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

This study has been completed.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00140725

First received: August 31, 2005

Last updated: October 15, 2008

Last verified: October 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

August 31, 2005

Last Updated Date

October 15, 2008

Start Date ^ICMJE

April 2000

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Proportion of patients with HBeAg seroconversion to anti-HBe

Original Primary Outcome Measures ^ICMJE

HBeAg seroconversion to anti-Hbe

Change History

Complete list of historical versions of study NCT00140725 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Normalization of alanine aminotransferase (ALT)
Undetectable HBV DNA
Histologic improvement
Tyrosine, methionine, aspartate, aspartate (YMDD) mutants among the viremic relapsers at the end of therapy and safety of treatment

Original Secondary Outcome Measures ^ICMJE

Sustained normalization of ALT undetectable HBV DNA histologic improvement YMDD mutants among the viremic relapsers at the end of therapy and safety of treatment

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Randomised Trial of Lamivudine Plus Interferon Versus Lamivudine for the Treatment of HBeAg Positive Chronic Hepatitis B Virus (HBV)

Brief Summary

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Chronic Hepatitis B

Intervention ^ICMJE

Drug: Lamivudine plus Polyethylene glyco-interferon alfa-2b
Drug: Lamivudine
Other Names:
- Lamivudine
- Lamivudine plus Polyethylene glyco-interferon alfa-2b

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

160

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Hong Kong

Administrative Information

NCT Number ^ICMJE

NCT00140725

Other Study ID Numbers ^ICMJE

NUC30938

Has Data Monitoring Committee

Not Provided

Responsible Party

Study Director, GSK

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

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

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