A Phase II Clinical Study of BW-20507 in Combination With PEG-IFNα for the Treatment of Hepatitis B
NCT ID: NCT07135349
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
209 participants
INTERVENTIONAL
2025-09-02
2028-05-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1
BW-20507 with/without NUC
BW-20507 with/without NUC
• BW-20507 with/without NUCs will be administrated for 48 weeks
Cohort 2
BW-20507 with/without NUC, Peg-IFNa
BW-20507 with/without NUC, Peg-IFNa
• BW-20507 with/without NUC will be administrated for 48 weeks, Peg-IFNa will be administrated.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
65 Years
ALL
No
Sponsors
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Shanghai Argo Biopharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Argo Investigative Site
Hefei, Anhui, China
Argo Investigative Site
Beijing, Beijing Municipality, China
Argo Investigative Site
Sichuan, Chengdu, China
Argo Investigative Site
Chongqing, Chongqing Municipality, China
Argo Investigative Site
Chongqing, Chongqing Municipality, China
Argo Investigative Site
Fuzhou, Fujian, China
Argo Investigative Site
Guangzhou, Guangdong, China
Argo Investigative Site
Shenzhen, Guangdong, China
Argo Investigative Site
Zunyi, Guizhou, China
Argo Investigative Site
Changzhou, Jiangsu, China
Argo Investigative Site
Xuzhou, Jiangsu, China
Argo Investigative Site
Nanchang, Jiangxi, China
Argo Investigative Site
Jiangxi, Nanchang, China
Argo Investigative Site
Shanghai, Shanghai Municipality, China
Argo Investigative Site
Chengdu, Sichaun, China
Argo Investigative Site
Chengdu, Sichuan, China
Argo Investigative Site
Zhejiang, Wenzhou, China
Argo Investigative Site
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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BW-20507-2002
Identifier Type: -
Identifier Source: org_study_id
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