Clinical trial NCT01464827: ABT-450 With Ritonavir and ABT-267 and/or ABT-333 With and Without Ribavirin in Genotype 1 Hepatitis C Virus Infected Patients
Official title: A Randomized, Open-Label, Multicenter Study to Evaluate the Antiviral Activity, Safety, and Pharmacokinetics, of ABT-450 With Ritonavir (ABT-450/r) in Combination With ABT-267 and/or ABT-333 With and Without Ribavirin (RBV) for 8, 12 or 24 Weeks in Treatment-Naïve and Null Responder Subjects With Genotype 1 Chronic Hepatitis C Virus Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C
Hepatitis C (HCV)
Hepatitis C Genotype 1
Keywords: Hepatitis C Genotype 1
Hepatitis C
Interferon-Free
HCV
Chronic Hepatitis C
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2011-11-04
Enrollment: 580
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: A study to evaluate the safety and effectiveness of experimental drugs ABT-450, ABT-267 (also known as ombitasvir), ABT-333 (also known as dasabuvir), ritonavir, and ribavirin in participants with HCV. The study will test the safety and effects of combinations of these drugs in treatments up to 24 weeks.

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

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: From the time of study drug administration until 30 days following discontinuation of study drug administration (up to 28 weeks).
measure: Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose for 8 Weeks Versus 12 Weeks of Treatment With 3 DAAs and Ribavirin
timeFrame: Post Treatment Week 24
Secondary outcomes:
measure: 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
timeFrame: Post-Treatment Week 24
measure: 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
timeFrame: Post-Treatment Week 24
measure: Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment for 12 Weeks With 3 DAAs With Versus Without Ribavirin
timeFrame: Post-Treatment Week 24
measure: Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose in Treatment-naïve Versus Null-responders
timeFrame: Post-Treatment Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site Reference ID/Investigator# 57583
state: Alabama
city: Birmingham
country: United States
facility: Site Reference ID/Investigator# 55530
state: Alabama
city: Dothan
country: United States
facility: Site Reference ID/Investigator# 55385
state: Alabama
city: Phoenix
country: United States
facility: Site Reference ID/Investigator# 55500
state: Arizona
city: Tucson
country: United States
facility: Site Reference ID/Investigator# 55382
state: Arizona
city: Bakersfield
country: United States
facility: Site Reference ID/Investigator# 61042
state: California
city: Coronado
country: United States
facility: Site Reference ID/Investigator# 43651
state: California
city: Costa Mesa
country: United States
facility: Site Reference ID/Investigator# 43652
state: California
city: Los Angeles
country: United States
facility: Site Reference ID/Investigator# 59130
state: California
city: San Diego
country: United States
facility: Site Reference ID/Investigator# 43565
state: California
city: Aurora
country: United States
facility: Site Reference ID/Investigator# 43910
state: Colorado
city: Bradenton
country: United States
facility: Site Reference ID/Investigator# 43572
state: Florida
city: Fort Pierce
country: United States
facility: Site Reference ID/Investigator# 43584
state: Florida
city: Gainesville
country: United States
facility: Site Reference ID/Investigator# 43917
state: Florida
city: Jacksonville
country: United States
facility: Site Reference ID/Investigator# 55384
state: Florida
city: Wellington
country: United States
facility: Site Reference ID/Investigator# 44610
state: Florida
city: Wellington
country: United States
facility: Site Reference ID/Investigator# 55531
state: Florida
city: Zephyrhills
country: United States
facility: Site Reference ID/Investigator# 55536
state: Florida
city: Macon
country: United States
facility: Site Reference ID/Investigator# 55540
state: Georgia
city: Marietta
country: United States
facility: Site Reference ID/Investigator# 55527
state: Georgia
city: Chicago
country: United States
facility: Site Reference ID/Investigator# 44621
state: Illinois
city: Indianapolis
country: United States
facility: Site Reference ID/Investigator# 43576
state: Indiana
city: Bowling Green
country: United States
facility: Site Reference ID/Investigator# 55383
state: Kentucky
city: Shreveport
country: United States
facility: Site Reference ID/Investigator# 59124
state: Louisiana
city: Annapolis
country: United States
facility: Site Reference ID/Investigator# 43568
state: Maryland
city: Baltimore
country: United States
facility: Site Reference ID/Investigator# 55901
state: Maryland
city: Lutherville
country: United States
facility: Site Reference ID/Investigator# 43588
state: Maryland
city: Boston
country: United States
facility: Site Reference ID/Investigator# 55534
state: Massachusetts
city: Springfield
country: United States
facility: Site Reference ID/Investigator# 43656
state: Massachusetts
city: Ann Arbor
country: United States
facility: Site Reference ID/Investigator# 43655
state: Michigan
city: Detroit
country: United States
facility: Site Reference ID/Investigator# 43913
state: Michigan
city: St. Paul
country: United States
facility: Site Reference ID/Investigator# 43587
state: Minnesota
city: Jackson
country: United States
facility: Site Reference ID/Investigator# 43661
state: Mississippi
city: Kansas City
country: United States
facility: Site Reference ID/Investigator# 43569
state: Missouri
city: St. Louis
country: United States
facility: Site Reference ID/Investigator# 44608
state: Missouri
city: Egg Harbor Township
country: United States
facility: Site Reference ID/Investigator# 55526
state: New Jersey
city: Manhasset
country: United States
facility: Site Reference ID/Investigator# 43566
state: New York
city: Monticello
country: United States
facility: Site Reference ID/Investigator# 59133
state: New York
city: New York
country: United States
facility: Site Reference ID/Investigator# 43586
state: New York
city: New York
country: United States
facility: Site Reference ID/Investigator# 43573
state: New York
city: Poughkeepsie
country: United States
facility: Site Reference ID/Investigator# 55532
state: New York
city: Rochester
country: United States
facility: Site Reference ID/Investigator# 55386
state: New York
city: Charlotte
country: United States
facility: Site Reference ID/Investigator# 55538
state: North Carolina
city: Fayetteville
country: United States
facility: Site Reference ID/Investigator# 55522
state: North Carolina
city: Statesville
country: United States
facility: Site Reference ID/Investigator# 55542
state: North Carolina
city: Cincinnati
country: United States
facility: Site Reference ID/Investigator# 55533
state: Ohio
city: Cincinnati
country: United States
facility: Site Reference ID/Investigator# 43665
state: Ohio
city: Medford
country: United States
facility: Site Reference ID/Investigator# 43585
state: Oregon
city: Portland
country: United States
facility: Site Reference ID/Investigator# 55539
state: Oregon
city: Philadelphia
country: United States
facility: Site Reference ID/Investigator# 56622
state: Pennsylvania
city: Germantown
country: United States
facility: Site Reference ID/Investigator# 43592
state: Tennessee
city: Germantown
country: United States
facility: Site Reference ID/Investigator# 55723
state: Tennessee
city: Nashville
country: United States
facility: Site Reference ID/Investigator# 43659
state: Tennessee
city: Houston
country: United States
facility: Site Reference ID/Investigator# 59132
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 43577
state: Texas
city: Annandale
country: United States
facility: Site Reference ID/Investigator# 43662
state: Virginia
city: Newport News
country: United States
facility: Site Reference ID/Investigator# 43666
state: Virginia
city: Seattle
country: United States
facility: Site Reference ID/Investigator# 43574
state: Washington
city: Madison
country: United States
facility: Site Reference ID/Investigator# 43578
state: Wisconsin
city: Milwaukee
country: United States
facility: Site Reference ID/Investigator# 55387
state: Wisconsin
city: Adelaide
country: Australia
facility: Site Reference ID/Investigator# 44850
city: Herston
country: Australia
facility: Site Reference ID/Investigator# 44849
city: Kogarah
country: Australia
facility: Site Reference ID/Investigator# 44852
city: Calgary
country: Canada
facility: Site Reference ID/Investigator# 44084
city: Vancouver
country: Canada
facility: Site Reference ID/Investigator# 43905
city: Clichy
country: France
facility: Site Reference ID/Investigator# 44755
city: Creteil
country: France
facility: Site Reference ID/Investigator# 44758
city: Lyon
country: France
facility: Site Reference ID/Investigator# 58884
city: Marseilles
country: France
facility: Site Reference ID/Investigator# 58887
city: Montpellier - Cedex 5
country: France
facility: Site Reference ID/Investigator# 58886
city: Paris
country: France
facility: Site Reference ID/Investigator# 44754
city: Pessac
country: France
facility: Site Reference ID/Investigator# 58889
city: Vandoeuvre Les Nancy
country: France
facility: Site Reference ID/Investigator# 44760
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 59304
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 59303
city: Frankfurt
country: Germany
facility: Site Reference ID/Investigator# 46103
city: Hamburg
country: Germany
facility: Site Reference ID/Investigator# 46106
city: Hannover
country: Germany
facility: Site Reference ID/Investigator# 46102
city: Kiel
country: Germany
facility: Site Reference ID/Investigator# 58922
city: Wuerzburg
country: Germany
facility: Site Reference ID/Investigator# 46105
city: Auckland
country: New Zealand
facility: Site Reference ID/Investigator# 44847
city: San Juan
country: Puerto Rico
facility: Site Reference ID/Investigator# 43672
city: San Juan
country: Puerto Rico
facility: Site Reference ID/Investigator# 43675
city: Barcelona
country: Spain
facility: Site Reference ID/Investigator# 46485
city: Barcelona
country: Spain
facility: Site Reference ID/Investigator# 45363
city: Barcelona
country: Spain
facility: Site Reference ID/Investigator# 45668
city: Madrid
country: Spain
facility: Site Reference ID/Investigator# 46484
city: Madrid
country: Spain
facility: Site Reference ID/Investigator# 45667
city: Majadahonda (Madrid)
country: Spain
facility: Site Reference ID/Investigator# 45671
city: Seville
country: Spain
facility: Site Reference ID/Investigator# 46583
city: Valencia
country: Spain
facility: Site Reference ID/Investigator# 45405
city: Dundee
country: United Kingdom
facility: Site Reference ID/Investigator# 57545
city: London
country: United Kingdom
facility: Site Reference ID/Investigator# 59262
city: London
country: United Kingdom
facility: Site Reference ID/Investigator# 57547
city: London
country: United Kingdom
facility: Site Reference ID/Investigator# 58811
city: Nottingham
country: United Kingdom
facility: Site Reference ID/Investigator# 57882
city: Southampton
country: United Kingdom
facility: Site Reference ID/Investigator# 57543
Study officials:
affiliation: AbbVie
name: Daniel Cohen, MD
role: STUDY_DIRECTOR
References:
citation: Krishnan P, Tripathi R, Schnell G, Reisch T, Beyer J, Irvin M, Xie W, Larsen L, Cohen D, Podsadecki T, Pilot-Matias T, Collins C. Resistance analysis of baseline and treatment-emergent variants in hepatitis C virus genotype 1 in the AVIATOR study with paritaprevir-ritonavir, ombitasvir, and dasabuvir. Antimicrob Agents Chemother. 2015 Sep;59(9):5445-54. doi: 10.1128/AAC.00998-15. Epub 2015 Jun 22.
citation: Kowdley KV, Lawitz E, Poordad F, Cohen DE, Nelson DR, Zeuzem S, Everson GT, Kwo P, Foster GR, Sulkowski MS, Xie W, Pilot-Matias T, Liossis G, Larsen L, Khatri A, Podsadecki T, Bernstein B. Phase 2b trial of interferon-free therapy for hepatitis C virus genotype 1. N Engl J Med. 2014 Jan 16;370(3):222-32. doi: 10.1056/NEJMoa1306227.