ACT201 Injection in Participants With Chronic Hepatitis B (CHB) on Nucleos(t)Ide Analog Therapy - Phase Ib
Key facts
- Where
- Beijing, Wuhan, Xi'an és Xiamen, KínaSee the 4 sites
- Phase
- 1. fázis
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?
Forrás: NCT07929805: ki vehet részt
Where in Kína
- Beijing Ditan Hospital, Capital Medical UniversityBeijing, KínaNo longer taking part
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, KínaNo longer taking part
- The Second Affiliated Hospital of Xi'an Jiaotong UniversityXi'an, KínaNo longer taking part
- The First Affiliated hospital of Xiamen UniversityXiamen, KínaNo 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?
Trial details
- Who runs it
- Xiamen Amoytop Biotech Co., Ltd.
- Trial code
- NCT07929805
- Record updated
- 2026. november 10.
- 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.