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

NCT ID: NCT00860626

Last Updated: 2009-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatitis B, Chronic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

interferon α plus nucleoside analogue

Intervention Type DRUG

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.

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.

Group Type ACTIVE_COMPARATOR

interferon α

Intervention Type DRUG

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.

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.

Group Type ACTIVE_COMPARATOR

interferon α

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

The Third Affliated Hospital of Sun Yat-sen University

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gao zhiliang, Doctor

Role: STUDY_CHAIR

The Third Affliated Hospital of Sun Yat-sen University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Third Affliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

huang zhanlian, doctor

Role: CONTACT

+86013580584031

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

huang zhanlian, Doctor

Role: primary

+86013580584031

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

interferonshorttermnucleoside

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.