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A clinical study of treatment efficacy and safety of inactive HBsAg carrier

A clinical study of treatment efficacy and safety of inactive HBsAg carrier

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPN-15007410
Enrollment
Unknown
Registered
2015-11-12
Start date
2016-01-01
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

inactive HBsAg carrier

Interventions

A:pegIFN alfa 2a 135ug/week or combine with adefovir 10mg/day, for 96weeks
B:no antiviral therapy

Sponsors

Beijing You’an Hosipital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: HBsAg positive >6months and HBsAg<1000IU/ml,HBeAg negative, anti-HBe postive, anti-HBc positive. HBV DNA<2000IU/ml. ALT normal. treatment naive for antiviral therapy

Exclusion criteria

Exclusion criteria: 1) cirrhosis; 2) diagnosed or suspected hepatocellular carcinoma(HCC); 3) allergy to IFN or nucleoside; 4) acute or chronic liver disease due to HAV,HCV,HDV or HEV infetion; 5) alcohol or drug abuse; 6) auto-immune liver disease, malignant carcinoma, IFN contraindication (e.g. Severe heart disease, Renal failure, uncontroled asthma, uncontroled diabetes mellitus, Autoimmune thyroiditis or other active autoimmune disorders, Uncontrolled seizures, Present or past psychosis or severe depression, presence of treatment for active pulmonary tuberculosis, psoriasis), pregnancy.

Design outcomes

Primary

MeasureTime frame
HBsAg clerance rate at week 96;

Secondary

MeasureTime frame
HBsAg seroconversion rate at week 96;HBV DNA undetactable rate at week 96;

Countries

China

Contacts

Public ContactXinyue Chen
chenxydoc@163.com+86 010-83997159

Outcome results

None listed

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