Hepatitis C Virus (HCV) Clinical Trial
— HCV PMSOfficial title:
Post-marketing Surveillance Study of Viekira/ Exviera Tablets for Korean Hepatitis C Patients According to the Standard for "Re-examination of New Drugs"
| NCT number | NCT03201718 |
| Other study ID # | P16-666 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | August 17, 2017 |
| Est. completion date | October 11, 2019 |
| Verified date | October 2020 |
| 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 Viekira/ Exviera (paritaprevir/ritonavir/ombitasvir and dasabuvir) administered under a normal, routine treatment practice by Korean patients with Hepatitis C.
| Status | Completed |
| Enrollment | 505 |
| Est. completion date | October 11, 2019 |
| Est. primary completion date | October 11, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 99 Years |
| Eligibility |
Inclusion Criteria: - Participants with type C hepatitis - Participants prescribed Viekira/Exviera in accordance with approved local label Exclusion Criteria: - None |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Bucheon St. Mary's hospital /ID# 170782 | Bucheon | |
| Korea, Republic of | Soon Chun Hyang University Hospital Bucheon /ID# 201803 | Buncheon | Gyeonggido |
| Korea, Republic of | Dong-A University Hospital /ID# 167362 | Busan | Busan Gwang Yeogsi |
| Korea, Republic of | Dongnam Institute of Radiologi /ID# 167721 | Busan | |
| Korea, Republic of | Good Samsun Hospital /ID# 167365 | Busan | |
| Korea, Republic of | Haeundae Paik Hospital /ID# 170767 | Busan | |
| Korea, Republic of | Inje University Busan Paik Hospital /ID# 167392 | Busan | Gyeongsangbugdo |
| Korea, Republic of | Kosin University Gospel Hosp /ID# 168797 | Busan | |
| Korea, Republic of | Maryknoll Medical Center /ID# 167418 | Busan | |
| Korea, Republic of | Pusan National University Hosp /ID# 167363 | Busan | Busan Gwang Yeogsi |
| Korea, Republic of | Changwon Fatima Hospital /ID# 201664 | Changwon | Gyeongsangnamdo |
| Korea, Republic of | Samsung Changwon Hospital /ID# 167732 | Changwon | |
| Korea, Republic of | Dankook University Hospital /ID# 167730 | Cheonan | |
| Korea, Republic of | Chuncheon Sacred Heart Hosp /ID# 167419 | Chuncheon | |
| Korea, Republic of | Daegu Catholic University Med /ID# 167714 | Daegu | |
| Korea, Republic of | Daegu Catholic University Med /ID# 168729 | Daegu | |
| 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 | Kyungpook National Univ Hosp /ID# 168731 | Daegu | Daegu Gwang Yeogsi |
| Korea, Republic of | Kyungpook National University Chilgok Hospital /ID# 201804 | Daegu | Seoul Teugbyeolsi |
| Korea, Republic of | Yeungnam University Med Ctr /ID# 167425 | Daegu | Daegu Gwang Yeogsi |
| Korea, Republic of | The Catholic Univ. of Korea /ID# 167733 | Daejeon | |
| Korea, Republic of | SMG-SNU Boramae Medical Center /ID# 201805 | Dongjak-gu | Seoul Teugbyeolsi |
| Korea, Republic of | Dongguk University Ilsan Hosp /ID# 168795 | Goyang | |
| Korea, Republic of | Myongji Hospital /ID# 170784 | Goyang | |
| Korea, Republic of | National health insurance cooperation ilsan hospital /ID# 201806 | Goyang | Gyeonggido |
| Korea, Republic of | CHA Gumi Medical Center /ID# 170783 | Gumi | |
| Korea, Republic of | Chonnam National University Hospital /ID# 167423 | Gwangju | Jeonranamdo |
| Korea, Republic of | Kwangju Christian Hospital /ID# 210823 | Gwangju | Jeonranamdo |
| Korea, Republic of | Korea University Ansan Hosp /ID# 201661 | Gyeonggi-do | |
| Korea, Republic of | Dongtan Sacred Heart Hospital /ID# 170759 | Hwaseong | |
| Korea, Republic of | The Catholic University of Korea Incheon St.Mary's Hospital /ID# 170769 | Incheon | |
| Korea, Republic of | Presbyterian Medical Center /ID# 167424 | Jeonju | |
| Korea, Republic of | Kangbuk Samsung Hospital /ID# 168792 | Jongno-Gu | Seoul Teugbyeolsi |
| Korea, Republic of | Chungnam National University Hospital /ID# 167724 | Jung-gu | Daejeon Gwang Yeogsi |
| Korea, Republic of | Inha University Hospital /ID# 201802 | Jung-gu | Incheon Gwang Yeogsi |
| Korea, Republic of | Bundang Jesaeng hospital /ID# 167725 | Seongnam | |
| Korea, Republic of | CHA Bundang Medical Center /ID# 170757 | Seongnam | |
| Korea, Republic of | Seoul National Univ Bundang ho /ID# 167394 | Seongnam | Gyeonggido |
| Korea, Republic of | Asan Medical Center /ID# 167390 | Seoul | |
| Korea, Republic of | Chung-Ang University Hostipal /ID# 167420 | Seoul | |
| Korea, Republic of | Inje University Sanggye Paik H /ID# 167427 | Seoul | |
| Korea, Republic of | Inje University Seoul Paik Hos /ID# 167426 | Seoul | |
| Korea, Republic of | Konkuk University Medical Ctr /ID# 167723 | Seoul | Seoul Teugbyeolsi |
| Korea, Republic of | Korea University Anam Hospital /ID# 167731 | Seoul | |
| Korea, Republic of | Korea Universtiy Guro Hospital /ID# 167388 | Seoul | Seoul Teugbyeolsi |
| Korea, Republic of | Samsung Medical Center /ID# 167722 | Seoul | Seoul Teugbyeolsi |
| Korea, Republic of | Seoul National University Hospital /ID# 167364 | Seoul | |
| Korea, Republic of | Seoul National University Hospital /ID# 167389 | Seoul | |
| Korea, Republic of | Severance Hospital /ID# 167361 | Seoul | Seoul Teugbyeolsi |
| Korea, Republic of | SoonChunHyang University Seoul /ID# 167711 | Seoul | |
| Korea, Republic of | St. Carollo General Hospital /ID# 167712 | Suncheon | |
| Korea, Republic of | St. Vincent's Hospital /ID# 201660 | Suwon | Gyeonggido |
| Korea, Republic of | Ajou University Hospital /ID# 167729 | Suwon-si | Gyeonggido |
| Korea, Republic of | Uijeongbu St. Mary's Hospital /ID# 168730 | Uijeongbu | |
| Korea, Republic of | Ulsan University Hospital /ID# 168796 | Ulsan | |
| Korea, Republic of | Wonju Severance Christian Hosp /ID# 167713 | Wonju | |
| Korea, Republic of | Pusan National University Yang /ID# 167710 | Yangsan-si | |
| Korea, Republic of | Yeosoo Hankook Hospital /ID# 168728 | Yeosu |
| 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) | 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 [| 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 at end of treatment with at least 6 weeks of treatment. | Up to 24 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 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 |
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