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

NCT ID: NCT04214028

Last Updated: 2025-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-26

Study Completion Date

2024-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis C Virus (HCV)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Maviret Participants

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Kariya Toyota General Hospital /ID# 239046

Kariya-shi, Aichi-ken, Japan

Site Status

Meijo Hospital /ID# 250955

Nagoya, Aichi-ken, Japan

Site Status

Nagoya University Hospital /ID# 226746

Nagoya, Aichi-ken, Japan

Site Status

Nagoya City University Hospital /ID# 238745

Nagoya, Aichi-ken, Japan

Site Status

Hirosaki University Hospital /ID# 262654

Hirosaki-shi, Aomori, Japan

Site Status

Misawa Municipal Misawa Hospital /ID# 229544

Misawa-shi, Aomori, Japan

Site Status

Chiba University Hospital /ID# 225889

Chiba, Chiba, Japan

Site Status

Japanese Red Cross Narita Hospital /ID# 261349

Narita-shi, Chiba, Japan

Site Status

Matsuyama Red Cross Hospital /ID# 239387

Matsuyama, Ehime, Japan

Site Status

Shikoku Central Hospital of the Mutual Aid /ID# 230273

Shikokuchūō, Ehime, Japan

Site Status

Kyushu University Hospital /ID# 261351

Fukuoka, Fukuoka, Japan

Site Status

Hospital of the University of Occupational and Environmental Health, Japan /ID# 255088

Kitakyushu-shi, Fukuoka, Japan

Site Status

Kurume University Hospital /ID# 224112

Kurume-shi, Fukuoka, Japan

Site Status

Aoyama Clinic /ID# 261942

Koriyama-shi, Fukushima, Japan

Site Status

Shirakawa Kosei General Hosp. /ID# 240816

Shirakawa-shi, Fukushima, Japan

Site Status

Gifu Municipal Hospital /ID# 225890

Gifu, Gifu, Japan

Site Status

Machida Clinic /ID# 238744

Maebashi, Gunma, Japan

Site Status

Gunma University Hospital /ID# 231700

Maebashi, Gunma, Japan

Site Status

Heisei Hidaka Clinic /ID# 231758

Takasaki, Gunma, Japan

Site Status

Kousei General Hospital /ID# 249395

Mihara-shi, Hiroshima, Japan

Site Status

Hyogo Prefectural Amagasaki General Medical Center /ID# 239388

Amagasaki-shi, Hyōgo, Japan

Site Status

Hyogo Prefectural Amagasaki General Medical Center /ID# 261350

Amagasaki-shi, Hyōgo, Japan

Site Status

Fujikawa Clinic /ID# 221135

Kanzaki-gun, Hyōgo, Japan

Site Status

Takano Kids Clinic /ID# 251656

Kobe, Hyōgo, Japan

Site Status

University of tsukuba Hospital /ID# 267373

Tsukuba, Ibaraki, Japan

Site Status

Yamada Clinic /ID# 225909

Fujisawa-shi, Kanagawa, Japan

Site Status

National Hospital Organization Sagamihara National Hospital /ID# 221136

Sagamihara-shi, Kanagawa, Japan

Site Status

Kawaguchi Clinic /ID# 226843

Yokohama, Kanagawa, Japan

Site Status

Kumamoto Shinto General Hospital /ID# 223245

Kumamoto, Kumamoto, Japan

Site Status

University Hospital Kyoto Prefectural University of Medicine /ID# 229599

Kyoto, Kyoto, Japan

Site Status

Kyoto Shimogamo Hospital /ID# 233903

Kyoto, Kyoto, Japan

Site Status

Okanami General Hospital /ID# 256995

Iga-shi, Mie-ken, Japan

Site Status

Ise Red Cross Hospital /ID# 222018

Ise-shi, Mie-ken, Japan

Site Status

Mie University Hospital /ID# 233864

Tsu, Mie-ken, Japan

Site Status

Miyagi Children's Hospital /ID# 258143

Sendai, Miyagi, Japan

Site Status

Aizawa Hospital /ID# 223247

Matsumoto-shi, Nagano, Japan

Site Status

Nara Hospital Kinki University Faculty of Medicine, /ID# 224609

Ikoma-shi, Nara, Japan

Site Status

Nakatsu Municipal Hospital /ID# 233390

Nakatsu-shi, Oita Prefecture, Japan

Site Status

Watanabe Clinic /ID# 261352

Kasaoka-shi, Okayama-ken, Japan

Site Status

Heartlife Hospital /ID# 249394

Nakagami-gun, Okinawa, Japan

Site Status

Kitano Hospital /ID# 255150

Osaka, Osaka, Japan

Site Status

Yumura Clinic /ID# 254478

Osaka, Osaka, Japan

Site Status

Osaka University Hospital /ID# 256174

Suita-shi, Osaka, Japan

Site Status

Saitama Medical University Hospital /ID# 258144

Iruma-gun, Saitama, Japan

Site Status

Saitama Children's Medical Center /ID# 227633

Saitama-shi, Saitama, Japan

Site Status

Tsukada Clinic /ID# 255152

Maibara-shi, Shiga, Japan

Site Status

Tamakoshi Clinic /ID# 224113

Hamamatsu, Shizuoka, Japan

Site Status

Tokyo Metropolitan Children's Medical Center /ID# 258142

Fuchu-shi, Tokyo, Japan

Site Status

National Center for Child Health and Development /ID# 225293

Setagaya-ku, Tokyo, Japan

Site Status

Tottori University Hospital /ID# 227634

Yonago-shi, Tottori, Japan

Site Status

Ishibashi Clinic /ID# 258148

Yonezawa-shi, Yamagata, Japan

Site Status

Yamaguchi University Hospital /ID# 262655

Ube-shi, Yamaguchi, Japan

Site Status

Oita Cardiovascular Hospital /ID# 239725

Ōita, , Japan

Site Status

Shonai Hospital /ID# 232294

Yamagata, , Japan

Site Status

Countries

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Japan

Related Links

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Other Identifiers

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P19-620

Identifier Type: -

Identifier Source: org_study_id

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