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AzTrials

Chronic Hepatitis BPhase 2NCT07845058

A Novel Combination Therapeutic Strategy Aiming to Functional Cure for Chronic Hepatitis B Virus Infection (B)

A Phase 2 study testing anti-PD-1/anti-PD-L1 antibody, NAs and PEG-IFNα in people with Chronic Hepatitis B and Anti-PD-1 Antibody, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Hepatitis B virus (HBV) infection is a major public health threat in China. At present, a functional cure, also known as clinical cure or sustained Hepatitis B surface antigen (HBsAg) loss, is recommended as the ideal endpoint of HBV treatment. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
anti-PD-1/anti-PD-L1 antibody, NAs and PEG-IFNα
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,200 participants
Where
1 siteChina
Study dates
10 Oct 2023to 31 Dec 2026
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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Sign the informed consent form before inclusion and be able to complete the study according to the study requirements;
  • 18-60 years old.
  • NAs-naive/NAs-experienced CHB patients.

Who cannot join

  • A history of allergy, or who are suspected by the researcher to be allergic to the active ingredient of the drug under study or its excipients;
  • Use of inhibitors, inducers or substrates of CYP3A4 within 28 days before enrollment;
  • Systematical use of immunosuppressants, immunomodulators (thymosin) and cytotoxic drugs within 6 months before enrollment, or vaccination of live attenuated vaccine within 1 month before enrollment;
  • Acute infection within 2 weeks before enrollment which requires intravenous antibiotic treatment, or existing infection which requires anti-infection treatment when enrollment;
  • Clinically significant acute and chronic liver disease not caused by HBV infection (judged by reseachers);
  • Confirmed or suspected decompensated cirrhosis, including but not limited to: hepatic encephalopathy, hepatorenal syndrome, bleeding from esophageal varices, splenomegaly, ascites, etc, or evidence of progressive liver fibrosis;
Show all 19Show fewer
  • Primary liver cancer, or alpha-fetoprotein (AFP) is greater than 50 ug/L or imaging suggests the possibility of malignant liver lesions, or other malignant tumors or a history of other malignant tumors within 5 years before enrollment (except that the malignant tumors have been completely relieved after treatment and patients have not received additional medical or surgical intervention within 3 years before screening);
  • A history of pathological fracture or osteoporosis;
  • Gastrointestinal dysfunction or gastrointestinal diseases that might affect the absorption of oral drugs, such as severe gastric ulcer, erosive gastritis, partial gastrectomy, and persistent gastrointestinal symptoms (such as nausea, vomiting, or diarrhea) >2 grades;
  • Serious diseases of circulatory, respiratory, urinary, blood, metabolic, immune, mental, neurological, renal and other systems;
  • Major trauma or major surgery within 3 months before enrollment, or planned surgery during the study period;
  • Blood donation/loss ≥ 400 mL within 3 months before enrollment, or given a blood transfusion within 3 months before enrollment, or blood donation/loss ≥ 200 mL within 1 month before enrollment;
  • Platelet count<90 × 10^9/L, white blood cell count<3.0 × 10^9/L, neutrophil count<1.3 × 10^9/L, total serum bilirubin>2 × upper limit of normal (ULN), albumin<30 g/L, creatinine clearance ≤ 60 mL/min (calculated by CKD-EPI formula), or international normalized ratio of prothrombin time (INR)>1.5 (unless receiving stable anticoagulant therapy);
  • Hepatitis C virus (HCV) antibody (+), HIV antigen/antibody (+), or treponema pallidum antibody (+) and rapid plasma regain (RPR) test (+);
  • A history of continuous alcohol abuse within 3 years before enrollment (average daily alcohol consumption exceeds 20 gram);
  • A history of drug dependence or drug abuse within 1 year before enrollment;
  • Those who have participated in clinical trials of other investigational drugs or medical devices and taken investigational drugs or used medical devices within 3 months before enrollment;
  • Female in suckling period or pregnancy test (+) during screening;
  • Subjects who are considered by the researcher to have other factors that are not suitable for the study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dachuan Cai, MD contact

+86 18323409779

cqmucdc@cqmu.edu.cn

Min Chen, PhD contact

+86 17338600343

mchen@hospital.cqmu.edu.cn

China1 site, 1 recruiting

  • The 2nd affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400010

    HONG REN, +8613983888786, renhong0531@vip.sina.com

    DACHUAN CAI, +8618323409779, cqmucdc@cqmu.edu.cn

    Recruiting

Other trials in China

About this study

Hepatitis B virus (HBV) infection is a major public health threat in China. At present, a functional cure, also known as clinical cure or sustained Hepatitis B surface antigen (HBsAg) loss, is recommended as the ideal endpoint of HBV treatment. However, HBsAg loss can be achieved in less than 10% of chronic hepatitis B (CHB) patients treated with current available antiviral drug interferon (IFNα) or nucleos(t)ide analogues (NAs) monotherapy. With the support of the national major special funding for infectious diseases from "11th Five-Year Plan" to "13th Five-Year Plan", we have implemented a pioneer clinical study of sequential combination of IFNα therapy on NAs to treat NAs-treated CHB patients (ie. New Switch Study). This is the world's first clinical trial aiming to functional cure, which increased the rate of HBsAg loss to 15% in the overall population in our study, and to 30-50% among those with lower baseline HBsAg levels. How to further improve the HBsAg loss rate is an urgent issue for us. The key point of achieving functional cure is to reverse the HBV-specific T cell exhaustion and establish the long-term immune control against HBV infection. (Programmed death-1) PD-1/programmed death-ligand 1 (PD-L1) axis blockade has been demonstrated to reinvigorate exhausted CD8+ T cells, and would be a potential strategy to treat chronic HBV infection. In this study, a large multicenter prospective study will be performed to explore the safety and efficacy of a novel combination strategy involving immune checkpoint inhibitor (anti-PD-1/anti-PD-L1 antibody) and IFNα in CHB patients, observe the HBsAg loss rate in NA-treated CHB patients receiving this combination strategy, evaluate the potential of breaking immune tolerance by this strategy, and further assess its efficacy to further improve the clinical cure rate on the basis of New Switch Study. Based on New Switch Study, this study further attempts to reverse T cell exhaustion in CHB patients, explore a novel platform of combination therapy development for clinical cure, and ultimately increase the HBsAg loss rate to higher than 50% in overall patients. The implementation of the project is expected to reduce the burden of HBV infection in China and contribute to the goal of global elimination of hepatitis B and C by 2030 (WHO 2030).

Being tested
anti-PD-1/anti-PD-L1 antibody, NAs, PEG-IFNα
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.

  • anti-PD-1/anti-PD-L1 antibodyDrug

    Once/two or three weeks, dose lower than the dose used in cancer patients, subcutaneous/intravenous injection

  • NAsDrug

    Once/day, 1 capsule/time, oral

  • PEG-IFNαDrug

    Once/week, 180μg/time, subcutaneous injection

Study groups in NCT07845058
Study groupRoleWhat they receive
Group 1ExperimentalNAs combined with anti-PD-1/anti-PD-L1 antibody and Peg-IFNα
Receives: Drug: anti-PD-1/anti-PD-L1 antibody; Drug: NAs; Drug: PEG-IFNα
Group 2Active comparatorNAs combined with Peg-IFNα
Receives: Drug: NAs; Drug: PEG-IFNα

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum HBsAg

    Serum HBsAg level

    Measured: Baseline

  2. Serum HBsAg

    Serum HBsAg level

    Measured: 24 weeks after the treatment

  3. Serum HBsAg

    Serum HBsAg level

    Measured: 48 weeks after the treatment

  4. Serum HBsAg

    Serum HBsAg level

    Measured: 24 weeks after the end of treatment

  5. Serum HBV DNA

    Serum HBV DNA level

    Measured: Baseline

  6. Serum HBV DNA

    Serum HBV DNA level

    Measured: 24 weeks after the treatment

  7. Serum HBV DNA

    Serum HBV DNA level

    Measured: 48 weeks after the treatment

  8. Serum HBV DNA

    Serum HBV DNA level

    Measured: 24 weeks after the end of treatment

  9. Serum alanine aminotransferase (ALT)

    Serum ALT level

    Measured: Baseline

  10. Serum alanine aminotransferase (ALT)

    Serum ALT level

    Measured: 24 weeks after the treatment

  11. Serum alanine aminotransferase (ALT)

    Serum ALT level

    Measured: 48 weeks after the treatment

  12. Serum alanine aminotransferase (ALT)

    Serum ALT level

    Measured: 24 weeks after the end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2026
  2. Study start10 Oct 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07845058
Sponsor's protocol ID
2025-0216
Status last verified
Sep 2026
First submitted
22 Sep 2026
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing anti-PD-1/anti-PD-L1 antibody, NAs and PEG-IFNα in people with Chronic Hepatitis B and Anti-PD-1 Antibody, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site 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 3 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Contact Dachuan Cai, MD (+86 18323409779, cqmucdc@cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum HBsAg (time frame: Baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07845058.

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 28 Sep 2026.

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