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

Primary Purpose

Hepatitis B, Chronic

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

interferon α plus nucleoside analogue

interferon α

About this trial

This is an interventional treatment trial for Hepatitis B, Chronic

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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

Sites / Locations

The Third Affliated Hospital of Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

HBeAg seroconversion rate

Secondary Outcome Measures

HBV DNA loss rate

HBsAg loss rate

Full Information

NCT ID

NCT00860626

First Posted

March 11, 2009

Last Updated

March 11, 2009

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT00860626

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Unknown status

Study Start Date

January 2008 (undefined)

Primary Completion Date

December 2009 (Anticipated)

Study Completion Date

February 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis B, Chronic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm 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.

Arm Title

Arm Type

Active Comparator

Arm 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.

Arm Title

Arm Type

Active Comparator

Arm 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.

Intervention Type

Drug

Intervention Name(s)

interferon α plus nucleoside analogue

Intervention Description

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

Intervention Name(s)

interferon α

Intervention Description

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

Intervention Name(s)

interferon α

Intervention Description

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.

Primary Outcome Measure Information:

Title

HBeAg seroconversion rate

Time Frame

3-6 months

Secondary Outcome Measure Information:

Title

HBV DNA loss rate

Time Frame

3-6 months

Title

HBsAg loss rate

Time Frame

3-6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

huang zhanlian, doctor

Phone

+86013580584031

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gao zhiliang, Doctor

Organizational Affiliation

The Third Affliated Hospital of Sun Yat-sen University

Official's Role

Study Chair

Facility Information:

Facility Name

The Third Affliated Hospital of Sun Yat-sen University

City

Guang zhou

State/Province

Guang dong

ZIP/Postal Code

510000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

huang zhanlian, Doctor

Phone

+86013580584031

zhanlianh@21cn.com

12. IPD Sharing Statement

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

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