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
- Conditions
- Hepatitis C
- Registration Number
- NCT03740230
- Lead Sponsor
- AbbVie
- Brief 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
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3134
- Participants with chronic C hepatitis genotypes 1 to 6.
- Participants prescribed Maviret in accordance with approved local label.
- Patients with contraindications to the approved local labels for Maviret.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) 12 weeks after the last dose of study drug SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after end of treatment.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Post-treatment Relapse Up to 28 weeks 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.
Percentage of Participants With On-treatment Virologic Failure Up to 30 weeks 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.
Trial Locations
- Locations (61)
Kwangju Christian Hospital /ID# 210623
🇰🇷Gwangju, Jeonranamdo, Korea, Republic of
SMG-SNU Boramae Medical Center /ID# 210610
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Wonkwang University Hospital /Id# 210620
🇰🇷Iksan, Jeonrabugdo, Korea, Republic of
Yonsei University Health System Severance Hospital /ID# 209636
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Inje University Busan Paik Hospital /ID# 209992
🇰🇷Busan, Korea, Republic of
Maryknoll Medical Center /ID# 210957
🇰🇷Busan, Korea, Republic of
Chuncheon Sacred Heart Hospital /ID# 210612
🇰🇷Chuncheon, Korea, Republic of
Keimyung University Dongsan Medical Center /ID# 212144
🇰🇷Daegu, Korea, Republic of
Dankook University Hospital /ID# 209297
🇰🇷Cheonan, Korea, Republic of
Kyungpook National University Hospital /ID# 209294
🇰🇷Daegu, Korea, Republic of
CHA Gumi Medical Center, CHA University /ID# 209994
🇰🇷Gumi-si, Korea, Republic of
Gachon University Gil Medical Center /ID# 212513
🇰🇷Incheon, Korea, Republic of
Chonnam National University Hwasun Hospital /ID# 209990
🇰🇷Jeonnam, Korea, Republic of
Wonju Severance Christian Hospital /ID# 210611
🇰🇷Wonju, Korea, Republic of
Good Samsun Hospital /ID# 209291
🇰🇷Busan, Korea, Republic of
Inje University Haeundae Hospital /ID# 209993
🇰🇷Busan, Korea, Republic of
Pusan National University Hospital /ID# 209813
🇰🇷Busan, Korea, Republic of
Samsung Changwon Hospital /ID# 211507
🇰🇷Changwon, Korea, Republic of
Keimyung University Dongsan Medical Center /ID# 212514
🇰🇷Daegu, Korea, Republic of
Yeungnam University Medical Center /ID# 209293
🇰🇷Daegu, Korea, Republic of
The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 216952
🇰🇷Daejeon, Korea, Republic of
Myongji Hospital /ID# 215595
🇰🇷Goyang, Korea, Republic of
Chosun University Hospital /ID# 210607
🇰🇷Gwangju, Korea, Republic of
The Catholic University of Korea Incheon St.Mary's Hospital /ID# 216950
🇰🇷Incheon, Korea, Republic of
Inje University Sanggye Paik Hospital /ID# 210811
🇰🇷Seoul, Korea, Republic of
Korea University Anam Hospital /ID# 210958
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center /ID# 209635
🇰🇷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
Kim Jun Hwan Sok Internal Medi /ID# 209292
🇰🇷Daegu, Korea, Republic of
Seoul National University Hospital /ID# 211365
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital /ID# 211369
🇰🇷Seoul, Korea, Republic of
National Medical Center /ID# 209911
🇰🇷Seoul, Korea, Republic of
Asan Medical Center /ID# 210622
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Bucheon St.Mary's Hospital /ID# 216869
🇰🇷Bucheon, Gyeonggido, Korea, Republic of
SoonChunHyang University CheonAn Hospital /ID# 209996
🇰🇷Cheonan-si, Chungcheongnamdo, Korea, Republic of
Hallym University Sacred Heart Hospital /ID# 210809
🇰🇷Anyang, Gyeonggido, Korea, Republic of
SoonChunHyang University Buchon Hospital /ID# 210618
🇰🇷Buncheon, Gyeonggido, Korea, Republic of
The Catholic University of Korea, ST. Vincent's Hospital /ID# 216951
🇰🇷Suwon, Gyeonggido, Korea, Republic of
Dongguk University Ilsan Hospital /ID# 210609
🇰🇷Goyang, Gyeonggido, Korea, Republic of
National health insurance Service ilsanhospital /ID# 209997
🇰🇷Goyang, Gyeonggido, Korea, Republic of
Seoul National University Bundang Hospital /ID# 210616
🇰🇷Seongnam, Gyeonggido, Korea, Republic of
Ajou University Hospital /ID# 209995
🇰🇷Suwon, Gyeonggido, Korea, Republic of
The Catholic University of Korea, Uijeongbu ST. Mary's Hospital /ID# 216949
🇰🇷Uijeongbu, Gyeonggido, Korea, Republic of
Pusan National University Yangsan Hospital /ID# 214960
🇰🇷Yangsan-si, Gyeongsangnamdo, Korea, Republic of
Dongnam Institute of Radiological & Medical Sciences /ID# 209991
🇰🇷Busan, Korea, Republic of
Kosin University Gospel Hospital /ID# 210608
🇰🇷Busan, Korea, Republic of
Dong-A University Hospital /ID# 209450
🇰🇷Busan, Korea, Republic of
Kyungpook National University Chilgok Hospital /ID# 209988
🇰🇷Daegu, Korea, Republic of
Samsung Changwon Hospital /ID# 211743
🇰🇷Changwon, Korea, Republic of
Chungnam National University Hospital /ID# 209637
🇰🇷Daejeon, Korea, Republic of
Jeju National University Hospital /ID# 214700
🇰🇷Jeju, Korea, Republic of
Inha University Hospital /ID# 210617
🇰🇷Incheon, Korea, Republic of
Seoul National University Hospital /ID# 210959
🇰🇷Seoul, Korea, Republic of
Gangnam Severance Hospital /ID# 212512
🇰🇷Seoul, Korea, Republic of
Kangdong Sacred Heart Hospital /ID# 210621
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center /ID# 209296
🇰🇷Seoul, Korea, Republic of
Ulsan University Hospital /ID# 210810
🇰🇷Ulsan, Korea, Republic of
Korea University Guro Hospital /ID# 209989
🇰🇷Seoul, Korea, Republic of
St. Carollo General Hospital /ID# 210619
🇰🇷Suncheon, Korea, Republic of
Ewha Womans University Mokdong Hospital /ID# 216412
🇰🇷Seoul, Korea, Republic of