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

Shanghai Argo Biopharmaceutical Co., Ltd.

Status and phase: Begins enrollment this month; Phase 2

Conditions: Chronic Hepatitis B

Treatments: Drug: BW-20507 with/without NUC, Peg-IFNa; Drug: BW-20507 with/without NUC

Study type: Interventional

Funder types: Industry

Identifiers

NCT07135349

BW-20507-2002

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Cohort 1

Experimental group

Description:

BW-20507 with/without NUC

Treatment:

Drug: BW-20507 with/without NUC

Cohort 2

Experimental group

Description:

BW-20507 with/without NUC, Peg-IFNa

Treatment:

Drug: BW-20507 with/without NUC, Peg-IFNa