NCT03236584

Brief Summary

Little is known about efficacy of switching to tenofovir monotherapy for lam-resistant chronic hepatitis B patients who achieved a complete virological response to lamivudine plus adefovir. This study was to investigate the efficacy of switching to tenofovir monotherapy for lamivudine -resistant chronic hepatitis B patients with undetectable hepatitis B virus DNA while on lamivudine plus adefovir combination therapy

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2015

Typical duration for phase_3

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 2, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2019

Completed
Last Updated

August 2, 2017

Status Verified

July 1, 2017

Enrollment Period

2.6 years

First QC Date

July 28, 2017

Last Update Submit

July 28, 2017

Conditions

Proportion of Patients With a Sustained Virological Response (Serum HBV DNA <20 IU/mL) at Week 48

Outcome Measures

Primary Outcomes (1)

  • SVR

    Proportion of patients with a sustained virological response (serum HBV DNA \<20 IU/mL) at week 48

    48 WEEK

Study Arms (2)

lamivudine adefovir

ACTIVE COMPARATOR
Drug: lamivudine plus adefovir combination

tenofovir

EXPERIMENTAL
Drug: Tenofovir Disoproxil Fumarate

Interventions

lamivudine plus adefovir combinationDRUG

continuing lamivudine plus adefovir

lamivudine adefovir
Tenofovir Disoproxil FumarateDRUG

switching to tenofovir

tenofovir

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HBsAg (+) for \> 6 months age \>19 years antiviral resistance to LAM (rtL180M and/or M204V/I) currently receiving LAM plus ADV for more than 12 months HBV DNA levels \<20 IU/ml on two consecutive tests of 3-month interval

You may not qualify if:

  • Cr ≥1.5 mg/dL Evidence of decompensated liver disease Malignant neoplasm Coinfection with HIV, HCV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

LamivudineTenofovir

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
C.W. Kim

Study Record Dates

First Submitted

July 28, 2017

First Posted

August 2, 2017

Study Start

September 1, 2015

Primary Completion

March 30, 2018

Study Completion

March 30, 2019

Last Updated

August 2, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share