Hepatitis b cure breakthrough? new combo aims for 50%+ cure rate
NCT ID NCT07573943
First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 4 times
Summary
This study tests a new two-drug combination (ASC22 and Peg-IFNa) to see if it can functionally cure chronic hepatitis B. About 150 adults with low virus levels will receive the treatment. The goal is to raise the cure rate above 50% without needing lifelong medication.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Sign the informed consent form before inclusion and be able to complete the study according to the study requirements 2. From inclusion to 30 days after the last administration of the study drug, male subjects or female subjects of childbearing age are willing to voluntarily take effective contraceptive measures 3. 18-60 years old. The weight of male subjects is not less than 45 kg, and the weight of female subjects is not less than 40 kg. Body mass index (BMI) is within the range of 18-32 kg/m2 4. Serum HBsAg\<100 IU/mL 5. HBV DNA\<20 IU/mL 6. HBeAg-negative Exclusion Criteria: 1. A history of allergy, or who are suspected by the researcher to be allergic to the active ingredient of the drug under study or its excipients 2. Use of inhibitors, inducers or substrates of CYP3A4 within 28 days before enrollment 3. Systematical use of immunosuppressants, immunomodulators (thymosin) and cytotoxic drugs within 6 months before enrollment, or vaccination of live attenuated vaccine within 1 month before enrollment 4. Acute infection within 2 weeks before enrollment which requires intravenous antibiotic treatment, or existing infection which requires anti-infection treatment when enrollment 5. Clinically significant acute and chronic liver disease not caused by HBV infection (judged by reseachers) 6. Confirmed or suspected decompensated cirrhosis, including but not limited to: hepatic encephalopathy, hepatorenal syndrome, bleeding from esophageal varices, splenomegaly, ascites, etc, or evidence of progressive liver fibrosis 7. Primary liver cancer, or alpha-fetoprotein (AFP) is greater than 50 ug/L or imaging suggests the possibility of malignant liver lesions, or other malignant tumors or a history of other malignant tumors within 5 years before enrollment (except that the malignant tumors have been completely relieved after treatment and patients have not received additional medical or surgical intervention within 3 years before screening) 8. A history of pathological fracture or osteoporosis 9. Gastrointestinal dysfunction or gastrointestinal diseases that might affect the absorption of oral drugs, such as severe gastric ulcer, erosive gastritis, partial gastrectomy, and persistent gastrointestinal symptoms (such as nausea, vomiting, or diarrhea) \>2 grades 10. Serious diseases of circulatory, respiratory, urinary, blood, metabolic, immune, mental, neurological, renal and other systems 11. Major trauma or major surgery within 3 months before enrollment, or planned surgery during the study period 12. Blood donation/loss ≥ 400 mL within 3 months before enrollment, or given a blood transfusion within 3 months before enrollment, or blood donation/loss ≥ 200 mL within 1 month before enrollment 13. Platelet count\<90 × 10\^9/L, white blood cell count\<3.0 × 10\^9/L, neutrophil count\<1.3 × 10\^9/L, total serum bilirubin\>2 × ULN, albumin\<30 g/L, creatinine clearance ≤ 60 mL/min (calculated by CKD-EPI formula), or international normalized ratio of prothrombin time (INR)\>1.5 (unless receiving stable anticoagulant therapy) 14. HCV antibody (+), HIV antigen/antibody (+), or treponema pallidum antibody (+) and RPR test (+) 15. A history of continuous alcohol abuse within 3 years before enrollment (average daily alcohol consumption exceeds 20 gram) 16. A history of drug dependence or drug abuse within 1 year before enrollment 17. Those who have participated in clinical trials of other investigational drugs or medical devices and taken investigational drugs or used medical devices within 3 months before enrollment 18. Female in suckling period or pregnancy test (+) during screening 19. Subjects who are considered by the researcher to have other factors that are not suitable for the study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The 2nd affiliated Hospital of Chongqing Medical University
RECRUITINGChongqing, Chongqing Municipality, 400010, China
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Other studies related to the condition(s) this trial covers.
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- Can a newer hepatitis b drug protect babies while being gentler on their bones?
- CRISPR 'Brake Release' may reawaken immune cells to beat hepatitis b
- Can a vaccine teach the immune system to fight hepatitis b?