Clinical trial NCT03740230: 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
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"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Keywords: Hepatitis C
Chronic Hepatitis C
Genotypes
Genotypes 1 to 6
Maviret
Glecaprevir
Pibrentasvir
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2018-11-14
Enrollment: 3134
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with Hepatitis C Genotypes 1 to 6 receiving Maviret (glecaprevir/pibrentasvir) for 8, 12, or 16 weeks.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)
timeFrame: 12 weeks after the last dose of study drug
Secondary outcomes:
measure: Percentage of Participants With On-treatment Virologic Failure
timeFrame: Up to 30 weeks
measure: Percentage of Participants With Post-treatment Relapse
timeFrame: Up to 28 weeks
Other outcomes:
Locations:
city: Cheonan-si
country: Korea, Republic of
facility: SoonChunHyang University CheonAn Hospital /ID# 209996
state: Chungcheongnamdo
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital /ID# 210809
state: Gyeonggido
city: Bucheon
country: Korea, Republic of
facility: The Catholic University of Korea, Bucheon St.Mary's Hospital /ID# 216869
state: Gyeonggido
city: Buncheon
country: Korea, Republic of
facility: SoonChunHyang University Buchon Hospital /ID# 210618
state: Gyeonggido
city: Goyang
country: Korea, Republic of
facility: Dongguk University Ilsan Hospital /ID# 210609
state: Gyeonggido
city: Goyang
country: Korea, Republic of
facility: National health insurance Service ilsanhospital /ID# 209997
state: Gyeonggido
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital /ID# 210616
state: Gyeonggido
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea, ST. Vincent's Hospital /ID# 216951
state: Gyeonggido
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital /ID# 209995
state: Gyeonggido
city: Uijeongbu
country: Korea, Republic of
facility: The Catholic University of Korea, Uijeongbu ST. Mary's Hospital /ID# 216949
state: Gyeonggido
city: Yangsan-si
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital /ID# 214960
state: Gyeongsangnamdo
city: Iksan
country: Korea, Republic of
facility: Wonkwang University Hospital /Id# 210620
state: Jeonrabugdo
city: Gwangju
country: Korea, Republic of
facility: Kwangju Christian Hospital /ID# 210623
state: Jeonranamdo
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System Severance Hospital /ID# 209636
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center /ID# 210610
state: Seoul Teugbyeolsi
city: Busan
country: Korea, Republic of
facility: Dongnam Institute of Radiological & Medical Sciences /ID# 209991
city: Busan
country: Korea, Republic of
facility: Good Samsun Hospital /ID# 209291
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital /ID# 209992
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Hospital /ID# 209993
city: Busan
country: Korea, Republic of
facility: Maryknoll Medical Center /ID# 210957
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital /ID# 209450
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital /ID# 209813
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital /ID# 210608
city: Changwon
country: Korea, Republic of
facility: Samsung Changwon Hospital /ID# 211507
city: Changwon
country: Korea, Republic of
facility: Samsung Changwon Hospital /ID# 211743
city: Cheonan
country: Korea, Republic of
facility: Dankook University Hospital /ID# 209297
city: Chuncheon
country: Korea, Republic of
facility: Chuncheon Sacred Heart Hospital /ID# 210612
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital /ID# 209988
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center /ID# 212144
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center /ID# 212514
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital /ID# 209294
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center /ID# 209293
city: Daegu
country: Korea, Republic of
facility: Kim Jun Hwan Sok Internal Medi /ID# 209292
city: Daejeon
country: Korea, Republic of
facility: The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 216952
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital /ID# 209637
city: Goyang
country: Korea, Republic of
facility: Myongji Hospital /ID# 215595
city: Gumi-si
country: Korea, Republic of
facility: CHA Gumi Medical Center, CHA University /ID# 209994
city: Gwangju
country: Korea, Republic of
facility: Chosun University Hospital /ID# 210607
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea Incheon St.Mary's Hospital /ID# 216950
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center /ID# 212513
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital /ID# 210617
city: Jeju
country: Korea, Republic of
facility: Jeju National University Hospital /ID# 214700
city: Jeonnam
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital /ID# 209990
city: Seoul
country: Korea, Republic of
facility: Inje University Sanggye Paik Hospital /ID# 210811
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital /ID# 210958
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 210959
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 211365
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 211369
city: Seoul
country: Korea, Republic of
facility: National Medical Center /ID# 209911
city: Seoul
country: Korea, Republic of
facility: Kangdong Sacred Heart Hospital /ID# 210621
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center /ID# 210622
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital /ID# 212512
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 209296
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 209635
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hostipal /ID# 209295
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital /ID# 214961
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital /ID# 216412
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital /ID# 209989
city: Suncheon
country: Korea, Republic of
facility: St. Carollo General Hospital /ID# 210619
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital /ID# 210810
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital /ID# 210611
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: