Safety and efficacy of a therapeutic hepatitis B vaccine

Multi-center, randomized, double-blinded, placebo controlled clinical trial on the safety and efficacy of a therapeutic hepatitis B vaccine (YIC)in treating HBeAg positive chronic hepatitis B patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-13003441

Enrollment

Unknown

Registered

2013-04-03

Start date

2013-06-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Chronic Hepatitis B

Interventions

VACCINE GROUP:ANTIGEN-ANTIBODY IMMUNOCOMPLEXED THERAPEUTIC HEPAT

PLACEBO CONTROL GROUP:ANTIGEN-ANTIBODY IMMUNOCOMPLEXED THERAPEUTIC HEPAT

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patient with signed informed consent form; 2. Patients with chronic hepatitis B aged 18 to 65 years; 3. Patients with > 6 months HBsAg positive prior to study; 4. HBeAg positive, HBeAb negative, and HBV DNA 1*10^5 copies/ml; 5. Patient without anti-viral therapy prior to recruitment; 6. Patients with ALT abnormal (2-fold higher but 10-fold less than cutoff at baseline.); 7. Preganency testing negative for female patients.

Exclusion criteria

Exclusion criteria: 1. Co-infection with hepatitis A, C, D and E virus, or HIV; 2. Taking antiviral, hepatotoxic or immunosuppressive drugs or products within the preceding 6 months; 3. Other causes of liver disease; 4. Serious medical or psychiatric illness; 5. Hepatic cirrhosis or AFP>100 ng/ml; 6. Abnormal serum creatinine, thrombocyte count, 7. Hematoglobin or serum total bilirubin abnormal; 8. And pregnancy.

Design outcomes

Primary

Measure	Time frame
HBeAg seroconversion;	—

Countries

China

Contacts

Public ContactDAO-ZHEN XU

xudaozhen@126.com+86 13601318938

Outcome results

None listed

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