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

Sun Yat-sen University

Status: Unknown

Conditions: Hepatitis B, Chronic

Treatments: Drug: interferon α plus nucleoside analogue; Drug: interferon α

Study type: Interventional

Funder types: Other

Identifiers

NCT00860626

interferonshorttermnucleoside

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

1

Experimental group

Description:

At the twelfth week of interferon α treatment, HBV DNA is detectable(\>1000 copies/ml), or HBeAg is still positive. And nucleoside analogue is added for 12 weeks.

Treatment:

Drug: interferon α plus nucleoside analogue

2

Active Comparator group

Description:

At the twelfth week of interferon α treatment, HBV DNA is detectable (\>1000 copies/ml), or HBeAg is still positive. But no nucleoside analogue is added.

Treatment:

Drug: interferon α

Drug: interferon α

3

Active Comparator group

Description:

At the twelfth week of interferon α treatment, HBV DNA is undetectable (\<1000 copies/ml), or HBeAg is negative. And interferon is continued for another 9 months.

Treatment:

Drug: interferon α

Drug: interferon α