Lamivudine Therapy in Patients With Prior Entecavir Treat... | NCT01013272

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

NCT01013272

Sponsor

The University of Hong Kong

Status

Completed

Last Update Posted

Dec 2, 2015Estimated

Enrollment

50Actual

Phase

Not Applicable

Conditions

Hepatitis B, Chronic

Interventions

Entecavir
Lamivudine

Countries

China

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

Nov 2015

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

Jun 2007

Primary Completion Date

Jul 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Nov 12, 2009

First Submission Date that Met QC Criteria

Nov 12, 2009

First Posted Date

Nov 13, 2009Estimated

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

Nov 30, 2015

Last Update Posted Date

Dec 2, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Entecavir	Active Comparator	Ongoing entecavir 0.5mg daily	Drug: Entecavir
Lamivudine	Active Comparator	Switch to lamivudine 100mg daily	Drug: Lamivudine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Entecavir	Drug	Entecavir 0.5mg orally daily	Entecavir	Baraclude

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determine the efficacy of lamivudine therapy in patients with prior entecavir treatment with undetectable viral load		96 weeks

Secondary Outcomes

Measure	Description	Time Frame
Determine the chance of lamivudine resistance in patients with prior entecavir treatment with undetectable viral load		96 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 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
James Fung, MBChB	The University of Hong Kong	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Hong Kong		Hong Kong			China

Condition Browse Module

MeSH Terms

ID	Term
D019694	Hepatitis B, Chronic

Ancestor Terms

ID	Term
D006509	Hepatitis B
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C413685	entecavir
D019259	Lamivudine

Ancestor Terms

ID	Term
D016047	Zalcitabine
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides

Browse Leaves

Not provided

Browse Branches

Not provided