Phase 2
Completed N=110
A Study to Evaluate ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Japanese Adults With Chronic Hepatitis C Virus Infection
Chronic Hepatitis C Infection
Source: ClinicalTrials.gov NCT01672983 ↗
Enrolled (actual)
110
Serious AEs
4.6%
Results posted
Nov 2015
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment (SVR24) — 100; 88.9; 100; 100 percentage of participants
Summary
This study evaluated the safety, tolerability, antiviral activity, and pharmacokinetics of ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as ombitasvir) in adult Japanese patients with chronic hepatitis C virus genotype 1b (HCV GT1b) or genotype 2 (HCV GT2) infection who were previous treated with pegylated interferon/ribavirin (pegIFN/RBV).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment (SVR24) |
100; 88.9; 100; 100; 57.9; 72.2 | — |
| PRIMARY Number of Participants With Adverse Events (AEs) |
28; 31; 16; 15; 1; 2 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (SVR12) |
100; 88.9; 100; 100; 57.9; 72.2 | — |
| SECONDARY Percentage of Participants With End of Treatment (EOT) Response |
100; 100; 100; 100; 63.2; 83.3 | — |
Eligibility Criteria
Inclusion Criteria
- Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile
- Chronic hepatitis C, genotype 1b (HCV-GT1b) or genotype 2 (HCV GT2) infection (HCV RNA level greater than 10,000 IU/mL at screening) previously treated with pegylated interferon/ribavirin (pegIFN/RBV).
- Subject's hepatitis C virus genotype is subgenotype 1b and subject was a null responder or partial responder, OR
- Subject's hepatitis C virus genotype is subgenotype 2 and subject was a null responder, partial responder, or relapser (Null responder: received at least 10 weeks of pegIFN/RBV for the treatment of HCV and failed to achieve a 2 log10 IU/mL reduction in HCV RNA at Week 12; Partial responders: received at least 20 weeks of pegIFN/RBV for the treatment of HCV and achieved ≥ 2 log10 IU/mL reduction in HCV RNA at Week 12, but failed to achieve HCV RNA undetectable (HCV RNA < lower limit of detection [< LLOD]) at the end of treatment; Relapsers: received at least 1 course of pegIFN/RBV for the treatment of HCV and was undetectable at the end of treatment, but HCV RNA was detectable within 24 weeks of treatment follow-up).
Exclusion Criteria
- Significant liver disease with any cause other than HCV as the primary cause
- Positive screen for drugs or alcohol.
- Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody.
- Use of contraindicated medications within 2 weeks of dosing
- Previous use of any investigational or commercially available anti-Hepatitis C virus agent other than pegIFN/RBV, including previous exposure to ABT-450 or ABT-267.
Data sourced from ClinicalTrials.gov (NCT01672983). 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. Informational only — not medical advice.