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Lamivudine Plus Interferon Versus Lamivudine For The Treatment Of HBeAg Positive Chronic Hepatitis B Virus (HBV)

NCT ID: NCT00140725

Last Updated: 2008-10-16

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-04-30

Brief Summary

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This is a single-centre prospective randomised study comparing the virological and histological response of HBV infection to lamivudine in combination with interferon versus lamivudine alone.

Detailed Description

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Conditions

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Chronic Hepatitis B

Keywords

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HBeAg-positive chronic Hepatitis B lamivudine seroconversion Chronic Hepatitis B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Lamivudine plus Polyethylene glyco-interferon alfa-2b

Intervention Type DRUG

Lamivudine

Intervention Type DRUG

Other Intervention Names

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Lamivudine plus Polyethylene glyco-interferon alfa-2b

Eligibility Criteria

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Inclusion Criteria

* Untreated chronic hepatitis B patients with evidence of HBV replication as documented by serum HNV-DNA positive within 3 months prior to entry and serum HBeAg positive at screening.
* Documented presence of abnormal alanine aminotransferase (ALT) (1.3 - 5X upper limit normal (ULN)) within 1 month prior to entry and signs of compensated liver disease.

Exclusion Criteria

* Patients with any cause for liver disease other than chronic hepatitis B and evidence or history of decompensated liver disease.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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GSK

Principal Investigators

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GSK Clinical Trials, MD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Shatin, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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NUC30938

Identifier Type: -

Identifier Source: org_study_id