A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered With Ribavirin (RBV) in Treatment-Naïve Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (SAPPHIRE-I)
Overview
- Phase
- Phase 3
- Intervention
- ABT-450/r/ABT-267, ABT-333
- Conditions
- Chronic Hepatitis C Infection
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Enrollment
- 636
- Primary Endpoint
- Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected treatment-naïve adults.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Females must be post-menopausal for at least 2 years or surgically sterile or practicing specific forms of birth control
- •Chronic hepatitis C, genotype 1-infection and HCV RNA level greater than 10,000 IU/mL at screening
- •Subject has never received antiviral treatment for hepatitis C infection
- •No evidence of liver cirrhosis
Exclusion Criteria
- •Positive screen for drugs or alcohol
- •Significant sensitivity to any drug
- •Use of contraindicated medications within 2 weeks of dosing
- •Certain predefined abnormal laboratory tests
- •Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody
Arms & Interventions
ABT-450/r/ABT-267 and ABT-333, plus RBV
Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Intervention: ABT-450/r/ABT-267, ABT-333
ABT-450/r/ABT-267 and ABT-333, plus RBV
Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Intervention: Ribavirin
Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV
Double-blind placebo for 12 weeks, followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Intervention: ABT-450/r/ABT-267, ABT-333
Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV
Double-blind placebo for 12 weeks, followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Intervention: Ribavirin
Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV
Double-blind placebo for 12 weeks, followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Intervention: Placebo for ABT-450/r/ABT-267
Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV
Double-blind placebo for 12 weeks, followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Intervention: Placebo for ABT-333
Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV
Double-blind placebo for 12 weeks, followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Intervention: Placebo for ribavirin
Outcomes
Primary Outcomes
Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment
Time Frame: 12 weeks after the last actual dose of active study drug
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\< LLOQ\]) 12 weeks after the last dose of study drug.
Secondary Outcomes
- Percentage of HCV Genotype 1a-infected Participants With Sustained Virologic Response 12 Weeks After Treatment(12 weeks after the last actual dose of active study drug)
- Percentage of Participants With Virologic Relapse After Treatment: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm(Within 12 weeks post-treatment)
- Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period(At 12 weeks)
- Percentage of HCV Genotype 1b-infected Participants With Sustained Virologic Response 12 Weeks After Treatment(12 weeks after the last actual dose of active study drug)
- Percentage of Participants With On-treatment Virologic Failure During the Double-blind Treatment Period: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm(12 weeks after the last actual dose of active study drug)