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

NCT03201718 | Completed

• 1 other identifier: P16-666
• Study Type: observational
• Target: 505
• Locations: 1 country
• Sites: 59

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.

Conditions

Hepatitis C Virus (HCV)

Keywords

Hepatitis C; Paritaprevir; Ritonavir; Ombitasvir; Dasabuvir

Outcome Measures

Primary Outcomes (1)

• 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 \[\<LLOQ\]) 12 weeks after the last dose of study drug.

  12 weeks after the last dose of study drug

Secondary Outcomes (2)

• Percentage of Participants With On-treatment Virologic Failure

  Up to 24 weeks

• Percentage of Participants With Post-treatment Relapse

  From the end of treatment through 12 weeks after the last dose of study drug

Study Arms (1)

Hepatitis C

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Type C Hepatitis patients who had been prescribed Viekira/Exviera (paritaprevir/ritonavir/ombitasvir and dasabuvir) in accordance with approved local label.

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• AbbVie: lead

Study Sites (59)

Dong-A University Hospital /ID# 167362

Busan, Busan Gwang Yeogsi, 49201, South Korea

Location

Pusan National University Hosp /ID# 167363

Busan, Busan Gwang Yeogsi, 602-739, South Korea

Location

Kyungpook National Univ Hosp /ID# 168731

Daegu, Daegu Gwang Yeogsi, 41944, South Korea

Location

Yeungnam University Med Ctr /ID# 167425

Daegu, Daegu Gwang Yeogsi, 42415, South Korea

Location

Chungnam National University Hospital /ID# 167724

Junggu, Daejeon Gwang Yeogsi, 35015, South Korea

Location

National health insurance cooperation ilsan hospital /ID# 201806

Goyang, Gyeonggido, 10444, South Korea

Location

Soon Chun Hyang University Hospital Bucheon /ID# 201803

Habun, Gyeonggido, 14584, South Korea

Location

Seoul National Univ Bundang ho /ID# 167394

Seongnam, Gyeonggido, 13620, South Korea

Location

St. Vincent's Hospital /ID# 201660

Suwon, Gyeonggido, 16247, South Korea

Location

Ajou University Hospital /ID# 167729

Suwon, Gyeonggido, 16499, South Korea

Location

Inje University Busan Paik Hospital /ID# 167392

Pusan, Gyeongsangbuk-do, 47392, South Korea

Location

Changwon Fatima Hospital /ID# 201664

Changwon, Gyeongsangnam-do, 51394, South Korea

Location

Inha University Hospital /ID# 201802

Junggu, Incheon Gwang Yeogsi, 22332, South Korea

Location

Chonnam National University Hospital /ID# 167423

Gwangju, Jeonranamdo, 61469, South Korea

Location

Kwangju Christian Hospital /ID# 210823

Gwangju, Jeonranamdo, 61661, South Korea

Location

Kyungpook National University Chilgok Hospital /ID# 201804

Daegu, Seoul Teugbyeolsi, 41404, South Korea

Location

SMG-SNU Boramae Medical Center /ID# 201805

Dongjak-gu, Seoul Teugbyeolsi, 07061, South Korea

Location

Kangbuk Samsung Hospital /ID# 168792

Jongno-Gu, Seoul Teugbyeolsi, 03181, South Korea

Location

Severance Hospital /ID# 167361

Seoul, Seoul Teugbyeolsi, 03722, South Korea

Location

Konkuk University Medical Ctr /ID# 167723

Seoul, Seoul Teugbyeolsi, 05030, South Korea

Location

Samsung Medical Center /ID# 167722

Seoul, Seoul Teugbyeolsi, 06351, South Korea

Location

Korea Universtiy Guro Hospital /ID# 167388

Seoul, Seoul Teugbyeolsi, 08308, South Korea

Location

Bucheon St. Mary's hospital /ID# 170782

Bucheon-si, 420-818, South Korea

Location

Dongnam Institute of Radiologi /ID# 167721

Busan, 46033, South Korea

Location

Good Samsun Hospital /ID# 167365

Busan, 47007, South Korea

Location

Haeundae Paik Hospital /ID# 170767

Busan, 48108, South Korea

Location

Maryknoll Medical Center /ID# 167418

Busan, 48972, South Korea

Location

Kosin University Gospel Hosp /ID# 168797

Busan, 602-702, South Korea

Location

Samsung Changwon Hospital /ID# 167732

Changwon, 630-723, South Korea

Location

Dankook University Hospital /ID# 167730

Cheonan, 330-715, South Korea

Location

Chuncheon Sacred Heart Hosp /ID# 167419

Chuncheon, 200-704, South Korea

Location

Kim Jun Hwan Sok Internal Medi /ID# 168794

Daegu, 42488, South Korea

Location

Keimyung Univ Dongsan medical /ID# 168793

Daegu, 700-712, South Korea

Location

Daegu Catholic University Med /ID# 167714

Daegu, 705-718, South Korea

Location

Daegu Catholic University Med /ID# 168729

Daegu, 705-718, South Korea

Location

The Catholic Univ. of Korea /ID# 167733

Daejeon, 301-723, South Korea

Location

Dongguk University Ilsan Hosp /ID# 168795

Goyang, 410-773, South Korea

Location

Myongji Hospital /ID# 170784

Goyang, 412-270, South Korea

Location

CHA Gumi Medical Center /ID# 170783

Gumi, 39295, South Korea

Location

Korea University Ansan Hosp /ID# 201661

Gyeonggi-do, 152-703, South Korea

Location

Dongtan Sacred Heart Hospital /ID# 170759

Hwaseong, 18450, South Korea

Location

The Catholic University of Korea Incheon St.Mary's Hospital /ID# 170769

Incheon, 21431, South Korea

Location

Presbyterian Medical Center /ID# 167424

Jeonju, 54987, South Korea

Location

CHA Bundang Medical Center /ID# 170757

Seongnam, 463-712, South Korea

Location

Bundang Jesaeng hospital /ID# 167725

Seongnam, 463-824, South Korea

Location

Korea University Anam Hospital /ID# 167731

Seoul, 02841, South Korea

Location

Seoul National University Hospital /ID# 167364

Seoul, 03080, South Korea

Location

Seoul National University Hospital /ID# 167389

Seoul, 03080, South Korea

Location

SoonChunHyang University Seoul /ID# 167711

Seoul, 04401, South Korea

Location

Asan Medical Center /ID# 167390

Seoul, 05505, South Korea

Location

Chung-Ang University Hostipal /ID# 167420

Seoul, 06973, South Korea

Location

Inje University Seoul Paik Hos /ID# 167426

Seoul, 100-032, South Korea

Location

Inje University Sanggye Paik H /ID# 167427

Seoul, 139-707, South Korea

Location

St. Carollo General Hospital /ID# 167712

Suncheon, 57931, South Korea

Location

Uijeongbu St. Mary's Hospital /ID# 168730

Uijeongbu-si, 480-717, South Korea

Location

Ulsan University Hospital /ID# 168796

Ulsan, 682-714, South Korea

Location

Wonju Severance Christian Hosp /ID# 167713

Wŏnju, 220-701, South Korea

Location

Pusan National University Yang /ID# 167710

Yangsan, 50612, South Korea

Location

Yeosoo Hankook Hospital /ID# 168728

Yeosu, 59684, South Korea

Location

Related Links

• clinical study report synopsis

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: June 28, 2017
• Study Start: August 17, 2017
• Primary Completion: October 11, 2019
• Study Completion: October 11, 2019
• Last Updated: October 8, 2020

Record last verified: 2020-10

Locations

KR (59)