Chronic Hepatitis BPhase 2HBVNCT07135349
A Phase II Clinical Study of BW-20507 in Combination With PEG-IFNα for the Treatment of Hepatitis B
A Phase 2 study testing BW-20507 with/without NUC and BW-20507 with/without NUC, Peg-IFNa in people with Chronic Hepatitis B, run by Shanghai Argo Biopharmaceutical Co., Ltd. at 18 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- BW-20507 with/without NUC and BW-20507 with/without NUC, Peg-IFNa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 18 sitesChina
- Study dates
- 2 Sep 2025to 8 May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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 locations and contacts
18 sites in 1 country.
18 sites in 1 country
China18 sites
Argo Investigative Site
Beijing, Beijing Municipality, 100015
Argo Investigative Site
Changzhou, Jiangsu, 213000
Argo Investigative Site
Chengdu, Sichaun, 610041
Argo Investigative Site
Chengdu, Sichuan, 610041
Argo Investigative Site
Chongqing, Chongqing Municipality, 400000
Argo Investigative Site
Chongqing, Chongqing Municipality
Argo Investigative Site
Fuzhou, Fujian, 350000
Argo Investigative Site
Guangzhou, Guangdong, 510515
Argo Investigative Site
Hangzhou, Zhejiang, 310000
Argo Investigative Site
Hefei, Anhui, 230022
Argo Investigative Site
Jiangxi, Nanchang
Argo Investigative Site
Nanchang, Jiangxi, 330000
Argo Investigative Site
Shanghai, Shanghai Municipality, 2000001
Argo Investigative Site
Shenzhen, Guangdong, 518000
Argo Investigative Site
Sichuan, Chengdu
Argo Investigative Site
Xuzhou, Jiangsu, 22100
Argo Investigative Site
Zhejiang, Wenzhou
Argo Investigative Site
Zunyi, Guizhou, 563000
About this study
Official 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
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
- Conditions
- Chronic Hepatitis B
- Being tested
- BW-20507 with/without NUC, BW-20507 with/without NUC, Peg-IFNa
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BW-20507 with/without NUCDrug
- BW-20507 with/without NUCs will be administrated for 48 weeks
BW-20507 with/without NUC, Peg-IFNaDrug
- BW-20507 with/without NUC will be administrated for 48 weeks, Peg-IFNa will be administrated.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | BW-20507 with/without NUC Receives: Drug: BW-20507 with/without NUC |
| Cohort 2 | Experimental | BW-20507 with/without NUC, Peg-IFNa Receives: Drug: BW-20507 with/without NUC, Peg-IFNa |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 72
Secondary outcomes (1)
HBsAg changes throughout the study
Measured: up to 124 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start2 Sep 2025
- Primary completion7 Jun 2026 (estimated)
- Study completion8 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Argo Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135349
- Sponsor's protocol ID
- BW-20507-2002
- Acronym
- HBV
- Status last verified
- Jan 2026
- First submitted
- 8 Aug 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07135349
- Acronym / sponsor ID
- HBV / BW-20507-2002
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Shanghai Argo Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- 7 Jun 2026 (estimated)
- Study completion
- 8 May 2028 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: BW-20507 with/without NUCBW-20507 with/without NUC |
| Cohort 2 | Experimental | Drug: BW-20507 with/without NUC, Peg-IFNaBW-20507 with/without NUC, Peg-IFNa |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BW-20507 with/without NUC• BW-20507 with/without NUCs will be administrated for 48 weeks | Drug | Cohort 1 |
| BW-20507 with/without NUC, Peg-IFNa• BW-20507 with/without NUC will be administrated for 48 weeks, Peg-IFNa will be administrated. | Drug | Cohort 2 |
Primary outcome
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
1 secondary outcome
HBsAg changes throughout the study
Time frame: up to 124 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BW-20507 with/without NUC and BW-20507 with/without NUC, Peg-IFNa in people with Chronic Hepatitis B, run by Shanghai Argo Biopharmaceutical Co., Ltd. at 18 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.