An Observational Study of Maviret (Glecaprevir/Pibrentasvir) for Korean Chronic Hepatitis C Genotypes 1 to 6 Patients According to the Standard for Re-examination of New Drugs

NCT ID: NCT03740230

Last Updated: 2024-07-19

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

3134 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-26

Study Completion Date

2023-07-21

Brief Summary

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Post-marketing surveillance study to evaluate the real world safety and effectiveness of Maviret (Glecaprevir/Pibrentasvir) administered under a normal, routine treatment practice by Korean patients with Chronic Hepatitis C Genotypes 1 to 6

Detailed Description

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Patients with type C hepatitis genotypes 1-6 who had been prescribed Maviret (glecaprevir/pibrentasvir) in accordance with approved local label.

The sample size for this study is due to a requirement by local authorities.

Conditions

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Hepatitis C

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hepatitis C

Participants with Hepatitis C Genotypes 1 to 6 receiving Maviret (glecaprevir/pibrentasvir) for 8, 12, or 16 weeks.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Participants with chronic C hepatitis genotypes 1 to 6.
* Participants prescribed Maviret in accordance with approved local label.

Exclusion Criteria

\- Patients with contraindications to the approved local labels for Maviret.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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SoonChunHyang University CheonAn Hospital /ID# 209996

Cheonan-si, Chungcheongnam-do, South Korea

Site Status

Hallym University Sacred Heart Hospital /ID# 210809

Anyang, Gyeonggido, South Korea

Site Status

The Catholic University of Korea, Bucheon St.Mary's Hospital /ID# 216869

Bucheon-si, Gyeonggido, South Korea

Site Status

Dongguk University Ilsan Hospital /ID# 210609

Goyang, Gyeonggido, South Korea

Site Status

National health insurance Service ilsanhospital /ID# 209997

Goyang, Gyeonggido, South Korea

Site Status

SoonChunHyang University Buchon Hospital /ID# 210618

Habun, Gyeonggido, South Korea

Site Status

Seoul National University Bundang Hospital /ID# 210616

Seongnam, Gyeonggido, South Korea

Site Status

The Catholic University of Korea, ST. Vincent's Hospital /ID# 216951

Suwon, Gyeonggido, South Korea

Site Status

Ajou University Hospital /ID# 209995

Suwon, Gyeonggido, South Korea

Site Status

The Catholic University of Korea, Uijeongbu ST. Mary's Hospital /ID# 216949

Uijeongbu-si, Gyeonggido, South Korea

Site Status

Pusan National University Yangsan Hospital /ID# 214960

Yangsan, Gyeongsangnam-do, South Korea

Site Status

Wonkwang University Hospital /Id# 210620

Iksan, Jeonrabugdo, South Korea

Site Status

Kwangju Christian Hospital /ID# 210623

Gwangju, Jeonranamdo, South Korea

Site Status

Yonsei University Health System Severance Hospital /ID# 209636

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

SMG-SNU Boramae Medical Center /ID# 210610

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

Dongnam Institute of Radiological & Medical Sciences /ID# 209991

Busan, , South Korea

Site Status

Good Samsun Hospital /ID# 209291

Busan, , South Korea

Site Status

Inje University Busan Paik Hospital /ID# 209992

Busan, , South Korea

Site Status

Inje University Haeundae Hospital /ID# 209993

Busan, , South Korea

Site Status

Maryknoll Medical Center /ID# 210957

Busan, , South Korea

Site Status

Dong-A University Hospital /ID# 209450

Busan, , South Korea

Site Status

Pusan National University Hospital /ID# 209813

Busan, , South Korea

Site Status

Kosin University Gospel Hospital /ID# 210608

Busan, , South Korea

Site Status

Samsung Changwon Hospital /ID# 211507

Changwon, , South Korea

Site Status

Samsung Changwon Hospital /ID# 211743

Changwon, , South Korea

Site Status

Dankook University Hospital /ID# 209297

Cheonan, , South Korea

Site Status

Chuncheon Sacred Heart Hospital /ID# 210612

Chuncheon, , South Korea

Site Status

Kyungpook National University Chilgok Hospital /ID# 209988

Daegu, , South Korea

Site Status

Keimyung University Dongsan Medical Center /ID# 212144

Daegu, , South Korea

Site Status

Keimyung University Dongsan Medical Center /ID# 212514

Daegu, , South Korea

Site Status

Kyungpook National University Hospital /ID# 209294

Daegu, , South Korea

Site Status

Yeungnam University Medical Center /ID# 209293

Daegu, , South Korea

Site Status

Kim Jun Hwan Sok Internal Medi /ID# 209292

Daegu, , South Korea

Site Status

The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 216952

Daejeon, , South Korea

Site Status

Chungnam National University Hospital /ID# 209637

Daejeon, , South Korea

Site Status

Myongji Hospital /ID# 215595

Goyang, , South Korea

Site Status

CHA Gumi Medical Center, CHA University /ID# 209994

Gumi, , South Korea

Site Status

Chosun University Hospital /ID# 210607

Gwangju, , South Korea

Site Status

The Catholic University of Korea Incheon St.Mary's Hospital /ID# 216950

Incheon, , South Korea

Site Status

Gachon University Gil Medical Center /ID# 212513

Incheon, , South Korea

Site Status

Inha University Hospital /ID# 210617

Incheon, , South Korea

Site Status

Jeju National University Hospital /ID# 214700

Jeju City, , South Korea

Site Status

Chonnam National University Hwasun Hospital /ID# 209990

Jeonnam, , South Korea

Site Status

Inje University Sanggye Paik Hospital /ID# 210811

Seoul, , South Korea

Site Status

Korea University Anam Hospital /ID# 210958

Seoul, , South Korea

Site Status

Seoul National University Hospital /ID# 210959

Seoul, , South Korea

Site Status

Seoul National University Hospital /ID# 211365

Seoul, , South Korea

Site Status

Seoul National University Hospital /ID# 211369

Seoul, , South Korea

Site Status

National Medical Center /ID# 209911

Seoul, , South Korea

Site Status

Kangdong Sacred Heart Hospital /ID# 210621

Seoul, , South Korea

Site Status

Asan Medical Center /ID# 210622

Seoul, , South Korea

Site Status

Gangnam Severance Hospital /ID# 212512

Seoul, , South Korea

Site Status

Samsung Medical Center /ID# 209296

Seoul, , South Korea

Site Status

Samsung Medical Center /ID# 209635

Seoul, , South Korea

Site Status

Chung-Ang University Hostipal /ID# 209295

Seoul, , South Korea

Site Status

Ewha Womans University Mokdong Hospital /ID# 214961

Seoul, , South Korea

Site Status

Ewha Womans University Mokdong Hospital /ID# 216412

Seoul, , South Korea

Site Status

Korea University Guro Hospital /ID# 209989

Seoul, , South Korea

Site Status

St. Carollo General Hospital /ID# 210619

Suncheon, , South Korea

Site Status

Ulsan University Hospital /ID# 210810

Ulsan, , South Korea

Site Status

Wonju Severance Christian Hospital /ID# 210611

Wŏnju, , South Korea

Site Status

Countries

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South Korea

Related Links

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Other Identifiers

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P19-423

Identifier Type: -

Identifier Source: org_study_id

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