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Hepatitis CMaviret PMSNCT03740230

An Observational Study of Maviret (Glecaprevir/Pibrentasvir) for Korean Chronic Hepatitis C Genotypes 1 to 6 Patients According to the Standard for Re-examination of New Drugs

An observational study of Hepatitis C, run by AbbVie at 61 sites in South Korea.

Completed

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

Official record
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Trial summary

Post-marketing surveillance study to evaluate the real world safety and effectiveness of Maviret (Glecaprevir/Pibrentasvir) administered under a normal, routine treatment practice by Korean patients with Chronic Hepatitis C Genotypes 1 to 6 Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Hepatitis C
How many people
3,134 participants
Where
61 sitesSouth Korea
Study dates
26 Sep 2018to 21 Jul 2023
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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Participants with Hepatitis C Genotypes 1 to 6 receiving Maviret (glecaprevir/pibrentasvir) for 8, 12, or 16 weeks.

Who may be able to join

  • Participants with chronic C hepatitis genotypes 1 to 6.
  • Participants prescribed Maviret in accordance with approved local label.

Who cannot join

  • Patients with contraindications to the approved local labels for Maviret.

Trial locations and contacts

61 sites in 1 country.

61 sites in 1 country

South Korea61 sites

  • Hallym University Sacred Heart Hospital /ID# 210809

    Anyang, Gyeonggido, 14068

  • The Catholic University of Korea, Bucheon St.Mary's Hospital /ID# 216869

    Bucheon-si, Gyeonggido, 14647

  • Dongnam Institute of Radiological & Medical Sciences /ID# 209991

    Busan, 46033

  • Good Samsun Hospital /ID# 209291

    Busan, 47007

  • Inje University Busan Paik Hospital /ID# 209992

    Busan, 47392

  • Inje University Haeundae Hospital /ID# 209993

    Busan, 48108

  • Maryknoll Medical Center /ID# 210957

    Busan, 48972

  • Dong-A University Hospital /ID# 209450

    Busan, 49201

  • Pusan National University Hospital /ID# 209813

    Busan, 49241

  • Kosin University Gospel Hospital /ID# 210608

    Busan, 49267

  • Samsung Changwon Hospital /ID# 211507

    Changwon, 51353

  • Samsung Changwon Hospital /ID# 211743

    Changwon, 51353

  • Dankook University Hospital /ID# 209297

    Cheonan, 31116

  • SoonChunHyang University CheonAn Hospital /ID# 209996

    Cheonan-si, Chungcheongnam-do, 31151

  • Chuncheon Sacred Heart Hospital /ID# 210612

    Chuncheon, 24253

  • Kyungpook National University Chilgok Hospital /ID# 209988

    Daegu, 41404

  • Keimyung University Dongsan Medical Center /ID# 212144

    Daegu, 41931

  • Keimyung University Dongsan Medical Center /ID# 212514

    Daegu, 41931

  • Kyungpook National University Hospital /ID# 209294

    Daegu, 41944

  • Yeungnam University Medical Center /ID# 209293

    Daegu, 42415

  • Kim Jun Hwan Sok Internal Medi /ID# 209292

    Daegu, 42488

  • The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 216952

    Daejeon, 34943

  • Chungnam National University Hospital /ID# 209637

    Daejeon, 35015

  • Dongguk University Ilsan Hospital /ID# 210609

    Goyang, Gyeonggido, 10325

  • National health insurance Service ilsanhospital /ID# 209997

    Goyang, Gyeonggido, 10444

  • Myongji Hospital /ID# 215595

    Goyang, 10475

  • CHA Gumi Medical Center, CHA University /ID# 209994

    Gumi, 39295

  • Kwangju Christian Hospital /ID# 210623

    Gwangju, Jeonranamdo, 61661

  • Chosun University Hospital /ID# 210607

    Gwangju, 61453

  • SoonChunHyang University Buchon Hospital /ID# 210618

    Habun, Gyeonggido, 14584

  • Wonkwang University Hospital /Id# 210620

    Iksan, Jeonrabugdo, 54538

  • The Catholic University of Korea Incheon St.Mary's Hospital /ID# 216950

    Incheon, 21431

  • Gachon University Gil Medical Center /ID# 212513

    Incheon, 21565

  • Inha University Hospital /ID# 210617

    Incheon, 22332

  • Jeju National University Hospital /ID# 214700

    Jeju City, 63238

  • Chonnam National University Hwasun Hospital /ID# 209990

    Jeonnam, 58128

  • Seoul National University Bundang Hospital /ID# 210616

    Seongnam, Gyeonggido, 13620

  • Yonsei University Health System Severance Hospital /ID# 209636

    Seoul, Seoul Teugbyeolsi, 03722

  • SMG-SNU Boramae Medical Center /ID# 210610

    Seoul, Seoul Teugbyeolsi, 07061

  • Inje University Sanggye Paik Hospital /ID# 210811

    Seoul, 01755

  • Korea University Anam Hospital /ID# 210958

    Seoul, 02841

  • Seoul National University Hospital /ID# 210959

    Seoul, 03080

  • Seoul National University Hospital /ID# 211365

    Seoul, 03080

  • Seoul National University Hospital /ID# 211369

    Seoul, 03080

  • National Medical Center /ID# 209911

    Seoul, 04564

  • Kangdong Sacred Heart Hospital /ID# 210621

    Seoul, 05355

  • Asan Medical Center /ID# 210622

    Seoul, 05505

  • Gangnam Severance Hospital /ID# 212512

    Seoul, 06273

  • Samsung Medical Center /ID# 209296

    Seoul, 06351

  • Samsung Medical Center /ID# 209635

    Seoul, 06351

  • Chung-Ang University Hostipal /ID# 209295

    Seoul, 06973

  • Ewha Womans University Mokdong Hospital /ID# 214961

    Seoul, 07985

  • Ewha Womans University Mokdong Hospital /ID# 216412

    Seoul, 07985

  • Korea University Guro Hospital /ID# 209989

    Seoul, 08308

  • St. Carollo General Hospital /ID# 210619

    Suncheon, 57931

  • The Catholic University of Korea, ST. Vincent's Hospital /ID# 216951

    Suwon, Gyeonggido, 16247

  • Ajou University Hospital /ID# 209995

    Suwon, Gyeonggido, 16499

  • The Catholic University of Korea, Uijeongbu ST. Mary's Hospital /ID# 216949

    Uijeongbu-si, Gyeonggido, 11765

  • Ulsan University Hospital /ID# 210810

    Ulsan, 44033

  • Wonju Severance Christian Hospital /ID# 210611

    Wŏnju, 26426

  • Pusan National University Yangsan Hospital /ID# 214960

    Yangsan, Gyeongsangnam-do, 50612

Other trials in South Korea

About this study

Official title: Post-marketing Surveillance to Assess the Safety and Effectiveness of Maviret (Glecaprevir/Pibrentasvir) for Korean Chronic Hepatitis C Genotypes 1 to 6 Patients According to the "Standard for Re-examination of New Drugs"

Post-marketing surveillance study to evaluate the real world safety and effectiveness of Maviret (Glecaprevir/Pibrentasvir) administered under a normal, routine treatment practice by Korean patients with Chronic Hepatitis C Genotypes 1 to 6

Read the detailed description

Patients with type C hepatitis genotypes 1-6 who had been prescribed Maviret (glecaprevir/pibrentasvir) in accordance with approved local label.

The sample size for this study is due to a requirement by local authorities.

Conditions
Hepatitis C
Keywords
Hepatitis C, Chronic Hepatitis C, Genotypes, Genotypes 1 to 6, Maviret, Glecaprevir, Pibrentasvir
Medical subject headings
Hepatitis C, Hepatitis C, Chronic

What participants receive

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

Study groups in NCT03740230
Study groupRoleWhat they receive
Hepatitis CParticipants with Hepatitis C Genotypes 1 to 6 receiving Maviret (glecaprevir/pibrentasvir) for 8, 12, or 16 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)

    SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after end of treatment.

    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 persistently during treatment period.

    Measured: Up to 30 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 end of treatment among participants who complete treatment and with HCV RNA levels < LLOQ at the end of treatment.

    Measured: Up to 28 weeks

Timeline

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

  1. First posted14 Nov 2018
  2. Study start26 Sep 2018
  3. Primary completion21 Jul 2023
  4. Study completion21 Jul 2023

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
3,134 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03740230
Sponsor's protocol ID
P19-423
Acronym
Maviret PMS
Status last verified
Jul 2024
First submitted
9 Nov 2018
Last updated
19 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Lee JW, Ahn SH, Park JG, Jeong JY, Yoon KT, Tak WY, Baek YH, Yu SJ, Song MJ, Seo YS, Jeong JY, Heo J. Observational, Post-marketing Surveillance of Safety and Effectiveness of Glecaprevir/Pibrentasvir in Korean Patients with Chronic Hepatitis C. Infect Dis Ther. 2026 Jun;15(6):1747-1761. doi: 10.1007/s40121-026-01349-w. Epub 2026 May 8.

    PubMed 42104178

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis C, run by AbbVie at 61 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 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 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 NCT03740230, which also lists 1 linked publication.

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 19 Jul 2024.

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