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

Completed

• 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

Study Timeline

• Study Start: 2019-12-26
• Study First Submitted: 2019-12-27
• Study First Submitted QC: 2019-12-27
• Study First Posted: 2019-12-30
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-17
• Last Update Posted: 2025-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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

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