Early Response to Interferon Combined Short-Term Nucleoside Analogue Therapy in HBeAg(+) Chronic Hepatitis B

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00860626

Enrollment

Registered

2009-03-12

Start date

2008-01-31

Completion date

2010-02-28

Last updated

2009-03-12

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

Conditions

Hepatitis B, Chronic

Brief summary

For HBeAg(+) patients, interferon is used for 12 weeks. On 12th week of treatment, If HBV DNA is undetectable (\<1000 copies/ml), interferon is continued alone for one year. If HBV DNA is still positive, nucleoside analogue is added for 3 months. After nucleoside analogue is added for 3 months, HBV DNA is tested again. If negative, stop nucleoside analogue and use interferon alone for another 6 months or longer. If HBV DNA is still positive, change to another nucleoside analogue or add another nucleoside analogue.

Interventions

DRUGinterferon α plus nucleoside analogue

Standard dose of interferon is used for 12 weeks. On 12th week of treatment, HBV DNA is still detectable (\>1000 copies/ml), or HBeAg is still positive. And lamivudine is added for 3 months. After nucleoside analogue is added for 3 months, HBV DNA is tested again. If negative, stop nucleoside analogue and use interferon alone for another 6 months or longer. If HBV DNA is still positive, change to another nucleoside analogue or add another nucleoside analogue.

DRUGinterferon α

Standard dose of interferon is used for 12 weeks.On 12th week of treatment, HBV DNA is still detectable (\>1000 copies/ml), or HBeAg is still positive. But no nucleoside analogue is added.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Inclusion criteria

* HBsAg posive for 6 months * HBeAg positive, and HBeAb negative * HBV DNA\>1.0×E5 copies/ml * ALT\>80 u/L within 3 months

Exclusion criteria

* pregnant women * conbination infection of HCV, HAV, or HEV * conbination infection of HIV * any contraindication of interferon α

Design outcomes

Primary

Measure	Time frame
HBeAg seroconversion rate	3-6 months

Secondary

Measure	Time frame
HBV DNA loss rate	3-6 months
HBsAg loss rate	3-6 months

Countries

China

Contacts

Primary Contacthuang zhanlian, doctor

+86013580584031

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026