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Tenofovir Disoproxil Fumarate vs. Entecavir in Chronic Hepatitis B Patients With Partial Virologic Response to Entecavir

NCT ID: NCT01711567

Last Updated: 2016-11-09

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2016-11-30

Brief Summary

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Entecavir, a potent antiviral agent, has been widely used for treatment-naïve chronic hepatitis B patients. However, about 20% of patients showed partial virologic response after 2 year of entecavir therapy (33% in HBeAg positive, 10% in HBeAg negative patients). Tenofovir is a nucleotide analogue with more potent antiviral activity. In addition, there is no cross resistance between the two drugs. Therefore it is assumed that tenofovir would be effective in the treatment of chronic hepatitis B patients who shows partial virologic response (detectable HBV DNA by real time PCR after 12 months of treatment) despite treatment with entecavir. In this study, we will compare the efficacy of switching to tenofovir with continuing entecavir in patients who shows partial virologic response to entecavir.

Detailed Description

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The number of patients needed was calculated using PASS 2008. We hypothesized that two-thirds (65%) of the patients receiving TDF, and one-fifth (20%) of the patients receiving ETV, would achieve virologic response. We also assumed a 15% drop-out rate; thus, 22 patients were needed in each group to achieve 80% power to demonstrate a difference between the groups with a 5% level of significance.

The primary efficacy end point will be analyzed on a per-protocol basis, including only those patients who had completed the treatment schedule of study. In contrast, the intention-to-treat analysis will include all randomized subjects, even those dropped-out from the study before 12 months, as cases of treatment failure.

Conditions

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Chronic Hepatitis B

Keywords

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Chronic Hepatitis B TENOFOVIR ENTECAVIR PARTIAL RESPONDER

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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entecavir

standard drugs

Group Type ACTIVE_COMPARATOR

entecavir

Intervention Type DRUG

entecavir 0.5 mg qd

tenofovir

study drugs

Group Type ACTIVE_COMPARATOR

tenofovir

Intervention Type DRUG

tenofovir 300 mg qd

Interventions

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tenofovir

tenofovir 300 mg qd

Intervention Type DRUG

entecavir

entecavir 0.5 mg qd

Intervention Type DRUG

Other Intervention Names

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tenofovir (viread) entecavir(baraclude) 0.5 mg qd

Eligibility Criteria

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Inclusion Criteria

1. CHB patients (positive HBsAg more than 6 months)
2. Age 19 years old
3. HBeAg positive or negative patients
4. Patients receiving entecavir 0.5 mg more than 12 months
5. Detectable HBV DNA by real time PCR (HBV \> 60 IU/mL)
6. Compensated liver function (Child-Pugh-Turcotte score ≤7, prothrombin time 3 sec above ULN or INR ≤1.5, serum albumin \>3 g/dL, total bilirubin \<2.5 mg/dL, no history of variceal bleeding, diuretics or ascites requiring paracentesis, hepatic encephalopathy)

Exclusion Criteria

1. History of treatment with nucleotide analogue other than 0.5 mg of ETV
2. Serum creatinine level \> 1.5 mg/dL or creatinine clearance \< 50 mL/min
3. Absolute neutrophil count ≤ 1000 cell/mL
4. Hemoglobin level ≤ 10 g/dL in men or ≤ 9 g/dL in women
5. Antiviral resistance mutations on rtT184, rtS202, or rtM250 + rtM204V/I
6. A positive antibody test for human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
7. Pregnancy or lactation
8. HCC (in cases where alfa-fetoprotein levels were over 100 ng/mL, abdominal computed tomography or magnetic resonance image was performed to exclude HCC)
9. Untreated malignancy other than HCC.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role collaborator

Korea University

OTHER

Sponsor Role lead

Responsible Party

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Hyung Joon Yim

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hyung Joon Yim, M.D.

Role: PRINCIPAL_INVESTIGATOR

Korea University

Locations

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Korea University Ansan Hospital

Ansan, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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STEEP study

Identifier Type: -

Identifier Source: org_study_id