NCT Number: NCT04214028
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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Notify Me12 year–17 year
All sexes
Observational
Kariya Toyota General Hospital /ID# 239046, Kariya-shi, Aichi-ken, Japan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
None
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At Week 12
Defined as HCV Ribonucleic acid (RNA) not detected 12 weeks after the last dose of study drug.
Time frame: 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).
Time frame: 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).
Time frame: 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.
AbbVie
Industry
Real World Evidence of the Safety and Clinical Practice Use of Maviret in Adolescents Patients Infected With Chronic Hepatitis C Virus (All Case Survey)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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