AzTrials
AzTrials

Hepatitis C Virus (HCV)HCV PMSNCT03201718

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

An observational study of Hepatitis C Virus (HCV), run by AbbVie at 59 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Hepatitis C Virus (HCV)
How many people
505 participants
Where
59 sitesSouth Korea
Study dates
17 Aug 2017to 11 Oct 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • None

Trial locations and contacts

59 sites in 1 country.

59 sites in 1 country

South Korea59 sites

  • Bucheon St. Mary's hospital /ID# 170782

    Bucheon-si, 420-818

  • Dong-A University Hospital /ID# 167362

    Busan, Busan Gwang Yeogsi, 49201

  • Pusan National University Hosp /ID# 167363

    Busan, Busan Gwang Yeogsi, 602-739

  • Dongnam Institute of Radiologi /ID# 167721

    Busan, 46033

  • Good Samsun Hospital /ID# 167365

    Busan, 47007

  • Haeundae Paik Hospital /ID# 170767

    Busan, 48108

  • Maryknoll Medical Center /ID# 167418

    Busan, 48972

  • Kosin University Gospel Hosp /ID# 168797

    Busan, 602-702

  • Changwon Fatima Hospital /ID# 201664

    Changwon, Gyeongsangnam-do, 51394

  • Samsung Changwon Hospital /ID# 167732

    Changwon, 630-723

  • Dankook University Hospital /ID# 167730

    Cheonan, 330-715

  • Chuncheon Sacred Heart Hosp /ID# 167419

    Chuncheon, 200-704

  • Kyungpook National Univ Hosp /ID# 168731

    Daegu, Daegu Gwang Yeogsi, 41944

  • Yeungnam University Med Ctr /ID# 167425

    Daegu, Daegu Gwang Yeogsi, 42415

  • Kyungpook National University Chilgok Hospital /ID# 201804

    Daegu, Seoul Teugbyeolsi, 41404

  • Kim Jun Hwan Sok Internal Medi /ID# 168794

    Daegu, 42488

  • Keimyung Univ Dongsan medical /ID# 168793

    Daegu, 700-712

  • Daegu Catholic University Med /ID# 167714

    Daegu, 705-718

  • Daegu Catholic University Med /ID# 168729

    Daegu, 705-718

  • The Catholic Univ. of Korea /ID# 167733

    Daejeon, 301-723

  • SMG-SNU Boramae Medical Center /ID# 201805

    Dongjak-gu, Seoul Teugbyeolsi, 07061

  • National health insurance cooperation ilsan hospital /ID# 201806

    Goyang, Gyeonggido, 10444

  • Dongguk University Ilsan Hosp /ID# 168795

    Goyang, 410-773

  • Myongji Hospital /ID# 170784

    Goyang, 412-270

  • CHA Gumi Medical Center /ID# 170783

    Gumi, 39295

  • Chonnam National University Hospital /ID# 167423

    Gwangju, Jeonranamdo, 61469

  • Kwangju Christian Hospital /ID# 210823

    Gwangju, Jeonranamdo, 61661

  • Korea University Ansan Hosp /ID# 201661

    Gyeonggi-do, 152-703

  • Soon Chun Hyang University Hospital Bucheon /ID# 201803

    Habun, Gyeonggido, 14584

  • Dongtan Sacred Heart Hospital /ID# 170759

    Hwaseong, 18450

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

    Incheon, 21431

  • Presbyterian Medical Center /ID# 167424

    Jeonju, 54987

  • Kangbuk Samsung Hospital /ID# 168792

    Jongno-Gu, Seoul Teugbyeolsi, 03181

  • Chungnam National University Hospital /ID# 167724

    Junggu, Daejeon Gwang Yeogsi, 35015

  • Inha University Hospital /ID# 201802

    Junggu, Incheon Gwang Yeogsi, 22332

  • Inje University Busan Paik Hospital /ID# 167392

    Pusan, Gyeongsangbuk-do, 47392

  • Seoul National Univ Bundang ho /ID# 167394

    Seongnam, Gyeonggido, 13620

  • CHA Bundang Medical Center /ID# 170757

    Seongnam, 463-712

  • Bundang Jesaeng hospital /ID# 167725

    Seongnam, 463-824

  • Severance Hospital /ID# 167361

    Seoul, Seoul Teugbyeolsi, 03722

  • Konkuk University Medical Ctr /ID# 167723

    Seoul, Seoul Teugbyeolsi, 05030

  • Samsung Medical Center /ID# 167722

    Seoul, Seoul Teugbyeolsi, 06351

  • Korea Universtiy Guro Hospital /ID# 167388

    Seoul, Seoul Teugbyeolsi, 08308

  • Korea University Anam Hospital /ID# 167731

    Seoul, 02841

  • Seoul National University Hospital /ID# 167364

    Seoul, 03080

  • Seoul National University Hospital /ID# 167389

    Seoul, 03080

  • SoonChunHyang University Seoul /ID# 167711

    Seoul, 04401

  • Asan Medical Center /ID# 167390

    Seoul, 05505

  • Chung-Ang University Hostipal /ID# 167420

    Seoul, 06973

  • Inje University Seoul Paik Hos /ID# 167426

    Seoul, 100-032

  • Inje University Sanggye Paik H /ID# 167427

    Seoul, 139-707

  • St. Carollo General Hospital /ID# 167712

    Suncheon, 57931

  • St. Vincent's Hospital /ID# 201660

    Suwon, Gyeonggido, 16247

  • Ajou University Hospital /ID# 167729

    Suwon, Gyeonggido, 16499

  • Uijeongbu St. Mary's Hospital /ID# 168730

    Uijeongbu-si, 480-717

  • Ulsan University Hospital /ID# 168796

    Ulsan, 682-714

  • Wonju Severance Christian Hosp /ID# 167713

    Wŏnju, 220-701

  • Pusan National University Yang /ID# 167710

    Yangsan, 50612

  • Yeosoo Hankook Hospital /ID# 168728

    Yeosu, 59684

Other trials in South Korea

About this study

Official title: 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.

Keywords
Hepatitis C, Paritaprevir, Ritonavir, Ombitasvir, Dasabuvir
Medical subject headings
Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03201718
Study groupRoleWhat they receive
Hepatitis CParticipants with Hepatitis C receiving Viekira/Exviera (paritaprevir/ritonavir/ombitasvir and dasabuvir) for 12 or 24 weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 weeks after the last dose of study drug

Secondary outcomes (2)

  1. Percentage of Participants With On-treatment Virologic Failure

    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.

    Measured: Up to 24 weeks

  2. Percentage of Participants With Post-treatment Relapse

    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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2017
  2. Study start17 Aug 2017
  3. Primary completion11 Oct 2019
  4. Study completion11 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
505 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03201718
Sponsor's protocol ID
P16-666
Acronym
HCV PMS
Status last verified
Oct 2020
First submitted
27 Jun 2017
Last updated
8 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis C Virus (HCV), run by AbbVie at 59 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) (time frame: 12 weeks after the last dose of study drug). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03201718.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in