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Active, Not Recruiting

NCT Number: NCT07135349

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Argo Investigative Site, Hefei, Anhui, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BW-20507 with/without NUC

Drug
  • BW-20507 with/without NUCs will be administrated for 48 weeks

BW-20507 with/without NUC, Peg-IFNa

Drug
  • BW-20507 with/without NUC will be administrated for 48 weeks, Peg-IFNa will be administrated.

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.

    Time frame: Week 72

Secondary outcomes

  1. HBsAg changes throughout the study

    Time frame: up to 124 weeks

Sponsors and collaborators

Lead sponsor

Shanghai Argo Biopharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Acronym: HBV

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Aug 22, 2025
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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