Phase 2 N=580 Randomized Treatment

ABT-450 With Ritonavir and ABT-267 and/or ABT-333 With and Without Ribavirin in Genotype 1 Hepatitis C Virus Infected Patients

Chronic Hepatitis C · Hepatitis C (HCV) · Hepatitis C Genotype 1

Bottom Line

View on ClinicalTrials.gov: NCT01464827 ↗

Enrolled (actual)

580

Serious AEs

1.4%

Results posted

Jan 2015

Primary outcome: Primary: Number of Participants With Adverse Events (AEs) — 67; 36; 71; 68 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: ABT-450 (Drug); ABT-333 (Drug); ABT-267 (Drug); Ribavirin (Drug); Ritonavir (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AbbVie (prior sponsor, Abbott)
Primary completion: Mar 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adverse Events (AEs)	67; 36; 71; 68; 71; 77	—
PRIMARY Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose for 8 Weeks Versus 12 Weeks of Treatment With 3 DAAs and Ribavirin	87.5; 82.9; 84.6; 92.5; 88.6; 97.4	0.406
SECONDARY Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment of Different Durations With 3 Direct-acting Antiviral Agents (DAAs) and Ribavirin	87.5; 95.2; 92.7	0.266
SECONDARY Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment for 12 Weeks With 2 DAAs and Ribavirin Versus 3 DAAs and Ribavirin	82.9; 88.7; 95.2	0.068
SECONDARY Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment for 12 Weeks With 3 DAAs With Versus Without Ribavirin	88.6; 95.2	0.106
SECONDARY Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose in Treatment-naïve Versus Null-responders	93.7; 94.3	0.616

Summary

This is a study of combination direct-acting antiviral agents (DAA) with or without ribavirin (RBV) in patients with chronic Hepatitis C Virus (HCV).

Eligibility Criteria

Inclusion Criteria

Males and females 18-70 years old, inclusive
Females must be post-menopausal for more than 2 years or surgically sterile or practicing specific forms of birth control
Chronic hepatitis C virus (HCV), genotype 1 infection
Treatment-naive OR null-responders to previous treatment with pegylated interferon (pegIFN) and ribavirin (at least 12 weeks of treatment and failure to achieve a 2 log10 HCV RNA decrease at Week 12)
No evidence of liver cirrhosis

Exclusion Criteria

Significant liver disease with any cause other than HCV as the primary cause
Positive hepatitis B surface antigen and anti-human immunodeficiency virus antibody
Positive screen for drugs and alcohol
Significant sensitivity to any drug
Use of contraindicated or prohibited medications within 1 month of dosing
Abnormal laboratory tests

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01464827). 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.