Clinical trial NCT01358864: Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-Experienced Genotype 1 Hepatitis C Infected Patients (STARTverso 3)
Official title: A Phase III, Randomised, Double-blind and Placebo Controlled Study of Once Daily BI 201335, 240 mg for 12 or 24 Weeks in Combination With Pegylated interferon-a (PegIFNa) and Ribavirin (RBV) in Patients With Genotype 1 Chronic Hepatitis C Infection Who Failed a Prior PegIFN/RBV Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C, Chronic
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2011-05-24
Enrollment: 678
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: The aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 48 weeks as compared to PegIFN/RBV alone in chronic GT-1 hepatitis C virus infected patients who failed a prior PegIFN/RBV treatment.


Eligibility criteria: Inclusion criteria:

1. Chronic hepatitis C genotype 1 infection, diagnosed at least 6 months prior to screening
2. Confirmed prior virological failure with an approved dose of PegIFN/RBV
3. Age 18 to 70 years,
4. HCV RNA (RiboNucleic Acid) = 1,000 IU/mL at screening,

Exclusion criteria:

1. HCV infection of mixed genotype; Hepatitis B Virus (HBV) or Human Immunodeficiency Virus (HIV) co-infection
2. Evidence of acute or chronic liver disease due to causes other than chronic HCV infection,
3. Decompensated liver disease, or history of decompensated liver disease,
4. Body weight \< 40 or \> 125 kg,
5. Clinical evidence of significant or unstable cardiovascular disease, chronic pulmonary disease, history or evidence of retinopathy or clinically significant ophthalmological disorder
6. Pre-existing psychiatric condition that could interfere with the subject's participation in and completion of the study
7. Laboratory parameters disorders (thalassemia major, sickle cell anemia or G6PD deficit)
8. Hemoglobin \< 12 g/dL for women and \< 13 g/dL for men
9. Patients who have been previously treated with at least one dose of any antiviral or immunomodulatory drug other than interferon alfa or ribavirin for acute or chronic HCV infection including and not restricted to protease or polymerase inhibitors,

Primary outcomes:
measure: Sustained Virological Response 12 Weeks Post Treatment (SVR12)
timeFrame: 12 weeks post treatment, up to 60 weeks
Secondary outcomes:
measure: Virological Response After 24 Weeks of Treatment Discontinuation (SVR24)
timeFrame: 24 weeks post treatment, up to 72 weeks
measure: Early Treatment Success (ETS)
timeFrame: Week 4 and Week 8
measure: ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO
timeFrame: End of treatment, up to 48 weeks
measure: ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES
timeFrame: End of treatment, up to 48 weeks
measure: AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO
timeFrame: End of treatment, up to 48 weeks
measure: AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES
timeFrame: End of treatment, up to 48 weeks
measure: ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO
timeFrame: 12 weeks post treatment, up to 60 weeks
measure: ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES
timeFrame: 12 weeks post treatment, up to 60 weeks
measure: AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO
timeFrame: 12 weeks post treatment, up to 60 weeks
measure: AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES
timeFrame: 12 weeks post treatment, up to 60 weeks
Other outcomes:
Locations:
city: North Little Rock
country: United States
facility: 1220.7.0091 Boehringer Ingelheim Investigational Site
state: Arkansas
city: Englewood
country: United States
facility: 1220.7.0082 Boehringer Ingelheim Investigational Site
state: Colorado
city: Palm Harbor
country: United States
facility: 1220.7.0095 Boehringer Ingelheim Investigational Site
state: Florida
city: Columbus
country: United States
facility: 1220.7.0039 Boehringer Ingelheim Investigational Site
state: Georgia
city: Chicago
country: United States
facility: 1220.7.0013 Boehringer Ingelheim Investigational Site
state: Illinois
city: Vaiparaiso
country: United States
facility: 1220.7.0062 Boehringer Ingelheim Investigational Site
state: Indiana
city: Baton Rouge
country: United States
facility: 1220.7.0085 Boehringer Ingelheim Investigational Site
state: Louisiana
city: Baton Rouge
country: United States
facility: 1220.7.0087 Boehringer Ingelheim Investigational Site
state: Louisiana
city: New Orleans
country: United States
facility: 1220.7.0101 Boehringer Ingelheim Investigational Site
state: Louisiana
city: Framingham
country: United States
facility: 1220.7.0027 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: New York
country: United States
facility: 1220.7.0012 Boehringer Ingelheim Investigational Site
state: New York
city: Winston-Salem
country: United States
facility: 1220.7.0077 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Portland
country: United States
facility: 1220.7.0058 Boehringer Ingelheim Investigational Site
state: Oregon
city: Arlington
country: United States
facility: 1220.7.0063 Boehringer Ingelheim Investigational Site
state: Texas
city: Austin
country: United States
facility: 1220.7.0029 Boehringer Ingelheim Investigational Site
state: Texas
city: Dallas
country: United States
facility: 1220.7.0071 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 1220.7.0009 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 1220.7.0016 Boehringer Ingelheim Investigational Site
state: Texas
city: Linz
country: Austria
facility: 1220.7.4303 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 1220.7.4301 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 1220.7.4302 Boehringer Ingelheim Investigational Site
city: Bruxelles
country: Belgium
facility: 1220.7.3201 Boehringer Ingelheim Investigational Site
city: Bruxelles
country: Belgium
facility: 1220.7.3207 Boehringer Ingelheim Investigational Site
city: Edegem
country: Belgium
facility: 1220.7.3204 Boehringer Ingelheim Investigational Site
city: Gent
country: Belgium
facility: 1220.7.3205 Boehringer Ingelheim Investigational Site
city: Jette
country: Belgium
facility: 1220.7.3206 Boehringer Ingelheim Investigational Site
city: Leuven
country: Belgium
facility: 1220.7.3202 Boehringer Ingelheim Investigational Site
city: Liège
country: Belgium
facility: 1220.7.3203 Boehringer Ingelheim Investigational Site
city: Calgary
country: Canada
facility: 1220.7.1011 Boehringer Ingelheim Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: 1220.7.1012 Boehringer Ingelheim Investigational Site
state: Alberta
city: Vancouver
country: Canada
facility: 1220.7.1003 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: 1220.7.1016 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Victoria
country: Canada
facility: 1220.7.1007 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Ottawa
country: Canada
facility: 1220.7.1004 Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: 1220.7.1006 Boehringer Ingelheim Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: 1220.7.1010 Boehringer Ingelheim Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: 1220.7.1014 Boehringer Ingelheim Investigational Site
state: Quebec
city: Clichy
country: France
facility: 1220.7.3301 Boehringer Ingelheim Investigational Site
city: Lille
country: France
facility: 1220.7.3311 Boehringer Ingelheim Investigational Site
city: Marseille
country: France
facility: 1220.7.3303 Boehringer Ingelheim Investigational Site
city: Montpellier
country: France
facility: 1220.7.3304 Boehringer Ingelheim Investigational Site
city: Nice Cedex 3
country: France
facility: 1220.7.3305 Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: 1220.7.3302 Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: 1220.7.3310 Boehringer Ingelheim Investigational Site
city: Pessac Cedex
country: France
facility: 1220.7.3316 Boehringer Ingelheim Investigational Site
city: Reims
country: France
facility: 1220.7.3317 Boehringer Ingelheim Investigational Site
city: Rennes Cedex 09
country: France
facility: 1220.7.3315 Boehringer Ingelheim Investigational Site
city: Strasbourg
country: France
facility: 1220.7.3318 Boehringer Ingelheim Investigational Site
city: Vandoeuvre Cedex
country: France
facility: 1220.7.3308 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1220.7.4902 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1220.7.4904 Boehringer Ingelheim Investigational Site
city: Dortmund
country: Germany
facility: 1220.7.4913 Boehringer Ingelheim Investigational Site
city: Düsseldorf
country: Germany
facility: 1220.7.4906 Boehringer Ingelheim Investigational Site
city: Frankfurt am Main
country: Germany
facility: 1220.7.4901 Boehringer Ingelheim Investigational Site
city: Hamburg
country: Germany
facility: 1220.7.4908 Boehringer Ingelheim Investigational Site
city: Hannover
country: Germany
facility: 1220.7.4918 Boehringer Ingelheim Investigational Site
city: Herne
country: Germany
facility: 1220.7.4907 Boehringer Ingelheim Investigational Site
city: Leipzig
country: Germany
facility: 1220.7.4903 Boehringer Ingelheim Investigational Site
city: Mainz
country: Germany
facility: 1220.7.4911 Boehringer Ingelheim Investigational Site
city: München
country: Germany
facility: 1220.7.4905 Boehringer Ingelheim Investigational Site
city: Chiba, Chiba
country: Japan
facility: 1220.7.8106 Boehringer Ingelheim Investigational Site
city: Gifu, Gifu
country: Japan
facility: 1220.7.8111 Boehringer Ingelheim Investigational Site
city: Itabashi-ku, Tokyo
country: Japan
facility: 1220.7.8107 Boehringer Ingelheim Investigational Site
city: Izunokuni, Shizuoka
country: Japan
facility: 1220.7.8112 Boehringer Ingelheim Investigational Site
city: Kamakura, Kanagawa
country: Japan
facility: 1220.7.8108 Boehringer Ingelheim Investigational Site
city: Kita-gun, Kagawa
country: Japan
facility: 1220.7.8117 Boehringer Ingelheim Investigational Site
city: Kofu, Yamanashi
country: Japan
facility: 1220.7.8109 Boehringer Ingelheim Investigational Site
city: Kurashiki, Okayama
country: Japan
facility: 1220.7.8116 Boehringer Ingelheim Investigational Site
city: Kurume, Fukuoka
country: Japan
facility: 1220.7.8118 Boehringer Ingelheim Investigational Site
city: Matsumoto, Nagano
country: Japan
facility: 1220.7.8110 Boehringer Ingelheim Investigational Site
city: Matsuyama, Ehime
country: Japan
facility: 1220.7.8124 Boehringer Ingelheim Investigational Site
city: Nagoya, Aichi
country: Japan
facility: 1220.7.8113 Boehringer Ingelheim Investigational Site
city: Namegata, Ibaraki
country: Japan
facility: 1220.7.8105 Boehringer Ingelheim Investigational Site
city: Nishinomiya, Hyogo
country: Japan
facility: 1220.7.8114 Boehringer Ingelheim Investigational Site
city: Ogaki, Gifu
country: Japan
facility: 1220.7.8125 Boehringer Ingelheim Investigational Site
city: Omura, Nagasaki
country: Japan
facility: 1220.7.8119 Boehringer Ingelheim Investigational Site
city: Omuta, Fukuoka
country: Japan
facility: 1220.7.8122 Boehringer Ingelheim Investigational Site
city: Osaka, Osaka
country: Japan
facility: 1220.7.8121 Boehringer Ingelheim Investigational Site
city: Sapporo, Hokkaido
country: Japan
facility: 1220.7.8101 Boehringer Ingelheim Investigational Site
city: Sendai, Miyagi
country: Japan
facility: 1220.7.8102 Boehringer Ingelheim Investigational Site
city: Tanabe, Wakayama
country: Japan
facility: 1220.7.8115 Boehringer Ingelheim Investigational Site
city: Toyama,Toyama
country: Japan
facility: 1220.7.8123 Boehringer Ingelheim Investigational Site
city: Tsu, Mie
country: Japan
facility: 1220.7.8126 Boehringer Ingelheim Investigational Site
city: Tsuchiura, Ibaraki
country: Japan
facility: 1220.7.8104 Boehringer Ingelheim Investigational Site
city: Aveiro
country: Portugal
facility: 1220.7.3503 Boehringer Ingelheim Investigational Site
city: Barreiro
country: Portugal
facility: 1220.7.3509 Boehringer Ingelheim Investigational Site
city: Coimbra
country: Portugal
facility: 1220.7.3506 Boehringer Ingelheim Investigational Site
city: Lisboa
country: Portugal
facility: 1220.7.3501 Boehringer Ingelheim Investigational Site
city: Lisboa
country: Portugal
facility: 1220.7.3505 Boehringer Ingelheim Investigational Site
city: Porto
country: Portugal
facility: 1220.7.3502 Boehringer Ingelheim Investigational Site
city: San Juan
country: Puerto Rico
facility: 1220.7.0034 Boehringer Ingelheim Investigational Site
city: A Coruña
country: Spain
facility: 1220.7.3406 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1220.7.3402 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1220.7.3404 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1220.7.3411 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1220.7.3412 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1220.7.3405 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1220.7.3409 Boehringer Ingelheim Investigational Site
city: Majadahonda-Madrid
country: Spain
facility: 1220.7.3410 Boehringer Ingelheim Investigational Site
city: Santander
country: Spain
facility: 1220.7.3408 Boehringer Ingelheim Investigational Site
city: Sevilla
country: Spain
facility: 1220.7.3403 Boehringer Ingelheim Investigational Site
city: Valencia
country: Spain
facility: 1220.7.3401 Boehringer Ingelheim Investigational Site
city: Vigo (Pontevedra)
country: Spain
facility: 1220.7.3407 Boehringer Ingelheim Investigational Site
city: Bern
country: Switzerland
facility: 1220.7.4106 Boehringer Ingelheim Investigational Site
city: La Chaux-de-Fonds
country: Switzerland
facility: 1220.7.4103 Boehringer Ingelheim Investigational Site
city: Lugano
country: Switzerland
facility: 1220.7.4107 Boehringer Ingelheim Investigational Site
city: St. Gallen
country: Switzerland
facility: 1220.7.4108 Boehringer Ingelheim Investigational Site
city: Zürich
country: Switzerland
facility: 1220.7.4101 Boehringer Ingelheim Investigational Site
city: Bristol
country: United Kingdom
facility: 1220.7.4405 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1220.7.4404 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1220.7.4409 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1220.7.4410 Boehringer Ingelheim Investigational Site
city: Manchester
country: United Kingdom
facility: 1220.7.4401 Boehringer Ingelheim Investigational Site
city: Nottingham
country: United Kingdom
facility: 1220.7.4408 Boehringer Ingelheim Investigational Site
city: Oxford
country: United Kingdom
facility: 1220.7.4407 Boehringer Ingelheim Investigational Site
city: Southampton
country: United Kingdom
facility: 1220.7.4403 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: