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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Sun Yat-sen University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00860626
First received: March 11, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted

March 11, 2009
March 11, 2009
January 2008
December 2009   (final data collection date for primary outcome measure)
HBeAg seroconversion rate [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • HBV DNA loss rate [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
  • HBsAg loss rate [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Early Response to Interferon Combined Short-Term Nucleoside Analogue Therapy in HBeAg(+) Chronic Hepatitis B
Early Response to Interferon Combined Short-Term Nucleoside Analogue Therapy in HBeAg(+) Chronic Hepatitis B

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis B, Chronic
  • Drug: interferon 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.
  • Drug: interferon 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.
  • Drug: interferon α
    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.
  • Experimental: 1
    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.
    Intervention: Drug: interferon α plus nucleoside analogue
  • Active Comparator: 2
    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.
    Intervention: Drug: interferon α
  • Active Comparator: 3
    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.
    Intervention: Drug: interferon α
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
February 2010
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact: huang zhanlian, doctor +86013580584031
China
 
NCT00860626
interferonshorttermnucleoside
No
The Third Affliated Hospital of Sun Yat-sen University
Sun Yat-sen University
Not Provided
Study Chair: Gao zhiliang, Doctor The Third Affliated Hospital of Sun Yat-sen University
Sun Yat-sen University
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP