Hepatitis C Clinical Trial
— Maviret PMSOfficial 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"
| 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 |
| Verified date | August 2023 |
| Source | AbbVie |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| 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. |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie |
Korea, Republic of,
| 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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