A Post-marketing Surveillance to Assess Safety and Efficacy of Besivo

NCT ID: NCT03642340

Last Updated: 2018-08-31

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

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-15

Study Completion Date

2023-08-15

Brief Summary

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This study is a post-marketing surveillance of Besivo in participants with chronic hepatitis B.

Detailed Description

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This post-marketing surveillance required by Korea MFDS regulation. The objectives of this study are to monitor adverse events and effectiveness of Besivo.

Conditions

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Chronic Hepatitis b

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* The patient diagnosed with chronic hepatitis B.
* The patient who is first prescribed and administered Besivo.

Exclusion Criteria

* The patients who are overreacting to this drug or its components
* Medium to severe Renal function disorder
* The patient under 19
* The Patient who are taboo with L-Carnitine
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IlDong Pharmaceutical Co Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ildong Ildong

Role: STUDY_DIRECTOR

PV

Locations

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Severance Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Ildong Ildong

Role: CONTACT

82-2-526-3295

Ildong Ildong

Role: CONTACT

82-2-526-3392

Facility Contacts

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Ahn SangHoon

Role: primary

Other Identifiers

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ID-BSB-401

Identifier Type: -

Identifier Source: org_study_id

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