Phase 3 N=636 Randomized Double-blind Treatment

A Study to Evaluate Chronic Hepatitis C Infection

Chronic Hepatitis C Infection

Bottom Line

View on ClinicalTrials.gov: NCT01716585 ↗

Enrolled (actual)

636

Serious AEs

1.5%

Results posted

Jan 2015

Primary outcome: Primary: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment — 96.4 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: ABT-450/r/ABT-267, ABT-333 (Drug); Ribavirin (Drug); Placebo for ABT-450/r/ABT-267 (Drug); Placebo for ABT-333 (Drug); Placebo for ribavirin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AbbVie (prior sponsor, Abbott)
Primary completion: Oct 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment	96.4	—
SECONDARY Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period	97.0; 15.8	< 0.001 sig
SECONDARY Percentage of HCV Genotype 1a-infected Participants With Sustained Virologic Response 12 Weeks After Treatment	95.7	—
SECONDARY Percentage of HCV Genotype 1b-infected Participants With Sustained Virologic Response 12 Weeks After Treatment	98.0	—
SECONDARY 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	0.2	—
SECONDARY Percentage of Participants With Virologic Relapse After Treatment: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm	1.5	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01716585). 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.