A Study of Viekira/Exviera for Korean Hepatitis C Patients According to the Standard for Re-examination of New Drugs

NCT03201718 — Completed, 505 participants, AbbVie

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Post-marketing Surveillance Study of Viekira/ Exviera Tablets for Korean Hepatitis C Patients According to the Standard for "Re-examination of New Drugs"

Registry	NCT03201718, acronym HCV PMS
Status	Completed
Study type	Observational
Enrollment	505 (Actual)
Sponsor	AbbVie (Industry)
Conditions	Hepatitis C Virus (HCV)
Dates	start 2017-08-17, primary completion 2019-10-11, completion 2019-10-11, first posted 2017-06-28, last updated 2020-10-08
Locations	59 sites in South Korea

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Hepatitis C			Participants with Hepatitis C receiving Viekira/Exviera (paritaprevir/ritonavir/ombitasvir and dasabuvir) for 12 or 24 weeks.

+Outcome measures

Primary outcomes

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 outcomes

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.
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

+Eligibility

Sex: All, ages: 18 Years to 99 Years

Inclusion Criteria:

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

Exclusion Criteria:

* None

+Locations (59)

Facility	City	Country
Dong-A University Hospital /ID# 167362	Busan, Busan Gwang Yeogsi	South Korea
Pusan National University Hosp /ID# 167363	Busan, Busan Gwang Yeogsi	South Korea
Kyungpook National Univ Hosp /ID# 168731	Daegu, Daegu Gwang Yeogsi	South Korea
Yeungnam University Med Ctr /ID# 167425	Daegu, Daegu Gwang Yeogsi	South Korea
Chungnam National University Hospital /ID# 167724	Junggu, Daejeon Gwang Yeogsi	South Korea
National health insurance cooperation ilsan hospital /ID# 201806	Goyang, Gyeonggido	South Korea
Soon Chun Hyang University Hospital Bucheon /ID# 201803	Habun, Gyeonggido	South Korea
Seoul National Univ Bundang ho /ID# 167394	Seongnam, Gyeonggido	South Korea
St. Vincent's Hospital /ID# 201660	Suwon, Gyeonggido	South Korea
Ajou University Hospital /ID# 167729	Suwon, Gyeonggido	South Korea
Inje University Busan Paik Hospital /ID# 167392	Pusan, Gyeongsangbuk-do	South Korea
Changwon Fatima Hospital /ID# 201664	Changwon, Gyeongsangnam-do	South Korea
Inha University Hospital /ID# 201802	Junggu, Incheon Gwang Yeogsi	South Korea
Chonnam National University Hospital /ID# 167423	Gwangju, Jeonranamdo	South Korea
Kwangju Christian Hospital /ID# 210823	Gwangju, Jeonranamdo	South Korea
Kyungpook National University Chilgok Hospital /ID# 201804	Daegu, Seoul Teugbyeolsi	South Korea
SMG-SNU Boramae Medical Center /ID# 201805	Dongjak-gu, Seoul Teugbyeolsi	South Korea
Kangbuk Samsung Hospital /ID# 168792	Jongno-Gu, Seoul Teugbyeolsi	South Korea
Severance Hospital /ID# 167361	Seoul, Seoul Teugbyeolsi	South Korea
Konkuk University Medical Ctr /ID# 167723	Seoul, Seoul Teugbyeolsi	South Korea
Samsung Medical Center /ID# 167722	Seoul, Seoul Teugbyeolsi	South Korea
Korea Universtiy Guro Hospital /ID# 167388	Seoul, Seoul Teugbyeolsi	South Korea
Bucheon St. Mary's hospital /ID# 170782	Bucheon-si	South Korea
Dongnam Institute of Radiologi /ID# 167721	Busan	South Korea
Good Samsun Hospital /ID# 167365	Busan	South Korea
Haeundae Paik Hospital /ID# 170767	Busan	South Korea
Maryknoll Medical Center /ID# 167418	Busan	South Korea
Kosin University Gospel Hosp /ID# 168797	Busan	South Korea
Samsung Changwon Hospital /ID# 167732	Changwon	South Korea
Dankook University Hospital /ID# 167730	Cheonan	South Korea
Chuncheon Sacred Heart Hosp /ID# 167419	Chuncheon	South Korea
Kim Jun Hwan Sok Internal Medi /ID# 168794	Daegu	South Korea
Keimyung Univ Dongsan medical /ID# 168793	Daegu	South Korea
Daegu Catholic University Med /ID# 167714	Daegu	South Korea
Daegu Catholic University Med /ID# 168729	Daegu	South Korea
The Catholic Univ. of Korea /ID# 167733	Daejeon	South Korea
Dongguk University Ilsan Hosp /ID# 168795	Goyang	South Korea
Myongji Hospital /ID# 170784	Goyang	South Korea
CHA Gumi Medical Center /ID# 170783	Gumi	South Korea
Korea University Ansan Hosp /ID# 201661	Gyeonggi-do	South Korea
Dongtan Sacred Heart Hospital /ID# 170759	Hwaseong	South Korea
The Catholic University of Korea Incheon St.Mary's Hospital /ID# 170769	Incheon	South Korea
Presbyterian Medical Center /ID# 167424	Jeonju	South Korea
CHA Bundang Medical Center /ID# 170757	Seongnam	South Korea
Bundang Jesaeng hospital /ID# 167725	Seongnam	South Korea
Korea University Anam Hospital /ID# 167731	Seoul	South Korea
Seoul National University Hospital /ID# 167364	Seoul	South Korea
Seoul National University Hospital /ID# 167389	Seoul	South Korea
SoonChunHyang University Seoul /ID# 167711	Seoul	South Korea
Asan Medical Center /ID# 167390	Seoul	South Korea
Chung-Ang University Hostipal /ID# 167420	Seoul	South Korea
Inje University Seoul Paik Hos /ID# 167426	Seoul	South Korea
Inje University Sanggye Paik H /ID# 167427	Seoul	South Korea
St. Carollo General Hospital /ID# 167712	Suncheon	South Korea
Uijeongbu St. Mary's Hospital /ID# 168730	Uijeongbu-si	South Korea
Ulsan University Hospital /ID# 168796	Ulsan	South Korea
Wonju Severance Christian Hosp /ID# 167713	Wŏnju	South Korea
Pusan National University Yang /ID# 167710	Yangsan	South Korea
Yeosoo Hankook Hospital /ID# 168728	Yeosu	South Korea

+Investigators

AbbVie Inc., Study director, AbbVie

My Notes

Public

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