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

October 6, 2020 updated by: AbbVie

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

505

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Bucheon, Korea, Republic of, 420-818
        • Bucheon St. Mary's hospital /ID# 170782
      • Busan, Korea, Republic of, 46033
        • Dongnam Institute of Radiologi /ID# 167721
      • Busan, Korea, Republic of, 47007
        • Good Samsun Hospital /ID# 167365
      • Busan, Korea, Republic of, 48108
        • Haeundae Paik Hospital /ID# 170767
      • Busan, Korea, Republic of, 48972
        • Maryknoll Medical Center /ID# 167418
      • Busan, Korea, Republic of, 602-702
        • Kosin University Gospel Hosp /ID# 168797
      • Changwon, Korea, Republic of, 630-723
        • Samsung Changwon Hospital /ID# 167732
      • Cheonan, Korea, Republic of, 330-715
        • Dankook University Hospital /ID# 167730
      • Chuncheon, Korea, Republic of, 200-704
        • Chuncheon Sacred Heart Hosp /ID# 167419
      • Daegu, Korea, Republic of, 42488
        • Kim Jun Hwan Sok Internal Medi /ID# 168794
      • Daegu, Korea, Republic of, 700-712
        • Keimyung Univ Dongsan medical /ID# 168793
      • Daegu, Korea, Republic of, 705-718
        • Daegu Catholic University Med /ID# 167714
      • Daegu, Korea, Republic of, 705-718
        • Daegu Catholic University Med /ID# 168729
      • Daejeon, Korea, Republic of, 301-723
        • The Catholic Univ. of Korea /ID# 167733
      • Goyang, Korea, Republic of, 410-773
        • Dongguk University Ilsan Hosp /ID# 168795
      • Goyang, Korea, Republic of, 412-270
        • Myongji Hospital /ID# 170784
      • Gumi, Korea, Republic of, 39295
        • CHA Gumi Medical Center /ID# 170783
      • Gyeonggi-do, Korea, Republic of, 152-703
        • Korea University Ansan Hosp /ID# 201661
      • Hwaseong, Korea, Republic of, 18450
        • Dongtan Sacred Heart Hospital /ID# 170759
      • Incheon, Korea, Republic of, 21431
        • The Catholic University of Korea Incheon St.Mary's Hospital /ID# 170769
      • Jeonju, Korea, Republic of, 54987
        • Presbyterian Medical Center /ID# 167424
      • Seongnam, Korea, Republic of, 463-712
        • CHA Bundang Medical Center /ID# 170757
      • Seongnam, Korea, Republic of, 463-824
        • Bundang Jesaeng hospital /ID# 167725
      • Seoul, Korea, Republic of, 02841
        • Korea University Anam Hospital /ID# 167731
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital /ID# 167364
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital /ID# 167389
      • Seoul, Korea, Republic of, 04401
        • SoonChunHyang University Seoul /ID# 167711
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center /ID# 167390
      • Seoul, Korea, Republic of, 06973
        • Chung-Ang University Hostipal /ID# 167420
      • Seoul, Korea, Republic of, 100-032
        • Inje University Seoul Paik Hos /ID# 167426
      • Seoul, Korea, Republic of, 139-707
        • Inje University Sanggye Paik H /ID# 167427
      • Suncheon, Korea, Republic of, 57931
        • St. Carollo General Hospital /ID# 167712
      • Uijeongbu, Korea, Republic of, 480-717
        • Uijeongbu St. Mary's Hospital /ID# 168730
      • Ulsan, Korea, Republic of, 682-714
        • Ulsan University Hospital /ID# 168796
      • Wonju, Korea, Republic of, 220-701
        • Wonju Severance Christian Hosp /ID# 167713
      • Yangsan-si, Korea, Republic of, 50612
        • Pusan National University Yang /ID# 167710
      • Yeosu, Korea, Republic of, 59684
        • Yeosoo Hankook Hospital /ID# 168728
    • Busan Gwang Yeogsi
      • Busan, Busan Gwang Yeogsi, Korea, Republic of, 49201
        • Dong-A University Hospital /ID# 167362
      • Busan, Busan Gwang Yeogsi, Korea, Republic of, 602-739
        • Pusan National University Hosp /ID# 167363
    • Daegu Gwang Yeogsi
      • Daegu, Daegu Gwang Yeogsi, Korea, Republic of, 41944
        • Kyungpook National Univ Hosp /ID# 168731
      • Daegu, Daegu Gwang Yeogsi, Korea, Republic of, 42415
        • Yeungnam University Med Ctr /ID# 167425
    • Daejeon Gwang Yeogsi
      • Jung-gu, Daejeon Gwang Yeogsi, Korea, Republic of, 35015
        • Chungnam National University Hospital /ID# 167724
    • Gyeonggido
      • Buncheon, Gyeonggido, Korea, Republic of, 14584
        • Soon Chun Hyang University Hospital Bucheon /ID# 201803
      • Goyang, Gyeonggido, Korea, Republic of, 10444
        • National health insurance cooperation ilsan hospital /ID# 201806
      • Seongnam, Gyeonggido, Korea, Republic of, 13620
        • Seoul National Univ Bundang ho /ID# 167394
      • Suwon, Gyeonggido, Korea, Republic of, 16247
        • St. Vincent's Hospital /ID# 201660
      • Suwon-si, Gyeonggido, Korea, Republic of, 16499
        • Ajou University Hospital /ID# 167729
    • Gyeongsangbugdo
      • Busan, Gyeongsangbugdo, Korea, Republic of, 47392
        • Inje University Busan Paik Hospital /ID# 167392
    • Gyeongsangnamdo
      • Changwon, Gyeongsangnamdo, Korea, Republic of, 51394
        • Changwon Fatima Hospital /ID# 201664
    • Incheon Gwang Yeogsi
      • Jung-gu, Incheon Gwang Yeogsi, Korea, Republic of, 22332
        • Inha University Hospital /ID# 201802
    • Jeonranamdo
      • Gwangju, Jeonranamdo, Korea, Republic of, 61469
        • Chonnam National University Hospital /ID# 167423
      • Gwangju, Jeonranamdo, Korea, Republic of, 61661
        • Kwangju Christian Hospital /ID# 210823
    • Seoul Teugbyeolsi
      • Daegu, Seoul Teugbyeolsi, Korea, Republic of, 41404
        • Kyungpook National University Chilgok Hospital /ID# 201804
      • Dongjak-gu, Seoul Teugbyeolsi, Korea, Republic of, 07061
        • SMG-SNU Boramae Medical Center /ID# 201805
      • Jongno-Gu, Seoul Teugbyeolsi, Korea, Republic of, 03181
        • Kangbuk Samsung Hospital /ID# 168792
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
        • Severance Hospital /ID# 167361
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05030
        • Konkuk University Medical Ctr /ID# 167723
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
        • Samsung Medical Center /ID# 167722
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 08308
        • Korea Universtiy Guro Hospital /ID# 167388

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)
Time Frame: 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.
12 weeks after the last dose of study drug

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With On-treatment Virologic Failure
Time Frame: 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.
Up to 24 weeks
Percentage of Participants With Post-treatment Relapse
Time Frame: 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
From the end of treatment through 12 weeks after the last dose of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2017

Primary Completion (Actual)

October 11, 2019

Study Completion (Actual)

October 11, 2019

Study Registration Dates

First Submitted

June 27, 2017

First Submitted That Met QC Criteria

June 27, 2017

First Posted (Actual)

June 28, 2017

Study Record Updates

Last Update Posted (Actual)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 6, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P16-666

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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