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Therapeutic effect of pegylated interferon combined with acupoint-embedding on chronic hepatitis B

A multicenter, randomized, open study: the efficacy of pegylated interferon combined with acupoint-embedding for chronic hepatitis B (zebra study)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027949
Enrollment
Unknown
Registered
2019-12-06
Start date
2019-12-31
Completion date
Unknown
Last updated
2019-12-10

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

Conditions

Chronic hepatitis B

Interventions

Experimental group:pegylated interferon combined with acupoint-embedding
Control group:no

Sponsors

The Second Hospital of Nanjing
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 40 years old, male or female; 2. Nucleoside treatment for more than 24 weeks, and currently receiving nucleoside treatment, HBV DNA cannot be detected; 3. CHB patients with HBsAg positive> 6 months and HBeAg negative or positive; 4. HBsAg =90 g/L; ANC >=1.5x10^9/L; PLT >=80x10^9/L; (2) Biochemical inspection must meet the following standards: TBIL <1.5 ULN; ALT and AST <10 ULN; Serum Cr <=1.25 ULN 6. Women of childbearing age must have taken reliable contraceptive measures or performed a pregnancy test (serum or urine) within 7 days before enrollment, with a negative result. In addition, all men and women of childbearing age are willing to give the test drug during and at the end of the test. The appropriate method of contraception was used after 8 weeks; 7. Participants voluntarily joined the study and signed informed consent, with good compliance and cooperation with follow-up.

Exclusion criteria

Exclusion criteria: 1. pregnant or lactating women; 2. Decompensated liver disease (Child-Pugh score >=5); 3. Contraindications for local treatment of interferon, patients who are allergic to pegylated interferon or NAs; 4. Hepatitis C virus immunoglobulin M antibody, hepatitis C virus RNA or hepatitis C virus antibody, hepatitis D virus antibody or HIV antibody screened positive; 5. Patients diagnosed with liver cancer; 6. In addition to viral hepatitis, have other history or evidence related to chronic liver disease (such as hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure, thalassemia); 7. Patients with hypertension who cannot be reduced to normal range with antihypertensive drugs (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg) have myocardial ischemia or myocardial infarction, arrhythmia (including QT Period >=440 ms) and class II cardiac insufficiency; 8. Factors that significantly affect oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction; 9. Abnormal coagulation function (INR> 1.5 or prothrombin time (PT)> ULN + 4 seconds or APTT> 1.5 ULN), have bleeding tendency or are receiving thrombolytic or anticoagulant therapy; 10. Patients with a history of thyroid disease: poorly controlled prescription drugs, elevated thyroid stimulating hormone (TSH) concentrations, elevated thyroid peroxidase antibodies, and any clinical manifestations of thyroid disease; 11. Those who have a history of psychotropic substance abuse and are unable to quit or have a mental disorder; 12. Participated in clinical trials of other drugs within four weeks; 13. The investigator judges other circumstances that may affect the conduct of clinical research and the determination of research results.

Design outcomes

Primary

MeasureTime frame
HBsAg;

Countries

China

Contacts

Public ContactJianjun Shen

The Second Hospital of Nanjing

zys0243001@163.com+86 13605167616

Outcome results

None listed

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