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

Completed

• 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

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2017-06-27
• Study First Submitted QC: 2017-06-27
• Study First Posted: 2017-06-28
• Study Start: 2017-08-17
• Primary Completion: 2019-10-11
• Study Completion: 2019-10-11
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-06
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 505

Inclusion Criteria

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

Read More

Exclusion Criteria

• None

Read More

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