Status:
RECRUITING
A Phase II Clinical Study of BW-20507 in Combination With PEG-IFNα for the Treatment of Hepatitis B
Lead Sponsor:
Shanghai Argo Biopharmaceutical Co., Ltd.
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
16-65 years
Phase:
PHASE2
Brief 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 Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 8 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07135349
Start Date
September 2 2025
End Date
May 8 2028
Last Update
November 25 2025
Active Locations (18)
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1
Argo Investigative Site
Hefei, Anhui, China, 230022
2
Argo Investigative Site
Beijing, Beijing Municipality, China, 100015
3
Argo Investigative Site
Sichuan, Chengdu, China
4
Argo Investigative Site
Chongqing, Chongqing Municipality, China, 400000