NCT01732367

Brief Summary

This study will provide a rationale for switch from lamivudine plus adefovir to tenofovir monotherapy in Lamivudine plus Adefovir Treated Lamivudine-resistant chronic hepatitis B patients with Undetectable Hepatitis B Virus DNA

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2012

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 22, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

October 28, 2016

Status Verified

October 1, 2016

Enrollment Period

3.3 years

First QC Date

November 19, 2012

Last Update Submit

October 27, 2016

Conditions

Chronic Hepatitis B

Keywords

TenofovirLamivudineAdefovirChronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

  • Percentage number of patients with virus reactivation

    Percentage number of patients with virus reactivation (HBV DNA \> 40 IU/mL on two consecutive samples taken 1 month apart, or persistent HBV DNA levels of 20-40 IU/mL on three consecutive 1 month interval) at Week 96 while on treatment.

    Week 96 while on treatment

Secondary Outcomes (5)

  • Virologic response

    Week 96 while on treatment

  • Antiviral resistance

    Week 96 while on treatment

  • Biochemical response

    Week 96 while on treatment

  • Serologic response

    Week 96 while on treatment

  • Safety assessment

    Week 96 while on treatment

Study Arms (2)

Lamivudine plus adefovir

ACTIVE COMPARATOR

Continue lamivudine/adefovir add on treatment (standard treatment)

Drug: Lamivudine plus adefovir

Tenofovir

EXPERIMENTAL

Switch from lamivudine/adefovir add on treatment to tenofovir monotherapy

Drug: Tenofovir

Interventions

Lamivudine plus adefovirDRUG

Lamivudine 100mg QD for 96 weeks + Adefovir 10mg QD for 96 weeks

Also known as: Zeffix, Hepsera
Lamivudine plus adefovir
TenofovirDRUG

Tenofovir 300mg QD for 96 weeks

Also known as: Viread
Tenofovir

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients aged 18 or older
  • The CHB patients (both HBeAg-positive and - negative) who have at least 6 months undetectable HBV DNA (serum HBV DNA ≤ 20 IU/mL) after lamivudine plus adefovir combination therapy.

You may not qualify if:

  • Patients with decompensated liver disease
  • Patients with HCV, HDV or HIV
  • Patients with HCC
  • Serum ALT \> 2x ULN level
  • Serum creatinine \> 2.0mg/dL
  • Pregnant or lactating women
  • Women who have a plan for pregnancy within the three coming years
  • Patients who have uncontrolled severe concomitant diseases- severe cardiovascular diseases and other infection
  • Those who have no capabilities to understand and sign an informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine, Keimyung University Dongsan Medical Center

Daegu, ASI|KR|KS002|TAEGU, South Korea

Location

Related Publications (1)

  • Lee HJ, Kim SJ, Kweon YO, Park SY, Heo J, Woo HY, Hwang JS, Chung WJ, Lee CH, Kim BS, Suh JI, Tak WY, Jang BK. Evaluating the efficacy of switching from lamivudine plus adefovir to tenofovir disoproxil fumarate monotherapy in lamivudine-resistant stable hepatitis B patients. PLoS One. 2018 Jan 12;13(1):e0190581. doi: 10.1371/journal.pone.0190581. eCollection 2018.

    PMID: 29329305DERIVED

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Lamivudineadefoviradefovir dipivoxilTenofovir

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosidesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Byoung Kuk Jang, M.D

    Department of Internal Medicine, Keimyung University Dongsan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Keimyung University Dongsan Medical Center

Study Record Dates

First Submitted

November 19, 2012

First Posted

November 22, 2012

Study Start

November 1, 2012

Primary Completion

March 1, 2016

Study Completion

April 1, 2016

Last Updated

October 28, 2016

Record last verified: 2016-10

Locations

KR(1)