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NCT00140725 Clinical Trial

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

Chronic Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00140725
Other study ID # NUC30938
Secondary ID
Status Completed
Phase Phase 3
First received August 31, 2005
Last updated October 15, 2008
Start date April 2000

Study information
Verified date October 2008
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Department of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 160
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Lamivudine plus Polyethylene glyco-interferon alfa-2b

• Lamivudine

Locations
Country Name City State
Hong Kong GSK Investigational Site Shatin

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Hong Kong, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of patients with HBeAg seroconversion to anti-HBe
Secondary Normalization of alanine aminotransferase (ALT)
Secondary Undetectable HBV DNA
Secondary Histologic improvement
Secondary Tyrosine, methionine, aspartate, aspartate (YMDD) mutants among the viremic relapsers at the end of therapy and safety of treatment
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