Clinical trial NCT04214028: A Study of the Safety, Effectiveness and Clinical Use of Maviret in Adolescent Patients With Chronic Hepatitis C Virus
Official title: Real World Evidence of the Safety and Clinical Practice Use of Maviret in Adolescents Patients Infected With Chronic Hepatitis C Virus (All Case Survey)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C Virus (HCV)
Keywords: Hepatitis C Virus (HCV)
Chronic Hepatitis C (CHC)
Maviret
Mavyret
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-12-30
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with Adverse Drug Reactions (ADRs)
timeFrame: Up to approximately 36 weeks
measure: Percentage of Participants with Adverse Drug Reactions (ADRs)
timeFrame: Up to approximately 36 weeks
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: Up to approximately 36 weeks
measure: Percentage of Participants with Serious Adverse Events (SAEs)
timeFrame: Up to approximately 36 weeks
Secondary outcomes:
measure: Percentage of participants achieving Sustained Virologic Response 12 (SVR12)
timeFrame: At Week 12
measure: Percentage of participants achieving Sustained Virologic Response (SVR)
timeFrame: At 4, 8, 12 and 24 weeks after last dose of Maviret (up to approximately 36 weeks)
measure: Percentage of Participants with On-Treatment Virologic Failure (Breakthrough)
timeFrame: Up to approximately 36 weeks
measure: Percentage of Participants with After-Treatment Virologic Failure (Relapse)
timeFrame: Up to approximately 36 weeks
Other outcomes:
Locations:
city: Kariya-shi
country: Japan
facility: Kariya Toyota General Hospital /ID# 239046
state: Aichi
city: Nagoya shi
country: Japan
facility: Nagoya City University Hospital /ID# 238745
state: Aichi
city: Nagoya-shi
country: Japan
facility: Meijo Hospital /ID# 250955
state: Aichi
city: Nagoya-shi
country: Japan
facility: Nagoya University Hospital /ID# 226746
state: Aichi
city: Hirosaki-shi
country: Japan
facility: Hirosaki University Hospital /ID# 262654
state: Aomori
city: Misawa-shi
country: Japan
facility: Misawa Municipal Misawa Hospital /ID# 229544
state: Aomori
city: Chiba-shi
country: Japan
facility: Chiba University Hospital /ID# 225889
state: Chiba
city: Narita-shi
country: Japan
facility: Japanese Red Cross Narita Hospital /ID# 261349
state: Chiba
city: Matsuyama-shi
country: Japan
facility: Matsuyama Red Cross Hospital /ID# 239387
state: Ehime
city: Shikoku Chuo
country: Japan
facility: Shikoku Central Hospital of the Mutual Aid /ID# 230273
state: Ehime
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital /ID# 261351
state: Fukuoka
city: Kitakyushu-shi
country: Japan
facility: Hospital of the University of Occupational and Environmental Health, Japan /ID# 255088
state: Fukuoka
city: Kurume-shi
country: Japan
facility: Kurume University Hospital /ID# 224112
state: Fukuoka
city: Koriyama-shi
country: Japan
facility: Aoyama Clinic /ID# 261942
state: Fukushima
city: Shirakawa-shi
country: Japan
facility: Shirakawa Kosei General Hosp. /ID# 240816
state: Fukushima
city: Gifu-shi
country: Japan
facility: Gifu Municipal Hospital /ID# 225890
state: Gifu
city: Maebashi-shi
country: Japan
facility: Gunma University Hospital /ID# 231700
state: Gunma
city: Maebashi
country: Japan
facility: Machida Clinic /ID# 238744
state: Gunma
city: Takasaki City
country: Japan
facility: Heisei Hidaka Clinic /ID# 231758
state: Gunma
city: Mihara-shi
country: Japan
facility: Kousei General Hospital /ID# 249395
state: Hiroshima
city: Amagasaki-shi
country: Japan
facility: Hyogo Prefectural Amagasaki General Medical Center /ID# 239388
state: Hyogo
city: Amagasaki-shi
country: Japan
facility: Hyogo Prefectural Amagasaki General Medical Center /ID# 261350
state: Hyogo
city: Kanzaki-gun
country: Japan
facility: Fujikawa Clinic /ID# 221135
state: Hyogo
city: Kobe City
country: Japan
facility: Takano Kids Clinic /ID# 251656
state: Hyogo
city: Tsukuba-shi
country: Japan
facility: University of tsukuba Hospital /ID# 267373
state: Ibaraki
city: Fujisawa-shi
country: Japan
facility: Yamada Clinic /ID# 225909
state: Kanagawa
city: Sagamihara-shi
country: Japan
facility: National Hospital Organization Sagamihara National Hospital /ID# 221136
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Kawaguchi Clinic /ID# 226843
state: Kanagawa
city: Kumamoto-shi
country: Japan
facility: Kumamoto Shinto General Hospital /ID# 223245
state: Kumamoto
city: Kyoto City
country: Japan
facility: Kyoto Shimogamo Hospital /ID# 233903
state: Kyoto
city: Kyoto-shi
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine /ID# 229599
state: Kyoto
city: Iga-shi
country: Japan
facility: Okanami General Hospital /ID# 256995
state: Mie
city: Ise-shi
country: Japan
facility: Ise Red Cross Hospital /ID# 222018
state: Mie
city: Tsu-shi
country: Japan
facility: Mie University Hospital /ID# 233864
state: Mie
city: Sendai-shi
country: Japan
facility: Miyagi Children's Hospital /ID# 258143
state: Miyagi
city: Matsumoto-shi
country: Japan
facility: Aizawa Hospital /ID# 223247
state: Nagano
city: Ikoma-shi
country: Japan
facility: Nara Hospital Kinki University Faculty of Medicine, /ID# 224609
state: Nara
city: Nakatsu-shi
country: Japan
facility: Nakatsu Municipal Hospital /ID# 233390
state: Oita
city: Kasaoka-shi
country: Japan
facility: Watanabe Clinic /ID# 261352
state: Okayama
city: Nakagami-gun
country: Japan
facility: Heartlife Hospital /ID# 249394
state: Okinawa
city: Osaka-shi
country: Japan
facility: Kitano Hospital /ID# 255150
state: Osaka
city: Osaka-shi
country: Japan
facility: Yumura Clinic /ID# 254478
state: Osaka
city: Suita-shi
country: Japan
facility: Osaka University Hospital /ID# 256174
state: Osaka
city: Iruma-gun
country: Japan
facility: Saitama Medical University Hospital /ID# 258144
state: Saitama
city: Saitama-shi
country: Japan
facility: Saitama Children's Medical Center /ID# 227633
state: Saitama
city: Maibara-shi
country: Japan
facility: Tsukada Clinic /ID# 255152
state: Shiga
city: Hamamatsu-shi
country: Japan
facility: Tamakoshi Clinic /ID# 224113
state: Shizuoka
city: Fuchu-shi
country: Japan
facility: Tokyo Metropolitan Children's Medical Center /ID# 258142
state: Tokyo
city: Setagaya-ku
country: Japan
facility: National Center for Child Health and Development /ID# 225293
state: Tokyo
city: Yonago-shi
country: Japan
facility: Tottori University Hospital /ID# 227634
state: Tottori
city: Yonezawa-shi
country: Japan
facility: Ishibashi Clinic /ID# 258148
state: Yamagata
city: Ube-shi
country: Japan
facility: Yamaguchi University Hospital /ID# 262655
state: Yamaguchi
city: Oita
country: Japan
facility: Oita Cardiovascular Hospital /ID# 239725
city: Yamagata
country: Japan
facility: Shonai Hospital /ID# 232294
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: