A Study to Evaluate the Safety and Antiviral Effect of ABT-450/Ritonavir and ABT-530 Coadministered With and Without Ribavirin in Adults With Genotype 3 Hepatitis C (HCV) Infection
|ClinicalTrials.gov Identifier: NCT02068222|
Recruitment Status : Completed
First Posted : February 21, 2014
Results First Posted : February 2, 2017
Last Update Posted : February 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis C Hepatitis C Virus||Drug: ABT-450/ritonavir (r) Drug: ABT-530 Drug: Ribavirin (RBV)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Pilot Study to Evaluate the Antiviral Activity, Safety, Tolerability, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-530, With and Without Ribavirin (RBV) in Treatment-Naïve Subjects With Genotype 3 Chronic Hepatitis C Virus (HCV) Infection|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
Experimental: ABT-450/r and ABT-530 plus RBV
ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
Drug: ABT-450/ritonavir (r)
Other Name: ABT-450 also known as paritaprevirDrug: ABT-530
Other Name: pibrentasvirDrug: Ribavirin (RBV)
- The Percentage of Subjects Who Achieve 12-week Sustained Virologic Response (SVR12) [ Time Frame: 12 weeks after last dose of study drug ]SVR12 defined as hepatitis C (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
- The Percentage of Subjects Who Achieve 24-week Sustained Virologic Response (SVR24) [ Time Frame: 24 weeks after last dose of study drug ]SVR24 defined as HCV RNA LLOQ 24 weeks after last dose of study drug.
- The Percentage of Subjects With Virologic Failure During Treatment [ Time Frame: Up to Treatment Week 12 ]Percentage of subjects with quantifiable HCV RNA throughout the entire treatment period, confirmed quantifiable HCV RNA after previously having unquantifiable HCV RNA, or a confirmed increase of at least one log10 in HCV RNA during treatment.
- The Percentage of Subjects With Post-Treatment Relapse [ Time Frame: Within 12 weeks after the last dose of study drug ]Percentage of subjects with confirmed quantifiable HCV RNA within 12 weeks of last dose among subjects with unquantifiable hepatitis C virus ribonucleic acid at the end of treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02068222
|Study Director:||Armen Asatryan, MD||AbbVie|