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

Hepatitis C Virus (HCV) Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04214028
• Other study ID #: P19-620
• Status: Recruiting
• Start date: December 26, 2019
• Est. completion date: September 26, 2024

Study information

• Verified date: April 2024
• Source: AbbVie
• Contact: AbbVie GK Clinical Trial Registration Desk
• Phone: +81-3-4577-1111
• Email: abbvie_jpn_info_clingov[@]abbvie.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 26, 2024
• Est. primary completion date: September 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus (HCV)
• Hepatitis C, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
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	Chiba University Hospital /ID# 225889	Chiba-shi	Chiba
Japan	Tokyo Metropolitan Children's Medical Center /ID# 258142	Fuchu City	Tokyo
Japan	Yamada Clinic /ID# 225909	Fujisawa-shi	Kanagawa
Japan	Kyushu University Hospital /ID# 261351	Fukuoka-shi	Fukuoka
Japan	Gifu Municipal Hospital /ID# 225890	Gifu-shi	Gifu
Japan	Tamakoshi Clinic /ID# 224113	Hamamatsu-shi	Shizuoka
Japan	Hirosaki University Hospital /ID# 262654	Hirosaki-shi	Aomori
Japan	Okanami General Hospital /ID# 256995	Iga-shi	Mie
Japan	Nara Hospital Kinki University Faculty of Medicine, /ID# 224609	Ikoma-shi	Nara
Japan	Saitama Medical University Hospital /ID# 258144	Iruma-gun	Saitama
Japan	Ise Red Cross Hospital /ID# 222018	Ise-shi	Mie
Japan	Fujikawa Clinic /ID# 221135	Kanzaki-gun	Hyogo
Japan	Kariya Toyota General Hospital /ID# 239046	Kariya-shi	Aichi
Japan	Watanabe Clinic /ID# 261352	Kasaoka-shi	Okayama
Japan	Hospital of the University of Occupational and Environmental Health, Japan /ID# 255088	Kitakyushu-shi	Fukuoka
Japan	Takano Kids Clinic /ID# 251656	Kobe City	Hyogo
Japan	Aoyama Clinic /ID# 261942	Koriyama-shi	Fukushima
Japan	Kumamoto Shinto General Hospital /ID# 223245	Kumamoto-shi	Kumamoto
Japan	Kurume University Hospital /ID# 224112	Kurume-shi	Fukuoka
Japan	Kyoto Shimogamo Hospital /ID# 233903	Kyoto City	Kyoto
Japan	University Hospital Kyoto Prefectural University of Medicine /ID# 229599	Kyoto-shi	Kyoto
Japan	Machida Clinic /ID# 238744	Maebashi	Gunma
Japan	Gunma University Hospital /ID# 231700	Maebashi-shi	Gunma
Japan	Tsukada Clinic /ID# 255152	Maibara-shi	Shiga
Japan	Aizawa Hospital /ID# 223247	Matsumoto-shi	Nagano
Japan	Matsuyama Red Cross Hospital /ID# 239387	Matsuyama-shi	Ehime
Japan	Kousei General Hospital /ID# 249395	Mihara-shi	Hiroshima
Japan	Misawa Municipal Misawa Hospital /ID# 229544	Misawa-shi	Aomori
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	Heartlife Hospital /ID# 249394	Nakagami-gun
Japan	Nakatsu Municipal Hospital /ID# 233390	Nakatsu-shi	Oita
Japan	Japanese Red Cross Narita Hospital /ID# 261349	Narita-shi	Chiba
Japan	Oita Cardiovascular Hospital /ID# 239725	Oita
Japan	Kitano Hospital /ID# 255150	Osaka-shi	Osaka
Japan	Yumura Clinic /ID# 254478	Osaka-shi	Osaka
Japan	National Hospital Organization Sagamihara National Hospital /ID# 221136	Sagamihara-shi	Kanagawa
Japan	Saitama Children's Medical Center /ID# 227633	Saitama-shi	Saitama
Japan	Miyagi Children's Hospital /ID# 258143	Sendai-shi	Miyagi
Japan	National Center for Child Health and Development /ID# 225293	Setagaya-ku	Tokyo
Japan	Shikoku Central Hospital of the Mutual Aid /ID# 230273	Shikoku Chuo	Ehime
Japan	Shirakawa Kosei General Hosp. /ID# 240816	Shirakawa-shi	Fukushima
Japan	Osaka University Hospital /ID# 256174	Suita-shi	Osaka
Japan	Heisei Hidaka Clinic /ID# 231758	Takasaki City	Gunma
Japan	Mie University Hospital /ID# 233864	Tsu-shi	Mie
Japan	University of tsukuba Hospital /ID# 267373	Tsukuba-shi	Ibaraki
Japan	Yamaguchi University Hospital /ID# 262655	Ube-shi	Yamaguchi
Japan	Shonai Hospital /ID# 232294	Yamagata
Japan	Kawaguchi Clinic /ID# 226843	Yokohama-shi	Kanagawa
Japan	Tottori University Hospital /ID# 227634	Yonago-shi	Tottori
Japan	Ishibashi Clinic /ID# 258148	Yonezawa-shi	Yamagata

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Percentage of participants achieving Sustained Virologic Response (SVR)	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)
Secondary	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
Secondary	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

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