Study to Evaluate Adverse Events and Change in Disease Activity in Adult and Adolescent Participants With Acute Hepatitis C Virus (HCV) Infection on Treatment With Oral Tablets of Glecaprevir (GLE)/Pibrentasvir (PIB)
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|ClinicalTrials.gov Identifier: NCT04903626|
Recruitment Status : Recruiting
First Posted : May 26, 2021
Last Update Posted : November 1, 2022
Hepatitis C Virus (HCV) infection is a global health problem. HCV mainly affects liver cells and causes the liver to become inflamed and damaged. This study will evaluate how safe and effective glecaprevir/pibrentasvir (GLE/PIB) is in adult and adolescent participants with acute HCV infection.
GLE/PIB is an approved drug for the treatment of chronic HCV. Around 283 participants at least 12 years of age with acute HCV Infection will be enrolled in approximately 70 sites worldwide.
Participants will receive oral tablets of GLE/PIB once daily (QD) for 8 weeks and will be followed for 12 weeks after the end of treatment.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, monitoring for side effects and completing questionnaires.
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C Virus (HCV)||Drug: Glecaprevir/Pibrentasvir (GLE/PIB)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||283 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Single-Arm Prospective Study to Evaluate Safety and Efficacy of GLE/PIB 8-Week Treatment in Adults and Adolescents With Acute Hepatitis C Virus (HCV) Infection|
|Actual Study Start Date :||August 24, 2021|
|Estimated Primary Completion Date :||April 5, 2024|
|Estimated Study Completion Date :||April 5, 2024|
Experimental: Participants Treated With Glecaprevir/Pibrentasvir for 8 weeks
Participants treated once daily with oral tablets of glecaprevir/pibrentasvir for 8 weeks.
Drug: Glecaprevir/Pibrentasvir (GLE/PIB)
- Percentage of Participants With Sustained Virological Response 12 Weeks Post-treatment (SVR12) in the Intention-to-Treat (ITT) Population [ Time Frame: 12 weeks after last dose of study drug (Week 20) ]SVR12 is defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level less than the lower limit of quantification (<LLOQ) 12 weeks after the last dose of the study drug.
- Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-Treatment (SVR12) in the Modified ITT-Virologic Failure (mITT-VF) Population. [ Time Frame: 12 weeks after last dose of study drug (Week 20) ]SVR12 is defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level less than the lower limit of quantification (<LLOQ) 12 weeks after the last dose of the study drug.
- Percentage of Participants With On-Treatment Virologic Failure in the ITT Population [ Time Frame: Up to week 8 ]On-treatment virologic failure is defined as confirmed increase in HCV RNA of > 1 log10 IU/mL above nadir during treatment, confirmed HCV RNA >= 100 IU/mL after HCV RNA < lower limit of quantification (LLOQ) during treatment, or HCV RNA >= LLOQ at the end of treatment (EOT) with at least 6 weeks of treatment.
- Percentage of Participants With Post-Treatment Relapse in the ITT Population [ Time Frame: Up to 12 weeks after the last dose of study drug (Week 20) ]Post-treatment (PT) relapse is defined as confirmed HCV RNA >= LLOQ between the end of treatment (EOT) and 12 weeks after the last dose of study drug among participants who completed treatment as planned with HCV RNA < LLOQ at the EOT and with at least 1 PT HCV RNA value, excluding cases of reinfection.
- Percentage of Participants With Post-Treatment Reinfection With HCV in the ITT Population [ Time Frame: Up to 12 weeks after the last dose of study drug (Week 20) ]Post-treatment (PT) reinfection is defined as confirmed HCV RNA >= LLOQ in the PT period along with the PT detection of a different HCV genotype, subtype, or clade compared with baseline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04903626
|Contact: ABBVIE CALL CENTERemail@example.com|
|Study Director:||ABBVIE INC.||AbbVie|