Tenofovir Monotherapy in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Entecavir Plus Tenofovir

NCT ID: NCT03236610

Last Updated: 2017-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2019-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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tenofovir

Group Type EXPERIMENTAL

tenofovir monotherapy

Intervention Type DRUG

switching to tenofovir monotherapy

tenofovir plus entecavir

Group Type ACTIVE_COMPARATOR

tenofovir plus entecavir combination

Intervention Type DRUG

continuing tenofovir plus entecavir

Interventions

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tenofovir monotherapy

switching to tenofovir monotherapy

Intervention Type DRUG

tenofovir plus entecavir combination

continuing tenofovir plus entecavir

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Cr ≥1.5 mg/dL Evidence of decompensated liver disease Malignant neoplasm Coinfection with HIV, HCV
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uijeongbu St. Mary Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chang Wook Kim

C.W. Kim

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Uijeongbu St. Mary Hospital

Uijongbu, , South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Chang Wook Kim

Role: primary

82318203997

Other Identifiers

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XC15MIMI0100U

Identifier Type: -

Identifier Source: org_study_id

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