NCT07135349Active, not recruitingPhase 2
A Phase II Clinical Study of BW-20507 in Combination With PEG-IFNα for the Treatment of Hepatitis B
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
Source: ClinicalTrials.gov · Last updated 15 Jan 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 209 (actual)
- First submitted
- 8 Aug 2025
- Start date
- 2 Sept 2025
- Primary completion date
- 7 Jun 2026
- Lead sponsor
- Shanghai Argo Biopharmaceutical Co., Ltd.
- Diseases
- Hepatitis B
- NCT number
- NCT07135349
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 209
- From 2 Sept 2025 to the primary completion date, 7 Jun 2026
- 16 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant clinically significant other liver diseases
- Previous/current manifestations of hepatic decompensation
- 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
Other illness
- History of acute or chronic renal insufficiency
- Participants with a history of malignancy or who are being evaluated for a possible malignancy
- Serious mental illness or history
- Suspected history of allergy to any component of the study drug
- Any other circumstance or condition that, in the opinion of the investigator, the participants are inappropriate for participation in the study
Other
- Clinically significant abnormalities
- Significant liver fibrosis or cirrhosis at screening, or a liver stiffness value (LSM) \> 9.0 kPa
- Significant abnormal ECG at screening
- Thyroid dysfunction or DM
Who the study is looking for
- 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
Age in the registry: 16 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.