ACT201 injection added to usual treatment for chronic hepatitis B
Tests ACT201 injection with standard therapy in adults with chronic hepatitis B.
Plain-language title generated from the registry record
Registry title: ACT201 Injection in Participants With Chronic Hepatitis B (CHB) on Nucleos(t)Ide Analog Therapy - Phase Ib
Key facts
- Where
- Beijing, Wuhan, Xi'an, and Xiamen, ChinaSee the 4 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 65 with chronic hepatitis B who are on steady nucleos(t)ide analogue (NA) therapy and have low virus levels.
- Age
- 18 to 65 years
- Sex
- Men and women
- Disease stage
- Chronic hepatitis B (HBsAg-positive or HBV DNA-positive for at least 6 months). Summary: HBV DNA < 100 IU/mL, HBeAg negative, HBsAg ≤ 100 IU/mL.
- Earlier treatment
- Must be on stable nucleos(t)ide analogue (NA) therapy at screening. Must not have received prohibited study drugs, and must have finished any washout period set by the protocol.
- Biomarker or test result
- HBsAg-positive or HBV DNA-positive for at least 6 months; HBV DNA < 100 IU/mL, negative HBeAg, HBsAg ≤ 100 IU/mL. Body mass index 18 to 32 kg/m².
Main reasons for not taking part
- History of other liver disease, liver cirrhosis or liver decompensation
- History of cancer or a suspected malignant liver lesion
- Past solid organ or bone marrow transplant
- Breastfeeding, or a positive pregnancy test at screening
- Severe psychiatric or severe eye disease
Read by machine on 11 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07929805, who can take part
Where in China
- Beijing Ditan Hospital, Capital Medical UniversityBeijing, ChinaNo longer taking part
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaNo longer taking part
- The Second Affiliated Hospital of Xi'an Jiaotong UniversityXi'an, ChinaNo longer taking part
- The First Affiliated hospital of Xiamen UniversityXiamen, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Xiamen Amoytop Biotech Co., Ltd.
- Trial code
- NCT07929805
- Record updated
- 10 November 2026
- Original description
This is a multicenter, randomized, open-label, parallel-controlled Phase Ib clinical trial. It aims to evaluate the safety and preliminary efficacy of ACT201 Injection combined with standard therapy (PegIFNα, NA) in participants with chronic hepatitis B who are receiving NA treatment. A total of 40 participants with chronic hepatitis B will be enrolled. Eligible participants should have stable NA treatment, HBV DNA < 100 IU/mL, negative HBeAg, and HBsAg ≤ 100 IU/mL. They will be randomized into four treatment groups at a 1:1:1:1 ratio.Read full original descriptionShow less
A Multicenter, Randomized, Open-label Phase Ib Clinical Trial to Evaluate the Safety and Efficacy of ACT201 Injection in Participants With Chronic Hepatitis B (CHB) Receiving Nucleos(t)Ide Analog Therapy
This is a multicenter, randomized, open-label, parallel-controlled Phase Ib clinical trial. It aims to evaluate the safety and preliminary efficacy of ACT201 Injection combined with standard therapy (PegIFNα, NA) in participants with chronic hepatitis B who are receiving NA treatment. A total of 40 participants with chronic hepatitis B will be enrolled. Eligible participants should have stable NA treatment, HBV DNA < 100 IU/mL, negative HBeAg, and HBsAg ≤ 100 IU/mL. They will be randomized into four treatment groups at a 1:1:1:1 ratio.
Inclusion: Voluntarily participate in this trial and sign the informed consent form; Aged 18 to 65 years (inclusive), male or female; Body mass index (BMI) ranging from 18 to 32 kg/m² (inclusive); HBsAg-positive or HBV DNA-positive for at least 6 months, or with prior liver biopsy results consistent with chronic HBV infection, or HBsAg-positive and anti-HBc IgM-negative at screening; Receiving stable nucleos(t)ide analogue (NA) therapy at screening; Meeting the specified requirements for HBsAg, HBeAg, HBV DNA and liver function parameters; Willing to use effective contraception with no plan to conceive, donate sperm or donate ova.
Exclusion: Subjects who have sustained major trauma or undergone major surgery recently, or have a planned surgery; Subjects with prior or current manifestations of hepatic decompensation; Subjects with prior solid organ or bone marrow transplantation; Subjects who have received prohibited study drugs previously or currently; Subjects with concomitant hematological diseases; Subjects participating in another clinical trial, or those who have not completed the washout period specified in the protocol prior to this trial; Subjects with uncontrolled, clinically significant abnormalities or other severe illnesses in addition to chronic HBV infection; Subjects with a history of other liver diseases; Subjects with a history of liver cirrhosis; Subjects with imaging findings suggestive of a suspected malignant hepatic lesion; Subjects with a history of extrahepatic diseases potentially associated with HBV immune status; Subjects with other diseases associated with vasculitis; Subjects with infections (other than HBV) requiring systemic antiviral or antibacterial therapy at screening; Subjects with a history of malignancy; Subjects with current or past history of severe psychiatric disorders; Subjects with severe retinopathy or other severe ophthalmologic diseases; Subjects with a history of allergy; Any other condition that, in the opinion of the investigator, renders the subject unsuitable for participation in this trial; Subjects with abnormal laboratory findings; Subjects who are breastfeeding or have a positive serum pregnancy test at screening; Subjects with abnormal QTcF interval.