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Lamivudine Therapy in Patients With Prior Entecavir Treatment and Undetectable Viral Load

Primary Purpose

Hepatitis B, Chronic

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Entecavir
Lamivudine
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B, Chronic focused on measuring entecavir, lamivudine, sequential therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with chronic hepatitis B treated with entecavir for 6 months or more
  • Normal ALT
  • Undetectable HBV DNA by Roche Taqman PCR Assay
  • No other previous therapy with nucleoside/nucleotide analogues

Exclusion Criteria:

  • Presence of other liver diseases including hepatitis C co-infection, autoimmune hepatitis , primary biliary cirrhosis, primary sclerosing cholangitis, alcoholic liver disease, and Wilson's disease
  • History of hepatocellular carcinoma
  • History of decompensated liver disease

Sites / Locations

  • The University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Entecavir

Lamivudine

Arm Description

Ongoing entecavir 0.5mg daily

Switch to lamivudine 100mg daily

Outcomes

Primary Outcome Measures

Determine the efficacy of lamivudine therapy in patients with prior entecavir treatment with undetectable viral load

Secondary Outcome Measures

Determine the chance of lamivudine resistance in patients with prior entecavir treatment with undetectable viral load

Full Information

First Posted
November 12, 2009
Last Updated
November 30, 2015
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01013272
Brief Title
Lamivudine Therapy in Patients With Prior Entecavir Treatment and Undetectable Viral Load
Official Title
Lamivudine Therapy in Patients With Prior Entecavir Treatment and Undetectable Viral Load
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients with chronic hepatitis B and treated with entecavir for over 6 months (with no previous other antiviral treatment) will be invited to participate in this study. They will be eligible if their liver tests are normal and their viral load is undetectable. Patients will be switched to lamivudine treatment to assess whether lamivudine can maintain adequate suppression of the hepatitis B virus after successful treatment with entecavir. Patients will be monitored closely after switching treatment at 1 months and then every 3 monthly. If there is any evidence of increase in viral load then patients will be given the option of changing back to entecavir.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic
Keywords
entecavir, lamivudine, sequential therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Entecavir
Arm Type
Active Comparator
Arm Description
Ongoing entecavir 0.5mg daily
Arm Title
Lamivudine
Arm Type
Active Comparator
Arm Description
Switch to lamivudine 100mg daily
Intervention Type
Drug
Intervention Name(s)
Entecavir
Other Intervention Name(s)
Baraclude
Intervention Description
Entecavir 0.5mg orally daily
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Other Intervention Name(s)
Zeffix
Intervention Description
Lamivudine 100mg orally, daily
Primary Outcome Measure Information:
Title
Determine the efficacy of lamivudine therapy in patients with prior entecavir treatment with undetectable viral load
Time Frame
96 weeks
Secondary Outcome Measure Information:
Title
Determine the chance of lamivudine resistance in patients with prior entecavir treatment with undetectable viral load
Time Frame
96 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with chronic hepatitis B treated with entecavir for 6 months or more Normal ALT Undetectable HBV DNA by Roche Taqman PCR Assay No other previous therapy with nucleoside/nucleotide analogues Exclusion Criteria: Presence of other liver diseases including hepatitis C co-infection, autoimmune hepatitis , primary biliary cirrhosis, primary sclerosing cholangitis, alcoholic liver disease, and Wilson's disease History of hepatocellular carcinoma History of decompensated liver disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Fung, MBChB
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Hong Kong
City
Hong Kong
Country
China

12. IPD Sharing Statement

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Lamivudine Therapy in Patients With Prior Entecavir Treatment and Undetectable Viral Load

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