BW-20507 with/without NUC: • BW-20507 with/without NUCs will be administrated for 48 weeks
BW-20507 with/without NUC, Peg-IFNa: • BW-20507 with/without NUC will be administrated for 48 weeks, Peg-IFNa will be administrated.
Study summary
This is a randomized, open-label, multicenter phase II study to evaluate the efficacy and safety of BW-20507 in combination with PEG-IFNα in CHB patients
Eligibility
Sex
ALL
Min age
16 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* Participants must sign ICF and are able to complete the procedures as planned for this study.
* Males or females aged 18 to 65 (inclusive) when signing informed consent
* Body mass index (BMI) arranges 18.5 to 32.0 kg/m2 (inclusive)
* Participants must be diagnosed with chronic hepatitis B infection: HBsAg positivity at least 6 months (need documents)
* NUC treatment history and screening status of HBV DNA, HBeAg, HBsAg, and ALT must meet the requirements for different cohorts.
* Males of reproductive potential or females of childbearing potential must agree to utilize reliable contraception, refrain from childbearing plan, and will not donate sperm or eggs during the study
Exclusion Criteria:
* Clinically significant abnormalities
* Significant liver fibrosis or cirrhosis at screening, or a liver stiffness value (LSM) \> 9.0 kPa
* Concomitant clinically significant other liver diseases
* Previous/current manifestations of hepatic decompensation
* History of acute or chronic renal insufficiency
* Significant abnormal ECG at screening
* Participants with a history of malignancy or who are being evaluated for a possible malignancy
* Serious mental illness or history
* Thyroid dysfunction or DM
* Suspected history of allergy to any component of the study drug
* Those who are participating in another clinical study, or have not undergone a protocol-specified washout period prior to this study
* Protocol-specified prohibited therapies usage
* Received any antisense oligonucleotides (ASO) or small molecule interfering ribonucleic acid (siRNA) drug
* Any other circumstance or condition that, in the opinion of the investigator, the participants are inappropriate for participation in the study
Primary outcome measure(s)
1. The proportion of participants who meet the NUC discontinuation criteria at Week 72 in participants with baseline HBsAg ⩽ 3000 IU/mL and HBeAg-negative. — Week 72
Trial sites (18)
Facility
City
Region
Status
Argo Investigative Site
Hefei
Anhui
Argo Investigative Site
Beijing
Beijing Municipality
Argo Investigative Site
Sichuan
Chengdu
Argo Investigative Site
Chongqing
Chongqing Municipality
Argo Investigative Site
Chongqing
Chongqing Municipality
Argo Investigative Site
Fuzhou
Fujian
Argo Investigative Site
Guangzhou
Guangdong
Argo Investigative Site
Shenzhen
Guangdong
Argo Investigative Site
Zunyi
Guizhou
Argo Investigative Site
Changzhou
Jiangsu
Argo Investigative Site
Xuzhou
Jiangsu
Argo Investigative Site
Nanchang
Jiangxi
Argo Investigative Site
Jiangxi
Nanchang
Argo Investigative Site
Shanghai
Shanghai Municipality
Argo Investigative Site
Chengdu
Sichaun
Argo Investigative Site
Chengdu
Sichuan
Argo Investigative Site
Zhejiang
Wenzhou
Argo Investigative Site
Hangzhou
Zhejiang
More Shanghai Argo Biopharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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