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

NCT ID: NCT03201718

Last Updated: 2020-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

505 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-17

Study Completion Date

2019-10-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatitis C Virus (HCV)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hepatitis C

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dong-A University Hospital /ID# 167362

Busan, Busan Gwang Yeogsi, South Korea

Site Status

Pusan National University Hosp /ID# 167363

Busan, Busan Gwang Yeogsi, South Korea

Site Status

Kyungpook National Univ Hosp /ID# 168731

Daegu, Daegu Gwang Yeogsi, South Korea

Site Status

Yeungnam University Med Ctr /ID# 167425

Daegu, Daegu Gwang Yeogsi, South Korea

Site Status

Chungnam National University Hospital /ID# 167724

Junggu, Daejeon Gwang Yeogsi, South Korea

Site Status

National health insurance cooperation ilsan hospital /ID# 201806

Goyang, Gyeonggido, South Korea

Site Status

Soon Chun Hyang University Hospital Bucheon /ID# 201803

Habun, Gyeonggido, South Korea

Site Status

Seoul National Univ Bundang ho /ID# 167394

Seongnam, Gyeonggido, South Korea

Site Status

St. Vincent's Hospital /ID# 201660

Suwon, Gyeonggido, South Korea

Site Status

Ajou University Hospital /ID# 167729

Suwon, Gyeonggido, South Korea

Site Status

Inje University Busan Paik Hospital /ID# 167392

Pusan, Gyeongsangbuk-do, South Korea

Site Status

Changwon Fatima Hospital /ID# 201664

Changwon, Gyeongsangnam-do, South Korea

Site Status

Inha University Hospital /ID# 201802

Junggu, Incheon Gwang Yeogsi, South Korea

Site Status

Chonnam National University Hospital /ID# 167423

Gwangju, Jeonranamdo, South Korea

Site Status

Kwangju Christian Hospital /ID# 210823

Gwangju, Jeonranamdo, South Korea

Site Status

Kyungpook National University Chilgok Hospital /ID# 201804

Daegu, Seoul Teugbyeolsi, South Korea

Site Status

SMG-SNU Boramae Medical Center /ID# 201805

Dongjak-gu, Seoul Teugbyeolsi, South Korea

Site Status

Kangbuk Samsung Hospital /ID# 168792

Jongno-Gu, Seoul Teugbyeolsi, South Korea

Site Status

Severance Hospital /ID# 167361

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

Konkuk University Medical Ctr /ID# 167723

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

Samsung Medical Center /ID# 167722

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

Korea Universtiy Guro Hospital /ID# 167388

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

Bucheon St. Mary's hospital /ID# 170782

Bucheon-si, , South Korea

Site Status

Dongnam Institute of Radiologi /ID# 167721

Busan, , South Korea

Site Status

Good Samsun Hospital /ID# 167365

Busan, , South Korea

Site Status

Haeundae Paik Hospital /ID# 170767

Busan, , South Korea

Site Status

Maryknoll Medical Center /ID# 167418

Busan, , South Korea

Site Status

Kosin University Gospel Hosp /ID# 168797

Busan, , South Korea

Site Status

Samsung Changwon Hospital /ID# 167732

Changwon, , South Korea

Site Status

Dankook University Hospital /ID# 167730

Cheonan, , South Korea

Site Status

Chuncheon Sacred Heart Hosp /ID# 167419

Chuncheon, , South Korea

Site Status

Kim Jun Hwan Sok Internal Medi /ID# 168794

Daegu, , South Korea

Site Status

Keimyung Univ Dongsan medical /ID# 168793

Daegu, , South Korea

Site Status

Daegu Catholic University Med /ID# 167714

Daegu, , South Korea

Site Status

Daegu Catholic University Med /ID# 168729

Daegu, , South Korea

Site Status

The Catholic Univ. of Korea /ID# 167733

Daejeon, , South Korea

Site Status

Dongguk University Ilsan Hosp /ID# 168795

Goyang, , South Korea

Site Status

Myongji Hospital /ID# 170784

Goyang, , South Korea

Site Status

CHA Gumi Medical Center /ID# 170783

Gumi, , South Korea

Site Status

Korea University Ansan Hosp /ID# 201661

Gyeonggi-do, , South Korea

Site Status

Dongtan Sacred Heart Hospital /ID# 170759

Hwaseong, , South Korea

Site Status

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

Incheon, , South Korea

Site Status

Presbyterian Medical Center /ID# 167424

Jeonju, , South Korea

Site Status

CHA Bundang Medical Center /ID# 170757

Seongnam, , South Korea

Site Status

Bundang Jesaeng hospital /ID# 167725

Seongnam, , South Korea

Site Status

Korea University Anam Hospital /ID# 167731

Seoul, , South Korea

Site Status

Seoul National University Hospital /ID# 167364

Seoul, , South Korea

Site Status

Seoul National University Hospital /ID# 167389

Seoul, , South Korea

Site Status

SoonChunHyang University Seoul /ID# 167711

Seoul, , South Korea

Site Status

Asan Medical Center /ID# 167390

Seoul, , South Korea

Site Status

Chung-Ang University Hostipal /ID# 167420

Seoul, , South Korea

Site Status

Inje University Seoul Paik Hos /ID# 167426

Seoul, , South Korea

Site Status

Inje University Sanggye Paik H /ID# 167427

Seoul, , South Korea

Site Status

St. Carollo General Hospital /ID# 167712

Suncheon, , South Korea

Site Status

Uijeongbu St. Mary's Hospital /ID# 168730

Uijeongbu-si, , South Korea

Site Status

Ulsan University Hospital /ID# 168796

Ulsan, , South Korea

Site Status

Wonju Severance Christian Hosp /ID# 167713

Wŏnju, , South Korea

Site Status

Pusan National University Yang /ID# 167710

Yangsan, , South Korea

Site Status

Yeosoo Hankook Hospital /ID# 168728

Yeosu, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P16-666

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.