A clinical study of retreatment to chronic hepatitis B patients with NAs drug resistance

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-OPN-15007534

Enrollment

Unknown

Registered

2015-11-12

Start date

2016-01-05

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

NAs cohort:Add another NA without cross-resistnce

IFN cohort:add PEG-IFN alpha-2a on the basis of change/add another NA without cross-resistance

Eligibility

Sex/Gender

All

Age

16 Years to 55 Years

Inclusion criteria

Inclusion criteria: Detect NA-resistance mutation after treated by NA for more than 48weeks with good treatment compliance.

Exclusion criteria

Exclusion criteria: (1) cirrhosis; (2) diagnosed or suspected HCC; (3) allergy history of IFN or NA; (4) acute or chronic liver injury due to HAVHCVHDVHEV infection or other factors; (5) Alcohol abuse or drug user; (6) Autoimmune liver disease, malignancy, or IFN contro-indication (e.g.severe cardiopulmonary disorder, renal failure,uncontrolled asthma or diabetes, unstable thyroid or other endocrine disease, severe psychiatric disorders, active tuberculosis in treatment, psoriasis), pregnancy.

Design outcomes

Primary

Measure	Time frame
HBsAg;	—

Secondary

Measure	Time frame
HBeAg;HBV DNA;resistance gene;	—

Countries

China

Contacts

Public ContactXinyue Chen

chenxydoc@163.com+86 010-83697031

Outcome results

None listed

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