Persistence, Adherence and Clinical Effectiveness of Entecavir in Chronic Hepatitis B Patients

NCT ID: NCT01356901

Last Updated: 2015-07-07

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

Total Enrollment

230 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-01-31

Brief Summary

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The purpose of this observational study is to measure the real-life persistence, adherence and clinical effectiveness of entecavir in patients with chronic Hepatitis B viral infection.

Detailed Description

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Sampling Method: Probability Sample (consecutive patient sampling)

Conditions

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Hepatitis B, Chronic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Treatment naïve and pre-treated CHB patients

subanalysis with migrant and non-migrant patients

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Male and female treatment naïve or pre-treated CHB patients of at least 18 years of age
* Written informed consent

Exclusion Criteria

* All relevant conditions according to Summary of product characteristics (SmPC)
* Human immunodeficiency virus (HIV), Hepatitis C virus (HCV) or Hepatitis D virus (HDV) co-infection
* Patients currently included in any investigational trial on CHB
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Herne, , Germany

Site Status

Countries

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Germany

Related Links

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Other Identifiers

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AI463-232

Identifier Type: -

Identifier Source: org_study_id

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