Lamivudine Plus Interferon Versus Lamivudine For The Trea... | NCT00140725

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

NCT00140725

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Oct 16, 2008Estimated

Enrollment

160

Phase

Phase 3

Conditions

Chronic Hepatitis B

Interventions

Lamivudine plus Polyethylene glyco-interferon alfa-2b
Lamivudine

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2000

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Aug 31, 2005

First Submission Date that Met QC Criteria

Aug 31, 2005

First Posted Date

Sep 1, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 15, 2008

Last Update Posted Date

Oct 16, 2008Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160

Name	Type	Description	Arm Group Labels	Other Names
Lamivudine plus Polyethylene glyco-interferon alfa-2b	Drug
Lamivudine	Drug			Lamivudine plus Polyethylene glyco-interferon alfa-2b

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of patients with HBeAg seroconversion to anti-HBe

Secondary Outcomes

Measure	Description	Time Frame
Normalization of alanine aminotransferase (ALT)
Undetectable HBV DNA
Histologic improvement

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials, MD	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Shatin			Hong Kong

Condition Browse Module

MeSH Terms

ID	Term
D019694	Hepatitis B, Chronic
D000092122	Bronchiolitis Obliterans Syndrome
D006509	Hepatitis B
D006679	HIV Seropositivity

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D018347	Hepadnaviridae Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019259	Lamivudine

Ancestor Terms

ID	Term
D016047	Zalcitabine
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides

Browse Leaves

Not provided

Browse Branches

Not provided