NCT00860626

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 12, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

March 12, 2009

Status Verified

March 1, 2009

Enrollment Period

1.9 years

First QC Date

March 11, 2009

Last Update Submit

March 11, 2009

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (1)

  • HBeAg seroconversion rate

    3-6 months

Secondary Outcomes (2)

  • HBV DNA loss rate

    3-6 months

  • HBsAg loss rate

    3-6 months

Study Arms (3)

1

EXPERIMENTAL

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.

Drug: interferon α plus nucleoside analogue

2

ACTIVE COMPARATOR

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.

Drug: interferon α

3

ACTIVE COMPARATOR

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.

Drug: interferon α

Interventions

interferon α plus nucleoside analogueDRUG

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.

1
interferon αDRUG

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.

2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Third Affliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Nucleosides

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GlycosidesCarbohydratesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Gao zhiliang, Doctor

    The Third Affliated Hospital of Sun Yat-sen University

    STUDY CHAIR

Central Study Contacts

huang zhanlian, doctor

CONTACT

+86013580584031

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 11, 2009

First Posted

March 12, 2009

Study Start

January 1, 2008

Primary Completion

December 1, 2009

Study Completion

February 1, 2010

Last Updated

March 12, 2009

Record last verified: 2009-03

Locations

CN(1)