be judged as negative.
HBsAb conversion rate after 96 weeks of treatment
Time frame: 96 weeks
After 96 weeks of treatment, 5 ml of blood will be drawn from the patient, serum will be extracted, and HBsAb values will be quantified by chemiluminescence; samples greater than 10 miu/ml 0.5 will be judged as positive.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Hepatitis B, Chronic
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
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.
Jiabing Li, MD study chair
The First Affiliated Hospital of Anhui Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing PEGylated recombinant human interferon alpha-2b injection in people with Hepatitis B, Chronic, run by Anhui Medical 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 5 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 28 Jun 2023. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yufeng Gao, MD (13956938032, aygyf@anmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBsAg negative conversion rate after 96 weeks of treatment (time frame: 96 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 28 Jun 2023.