A Study to Evaluate Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus Genotype 1-6 Infection, With APRI (a Predictor of Hepatic Fibrosis) ≤ 1, and Have Never Received HCV Treatment
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|ClinicalTrials.gov Identifier: NCT03212521|
Recruitment Status : Completed
First Posted : July 11, 2017
Last Update Posted : August 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C Virus (HCV)||Drug: glecaprevir/pibrentasvir||Phase 4|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||230 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Arm, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment Naïve Adults With Chronic Hepatitis C Virus (HCV) Genotypes 1-6 Infection and Aspartate Aminotransferase to Platelet Ratio Index (APRI) ≤ 1|
|Actual Study Start Date :||August 7, 2017|
|Actual Primary Completion Date :||August 13, 2018|
|Actual Study Completion Date :||August 13, 2018|
Glecaprevir (GLE)/pibrentasvir (PIB) (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
Tablet; ABT-493 coformulated with ABT-530
Other Name: Glecaprevir also known as ABT-493 Pibrentasvir also known as ABT-530
- Percentage of Participants in the mITT Population With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [ Time Frame: 12 weeks after the last actual dose of study drug ]SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ) 12 weeks after the last dose of study drug (modified intent-to-treat [mITT] population).
- Percentage of Participants in the ITT Population With SVR12 [ Time Frame: 12 weeks after the last actual dose of study drug ]SVR12 was defined as HCV RNA level less than LLOQ 12 weeks after the last dose of study drug (intent-to-treat [ITT] population).
- Percentage of Participants With On-treatment Virologic Failure [ Time Frame: Up to approximately 8 weeks ]On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment.
- Percentage of Participants With Post-treatment Relapse [ Time Frame: From the end of treatment through 12 weeks after the last dose of study drug ]Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.
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): NCT03212521
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|Study Director:||AbbVie Inc.||AbbVie|