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

Hepatitis B, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00860626
• Other study ID #: interferonshorttermnucleoside
• Status: Recruiting
• Phase: N/A
• First received: March 11, 2009
• Last updated: March 11, 2009
• Start date: January 2008
• Est. completion date: February 2010

Study information

• Verified date: March 2009
• Source: Sun Yat-sen University
• Contact: huang zhanlian, doctor
• Phone: +86013580584031
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• interferon a 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.
• interferon a
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.
• interferon a
Standard dose of interferon is used for 12 weeks.On 12th week of treatment, HBV DNA is undetectable, or HBeAg is negative. And interferon is continued alone for another 9 months.

Locations

Country	Name	City	State
China	The Third Affliated Hospital of Sun Yat-sen University	Guang zhou	Guang dong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HBeAg seroconversion rate		3-6 months	No
Secondary	HBV DNA loss rate		3-6 months	No
Secondary	HBsAg loss rate		3-6 months	No