Clinical trial NCT02068222: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C
Hepatitis C Virus
Keywords: Hepatitis C
HCV
Interferon Free
Chronic Hepatitis C
Hepatitis C virus
Hepatitis C Genotype 3
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2014-02-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and antiviral effect of ABT-450/r and ABT-530 coadministered with and without Ribavirin in adults with genotype 3 HCV infection.

Detailed description: Once the efficacy and safety data were obtained from participants administered ABT-450/r + ABT-530 + RBV weight-based (Arm 1) in Study M14-213, the decision was made to end this study before subjects were enrolled into Arm 2.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The Percentage of Subjects Who Achieve 12-week Sustained Virologic Response (SVR12)
timeFrame: 12 weeks after last dose of study drug
Secondary outcomes:
measure: The Percentage of Subjects Who Achieve 24-week Sustained Virologic Response (SVR24)
timeFrame: 24 weeks after last dose of study drug
measure: The Percentage of Subjects With Virologic Failure During Treatment
timeFrame: Up to Treatment Week 12
measure: The Percentage of Subjects With Post-Treatment Relapse
timeFrame: Within 12 weeks after the last dose of study drug
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Armen Asatryan, MD
role: STUDY_DIRECTOR
References:
citation: Poordad F, Landis CS, Asatryan A, Jackson DF 3rd, Ng TI, Fu B, Lin CW, Yao B, Kort J. High antiviral activity of NS5A inhibitor ABT-530 with paritaprevir/ritonavir and ribavirin against hepatitis C virus genotype 3 infection. Liver Int. 2016 Aug;36(8):1125-32. doi: 10.1111/liv.13067. Epub 2016 Feb 3.