A Study of the Safety, Effectiveness and Clinical Use of Maviret in Adolescent Patients With Chronic Hepatitis C Virus

April 22, 2024 updated by: AbbVie

Real World Evidence of the Safety and Clinical Practice Use of Maviret in Adolescents Patients Infected With Chronic Hepatitis C Virus (All Case Survey)

This study will assess the safety and effectiveness of Maviret (Glecaprevir plus Pibrentasvir (GLE/PIB)) in adolescent participants diagnosed with chronic hepatitis C (CHC) in a real world setting across clinical practice in Japan.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

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

Study Contact

Study Locations

  • Japan
      • Nakagami-gun, Japan, 901-2417
        • Recruiting
        • Heartlife Hospital /ID# 249394
      • Oita, Japan, 861-1104
        • Recruiting
        • Oita Cardiovascular Hospital /ID# 239725
      • Yamagata, Japan, 9978515
        • Recruiting
        • Shonai Hospital /ID# 232294
    • Aichi
      • Kariya-shi, Aichi, Japan, 448-8505
        • Recruiting
        • Kariya Toyota General Hospital /ID# 239046
      • Nagoya shi, Aichi, Japan, 467-8602
        • Recruiting
        • Nagoya City University Hospital /ID# 238745
      • Nagoya-shi, Aichi, Japan, 460-0001
        • Recruiting
        • Meijo Hospital /ID# 250955
      • Nagoya-shi, Aichi, Japan, 4668560
        • Recruiting
        • Nagoya University Hospital /ID# 226746
    • Aomori
      • Hirosaki-shi, Aomori, Japan, 036-8203
        • Recruiting
        • Hirosaki University Hospital /ID# 262654
      • Misawa-shi, Aomori, Japan, 033-0123
        • Recruiting
        • Misawa Municipal Misawa Hospital /ID# 229544
    • Chiba
      • Chiba-shi, Chiba, Japan, 260-8677
        • Recruiting
        • Chiba University Hospital /ID# 225889
      • Narita-shi, Chiba, Japan, 286-8523
        • Recruiting
        • Japanese Red Cross Narita Hospital /ID# 261349
    • Ehime
      • Matsuyama-shi, Ehime, Japan, 790-8524
        • Recruiting
        • Matsuyama Red Cross Hospital /ID# 239387
      • Shikoku Chuo, Ehime, Japan, 799-0101
        • Recruiting
        • Shikoku Central Hospital of the Mutual Aid /ID# 230273
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 812-8582
        • Recruiting
        • Kyushu University Hospital /ID# 261351
      • Kitakyushu-shi, Fukuoka, Japan, 807-8556
        • Recruiting
        • Hospital of the University of Occupational and Environmental Health, Japan /ID# 255088
      • Kurume-shi, Fukuoka, Japan, 830-0011
        • Recruiting
        • Kurume University Hospital /ID# 224112
    • Fukushima
      • Koriyama-shi, Fukushima, Japan, 963-0534
        • Recruiting
        • Aoyama Clinic /ID# 261942
      • Shirakawa-shi, Fukushima, Japan, 961-0005
        • Recruiting
        • Shirakawa Kosei General Hosp. /ID# 240816
    • Gifu
      • Gifu-shi, Gifu, Japan, 500-8513
        • Recruiting
        • Gifu Municipal Hospital /ID# 225890
    • Gunma
      • Maebashi, Gunma, Japan, 371-0232
        • Recruiting
        • Machida Clinic /ID# 238744
      • Maebashi-shi, Gunma, Japan, 371-8511
        • Recruiting
        • Gunma University Hospital /ID# 231700
      • Takasaki City, Gunma, Japan, 370-0001
        • Recruiting
        • Heisei Hidaka Clinic /ID# 231758
    • Hiroshima
      • Mihara-shi, Hiroshima, Japan, 7230014
        • Recruiting
        • Kousei General Hospital /ID# 249395
    • Hyogo
      • Amagasaki-shi, Hyogo, Japan, 660-8550
        • Recruiting
        • Hyogo Prefectural Amagasaki General Medical Center /ID# 239388
      • Amagasaki-shi, Hyogo, Japan, 660-8550
        • Recruiting
        • Hyogo Prefectural Amagasaki General Medical Center /ID# 261350
      • Kanzaki-gun, Hyogo, Japan, 679-2337
        • Recruiting
        • Fujikawa Clinic /ID# 221135
      • Kobe City, Hyogo, Japan, 655-0004
        • Recruiting
        • Takano Kids Clinic /ID# 251656
    • Ibaraki
      • Tsukuba-shi, Ibaraki, Japan, 305-8576
        • Active, not recruiting
        • University of tsukuba Hospital /ID# 267373
    • Kanagawa
      • Fujisawa-shi, Kanagawa, Japan, 251-0046
        • Recruiting
        • Yamada Clinic /ID# 225909
      • Sagamihara-shi, Kanagawa, Japan, 252-0392
        • Recruiting
        • National Hospital Organization Sagamihara National Hospital /ID# 221136
      • Yokohama-shi, Kanagawa, Japan, 234-0054
        • Recruiting
        • Kawaguchi Clinic /ID# 226843
    • Kumamoto
      • Kumamoto-shi, Kumamoto, Japan, 862-8655
        • Recruiting
        • Kumamoto Shinto General Hospital /ID# 223245
    • Kyoto
      • Kyoto City, Kyoto, Japan, 6060866
        • Recruiting
        • Kyoto Shimogamo Hospital /ID# 233903
      • Kyoto-shi, Kyoto, Japan, 602-8566
        • Recruiting
        • University Hospital Kyoto Prefectural University of Medicine /ID# 229599
    • Mie
      • Iga-shi, Mie, Japan, 518-0121
        • Recruiting
        • Okanami General Hospital /ID# 256995
      • Ise-shi, Mie, Japan, 516-0008
        • Recruiting
        • Ise Red Cross Hospital /ID# 222018
      • Tsu-shi, Mie, Japan, 514-8507
        • Recruiting
        • Mie University Hospital /ID# 233864
    • Miyagi
      • Sendai-shi, Miyagi, Japan, 989-3126
        • Recruiting
        • Miyagi Children's Hospital /ID# 258143
    • Nagano
      • Matsumoto-shi, Nagano, Japan, 390-0814
        • Recruiting
        • Aizawa Hospital /ID# 223247
    • Nara
      • Ikoma-shi, Nara, Japan, 630-0227
        • Recruiting
        • Nara Hospital Kinki University Faculty of Medicine, /ID# 224609
    • Oita
      • Nakatsu-shi, Oita, Japan, 871-0011
        • Recruiting
        • Nakatsu Municipal Hospital /ID# 233390
    • Okayama
      • Kasaoka-shi, Okayama, Japan, 714-0088
        • Recruiting
        • Watanabe Clinic /ID# 261352
    • Osaka
      • Osaka-shi, Osaka, Japan, 530-8480
        • Recruiting
        • Kitano Hospital /ID# 255150
      • Osaka-shi, Osaka, Japan, 545-0021
        • Recruiting
        • Yumura Clinic /ID# 254478
      • Suita-shi, Osaka, Japan, 565-0871
        • Recruiting
        • Osaka University Hospital /ID# 256174
    • Saitama
      • Iruma-gun, Saitama, Japan, 350-0495
        • Recruiting
        • Saitama Medical University Hospital /ID# 258144
      • Saitama-shi, Saitama, Japan, 330-8777
        • Recruiting
        • Saitama Children's Medical Center /ID# 227633
    • Shiga
      • Maibara-shi, Shiga, Japan, 521-0072
        • Recruiting
        • Tsukada Clinic /ID# 255152
    • Shizuoka
      • Hamamatsu-shi, Shizuoka, Japan, 335-0023
        • Recruiting
        • Tamakoshi Clinic /ID# 224113
    • Tokyo
      • Fuchu City, Tokyo, Japan, 183-8524
        • Recruiting
        • Tokyo Metropolitan Children's Medical Center /ID# 258142
      • Setagaya-ku, Tokyo, Japan, 157-8535
        • Recruiting
        • National Center for Child Health and Development /ID# 225293
    • Tottori
      • Yonago-shi, Tottori, Japan, 683-8504
        • Recruiting
        • Tottori University Hospital /ID# 227634
    • Yamagata
      • Yonezawa-shi, Yamagata, Japan, 992-0046
        • Recruiting
        • Ishibashi Clinic /ID# 258148
    • Yamaguchi
      • Ube-shi, Yamaguchi, Japan, 755-8505
        • Recruiting
        • Yamaguchi University Hospital /ID# 262655

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

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants aged ≥ 12 to <18 years of age with chronic hepatitis C receiving Maviret in accordance with local label.

Description

Inclusion Criteria:

  • Chronic Hepatitis C Virus (HCV) infection treated in daily practice with Maviret
  • Enrolled after Maviret treatment begins
  • Prior treatment with Maviret

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
Maviret Participants
Participants receiving glecaprevir plus pibrentasvir (GLE/PIB, other names: Maviret) as routine standard of care for HCV.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Drug Reactions (ADRs)
Time Frame: Up to approximately 36 weeks
Adverse drug reactions are defined as adverse events of which a causal relationship with Maviret could not be ruled out.
Up to approximately 36 weeks
Percentage of Participants with Adverse Drug Reactions (ADRs)
Time Frame: Up to approximately 36 weeks
Adverse drug reactions are defined as adverse events of which a causal relationship with Maviret could not be ruled out.
Up to approximately 36 weeks
Number of Participants with Serious Adverse Events (SAEs)
Time Frame: Up to approximately 36 weeks
A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgement, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent serious adverse events (TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug.
Up to approximately 36 weeks
Percentage of Participants with Serious Adverse Events (SAEs)
Time Frame: Up to approximately 36 weeks
A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgement, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent serious adverse events (TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug.
Up to approximately 36 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants achieving Sustained Virologic Response 12 (SVR12)
Time Frame: At Week 12
Defined as HCV Ribonucleic acid (RNA) not detected 12 weeks after the last dose of study drug.
At Week 12
Percentage of participants achieving Sustained Virologic Response (SVR)
Time Frame: At 4, 8, 12 and 24 weeks after last dose of Maviret (up to approximately 36 weeks)
SVR defined as HCV Ribonucleic acid (RNA) < Lower limit of quantification (LLOQ).
At 4, 8, 12 and 24 weeks after last dose of Maviret (up to approximately 36 weeks)
Percentage of Participants with On-Treatment Virologic Failure (Breakthrough)
Time Frame: Up to approximately 36 weeks
On-treatment virologic failure (breakthrough) defined as at least 1 documented HCV RNA < 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment or failure to suppress (each measured on-treatment HCV RNA value ≥ 50 IU/mL).
Up to approximately 36 weeks
Percentage of Participants with After-Treatment Virologic Failure (Relapse)
Time Frame: Up to approximately 36 weeks
After-treatment virologic failure (relapse) is defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 24 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.
Up to approximately 36 weeks

Collaborators and Investigators

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

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., 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)

December 26, 2019

Primary Completion (Estimated)

September 26, 2024

Study Completion (Estimated)

September 26, 2024

Study Registration Dates

First Submitted

December 27, 2019

First Submitted That Met QC Criteria

December 27, 2019

First Posted (Actual)

December 30, 2019

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P19-620

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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