Phase 3
N=650
ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection
Hepatitis C Virus (HCV)
Bottom Line
View on ClinicalTrials.gov: NCT02517515 ↗Enrolled (actual)
650
Serious AEs
1.4%
Results posted
Oct 2017
Primary outcome: Primary: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) — 99.5; 100 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ombitasvir/paritaprevir/ritonavir and dasabuvir (Drug); Placebo for ombitasvir/paritaprevir/ritonavir and dasabuvir (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) |
99.5; 100 | — |
| PRIMARY Percentage of Participants With Sustained Virologic Response 24 Weeks Post-treatment (SVR24) |
99.5; 100 | — |
| SECONDARY Percentage of Participants With On-treatment Virologic Failure |
1.1; 0 | — |
| SECONDARY Percentage of Participants With Post-treatment Relapse by Post-treatment Week 12 |
0; 0 | — |
| SECONDARY Percentage of Participants With Post-treatment Relapse by Post-treatment Week 24 |
0; 0 | — |
Summary
This is a study to evaluate ABT 450/r/ABT-267 and ABT-333 in treatment-naïve and treatment-experienced Asian adults with subgenotype 1b chronic HCV without cirrhosis.
Eligibility Criteria
Inclusion Criteria
- Chinese, South Korean, and Taiwanese descent with full Chinese, South Korean, and Taiwanese parentage
- Chronic hepatitis C virus (HCV) infection prior to study enrollment.
- Screening laboratory result indicating HCV subtype 1b (GT1b) infection.
- Per local standard practice, documented absence of cirrhosis.
- Participant has never received antiviral treatment (including interferon [IFN]-based therapy [alpha, beta or pegylated (peg)IFN] with or without RBV) for HCV infection (treatment-naïve participant) or participant must have documentation that they met the definition of one of the following categories (treatment experienced participant): Non-responder or Relapser
- Participant has plasma HCV RNA level > 10,000 IU/mL at Screening.
Exclusion Criteria
- HCV genotype performed during screening indicating unable to genotype or infection with any HCV genotype other than GT1b.
- Positive test result at Screening for hepatitis B surface antigen (HBsAg), or hepatitis B virus DNA (HBV-DNA) > Lower Limit of Quantification (LLOQ) if HBsAg negative, or anti-human immunodeficiency virus antibody (HIV Ab) positive.
- Any current or past clinical evidence of cirrhosis.
- Any primary cause of liver disease other than chronic HCV infection.
- Screening laboratory analyses showing abnormal kidney, hepatic, or hematologic function.
- Use of known strong inducers of cytochrome P450 3A (CYP3A) or strong inhibitors of cytochrome P450 3A (CYP2C8) within 2 weeks or within 10 half-lives, whichever is longer, of the respective medication/supplement prior to study drug administration.
Data sourced from ClinicalTrials.gov (NCT02517515). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.