NCT03236610

Brief Summary

Little is known about efficacy of switching to tenofovir monotherapy for multidrug-resistant chronic ehpatitis B patients who achieved a complete virological response to entecavir and tenofovir. This study aimed to investigate the efficacy of switching to tenofovir monotherapy for multidrug-resistant chronic hepatitis B patients with undetectable heaptitis B virus DNA while on tenofovir plus entecavir combination therapy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2016

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2016

Completed
1.6 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
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

August 2, 2017

Status Verified

July 1, 2017

Enrollment Period

2.5 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 at week 48

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

    48 week

Study Arms (2)

tenofovir

EXPERIMENTAL
Drug: tenofovir monotherapy

tenofovir plus entecavir

ACTIVE COMPARATOR
Drug: tenofovir plus entecavir combination

Interventions

tenofovir monotherapyDRUG

switching to tenofovir monotherapy

tenofovir
tenofovir plus entecavir combinationDRUG

continuing tenofovir plus entecavir

tenofovir plus entecavir

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) \& ADV (rtA181V/T and/or rtN236T) or ETV (rtT184A/C/F/G/I/L/S, rtS202G, or rtM250L/V, in addition to rtM204V/I) HBV DNA levels \<20 IU/ml on two consecutive tests of 3-month interval currently receiving TDF+ETV for more than 12 months

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

Study Sites (1)

Uijeongbu St. Mary Hospital

Uijongbu, South Korea

RECRUITING

MeSH Terms

Interventions

Tenofovir

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

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

January 1, 2016

Primary Completion

June 30, 2018

Study Completion

June 30, 2019

Last Updated

August 2, 2017

Record last verified: 2017-07

Locations

KR(1)