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)
SoonChunHyang University CheonAn Hospital /ID# 209996
🇰🇷Cheonan-si, Chungcheongnamdo, 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
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
The Catholic University of Korea, ST. Vincent's Hospital /ID# 216951
🇰🇷Suwon, 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
Scroll for more (51 remaining)SoonChunHyang University CheonAn Hospital /ID# 209996🇰🇷Cheonan-si, Chungcheongnamdo, Korea, Republic of