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
|ClinicalTrials.gov Identifier: NCT03212521|
Recruitment Status : Active, not recruiting
First Posted : July 11, 2017
Last Update Posted : May 25, 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 8, 2017|
|Estimated Primary Completion Date :||July 16, 2018|
|Estimated Study Completion Date :||July 16, 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03212521
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|Study Director:||AbbVie Inc.||AbbVie|