An interventional study of Peginterferon α-2b based injection in Chronic Hepatitis b, sponsored by Xiamen Hospital of Traditional Chinese Medicine. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-04-09.
Sponsored by Xiamen Hospital of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment
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Among 375 studies in Hepatitis B, Chronic with a site in China — 89 open to participants now, 110 under way, 7 of them phase 3. Hepatitis B, Chronic · China.
Among the 375 studies in Hepatitis B, Chronic with a site in China, this one is the 247th largest by planned enrollment of the 273 interventional ones that give a count, is one of 23 that started in 2025, is one of 42 with no phase, reaches primary completion later than 80 of the 109 other live ones, and was the 316th registered.
895 studies on the registry are indexed under Hepatitis B, Chronic; 153 are open to participants now.
Browse Hepatitis B, Chronic studies →89 of the 375 studies in Hepatitis B, Chronic with a site in China are open now. Recruiting first, the newest first:
Jiyan Liu · Sites in China
Ages 18–65
Fujian Shengdi Pharmaceutical Co., Ltd. · Sites in China
Ages 18+
Fujian Akeylink Biotechnology Co., Ltd. · Sites in China
Ages 35–65
Ausper Biopharma Co., Ltd. · Sites in China
Ages 18–65 · Healthy volunteers
Zhiliang Gao · Sites in China
Ages 18–65 · Healthy volunteers
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 97 Hepatitis B, Chronic studies recruiting now, 33 (34%) set no upper age limit and 59 (61%) stop at 75 or younger; 11 take children under 18; 13 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
375 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 62 · Phase 2 85 · Phase 3 27 · Phase 4 73
First in 2000; this study’s year is marked. 23 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 30 is below the median of 100 across 659 interventional studies indexed under Hepatitis B, Chronic.
Median enrollment 120 across the 273 interventional studies, 500 across the 99 observational. Of the 151 that completed or were terminated, 29 (19%) have results posted.
This tab as a report to print or save as PDF → With an account.
167 of 375 have an industry lead sponsor. The 10 most frequent:
Xiamen Hospital of Traditional Chinese Medicine is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Xiamen Hospital of Traditional Chinese Medicine has 1 study filed under Hepatitis B, Chronic — fewer than ten, so there is no comparison to draw.
39 of the studies in Hepatitis B, Chronic with a site in China that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07090759Phase 3Fujian Akeylink Biotechnology Co., Ltd.To Evaluate the Efficacy, Safety and Population Pharmacokinetics of GST-HG141 in Patients With Chronic Hepatitis B (CHB) Who Have an Inadequate Response to Antiviral Drug Treatment | 2026-12-01 |
| NCT07246889Phase 3Ausper Biopharma Co., Ltd.Study of AHB-137 in Participants With Chronic Hepatitis B (CHB) Treated With Nucleos(t)Ide Analogues (NAs)(AUSHINE) | 2026-12-18 |
| NCT07307586Phase 3Zhigang RenA Small Sample Prospective Clinical Study of Azvudine Tablets to Promote Clinical Cure in Patients With Chronic Hepatitis B | 2026-12-31 |
| NCT07203118Phase 3Xi'an Xintong Pharmaceutical Research Co.,Ltd.A Phase II/III of Hepenofovir Fumarate Tablets (HTS) for Chronic Hepatitis B | 2027-06-30 |
| NCT02863757Humanity and Health Research CentreFollow-up of Chronic Hepatitis B Patients With Comorbid Nonalcoholic Fatty Liver Disease | 2026-12 |
Add all 39 to your calendar (.ics) → With an account.
Among the 375 studies in Hepatitis B, Chronic with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a single-center, prospective, exploratory clinical study. The study plans to enroll 30 chronic hepatitis B (CHB) patients which achieved HBsAg clearance based peginterferon α-2b treatment. Eligible subjects will receive either 12-24 weeks interferon consolidation therapy (180μg administered subcutaneously in the abdomen or thigh once weekly) or not according to physician's recommendation and patient's preference, with regular follow-up for HBV recurrence. Patients will be followed up every 12 weeks. The study will evaluate changes in intrahepatic covalently closed circular DNA (cccDNA) and peripheral blood HBV pregenomic RNA (pgRNA) levels after achieving HBsAg clearance.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Peginterferon α-2b based injection
Peginterferon α-2b injection, 180 μg administered subcutaneously in the abdomen or thigh once weekly, with regular follow-up for HBV recurrence. Patients will be followed up every 12 weeks.
Changes in intrahepatic cccDNA and peripheral blood pgRNA levels
Time frame: baseline to week48
Clearance rate of intrahepatic cccDNA
Time frame: week48
Correlation between changes in intrahepatic cccDNA levels and interferon consolidation therapy
Time frame: baseline to week48
Correlation between changes in peripheral blood pgRNA levels and interferon consolidation therapy
Time frame: baseline to week48
Correlation between intrahepatic cccDNA clearance and interferon consolidation therapy
Time frame: week48
Changes in intrahepatic cccDNA levels
Time frame: baseline to week48
Changes in intrahepatic HBsAg levels
Time frame: baseline to week48
intrahepatic HBsAg clearance rate
Time frame: baseline、week48
Histopathological scores in hepatic inflammation and fibrosis
Time frame: baseline、week48
Recurrence rate
Time frame: baseline to week48
Adverse Event#AE#
Time frame: baseline to week48
Start is estimated for Apr 2025; primary completion for Dec 2027, 32 months later.
Of 42 interventional studies with no phase under Hepatitis B, Chronic, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 121. This study's planned 32 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Xiamen Hospital of Traditional Chinese Medicine