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A Multi-Center, Prospective, Randomized, Double-Blind Clinical Study of the Efficacy and Safety of a Sequential Combination of Peginterferon a-2b with Washed Intestinal Microbiota Transplantation for the Treatment of HBeAg-Negative Chronic Hepatitis B

A Multi-Center, Prospective, Randomized, Double-Blind Clinical Study of the Efficacy and Safety of a Sequential Combination of Peginterferon a-2b with Washed Intestinal Microbiota Transplantation for the Treatment of HBeAg-Negative Chronic Hepatitis B

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104235
Enrollment
Unknown
Registered
2025-06-13
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic hepatitis B

Interventions

Study Group:The study group continued the original Peg-IFN-a-2b and/or nucleoside antiviral regimen plus wash-grade enteric bacterial capsule(50 ml/time, once every 4 weeks, no more than 3 times)
Control group:Peg-ifn-a-2b and/or nucleoside antiviral regimens are supplemented with a placebo

Sponsors

The First Affiliated Hospital of Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients with chronic hepatitis B (CHB-RRB- who were willing to sign an informed consent form; according to the diagnostic criteriaCHB CHB in the guidelines for the prevention and treatment of chronic hepatiBis b (2022 edition) : chronic inflammatory disease of the liver caused by persistHBV HBV infection; 2. Age 18-60 years; 3. HBeAg-negative CHB treated with Peg-IFN-a-2b or NAs alone in combination with Peg-IFN-a-2b antiviral Patients, regularly treated for 24 weeks or more, currently 0.05 IU/ml<= HBsAg <500 IU/ml, or HBsAg<0.05 IU/ml but Anti-HBs<10 IU/ml; 4. No contraindications for interferon treatment, willing to continue Peg-IFN-a-2b treatment and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. HIV infection, Hepatitis A, C, D, E virus infection, drug-induced liver disease, alcoholic liver disease, autoimmune diseases, etc. 2. Patients who fail to receive regular treatment for reasons such as intolerance of interferon side effects or compliance. 3. Patients with liver cancer, lung cancer, lymphoma and other malignant tumors; 4. Pregnant or lactating women 5. Oral or intravenous antimicrobial agents 6. Blood CD4 + cells were less than 200 × 10^6/ml.

Design outcomes

Primary

MeasureTime frame
HBsAg Clearance;

Secondary

MeasureTime frame
HBsAb positive conversion rate;

Countries

China

Contacts

Public ContactPan Jinshui

The First Affiliated Hospital of Fujian Medical University

363111396@qq.com+86 136 6608 3256

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026