Clinical trial NCT03201718: A Study of Viekira/Exviera for Korean Hepatitis C Patients According to the Standard for Re-examination of New Drugs
Official title: Post-marketing Surveillance Study of Viekira/ Exviera Tablets for Korean Hepatitis C Patients According to the Standard for "Re-examination of New Drugs"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C Virus (HCV)
Keywords: Hepatitis C
Paritaprevir
Ritonavir
Ombitasvir
Dasabuvir
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-06-28
Enrollment: 505
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Type C Hepatitis patients who had been prescribed Viekira/Exviera (paritaprevir/ritonavir/ombitasvir and dasabuvir) in accordance with approved local label.

Brief summary: Post-marketing surveillance study to evaluate the real world safety and effectiveness of Viekira/ Exviera (paritaprevir/ritonavir/ombitasvir and dasabuvir) administered under a normal, routine treatment practice by Korean patients with Hepatitis C.


Eligibility criteria: Inclusion Criteria:

* Participants with type C hepatitis
* Participants prescribed Viekira/Exviera in accordance with approved local label

Exclusion Criteria:

* None

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 24 weeks
measure: Percentage of Participants With Post-treatment Relapse
timeFrame: From the end of treatment through 12 weeks after the last dose of study drug
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital /ID# 167362
state: Busan Gwang Yeogsi
city: Busan
country: Korea, Republic of
facility: Pusan National University Hosp /ID# 167363
state: Busan Gwang Yeogsi
city: Daegu
country: Korea, Republic of
facility: Kyungpook National Univ Hosp /ID# 168731
state: Daegu Gwang Yeogsi
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Med Ctr /ID# 167425
state: Daegu Gwang Yeogsi
city: Jung-gu
country: Korea, Republic of
facility: Chungnam National University Hospital /ID# 167724
state: Daejeon Gwang Yeogsi
city: Buncheon
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon /ID# 201803
state: Gyeonggido
city: Goyang
country: Korea, Republic of
facility: National health insurance cooperation ilsan hospital /ID# 201806
state: Gyeonggido
city: Seongnam
country: Korea, Republic of
facility: Seoul National Univ Bundang ho /ID# 167394
state: Gyeonggido
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital /ID# 167729
state: Gyeonggido
city: Suwon
country: Korea, Republic of
facility: St. Vincent's Hospital /ID# 201660
state: Gyeonggido
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital /ID# 167392
state: Gyeongsangbugdo
city: Changwon
country: Korea, Republic of
facility: Changwon Fatima Hospital /ID# 201664
state: Gyeongsangnamdo
city: Jung-gu
country: Korea, Republic of
facility: Inha University Hospital /ID# 201802
state: Incheon Gwang Yeogsi
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital /ID# 167423
state: Jeonranamdo
city: Gwangju
country: Korea, Republic of
facility: Kwangju Christian Hospital /ID# 210823
state: Jeonranamdo
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital /ID# 201804
state: Seoul Teugbyeolsi
city: Dongjak-gu
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center /ID# 201805
state: Seoul Teugbyeolsi
city: Jongno-Gu
country: Korea, Republic of
facility: Kangbuk Samsung Hospital /ID# 168792
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Severance Hospital /ID# 167361
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Ctr /ID# 167723
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 167722
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Korea Universtiy Guro Hospital /ID# 167388
state: Seoul Teugbyeolsi
city: Bucheon
country: Korea, Republic of
facility: Bucheon St. Mary's hospital /ID# 170782
city: Busan
country: Korea, Republic of
facility: Dongnam Institute of Radiologi /ID# 167721
city: Busan
country: Korea, Republic of
facility: Good Samsun Hospital /ID# 167365
city: Busan
country: Korea, Republic of
facility: Haeundae Paik Hospital /ID# 170767
city: Busan
country: Korea, Republic of
facility: Maryknoll Medical Center /ID# 167418
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hosp /ID# 168797
city: Changwon
country: Korea, Republic of
facility: Samsung Changwon Hospital /ID# 167732
city: Cheonan
country: Korea, Republic of
facility: Dankook University Hospital /ID# 167730
city: Chuncheon
country: Korea, Republic of
facility: Chuncheon Sacred Heart Hosp /ID# 167419
city: Daegu
country: Korea, Republic of
facility: Kim Jun Hwan Sok Internal Medi /ID# 168794
city: Daegu
country: Korea, Republic of
facility: Keimyung Univ Dongsan medical /ID# 168793
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Med /ID# 167714
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Med /ID# 168729
city: Daejeon
country: Korea, Republic of
facility: The Catholic Univ. of Korea /ID# 167733
city: Goyang
country: Korea, Republic of
facility: Dongguk University Ilsan Hosp /ID# 168795
city: Goyang
country: Korea, Republic of
facility: Myongji Hospital /ID# 170784
city: Gumi
country: Korea, Republic of
facility: CHA Gumi Medical Center /ID# 170783
city: Gyeonggi-do
country: Korea, Republic of
facility: Korea University Ansan Hosp /ID# 201661
city: Hwaseong
country: Korea, Republic of
facility: Dongtan Sacred Heart Hospital /ID# 170759
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea Incheon St.Mary's Hospital /ID# 170769
city: Jeonju
country: Korea, Republic of
facility: Presbyterian Medical Center /ID# 167424
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center /ID# 170757
city: Seongnam
country: Korea, Republic of
facility: Bundang Jesaeng hospital /ID# 167725
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital /ID# 167731
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 167364
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 167389
city: Seoul
country: Korea, Republic of
facility: SoonChunHyang University Seoul /ID# 167711
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center /ID# 167390
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hostipal /ID# 167420
city: Seoul
country: Korea, Republic of
facility: Inje University Seoul Paik Hos /ID# 167426
city: Seoul
country: Korea, Republic of
facility: Inje University Sanggye Paik H /ID# 167427
city: Suncheon
country: Korea, Republic of
facility: St. Carollo General Hospital /ID# 167712
city: Uijeongbu
country: Korea, Republic of
facility: Uijeongbu St. Mary's Hospital /ID# 168730
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital /ID# 168796
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hosp /ID# 167713
city: Yangsan-si
country: Korea, Republic of
facility: Pusan National University Yang /ID# 167710
city: Yeosu
country: Korea, Republic of
facility: Yeosoo Hankook Hospital /ID# 168728
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: