Back to resultsA 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
Primary Purpose
Chronic Hepatitis C, Hepatitis C Virus
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ABT-450/ritonavir (r)
ABT-530
Ribavirin (RBV)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Hepatitis C, HCV, Interferon Free, Chronic Hepatitis C, Hepatitis C virus, Hepatitis C Genotype 3
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ABT-450/r and ABT-530 plus RBV
Arm Description
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.
Outcomes
Primary Outcome Measures
The Percentage of Subjects Who Achieve 12-week Sustained Virologic Response (SVR12)
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.
Secondary Outcome Measures
The Percentage of Subjects Who Achieve 24-week Sustained Virologic Response (SVR24)
SVR24 defined as HCV RNA LLOQ 24 weeks after last dose of study drug.
The Percentage of Subjects With Virologic Failure During Treatment
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02068222
Brief Title
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
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C, Hepatitis C Virus
Keywords
Hepatitis C, HCV, Interferon Free, Chronic Hepatitis C, Hepatitis C virus, Hepatitis C Genotype 3
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ABT-450/r and ABT-530 plus RBV
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ABT-450/ritonavir (r)
Other Intervention Name(s)
ABT-450 also known as paritaprevir
Intervention Description
Tablet
Intervention Type
Drug
Intervention Name(s)
ABT-530
Other Intervention Name(s)
pibrentasvir
Intervention Description
Tablet
Intervention Type
Drug
Intervention Name(s)
Ribavirin (RBV)
Intervention Description
Tablet
Primary Outcome Measure Information:
Title
The Percentage of Subjects Who Achieve 12-week Sustained Virologic Response (SVR12)
Description
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.
Time Frame
12 weeks after last dose of study drug
Secondary Outcome Measure Information:
Title
The Percentage of Subjects Who Achieve 24-week Sustained Virologic Response (SVR24)
Description
SVR24 defined as HCV RNA LLOQ 24 weeks after last dose of study drug.
Time Frame
24 weeks after last dose of study drug
Title
The Percentage of Subjects With Virologic Failure During Treatment
Description
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.
Time Frame
Up to Treatment Week 12
Title
The Percentage of Subjects With Post-Treatment Relapse
Description
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.
Time Frame
Within 12 weeks after the last dose of study drug
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armen Asatryan, MD
Organizational Affiliation
AbbVie
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
26778412
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.
Results Reference
result
Learn more about this trial
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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