Chronic Hepatitis B
Conditions
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
Interventions
DRUGBW-20507 with/without NUC
• BW-20507 with/without NUCs will be administrated for 48 weeks
DRUGBW-20507 with/without NUC, Peg-IFNa
• BW-20507 with/without NUC will be administrated for 48 weeks, Peg-IFNa will be administrated.
Sponsors
Shanghai Argo Biopharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| HBsAg changes throughout the study | up to 124 weeks |
Countries
China
Outcome results
None listed