A Study of Viekira/Exviera for Korean Hepatitis C Patients According to the Standard for Re-examination of New Drugs
- Conditions
- Hepatitis C Virus (HCV)
- Registration Number
- NCT03201718
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 505
- Participants with type C hepatitis
- Participants prescribed Viekira/Exviera in accordance with approved local label
- None
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 the lower limit of quantitation (LLOQ) SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Post-treatment Relapse From the end of treatment through 12 weeks after the last dose of study drug Post-treatment relapse defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after the last dose of study drugs 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 24 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 at end of treatment with at least 6 weeks of treatment.
Trial Locations
- Locations (59)
Kyungpook National Univ Hosp /ID# 168731
🇰🇷Daegu, Daegu Gwang Yeogsi, Korea, Republic of
Dong-A University Hospital /ID# 167362
🇰🇷Busan, Busan Gwang Yeogsi, Korea, Republic of
Yeungnam University Med Ctr /ID# 167425
🇰🇷Daegu, Daegu Gwang Yeogsi, Korea, Republic of
Seoul National University Hospital /ID# 167389
🇰🇷Seoul, Korea, Republic of
Dongguk University Ilsan Hosp /ID# 168795
🇰🇷Goyang, Korea, Republic of
Dongnam Institute of Radiologi /ID# 167721
🇰🇷Busan, Korea, Republic of
Chungnam National University Hospital /ID# 167724
🇰🇷Jung-gu, Daejeon Gwang Yeogsi, Korea, Republic of
Pusan National University Yang /ID# 167710
🇰🇷Yangsan-si, Korea, Republic of
Pusan National University Hosp /ID# 167363
🇰🇷Busan, Busan Gwang Yeogsi, Korea, Republic of
Kangbuk Samsung Hospital /ID# 168792
🇰🇷Jongno-Gu, Seoul Teugbyeolsi, Korea, Republic of
Soon Chun Hyang University Hospital Bucheon /ID# 201803
🇰🇷Buncheon, Gyeonggido, Korea, Republic of
National health insurance cooperation ilsan hospital /ID# 201806
🇰🇷Goyang, Gyeonggido, Korea, Republic of
Seoul National Univ Bundang ho /ID# 167394
🇰🇷Seongnam, Gyeonggido, Korea, Republic of
CHA Gumi Medical Center /ID# 170783
🇰🇷Gumi, Korea, Republic of
Good Samsun Hospital /ID# 167365
🇰🇷Busan, Korea, Republic of
St. Carollo General Hospital /ID# 167712
🇰🇷Suncheon, Korea, Republic of
Ajou University Hospital /ID# 167729
🇰🇷Suwon-si, Gyeonggido, Korea, Republic of
Chonnam National University Hospital /ID# 167423
🇰🇷Gwangju, Jeonranamdo, Korea, Republic of
SMG-SNU Boramae Medical Center /ID# 201805
🇰🇷Dongjak-gu, Seoul Teugbyeolsi, Korea, Republic of
Severance Hospital /ID# 167361
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Konkuk University Medical Ctr /ID# 167723
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Samsung Medical Center /ID# 167722
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Korea Universtiy Guro Hospital /ID# 167388
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Haeundae Paik Hospital /ID# 170767
🇰🇷Busan, Korea, Republic of
Maryknoll Medical Center /ID# 167418
🇰🇷Busan, Korea, Republic of
Daegu Catholic University Med /ID# 167714
🇰🇷Daegu, Korea, Republic of
Daegu Catholic University Med /ID# 168729
🇰🇷Daegu, Korea, Republic of
The Catholic Univ. of Korea /ID# 167733
🇰🇷Daejeon, Korea, Republic of
Myongji Hospital /ID# 170784
🇰🇷Goyang, Korea, Republic of
Korea University Ansan Hosp /ID# 201661
🇰🇷Gyeonggi-do, Korea, Republic of
The Catholic University of Korea Incheon St.Mary's Hospital /ID# 170769
🇰🇷Incheon, Korea, Republic of
Korea University Anam Hospital /ID# 167731
🇰🇷Seoul, Korea, Republic of
Dongtan Sacred Heart Hospital /ID# 170759
🇰🇷Hwaseong, Korea, Republic of
CHA Bundang Medical Center /ID# 170757
🇰🇷Seongnam, Korea, Republic of
Bundang Jesaeng hospital /ID# 167725
🇰🇷Seongnam, Korea, Republic of
SoonChunHyang University Seoul /ID# 167711
🇰🇷Seoul, Korea, Republic of
Inje University Seoul Paik Hos /ID# 167426
🇰🇷Seoul, Korea, Republic of
Uijeongbu St. Mary's Hospital /ID# 168730
🇰🇷Uijeongbu, Korea, Republic of
Chung-Ang University Hostipal /ID# 167420
🇰🇷Seoul, Korea, Republic of
Ulsan University Hospital /ID# 168796
🇰🇷Ulsan, Korea, Republic of
Yeosoo Hankook Hospital /ID# 168728
🇰🇷Yeosu, Korea, Republic of
Changwon Fatima Hospital /ID# 201664
🇰🇷Changwon, Gyeongsangnamdo, Korea, Republic of
Kwangju Christian Hospital /ID# 210823
🇰🇷Gwangju, Jeonranamdo, Korea, Republic of
Kyungpook National University Chilgok Hospital /ID# 201804
🇰🇷Daegu, Seoul Teugbyeolsi, Korea, Republic of
Bucheon St. Mary's hospital /ID# 170782
🇰🇷Bucheon, Korea, Republic of
Samsung Changwon Hospital /ID# 167732
🇰🇷Changwon, Korea, Republic of
Kosin University Gospel Hosp /ID# 168797
🇰🇷Busan, Korea, Republic of
Chuncheon Sacred Heart Hosp /ID# 167419
🇰🇷Chuncheon, Korea, Republic of
Dankook University Hospital /ID# 167730
🇰🇷Cheonan, Korea, Republic of
Keimyung Univ Dongsan medical /ID# 168793
🇰🇷Daegu, Korea, Republic of
Kim Jun Hwan Sok Internal Medi /ID# 168794
🇰🇷Daegu, Korea, Republic of
Presbyterian Medical Center /ID# 167424
🇰🇷Jeonju, Korea, Republic of
Seoul National University Hospital /ID# 167364
🇰🇷Seoul, Korea, Republic of
Wonju Severance Christian Hosp /ID# 167713
🇰🇷Wonju, Korea, Republic of
St. Vincent's Hospital /ID# 201660
🇰🇷Suwon, Gyeonggido, Korea, Republic of
Inje University Sanggye Paik H /ID# 167427
🇰🇷Seoul, Korea, Republic of
Inje University Busan Paik Hospital /ID# 167392
🇰🇷Busan, Gyeongsangbugdo, Korea, Republic of
Inha University Hospital /ID# 201802
🇰🇷Jung-gu, Incheon Gwang Yeogsi, Korea, Republic of
Asan Medical Center /ID# 167390
🇰🇷Seoul, Korea, Republic of