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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 17, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 11, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 11, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 8, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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