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

NCT04214028 | Completed

• 1 other identifier: P19-620
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 54

Brief Summary

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.

Conditions

Hepatitis C Virus (HCV)

Keywords

Hepatitis C Virus (HCV); Chronic Hepatitis C (CHC); Maviret; Mavyret

Outcome Measures

Primary Outcomes (4)

• Number of Participants with Adverse Drug Reactions (ADRs)

  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)

  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)

  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)

  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 Outcomes (4)

• Percentage of participants achieving Sustained Virologic Response 12 (SVR12)

  At Week 12

• Percentage of participants achieving Sustained Virologic Response (SVR)

  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)

  Up to approximately 36 weeks

• Percentage of Participants with After-Treatment Virologic Failure (Relapse)

  Up to approximately 36 weeks

Study Arms (1)

Maviret Participants

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

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• AbbVie: lead

Study Sites (54)

Kariya Toyota General Hospital /ID# 239046

Kariya-shi, Aichi-ken, 448-8505, Japan

Location

Meijo Hospital /ID# 250955

Nagoya, Aichi-ken, 460-0001, Japan

Location

Nagoya University Hospital /ID# 226746

Nagoya, Aichi-ken, 466-8560, Japan

Location

Nagoya City University Hospital /ID# 238745

Nagoya, Aichi-ken, 467-8602, Japan

Location

Hirosaki University Hospital /ID# 262654

Hirosaki-shi, Aomori, 036-8203, Japan

Location

Misawa Municipal Misawa Hospital /ID# 229544

Misawa-shi, Aomori, 033-0123, Japan

Location

Chiba University Hospital /ID# 225889

Chiba, Chiba, 260-8677, Japan

Location

Japanese Red Cross Narita Hospital /ID# 261349

Narita-shi, Chiba, 286-8523, Japan

Location

Matsuyama Red Cross Hospital /ID# 239387

Matsuyama, Ehime, 790-8524, Japan

Location

Shikoku Central Hospital of the Mutual Aid /ID# 230273

Shikokuchūō, Ehime, 799-0101, Japan

Location

Kyushu University Hospital /ID# 261351

Fukuoka, Fukuoka, 812-8582, Japan

Location

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

Kitakyushu-shi, Fukuoka, 807-8556, Japan

Location

Kurume University Hospital /ID# 224112

Kurume-shi, Fukuoka, 830-0011, Japan

Location

Aoyama Clinic /ID# 261942

Koriyama-shi, Fukushima, 963-0534, Japan

Location

Shirakawa Kosei General Hosp. /ID# 240816

Shirakawa-shi, Fukushima, 961-0005, Japan

Location

Gifu Municipal Hospital /ID# 225890

Gifu, Gifu, 500-8513, Japan

Location

Machida Clinic /ID# 238744

Maebashi, Gunma, 371-0232, Japan

Location

Gunma University Hospital /ID# 231700

Maebashi, Gunma, 371-8511, Japan

Location

Heisei Hidaka Clinic /ID# 231758

Takasaki, Gunma, 370-0001, Japan

Location

Kousei General Hospital /ID# 249395

Mihara-shi, Hiroshima, 7230014, Japan

Location

Hyogo Prefectural Amagasaki General Medical Center /ID# 239388

Amagasaki-shi, Hyōgo, 660-8550, Japan

Location

Hyogo Prefectural Amagasaki General Medical Center /ID# 261350

Amagasaki-shi, Hyōgo, 660-8550, Japan

Location

Fujikawa Clinic /ID# 221135

Kanzaki-gun, Hyōgo, 679-2337, Japan

Location

Takano Kids Clinic /ID# 251656

Kobe, Hyōgo, 655-0004, Japan

Location

University of tsukuba Hospital /ID# 267373

Tsukuba, Ibaraki, 305-8576, Japan

Location

Yamada Clinic /ID# 225909

Fujisawa-shi, Kanagawa, 251-0046, Japan

Location

National Hospital Organization Sagamihara National Hospital /ID# 221136

Sagamihara-shi, Kanagawa, 252-0392, Japan

Location

Kawaguchi Clinic /ID# 226843

Yokohama, Kanagawa, 234-0054, Japan

Location

Kumamoto Shinto General Hospital /ID# 223245

Kumamoto, Kumamoto, 862-8655, Japan

Location

University Hospital Kyoto Prefectural University of Medicine /ID# 229599

Kyoto, Kyoto, 602-8566, Japan

Location

Kyoto Shimogamo Hospital /ID# 233903

Kyoto, Kyoto, 6060866, Japan

Location

Okanami General Hospital /ID# 256995

Iga-shi, Mie-ken, 518-0121, Japan

Location

Ise Red Cross Hospital /ID# 222018

Ise-shi, Mie-ken, 516-0008, Japan

Location

Mie University Hospital /ID# 233864

Tsu, Mie-ken, 514-8507, Japan

Location

Miyagi Children's Hospital /ID# 258143

Sendai, Miyagi, 989-3126, Japan

Location

Aizawa Hospital /ID# 223247

Matsumoto-shi, Nagano, 390-0814, Japan

Location

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

Ikoma-shi, Nara, 630-0227, Japan

Location

Nakatsu Municipal Hospital /ID# 233390

Nakatsu-shi, Oita Prefecture, 871-0011, Japan

Location

Watanabe Clinic /ID# 261352

Kasaoka-shi, Okayama-ken, 714-0088, Japan

Location

Heartlife Hospital /ID# 249394

Nakagami-gun, Okinawa, 901-2417, Japan

Location

Kitano Hospital /ID# 255150

Osaka, Osaka, 530-8480, Japan

Location

Yumura Clinic /ID# 254478

Osaka, Osaka, 545-0021, Japan

Location

Osaka University Hospital /ID# 256174

Suita-shi, Osaka, 565-0871, Japan

Location

Saitama Medical University Hospital /ID# 258144

Iruma-gun, Saitama, 350-0495, Japan

Location

Saitama Children's Medical Center /ID# 227633

Saitama-shi, Saitama, 330-8777, Japan

Location

Tsukada Clinic /ID# 255152

Maibara-shi, Shiga, 521-0072, Japan

Location

Tamakoshi Clinic /ID# 224113

Hamamatsu, Shizuoka, 335-0023, Japan

Location

Tokyo Metropolitan Children's Medical Center /ID# 258142

Fuchu-shi, Tokyo, 183-8561, Japan

Location

National Center for Child Health and Development /ID# 225293

Setagaya-ku, Tokyo, 157-8535, Japan

Location

Tottori University Hospital /ID# 227634

Yonago-shi, Tottori, 683-8504, Japan

Location

Ishibashi Clinic /ID# 258148

Yonezawa-shi, Yamagata, 992-0046, Japan

Location

Yamaguchi University Hospital /ID# 262655

Ube-shi, Yamaguchi, 755-8505, Japan

Location

Oita Cardiovascular Hospital /ID# 239725

Ōita, 861-1104, Japan

Location

Shonai Hospital /ID# 232294

Yamagata, 9978515, Japan

Location

Related Links

• Clinical Study Report Synopsis

MeSH Terms

Conditions

Hepatitis C; Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Hepatitis, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2019
• First Posted: December 30, 2019
• Study Start: December 26, 2019
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

JP (54)