Phase 3 N=419 Randomized Double-blind Treatment

A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1b Infection

Chronic Hepatitis C Infection

Bottom Line

View on ClinicalTrials.gov: NCT01767116 ↗

Enrolled (actual)

419

Serious AEs

1.9%

Results posted

Jan 2015

Primary outcome: Primary: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analyses of Each Treatment Arm Compared to Historical Rate — 99.5; 100.0 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 ribavirin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AbbVie (prior sponsor, Abbott)
Primary completion: Dec 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analyses of Each Treatment Arm Compared to Historical Rate	99.5; 100.0	—
SECONDARY Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analysis of ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV Compared With ABT-450/r/ABT-267 and ABT-333, Plus RBV	99.5; 100	—
SECONDARY Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment	51.2; 3.4	<0.001 sig
SECONDARY Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Superiority Analyses of Each Treatment Arm Compared to Historical Rate	99.5; 100	—
SECONDARY Percentage of Participants With Virologic Failure During Treatment	0.5; 0; 0; 0	—
SECONDARY Percentage of Participants With Virologic Relapse After Treatment	0; 0	—

Summary

The purpose of this study is to evaluate the safety and antiviral activity of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin (RBV) in patients with chronic hepatitis C virus genotype 1b (HCV GT1b) infection without cirrhosis.

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-infection (HCV RNA level greater than or equal to 10,000 IU/mL at screening)
Subject has never received antiviral treatment for hepatitis C infection
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 or anti-human immunodeficiency virus antibody
Positive screen for drugs or alcohol
Significant sensitivity to any drug
Use of contraindicated medications within 2 weeks of dosing
Abnormal laboratory tests

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01767116). 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.