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NCT03740230 Clinical Trial

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

Hepatitis C Clinical Trial

— Maviret PMS  

Official title:
Post-marketing Surveillance to Assess the Safety and Effectiveness of Maviret (Glecaprevir/Pibrentasvir) for Korean Chronic Hepatitis C Genotypes 1 to 6 Patients According to the "Standard for Re-examination of New Drugs"

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03740230
Other study ID # P19-423
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 26, 2018
Est. completion date July 21, 2023

Study information
Verified date August 2023
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 3134
Est. completion date July 21, 2023
Est. primary completion date July 21, 2023
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Hallym University Sacred Heart Hospital /ID# 210809 Anyang Gyeonggido
Korea, Republic of The Catholic University of Korea, Bucheon St.Mary's Hospital /ID# 216869 Bucheon Gyeonggido
Korea, Republic of SoonChunHyang University Buchon Hospital /ID# 210618 Buncheon Gyeonggido
Korea, Republic of Dong-A University Hospital /ID# 209450 Busan
Korea, Republic of Dongnam Institute of Radiological & Medical Sciences /ID# 209991 Busan
Korea, Republic of Good Samsun Hospital /ID# 209291 Busan
Korea, Republic of Inje University Busan Paik Hospital /ID# 209992 Busan
Korea, Republic of Inje University Haeundae Hospital /ID# 209993 Busan
Korea, Republic of Kosin University Gospel Hospital /ID# 210608 Busan
Korea, Republic of Maryknoll Medical Center /ID# 210957 Busan
Korea, Republic of Pusan National University Hospital /ID# 209813 Busan
Korea, Republic of Samsung Changwon Hospital /ID# 211507 Changwon
Korea, Republic of Samsung Changwon Hospital /ID# 211743 Changwon
Korea, Republic of Dankook University Hospital /ID# 209297 Cheonan
Korea, Republic of SoonChunHyang University CheonAn Hospital /ID# 209996 Cheonan-si Chungcheongnamdo
Korea, Republic of Chuncheon Sacred Heart Hospital /ID# 210612 Chuncheon
Korea, Republic of Keimyung University Dongsan Medical Center /ID# 212144 Daegu
Korea, Republic of Keimyung University Dongsan Medical Center /ID# 212514 Daegu
Korea, Republic of Kim Jun Hwan Sok Internal Medi /ID# 209292 Daegu
Korea, Republic of Kyungpook National University Chilgok Hospital /ID# 209988 Daegu
Korea, Republic of Kyungpook National University Hospital /ID# 209294 Daegu
Korea, Republic of Yeungnam University Medical Center /ID# 209293 Daegu
Korea, Republic of Chungnam National University Hospital /ID# 209637 Daejeon
Korea, Republic of The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 216952 Daejeon
Korea, Republic of Dongguk University Ilsan Hospital /ID# 210609 Goyang Gyeonggido
Korea, Republic of Myongji Hospital /ID# 215595 Goyang
Korea, Republic of National health insurance Service ilsanhospital /ID# 209997 Goyang Gyeonggido
Korea, Republic of CHA Gumi Medical Center, CHA University /ID# 209994 Gumi-si
Korea, Republic of Chosun University Hospital /ID# 210607 Gwangju
Korea, Republic of Kwangju Christian Hospital /ID# 210623 Gwangju Jeonranamdo
Korea, Republic of Wonkwang University Hospital /Id# 210620 Iksan Jeonrabugdo
Korea, Republic of Gachon University Gil Medical Center /ID# 212513 Incheon
Korea, Republic of Inha University Hospital /ID# 210617 Incheon
Korea, Republic of The Catholic University of Korea Incheon St.Mary's Hospital /ID# 216950 Incheon
Korea, Republic of Jeju National University Hospital /ID# 214700 Jeju
Korea, Republic of Chonnam National University Hwasun Hospital /ID# 209990 Jeonnam
Korea, Republic of Seoul National University Bundang Hospital /ID# 210616 Seongnam Gyeonggido
Korea, Republic of Asan Medical Center /ID# 210622 Seoul
Korea, Republic of Chung-Ang University Hostipal /ID# 209295 Seoul
Korea, Republic of Ewha Womans University Mokdong Hospital /ID# 214961 Seoul
Korea, Republic of Ewha Womans University Mokdong Hospital /ID# 216412 Seoul
Korea, Republic of Gangnam Severance Hospital /ID# 212512 Seoul
Korea, Republic of Inje University Sanggye Paik Hospital /ID# 210811 Seoul
Korea, Republic of Kangdong Sacred Heart Hospital /ID# 210621 Seoul
Korea, Republic of Korea University Anam Hospital /ID# 210958 Seoul
Korea, Republic of Korea University Guro Hospital /ID# 209989 Seoul
Korea, Republic of National Medical Center /ID# 209911 Seoul
Korea, Republic of Samsung Medical Center /ID# 209296 Seoul
Korea, Republic of Samsung Medical Center /ID# 209635 Seoul
Korea, Republic of Seoul National University Hospital /ID# 210959 Seoul
Korea, Republic of Seoul National University Hospital /ID# 211365 Seoul
Korea, Republic of Seoul National University Hospital /ID# 211369 Seoul
Korea, Republic of SMG-SNU Boramae Medical Center /ID# 210610 Seoul Seoul Teugbyeolsi
Korea, Republic of Yonsei University Health System Severance Hospital /ID# 209636 Seoul Seoul Teugbyeolsi
Korea, Republic of St. Carollo General Hospital /ID# 210619 Suncheon
Korea, Republic of Ajou University Hospital /ID# 209995 Suwon Gyeonggido
Korea, Republic of The Catholic University of Korea, ST. Vincent's Hospital /ID# 216951 Suwon Gyeonggido
Korea, Republic of The Catholic University of Korea, Uijeongbu ST. Mary's Hospital /ID# 216949 Uijeongbu Gyeonggido
Korea, Republic of Ulsan University Hospital /ID# 210810 Ulsan
Korea, Republic of Wonju Severance Christian Hospital /ID# 210611 Wonju
Korea, Republic of Pusan National University Yangsan Hospital /ID# 214960 Yangsan-si Gyeongsangnamdo

Sponsors (1)
Lead Sponsor Collaborator
AbbVie

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [ 12 weeks after the last dose of study drug
Secondary Percentage of Participants With On-treatment Virologic Failure On-treatment virologic failure was defined as confirmed HCV RNA = LLOQ after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA = LLOQ persistently during treatment period. Up to 30 weeks
Secondary Percentage of Participants With Post-treatment Relapse Post-treatment relapse defined as confirmed HCV RNA = LLOQ between end of treatment and 12 weeks after the end of treatment among participants who complete treatment and with HCV RNA levels < LLOQ at the end of treatment. Up to 28 weeks
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