A Study of the Safety, Effectiveness and Clinical Use of Maviret in Adolescent Patients With Chronic Hepatitis C Virus
- Conditions
- Hepatitis C Virus (HCV)
- Registration Number
- NCT04214028
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- Chronic Hepatitis C Virus (HCV) infection treated in daily practice with Maviret
- Enrolled after Maviret treatment begins
- Prior treatment with Maviret
None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants with Adverse Drug Reactions (ADRs) 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.
Percentage of Participants with Adverse Drug Reactions (ADRs) 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.
Percentage of Participants with Serious Adverse Events (SAEs) 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.
Number of Participants with Serious Adverse Events (SAEs) 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.
- Secondary Outcome Measures
Name Time Method Percentage of participants achieving Sustained Virologic Response 12 (SVR12) At Week 12 Defined as HCV Ribonucleic acid (RNA) not detected 12 weeks after the last dose of study drug.
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) SVR defined as HCV Ribonucleic acid (RNA) \< Lower limit of quantification (LLOQ).
Percentage of Participants with After-Treatment Virologic Failure (Relapse) 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.
Percentage of Participants with On-Treatment Virologic Failure (Breakthrough) 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).
Trial Locations
- Locations (54)
Kariya Toyota General Hospital /ID# 239046
🇯🇵Kariya-shi, Aichi, Japan
Nagoya City University Hospital /ID# 238745
🇯🇵Nagoya shi, Aichi, Japan
Meijo Hospital /ID# 250955
🇯🇵Nagoya-shi, Aichi, Japan
Nagoya University Hospital /ID# 226746
🇯🇵Nagoya-shi, Aichi, Japan
Hirosaki University Hospital /ID# 262654
🇯🇵Hirosaki-shi, Aomori, Japan
Misawa Municipal Misawa Hospital /ID# 229544
🇯🇵Misawa-shi, Aomori, Japan
Chiba University Hospital /ID# 225889
🇯🇵Chiba-shi, Chiba, Japan
Japanese Red Cross Narita Hospital /ID# 261349
🇯🇵Narita-shi, Chiba, Japan
Matsuyama Red Cross Hospital /ID# 239387
🇯🇵Matsuyama-shi, Ehime, Japan
Shikoku Central Hospital of the Mutual Aid /ID# 230273
🇯🇵Shikoku Chuo, Ehime, Japan
Kyushu University Hospital /ID# 261351
🇯🇵Fukuoka-shi, Fukuoka, Japan
Hospital of the University of Occupational and Environmental Health, Japan /ID# 255088
🇯🇵Kitakyushu-shi, Fukuoka, Japan
Kurume University Hospital /ID# 224112
🇯🇵Kurume-shi, Fukuoka, Japan
Aoyama Clinic /ID# 261942
🇯🇵Koriyama-shi, Fukushima, Japan
Shirakawa Kosei General Hosp. /ID# 240816
🇯🇵Shirakawa-shi, Fukushima, Japan
Gifu Municipal Hospital /ID# 225890
🇯🇵Gifu-shi, Gifu, Japan
Gunma University Hospital /ID# 231700
🇯🇵Maebashi-shi, Gunma, Japan
Machida Clinic /ID# 238744
🇯🇵Maebashi, Gunma, Japan
Heisei Hidaka Clinic /ID# 231758
🇯🇵Takasaki City, Gunma, Japan
Kousei General Hospital /ID# 249395
🇯🇵Mihara-shi, Hiroshima, Japan
Hyogo Prefectural Amagasaki General Medical Center /ID# 239388
🇯🇵Amagasaki-shi, Hyogo, Japan
Hyogo Prefectural Amagasaki General Medical Center /ID# 261350
🇯🇵Amagasaki-shi, Hyogo, Japan
Fujikawa Clinic /ID# 221135
🇯🇵Kanzaki-gun, Hyogo, Japan
Takano Kids Clinic /ID# 251656
🇯🇵Kobe City, Hyogo, Japan
University of tsukuba Hospital /ID# 267373
🇯🇵Tsukuba-shi, Ibaraki, Japan
Yamada Clinic /ID# 225909
🇯🇵Fujisawa-shi, Kanagawa, Japan
National Hospital Organization Sagamihara National Hospital /ID# 221136
🇯🇵Sagamihara-shi, Kanagawa, Japan
Kawaguchi Clinic /ID# 226843
🇯🇵Yokohama-shi, Kanagawa, Japan
Kumamoto Shinto General Hospital /ID# 223245
🇯🇵Kumamoto-shi, Kumamoto, Japan
Kyoto Shimogamo Hospital /ID# 233903
🇯🇵Kyoto City, Kyoto, Japan
University Hospital Kyoto Prefectural University of Medicine /ID# 229599
🇯🇵Kyoto-shi, Kyoto, Japan
Okanami General Hospital /ID# 256995
🇯🇵Iga-shi, Mie, Japan
Ise Red Cross Hospital /ID# 222018
🇯🇵Ise-shi, Mie, Japan
Mie University Hospital /ID# 233864
🇯🇵Tsu-shi, Mie, Japan
Miyagi Children's Hospital /ID# 258143
🇯🇵Sendai-shi, Miyagi, Japan
Aizawa Hospital /ID# 223247
🇯🇵Matsumoto-shi, Nagano, Japan
Nara Hospital Kinki University Faculty of Medicine, /ID# 224609
🇯🇵Ikoma-shi, Nara, Japan
Nakatsu Municipal Hospital /ID# 233390
🇯🇵Nakatsu-shi, Oita, Japan
Watanabe Clinic /ID# 261352
🇯🇵Kasaoka-shi, Okayama, Japan
Heartlife Hospital /ID# 249394
🇯🇵Nakagami-gun, Okinawa, Japan
Kitano Hospital /ID# 255150
🇯🇵Osaka-shi, Osaka, Japan
Yumura Clinic /ID# 254478
🇯🇵Osaka-shi, Osaka, Japan
Osaka University Hospital /ID# 256174
🇯🇵Suita-shi, Osaka, Japan
Saitama Medical University Hospital /ID# 258144
🇯🇵Iruma-gun, Saitama, Japan
Saitama Children's Medical Center /ID# 227633
🇯🇵Saitama-shi, Saitama, Japan
Tsukada Clinic /ID# 255152
🇯🇵Maibara-shi, Shiga, Japan
Tamakoshi Clinic /ID# 224113
🇯🇵Hamamatsu-shi, Shizuoka, Japan
Tokyo Metropolitan Children's Medical Center /ID# 258142
🇯🇵Fuchu-shi, Tokyo, Japan
National Center for Child Health and Development /ID# 225293
🇯🇵Setagaya-ku, Tokyo, Japan
Tottori University Hospital /ID# 227634
🇯🇵Yonago-shi, Tottori, Japan
Ishibashi Clinic /ID# 258148
🇯🇵Yonezawa-shi, Yamagata, Japan
Yamaguchi University Hospital /ID# 262655
🇯🇵Ube-shi, Yamaguchi, Japan
Oita Cardiovascular Hospital /ID# 239725
🇯🇵Oita, Japan
Shonai Hospital /ID# 232294
🇯🇵Yamagata, Japan