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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hepatitis C | Participants with Hepatitis C receiving Viekira/Exviera (paritaprevir/ritonavir/ombitasvir and dasabuvir) for 12 or 24 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) | 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 [](streamdown:incomplete-link) | 12 weeks after the last dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 at end of treatment with at least 6 weeks of treatment. | Up to 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Type C Hepatitis patients who had been prescribed Viekira/Exviera (paritaprevir/ritonavir/ombitasvir and dasabuvir) in accordance with approved local label.
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dong-A University Hospital /ID# 167362 | Busan | Busan Gwang Yeogsi | 49201 | South Korea | ||
| Pusan National University Hosp /ID# 167363 |
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| Label | URL |
|---|---|
| clinical study report synopsis | View source |
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| 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 last dose of study drugs among participants who complete treatment and with HCV RNA levels < LLOQ at the end of treatment | From the end of treatment through 12 weeks after the last dose of study drug |
| Busan |
| Busan Gwang Yeogsi |
| 602-739 |
| South Korea |
| Kyungpook National Univ Hosp /ID# 168731 | Daegu | Daegu Gwang Yeogsi | 41944 | South Korea |
| Yeungnam University Med Ctr /ID# 167425 | Daegu | Daegu Gwang Yeogsi | 42415 | South Korea |
| Chungnam National University Hospital /ID# 167724 | Junggu | Daejeon Gwang Yeogsi | 35015 | South Korea |
| National health insurance cooperation ilsan hospital /ID# 201806 | Goyang | Gyeonggido | 10444 | South Korea |
| Soon Chun Hyang University Hospital Bucheon /ID# 201803 | Habun | Gyeonggido | 14584 | South Korea |
| Seoul National Univ Bundang ho /ID# 167394 | Seongnam | Gyeonggido | 13620 | South Korea |
| St. Vincent's Hospital /ID# 201660 | Suwon | Gyeonggido | 16247 | South Korea |
| Ajou University Hospital /ID# 167729 | Suwon | Gyeonggido | 16499 | South Korea |
| Inje University Busan Paik Hospital /ID# 167392 | Pusan | Gyeongsangbuk-do | 47392 | South Korea |
| Changwon Fatima Hospital /ID# 201664 | Changwon | Gyeongsangnam-do | 51394 | South Korea |
| Inha University Hospital /ID# 201802 | Junggu | Incheon Gwang Yeogsi | 22332 | South Korea |
| Chonnam National University Hospital /ID# 167423 | Gwangju | Jeonranamdo | 61469 | South Korea |
| Kwangju Christian Hospital /ID# 210823 | Gwangju | Jeonranamdo | 61661 | South Korea |
| Kyungpook National University Chilgok Hospital /ID# 201804 | Daegu | Seoul Teugbyeolsi | 41404 | South Korea |
| SMG-SNU Boramae Medical Center /ID# 201805 | Dongjak-gu | Seoul Teugbyeolsi | 07061 | South Korea |
| Kangbuk Samsung Hospital /ID# 168792 | Jongno-Gu | Seoul Teugbyeolsi | 03181 | South Korea |
| Severance Hospital /ID# 167361 | Seoul | Seoul Teugbyeolsi | 03722 | South Korea |
| Konkuk University Medical Ctr /ID# 167723 | Seoul | Seoul Teugbyeolsi | 05030 | South Korea |
| Samsung Medical Center /ID# 167722 | Seoul | Seoul Teugbyeolsi | 06351 | South Korea |
| Korea Universtiy Guro Hospital /ID# 167388 | Seoul | Seoul Teugbyeolsi | 08308 | South Korea |
| Bucheon St. Mary's hospital /ID# 170782 | Bucheon-si | 420-818 | South Korea |
| Dongnam Institute of Radiologi /ID# 167721 | Busan | 46033 | South Korea |
| Good Samsun Hospital /ID# 167365 | Busan | 47007 | South Korea |
| Haeundae Paik Hospital /ID# 170767 | Busan | 48108 | South Korea |
| Maryknoll Medical Center /ID# 167418 | Busan | 48972 | South Korea |
| Kosin University Gospel Hosp /ID# 168797 | Busan | 602-702 | South Korea |
| Samsung Changwon Hospital /ID# 167732 | Changwon | 630-723 | South Korea |
| Dankook University Hospital /ID# 167730 | Cheonan | 330-715 | South Korea |
| Chuncheon Sacred Heart Hosp /ID# 167419 | Chuncheon | 200-704 | South Korea |
| Kim Jun Hwan Sok Internal Medi /ID# 168794 | Daegu | 42488 | South Korea |
| Keimyung Univ Dongsan medical /ID# 168793 | Daegu | 700-712 | South Korea |
| Daegu Catholic University Med /ID# 167714 | Daegu | 705-718 | South Korea |
| Daegu Catholic University Med /ID# 168729 | Daegu | 705-718 | South Korea |
| The Catholic Univ. of Korea /ID# 167733 | Daejeon | 301-723 | South Korea |
| Dongguk University Ilsan Hosp /ID# 168795 | Goyang | 410-773 | South Korea |
| Myongji Hospital /ID# 170784 | Goyang | 412-270 | South Korea |
| CHA Gumi Medical Center /ID# 170783 | Gumi | 39295 | South Korea |
| Korea University Ansan Hosp /ID# 201661 | Gyeonggi-do | 152-703 | South Korea |
| Dongtan Sacred Heart Hospital /ID# 170759 | Hwaseong | 18450 | South Korea |
| The Catholic University of Korea Incheon St.Mary's Hospital /ID# 170769 | Incheon | 21431 | South Korea |
| Presbyterian Medical Center /ID# 167424 | Jeonju | 54987 | South Korea |
| CHA Bundang Medical Center /ID# 170757 | Seongnam | 463-712 | South Korea |
| Bundang Jesaeng hospital /ID# 167725 | Seongnam | 463-824 | South Korea |
| Korea University Anam Hospital /ID# 167731 | Seoul | 02841 | South Korea |
| Seoul National University Hospital /ID# 167364 | Seoul | 03080 | South Korea |
| Seoul National University Hospital /ID# 167389 | Seoul | 03080 | South Korea |
| SoonChunHyang University Seoul /ID# 167711 | Seoul | 04401 | South Korea |
| Asan Medical Center /ID# 167390 | Seoul | 05505 | South Korea |
| Chung-Ang University Hostipal /ID# 167420 | Seoul | 06973 | South Korea |
| Inje University Seoul Paik Hos /ID# 167426 | Seoul | 100-032 | South Korea |
| Inje University Sanggye Paik H /ID# 167427 | Seoul | 139-707 | South Korea |
| St. Carollo General Hospital /ID# 167712 | Suncheon | 57931 | South Korea |
| Uijeongbu St. Mary's Hospital /ID# 168730 | Uijeongbu-si | 480-717 | South Korea |
| Ulsan University Hospital /ID# 168796 | Ulsan | 682-714 | South Korea |
| Wonju Severance Christian Hosp /ID# 167713 | Wŏnju | 220-701 | South Korea |
| Pusan National University Yang /ID# 167710 | Yangsan | 50612 | South Korea |
| Yeosoo Hankook Hospital /ID# 168728 | Yeosu | 59684 | South Korea |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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