A Phase II Clinical Study of BW-20507 in Combination With PEG-IFNα for the Treatment of Hepatitis B
HBV
A Multi-center, Randomized, Open-label, Phase II Study to Evaluate the Efficacy and Safety of BW-20507 Injection Combined With Pegylated Interferon Alfa in Patients With Chronic Hepatitis B Infection
1 other identifier
interventional
209
1 country
18
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2025
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2025
CompletedFirst Posted
Study publicly available on registry
August 22, 2025
CompletedStudy Start
First participant enrolled
September 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 7, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 8, 2028
January 15, 2026
January 1, 2026
9 months
August 8, 2025
January 14, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
HBsAg changes throughout the study
up to 124 weeks
Study Arms (2)
Cohort 1
EXPERIMENTALBW-20507 with/without NUC
Cohort 2
EXPERIMENTALBW-20507 with/without NUC, Peg-IFNa
Interventions
• BW-20507 with/without NUCs will be administrated for 48 weeks
• BW-20507 with/without NUC will be administrated for 48 weeks, Peg-IFNa will be administrated.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Argo Investigative Site
Hefei, Anhui, 230022, China
Argo Investigative Site
Beijing, Beijing Municipality, 100015, China
Argo Investigative Site
Sichuan, Chengdu, China
Argo Investigative Site
Chongqing, Chongqing Municipality, 400000, China
Argo Investigative Site
Chongqing, Chongqing Municipality, China
Argo Investigative Site
Fuzhou, Fujian, 350000, China
Argo Investigative Site
Guangzhou, Guangdong, 510515, China
Argo Investigative Site
Shenzhen, Guangdong, 518000, China
Argo Investigative Site
Zunyi, Guizhou, 563000, China
Argo Investigative Site
Changzhou, Jiangsu, 213000, China
Argo Investigative Site
Xuzhou, Jiangsu, 22100, China
Argo Investigative Site
Nanchang, Jiangxi, 330000, China
Argo Investigative Site
Jiangxi, Nanchang, China
Argo Investigative Site
Shanghai, Shanghai Municipality, 2000001, China
Argo Investigative Site
Chengdu, Sichaun, 610041, China
Argo Investigative Site
Chengdu, Sichuan, 610041, China
Argo Investigative Site
Zhejiang, Wenzhou, China
Argo Investigative Site
Hangzhou, Zhejiang, 310000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2025
First Posted
August 22, 2025
Study Start
September 2, 2025
Primary Completion (Estimated)
June 7, 2026
Study Completion (Estimated)
May 8, 2028
Last Updated
January 15, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share