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
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|ClinicalTrials.gov Identifier: NCT02068222|
Recruitment Status : Completed
First Posted : February 21, 2014
Results First Posted : February 2, 2017
Last Update Posted : February 22, 2018
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|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 paritaprevir
Other Name: pibrentasvir
Drug: 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.
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|Ages Eligible for Study:||18 Years to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Male or female (of non-child bearing potential) between 18 and 70 years of age with Body Mass Index ≥18 to <38 kg/m2.
- Chronic HCV genotype 3 infection prior to study enrollment and has never received antiviral treatment for HCV.
- Subject has plasma HCV RNA level > 10,000 IU/mL at Screening.
- Sexually active males must be sterile, have male partners only, or agree to use two effective forms of birth control for 7 months after stopping study drug.
- History of severe, life-threatening or other significant sensitivity to any drug.
- Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab).
- Prior therapy for the treatment of HCV.
- Any current or past clinical evidence of cirrhosis.
- Any cause of liver disease other than chronic HCV-infection.
- HCV genotype co-infection with any other HCV genotype.
- Use of contraindicated medications within 2 weeks or 10 half-lives of dosing.
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): NCT02068222
|Study Director:||Armen Asatryan, MD||AbbVie|
|Other Study ID Numbers:||
|First Posted:||February 21, 2014 Key Record Dates|
|Results First Posted:||February 2, 2017|
|Last Update Posted:||February 22, 2018|
|Last Verified:||January 2018|
Chronic Hepatitis C
Hepatitis C virus
Hepatitis C Genotype 3
Hepatitis C, Chronic
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections
HIV Protease Inhibitors
Viral Protease Inhibitors
Molecular Mechanisms of Pharmacological Action