Clinical trial NCT01728324: Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2
Official title: A Phase III Randomised, Partially Double-blind and Placebo-controlled Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Chronic Genotype 1 Hepatitis C Infection in an Extended Population of Treatment naïve Patients That Includes Those Ineligible to Receive Peginterferon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C, Chronic
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2012-11-19
Enrollment: 496
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to confirm efficacy and safety of treatment with 600 mg of BID BI 207127 in combination with 120 mg QD FDV and RBV for 16 or 24 weeks in target chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.


Eligibility criteria: Inclusion criteria:

1. Chronic hepatitis C infection, diagnosed by positive anti-HCV antibodies and detected HCV RNA at screening
2. HCV infection of sub-GT1b confirmed by genotypic testing at screening.
3. HCV viral load =1,000 IU/mL at randomisation.
4. Patients who have never been previously treated with any other HCV treatment regimen.

Exclusion criteria:

1. HCV infection of mixed GT (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening.
2. HCV infection of sub-GT1a, mixed GT1a/1b, or undefined GT1.
3. Liver disease due to causes other than chronic HCV infection.
4. HIV infection.
5. Hepatitis B virus infection based on presence of HBs-Ag.
6. Confirmed or suspected active malignancy or history of malignancy within the last 5 years prior to screening.
7. History of illicit drug abuse other than cannabis or chronic alcohol abuse within 12 months prior to randomisation.
8. Subject is not willing to comply with the precautionary measures to prevent photosensitivity (avoid excessive sun exposure and use sun block on a daily basis).
9. Decompensated liver disease, or history of decompensated liver disease.
10. Clinical evidence of unstable cardiovascular disease which may further decompensate due to anemia.
11. Red blood cell disorders.
12. Body weight \<40 kg or \>125 kg.

Primary outcomes:
measure: SVR12 Rates With Historical Control
timeFrame: 12 Week (post-treatment)
measure: Comparisons of SVR12 Rates Across Treatment Arms
timeFrame: 12 Week (post-treatment)
Secondary outcomes:
measure: SVR4: Plasma HCV RNA Level <25 IU/mL at 4 Weeks After EOT.
timeFrame: 4 weeks (after End Of Treatment)
measure: SVR24: Plasma HCV RNA Level <25 IU/mL at 24 Weeks After EOT.
timeFrame: 4 weeks (after End Of Treatment)
measure: Prognostic Value of SVR12 Predicting SVR24
timeFrame: 24 Week (post-treatment)
Other outcomes:
Locations:
city: North Little Rock
country: United States
facility: 1241.36.00016 Boehringer Ingelheim Investigational Site
state: Arkansas
city: Anaheim
country: United States
facility: 1241.36.00020 Boehringer Ingelheim Investigational Site
state: California
city: Bakersfield
country: United States
facility: 1241.36.00005 Boehringer Ingelheim Investigational Site
state: California
city: La Jolla
country: United States
facility: 1241.36.00009 Boehringer Ingelheim Investigational Site
state: California
city: Los Angeles
country: United States
facility: 1241.36.00007 Boehringer Ingelheim Investigational Site
state: California
city: Oceanside
country: United States
facility: 1241.36.00013 Boehringer Ingelheim Investigational Site
state: California
city: San Diego
country: United States
facility: 1241.36.00019 Boehringer Ingelheim Investigational Site
state: California
city: San Francisco
country: United States
facility: 1241.36.00034 Boehringer Ingelheim Investigational Site
state: California
city: Bradenton
country: United States
facility: 1241.36.00022 Boehringer Ingelheim Investigational Site
state: Florida
city: Deland
country: United States
facility: 1241.36.00004 Boehringer Ingelheim Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: 1241.36.00006 Boehringer Ingelheim Investigational Site
state: Florida
city: Gainesville
country: United States
facility: 1241.36.00003 Boehringer Ingelheim Investigational Site
state: Florida
city: Orlando
country: United States
facility: 1241.36.00010 Boehringer Ingelheim Investigational Site
state: Florida
city: Palm Harbor
country: United States
facility: 1241.36.00024 Boehringer Ingelheim Investigational Site
state: Florida
city: Zephyrhills
country: United States
facility: 1241.36.00030 Boehringer Ingelheim Investigational Site
state: Florida
city: Atlanta
country: United States
facility: 1241.36.00027 Boehringer Ingelheim Investigational Site
state: Georgia
city: Chicago
country: United States
facility: 1241.36.00033 Boehringer Ingelheim Investigational Site
state: Illinois
city: Springfield
country: United States
facility: 1241.36.00035 Boehringer Ingelheim Investigational Site
state: Illinois
city: Valparaiso
country: United States
facility: 1241.36.00001 Boehringer Ingelheim Investigational Site
state: Indiana
city: Baton Rouge
country: United States
facility: 1241.36.00017 Boehringer Ingelheim Investigational Site
state: Louisiana
city: Tupelo
country: United States
facility: 1241.36.00018 Boehringer Ingelheim Investigational Site
state: Mississippi
city: Kansas City
country: United States
facility: 1241.36.00043 Boehringer Ingelheim Investigational Site
state: Missouri
city: Hillsborough
country: United States
facility: 1241.36.00032 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Arlington
country: United States
facility: 1241.36.00002 Boehringer Ingelheim Investigational Site
state: Texas
city: Austin
country: United States
facility: 1241.36.00039 Boehringer Ingelheim Investigational Site
state: Texas
city: Dallas
country: United States
facility: 1241.36.00031 Boehringer Ingelheim Investigational Site
state: Texas
city: Murray
country: United States
facility: 1241.36.00008 Boehringer Ingelheim Investigational Site
state: Utah
city: Charlottesville
country: United States
facility: 1241.36.00026 Boehringer Ingelheim Investigational Site
state: Virginia
city: Newport News
country: United States
facility: 1241.36.00044 Boehringer Ingelheim Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: 1241.36.00015 Boehringer Ingelheim Investigational Site
state: Virginia
city: Richmond
country: United States
facility: 1241.36.00029 Boehringer Ingelheim Investigational Site
state: Virginia
city: Camperdown
country: Australia
facility: 1241.36.61005 Boehringer Ingelheim Investigational Site
state: New South Wales
city: Kogarah
country: Australia
facility: 1241.36.61010 Boehringer Ingelheim Investigational Site
state: New South Wales
city: New Lambton
country: Australia
facility: 1241.36.61009 Boehringer Ingelheim Investigational Site
state: New South Wales
city: Randwick
country: Australia
facility: 1241.36.61007 Boehringer Ingelheim Investigational Site
state: New South Wales
city: Herston
country: Australia
facility: 1241.36.61002 Boehringer Ingelheim Investigational Site
state: Queensland
city: Clayton
country: Australia
facility: 1241.36.61004 Boehringer Ingelheim Investigational Site
state: Victoria
city: Darlinghurst
country: Australia
facility: 1241.36.61001 Boehringer Ingelheim Investigational Site
state: Victoria
city: Heidelberg
country: Australia
facility: 1241.36.61008 Boehringer Ingelheim Investigational Site
state: Victoria
city: Melbourne
country: Australia
facility: 1241.36.61006 Boehringer Ingelheim Investigational Site
state: Victoria
city: Antwerpen
country: Belgium
facility: 1241.36.32006 Boehringer Ingelheim Investigational Site
city: Bruxelles
country: Belgium
facility: 1241.36.32001 Boehringer Ingelheim Investigational Site
city: Edegem
country: Belgium
facility: 1241.36.32004 Boehringer Ingelheim Investigational Site
city: Gent
country: Belgium
facility: 1241.36.32005 Boehringer Ingelheim Investigational Site
city: Leuven
country: Belgium
facility: 1241.36.32002 Boehringer Ingelheim Investigational Site
city: Liège
country: Belgium
facility: 1241.36.32003 Boehringer Ingelheim Investigational Site
city: Roeselare
country: Belgium
facility: 1241.36.32007 Boehringer Ingelheim Investigational Site
city: Calgary
country: Canada
facility: 1241.36.01005 Boehringer Ingelheim Investigational Site
state: Alberta
city: Vancouver
country: Canada
facility: 1241.36.01006 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: 1241.36.01002 Boehringer Ingelheim Investigational Site
state: Manitoba
city: London
country: Canada
facility: 1241.36.01003 Boehringer Ingelheim Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: 1241.36.01001 Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: 1241.36.01004 Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: 1241.36.01007 Boehringer Ingelheim Investigational Site
state: Ontario
city: Clichy Cedex
country: France
facility: 1241.36.33001 Boehringer Ingelheim Investigational Site
city: Creteil
country: France
facility: 1241.36.33004 Boehringer Ingelheim Investigational Site
city: Grenoble Cedex 9
country: France
facility: 1241.36.33002 Boehringer Ingelheim Investigational Site
city: Paris Cedex 20
country: France
facility: 1241.36.33003 Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: 1241.36.33008 Boehringer Ingelheim Investigational Site
city: Saint Laurent du Var Cedex
country: France
facility: 1241.36.33006 Boehringer Ingelheim Investigational Site
city: Toulouse
country: France
facility: 1241.36.33005 Boehringer Ingelheim Investigational Site
city: Villejuif Cedex
country: France
facility: 1241.36.33007 Boehringer Ingelheim Investigational Site
city: Aachen
country: Germany
facility: 1241.36.49011 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1241.36.49001 Boehringer Ingelheim Investigational Site
city: Dortmund
country: Germany
facility: 1241.36.49012 Boehringer Ingelheim Investigational Site
city: Düsseldorf
country: Germany
facility: 1241.36.49004 Boehringer Ingelheim Investigational Site
city: Erlangen
country: Germany
facility: 1241.36.49008 Boehringer Ingelheim Investigational Site
city: Esslingen
country: Germany
facility: 1241.36.49009 Boehringer Ingelheim Investigational Site
city: Freiburg
country: Germany
facility: 1241.36.49014 Boehringer Ingelheim Investigational Site
city: Hamburg
country: Germany
facility: 1241.36.49002 Boehringer Ingelheim Investigational Site
city: Mainz
country: Germany
facility: 1241.36.49007 Boehringer Ingelheim Investigational Site
city: Tübingen
country: Germany
facility: 1241.36.49013 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1241.36.30001 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1241.36.30002 Boehringer Ingelheim Investigational Site
city: Patras
country: Greece
facility: 1241.36.30003 Boehringer Ingelheim Investigational Site
city: Rhodes
country: Greece
facility: 1241.36.30004 Boehringer Ingelheim Investigational Site
city: Antella (fi)
country: Italy
facility: 1241.36.39025 Boehringer Ingelheim Investigational Site
city: Bisceglie (bat)
country: Italy
facility: 1241.36.39023 Boehringer Ingelheim Investigational Site
city: Bologna
country: Italy
facility: 1241.36.39021 Boehringer Ingelheim Investigational Site
city: Milano
country: Italy
facility: 1241.36.39022 Boehringer Ingelheim Investigational Site
city: Palermo
country: Italy
facility: 1241.36.39020 Boehringer Ingelheim Investigational Site
city: Pavia
country: Italy
facility: 1241.36.39026 Boehringer Ingelheim Investigational Site
city: Pescara
country: Italy
facility: 1241.36.39028 Boehringer Ingelheim Investigational Site
city: Roma
country: Italy
facility: 1241.36.39029 Boehringer Ingelheim Investigational Site
city: San Giovanni Rotondo (fg)
country: Italy
facility: 1241.36.39024 Boehringer Ingelheim Investigational Site
city: Auckland NZ
country: New Zealand
facility: 1241.36.64001 Boehringer Ingelheim Investigational Site
city: Hamilton
country: New Zealand
facility: 1241.36.64002 Boehringer Ingelheim Investigational Site
city: Barreiro
country: Portugal
facility: 1241.36.35103 Boehringer Ingelheim Investigational Site
city: Coimbra
country: Portugal
facility: 1241.36.35104 Boehringer Ingelheim Investigational Site
city: Lisboa
country: Portugal
facility: 1241.36.35101 Boehringer Ingelheim Investigational Site
city: Badalona (Barcelona)
country: Spain
facility: 1241.36.34006 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1241.36.34002 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1241.36.34004 Boehringer Ingelheim Investigational Site
city: L'Hospitalet Llobregat (BCN)
country: Spain
facility: 1241.36.34001 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1241.36.34005 Boehringer Ingelheim Investigational Site
city: Malaga
country: Spain
facility: 1241.36.34008 Boehringer Ingelheim Investigational Site
city: Sevilla
country: Spain
facility: 1241.36.34003 Boehringer Ingelheim Investigational Site
city: Vigo (Pontevedra)
country: Spain
facility: 1241.36.34007 Boehringer Ingelheim Investigational Site
city: Birmingham
country: United Kingdom
facility: 1241.36.44003 Boehringer Ingelheim Investigational Site
city: Edinburgh
country: United Kingdom
facility: 1241.36.44006 Boehringer Ingelheim Investigational Site
city: Hull
country: United Kingdom
facility: 1241.36.44011 Boehringer Ingelheim Investigational Site
city: Leeds
country: United Kingdom
facility: 1241.36.44013 Boehringer Ingelheim Investigational Site
city: Leicester
country: United Kingdom
facility: 1241.36.44008 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1241.36.44001 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1241.36.44005 Boehringer Ingelheim Investigational Site
city: Manchester
country: United Kingdom
facility: 1241.36.44007 Boehringer Ingelheim Investigational Site
city: Newcastle upon Tyne
country: United Kingdom
facility: 1241.36.44010 Boehringer Ingelheim Investigational Site
city: Oxford
country: United Kingdom
facility: 1241.36.44002 Boehringer Ingelheim Investigational Site
city: Plymouth
country: United Kingdom
facility: 1241.36.44004 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Sarrazin C, Castelli F, Andreone P, Buti M, Colombo M, Pol S, Calinas F, Puoti M, Olveira A, Shiffman M, Stern JO, Kukolj G, Roehrle M, Aslanyan S, Deng Q, Vinisko R, Mensa FJ, Nelson DR. HCVerso1 and 2: faldaprevir with deleobuvir (BI 207127) and ribavirin for treatment-naive patients with chronic hepatitis C virus genotype-1b infection. Clin Exp Gastroenterol. 2016 Nov 24;9:351-363. doi: 10.2147/CEG.S111116. eCollection 2016.