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Clinical Trials in China / NCT07135349
Active, not recruiting Phase 2

A Phase II Clinical Study of BW-20507 in Combination With PEG-IFNα for the Treatment of Hepatitis B

NCT07135349 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Argo Biopharmaceutical Co., Ltd.
Phase
Phase 2
Started
2025-09-02
Last updated
2026-01-15

Condition(s) studied

Chronic Hepatitis B

Investigational drug(s) / intervention(s)

BW-20507 with/without NUCBW-20507 with/without NUC, Peg-IFNa

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)

Trial sites (18)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT07135349 on ClinicalTrials.gov ↗ ← All trials in China