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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maviret Participants | Participants receiving glecaprevir plus pibrentasvir (GLE/PIB, other names: Maviret) as routine standard of care for HCV. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants achieving Sustained Virologic Response 12 (SVR12) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Participants aged ≥ 12 to <18 years of age with chronic hepatitis C receiving Maviret in accordance with local label.
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kariya Toyota General Hospital /ID# 239046 | Kariya-shi | Aichi-ken | 448-8505 | Japan | ||
| Meijo Hospital /ID# 250955 |
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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) | 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) | 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 |
| Nagoya |
| Aichi-ken |
| 460-0001 |
| Japan |
| Nagoya University Hospital /ID# 226746 | Nagoya | Aichi-ken | 466-8560 | Japan |
| Nagoya City University Hospital /ID# 238745 | Nagoya | Aichi-ken | 467-8602 | Japan |
| Hirosaki University Hospital /ID# 262654 | Hirosaki-shi | Aomori | 036-8203 | Japan |
| Misawa Municipal Misawa Hospital /ID# 229544 | Misawa-shi | Aomori | 033-0123 | Japan |
| Chiba University Hospital /ID# 225889 | Chiba | Chiba | 260-8677 | Japan |
| Japanese Red Cross Narita Hospital /ID# 261349 | Narita-shi | Chiba | 286-8523 | Japan |
| Matsuyama Red Cross Hospital /ID# 239387 | Matsuyama | Ehime | 790-8524 | Japan |
| Shikoku Central Hospital of the Mutual Aid /ID# 230273 | Shikokuchūō | Ehime | 799-0101 | Japan |
| Kyushu University Hospital /ID# 261351 | Fukuoka | Fukuoka | 812-8582 | Japan |
| Hospital of the University of Occupational and Environmental Health, Japan /ID# 255088 | Kitakyushu-shi | Fukuoka | 807-8556 | Japan |
| Kurume University Hospital /ID# 224112 | Kurume-shi | Fukuoka | 830-0011 | Japan |
| Aoyama Clinic /ID# 261942 | Koriyama-shi | Fukushima | 963-0534 | Japan |
| Shirakawa Kosei General Hosp. /ID# 240816 | Shirakawa-shi | Fukushima | 961-0005 | Japan |
| Gifu Municipal Hospital /ID# 225890 | Gifu | Gifu | 500-8513 | Japan |
| Machida Clinic /ID# 238744 | Maebashi | Gunma | 371-0232 | Japan |
| Gunma University Hospital /ID# 231700 | Maebashi | Gunma | 371-8511 | Japan |
| Heisei Hidaka Clinic /ID# 231758 | Takasaki | Gunma | 370-0001 | Japan |
| Kousei General Hospital /ID# 249395 | Mihara-shi | Hiroshima | 7230014 | Japan |
| Hyogo Prefectural Amagasaki General Medical Center /ID# 239388 | Amagasaki-shi | Hyōgo | 660-8550 | Japan |
| Hyogo Prefectural Amagasaki General Medical Center /ID# 261350 | Amagasaki-shi | Hyōgo | 660-8550 | Japan |
| Fujikawa Clinic /ID# 221135 | Kanzaki-gun | Hyōgo | 679-2337 | Japan |
| Takano Kids Clinic /ID# 251656 | Kobe | Hyōgo | 655-0004 | Japan |
| University of tsukuba Hospital /ID# 267373 | Tsukuba | Ibaraki | 305-8576 | Japan |
| Yamada Clinic /ID# 225909 | Fujisawa-shi | Kanagawa | 251-0046 | Japan |
| National Hospital Organization Sagamihara National Hospital /ID# 221136 | Sagamihara-shi | Kanagawa | 252-0392 | Japan |
| Kawaguchi Clinic /ID# 226843 | Yokohama | Kanagawa | 234-0054 | Japan |
| Kumamoto Shinto General Hospital /ID# 223245 | Kumamoto | Kumamoto | 862-8655 | Japan |
| University Hospital Kyoto Prefectural University of Medicine /ID# 229599 | Kyoto | Kyoto | 602-8566 | Japan |
| Kyoto Shimogamo Hospital /ID# 233903 | Kyoto | Kyoto | 6060866 | Japan |
| Okanami General Hospital /ID# 256995 | Iga-shi | Mie-ken | 518-0121 | Japan |
| Ise Red Cross Hospital /ID# 222018 | Ise-shi | Mie-ken | 516-0008 | Japan |
| Mie University Hospital /ID# 233864 | Tsu | Mie-ken | 514-8507 | Japan |
| Miyagi Children's Hospital /ID# 258143 | Sendai | Miyagi | 989-3126 | Japan |
| Aizawa Hospital /ID# 223247 | Matsumoto-shi | Nagano | 390-0814 | Japan |
| Nara Hospital Kinki University Faculty of Medicine, /ID# 224609 | Ikoma-shi | Nara | 630-0227 | Japan |
| Nakatsu Municipal Hospital /ID# 233390 | Nakatsu-shi | Oita Prefecture | 871-0011 | Japan |
| Watanabe Clinic /ID# 261352 | Kasaoka-shi | Okayama-ken | 714-0088 | Japan |
| Heartlife Hospital /ID# 249394 | Nakagami-gun | Okinawa | 901-2417 | Japan |
| Kitano Hospital /ID# 255150 | Osaka | Osaka | 530-8480 | Japan |
| Yumura Clinic /ID# 254478 | Osaka | Osaka | 545-0021 | Japan |
| Osaka University Hospital /ID# 256174 | Suita-shi | Osaka | 565-0871 | Japan |
| Saitama Medical University Hospital /ID# 258144 | Iruma-gun | Saitama | 350-0495 | Japan |
| Saitama Children's Medical Center /ID# 227633 | Saitama-shi | Saitama | 330-8777 | Japan |
| Tsukada Clinic /ID# 255152 | Maibara-shi | Shiga | 521-0072 | Japan |
| Tamakoshi Clinic /ID# 224113 | Hamamatsu | Shizuoka | 335-0023 | Japan |
| Tokyo Metropolitan Children's Medical Center /ID# 258142 | Fuchu-shi | Tokyo | 183-8561 | Japan |
| National Center for Child Health and Development /ID# 225293 | Setagaya-ku | Tokyo | 157-8535 | Japan |
| Tottori University Hospital /ID# 227634 | Yonago-shi | Tottori | 683-8504 | Japan |
| Ishibashi Clinic /ID# 258148 | Yonezawa-shi | Yamagata | 992-0046 | Japan |
| Yamaguchi University Hospital /ID# 262655 | Ube-shi | Yamaguchi | 755-8505 | Japan |
| Oita Cardiovascular Hospital /ID# 239725 | Ōita | 861-1104 | Japan |
| Shonai Hospital /ID# 232294 | Yamagata | 9978515 | Japan |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006521 | Hepatitis, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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