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

NCT ID: NCT03236584

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

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-01

Study Completion Date

2019-03-30

Brief Summary

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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

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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lamivudine adefovir

Group Type ACTIVE_COMPARATOR

lamivudine plus adefovir combination

Intervention Type DRUG

continuing lamivudine plus adefovir

tenofovir

Group Type EXPERIMENTAL

Tenofovir Disoproxil Fumarate

Intervention Type DRUG

switching to tenofovir

Interventions

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lamivudine plus adefovir combination

continuing lamivudine plus adefovir

Intervention Type DRUG

Tenofovir Disoproxil Fumarate

switching to tenofovir

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) currently receiving LAM plus ADV for more than 12 months HBV DNA levels \<20 IU/ml on two consecutive tests of 3-month interval

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

Other Identifiers

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UC15MISI0099

Identifier Type: -

Identifier Source: org_study_id

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