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)

Hepatitis C, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01358864
• Other study ID #: 1220.7
• Secondary ID: 2010-021715-17
• Status: Completed
• Phase: Phase 3
• First received: May 23, 2011
• Last updated: September 22, 2015
• Start date: June 2011
• Est. completion date: May 2014

Study information

• Verified date: September 2015
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Medicines and Medical Devices AgencyBelgium: Federal Agency for Medicinal and Health ProductsCanada: Health CanadaFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesJapan: Ministry of Health, Labor and WelfarePortugal: National Pharmacy and Medicines InstituteSpain: Spanish Agency of MedicinesSwitzerland: SwissmedicUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 678
• Est. completion date: May 2014
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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,

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• BI 201335
BI 201335 once a day (QD) for 24 weeks
• Pegylated Interferon-alpha (IFN)
Pegylated Interferon-alpha for 48 weeks
• Ribavirin (RBV)
Ribavirin (RBV) for 24 or 48 weeks
• Placebo
Placebo to BI201335 for 24 weeks

Locations

Country	Name	City	State
Austria	1220.7.4303 Boehringer Ingelheim Investigational Site	Linz
Austria	1220.7.4301 Boehringer Ingelheim Investigational Site	Wien
Austria	1220.7.4302 Boehringer Ingelheim Investigational Site	Wien
Belgium	1220.7.3201 Boehringer Ingelheim Investigational Site	Bruxelles
Belgium	1220.7.3207 Boehringer Ingelheim Investigational Site	Bruxelles
Belgium	1220.7.3204 Boehringer Ingelheim Investigational Site	Edegem
Belgium	1220.7.3205 Boehringer Ingelheim Investigational Site	Gent
Belgium	1220.7.3206 Boehringer Ingelheim Investigational Site	Jette
Belgium	1220.7.3202 Boehringer Ingelheim Investigational Site	Leuven
Belgium	1220.7.3203 Boehringer Ingelheim Investigational Site	Liège
Canada	1220.7.1011 Boehringer Ingelheim Investigational Site	Calgary	Alberta
Canada	1220.7.1012 Boehringer Ingelheim Investigational Site	Edmonton	Alberta
Canada	1220.7.1010 Boehringer Ingelheim Investigational Site	Montreal	Quebec
Canada	1220.7.1014 Boehringer Ingelheim Investigational Site	Montreal	Quebec
Canada	1220.7.1004 Boehringer Ingelheim Investigational Site	Ottawa	Ontario
Canada	1220.7.1006 Boehringer Ingelheim Investigational Site	Toronto	Ontario
Canada	1220.7.1003 Boehringer Ingelheim Investigational Site	Vancouver	British Columbia
Canada	1220.7.1016 Boehringer Ingelheim Investigational Site	Vancouver	British Columbia
Canada	1220.7.1007 Boehringer Ingelheim Investigational Site	Victoria	British Columbia
France	1220.7.3301 Boehringer Ingelheim Investigational Site	Clichy
France	1220.7.3311 Boehringer Ingelheim Investigational Site	Lille
France	1220.7.3303 Boehringer Ingelheim Investigational Site	Marseille
France	1220.7.3304 Boehringer Ingelheim Investigational Site	Montpellier
France	1220.7.3305 Boehringer Ingelheim Investigational Site	Nice Cedex 3
France	1220.7.3302 Boehringer Ingelheim Investigational Site	Paris
France	1220.7.3310 Boehringer Ingelheim Investigational Site	Paris
France	1220.7.3316 Boehringer Ingelheim Investigational Site	Pessac Cedex
France	1220.7.3317 Boehringer Ingelheim Investigational Site	Reims
France	1220.7.3315 Boehringer Ingelheim Investigational Site	Rennes Cedex 09
France	1220.7.3318 Boehringer Ingelheim Investigational Site	Strasbourg
France	1220.7.3308 Boehringer Ingelheim Investigational Site	Vandoeuvre Cedex
Germany	1220.7.4902 Boehringer Ingelheim Investigational Site	Berlin
Germany	1220.7.4904 Boehringer Ingelheim Investigational Site	Berlin
Germany	1220.7.4913 Boehringer Ingelheim Investigational Site	Dortmund
Germany	1220.7.4906 Boehringer Ingelheim Investigational Site	Düsseldorf
Germany	1220.7.4901 Boehringer Ingelheim Investigational Site	Frankfurt am Main
Germany	1220.7.4908 Boehringer Ingelheim Investigational Site	Hamburg
Germany	1220.7.4918 Boehringer Ingelheim Investigational Site	Hannover
Germany	1220.7.4907 Boehringer Ingelheim Investigational Site	Herne
Germany	1220.7.4903 Boehringer Ingelheim Investigational Site	Leipzig
Germany	1220.7.4911 Boehringer Ingelheim Investigational Site	Mainz
Germany	1220.7.4905 Boehringer Ingelheim Investigational Site	München
Japan	1220.7.8106 Boehringer Ingelheim Investigational Site	Chiba, Chiba
Japan	1220.7.8111 Boehringer Ingelheim Investigational Site	Gifu, Gifu
Japan	1220.7.8107 Boehringer Ingelheim Investigational Site	Itabashi-ku, Tokyo
Japan	1220.7.8112 Boehringer Ingelheim Investigational Site	Izunokuni, Shizuoka
Japan	1220.7.8108 Boehringer Ingelheim Investigational Site	Kamakura, Kanagawa
Japan	1220.7.8117 Boehringer Ingelheim Investigational Site	Kita-gun, Kagawa
Japan	1220.7.8109 Boehringer Ingelheim Investigational Site	Kofu, Yamanashi
Japan	1220.7.8116 Boehringer Ingelheim Investigational Site	Kurashiki, Okayama
Japan	1220.7.8118 Boehringer Ingelheim Investigational Site	Kurume, Fukuoka
Japan	1220.7.8110 Boehringer Ingelheim Investigational Site	Matsumoto, Nagano
Japan	1220.7.8124 Boehringer Ingelheim Investigational Site	Matsuyama, Ehime
Japan	1220.7.8113 Boehringer Ingelheim Investigational Site	Nagoya, Aichi
Japan	1220.7.8105 Boehringer Ingelheim Investigational Site	Namegata, Ibaraki
Japan	1220.7.8114 Boehringer Ingelheim Investigational Site	Nishinomiya, Hyogo
Japan	1220.7.8125 Boehringer Ingelheim Investigational Site	Ogaki, Gifu
Japan	1220.7.8119 Boehringer Ingelheim Investigational Site	Omura, Nagasaki
Japan	1220.7.8122 Boehringer Ingelheim Investigational Site	Omuta, Fukuoka
Japan	1220.7.8121 Boehringer Ingelheim Investigational Site	Osaka, Osaka
Japan	1220.7.8101 Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	1220.7.8102 Boehringer Ingelheim Investigational Site	Sendai, Miyagi
Japan	1220.7.8115 Boehringer Ingelheim Investigational Site	Tanabe, Wakayama
Japan	1220.7.8123 Boehringer Ingelheim Investigational Site	Toyama,Toyama
Japan	1220.7.8126 Boehringer Ingelheim Investigational Site	Tsu, Mie
Japan	1220.7.8104 Boehringer Ingelheim Investigational Site	Tsuchiura, Ibaraki
Portugal	1220.7.3503 Boehringer Ingelheim Investigational Site	Aveiro
Portugal	1220.7.3509 Boehringer Ingelheim Investigational Site	Barreiro
Portugal	1220.7.3506 Boehringer Ingelheim Investigational Site	Coimbra
Portugal	1220.7.3501 Boehringer Ingelheim Investigational Site	Lisboa
Portugal	1220.7.3505 Boehringer Ingelheim Investigational Site	Lisboa
Portugal	1220.7.3502 Boehringer Ingelheim Investigational Site	Porto
Puerto Rico	1220.7.0034 Boehringer Ingelheim Investigational Site	San Juan
Spain	1220.7.3406 Boehringer Ingelheim Investigational Site	A Coruña
Spain	1220.7.3402 Boehringer Ingelheim Investigational Site	Barcelona
Spain	1220.7.3404 Boehringer Ingelheim Investigational Site	Barcelona
Spain	1220.7.3411 Boehringer Ingelheim Investigational Site	Barcelona
Spain	1220.7.3412 Boehringer Ingelheim Investigational Site	Barcelona
Spain	1220.7.3405 Boehringer Ingelheim Investigational Site	Madrid
Spain	1220.7.3409 Boehringer Ingelheim Investigational Site	Madrid
Spain	1220.7.3410 Boehringer Ingelheim Investigational Site	Majadahonda-Madrid
Spain	1220.7.3408 Boehringer Ingelheim Investigational Site	Santander
Spain	1220.7.3403 Boehringer Ingelheim Investigational Site	Sevilla
Spain	1220.7.3401 Boehringer Ingelheim Investigational Site	Valencia
Spain	1220.7.3407 Boehringer Ingelheim Investigational Site	Vigo (Pontevedra)
Switzerland	1220.7.4106 Boehringer Ingelheim Investigational Site	Bern
Switzerland	1220.7.4103 Boehringer Ingelheim Investigational Site	La Chaux-de-Fonds
Switzerland	1220.7.4107 Boehringer Ingelheim Investigational Site	Lugano
Switzerland	1220.7.4108 Boehringer Ingelheim Investigational Site	St. Gallen
Switzerland	1220.7.4101 Boehringer Ingelheim Investigational Site	Zürich
United Kingdom	1220.7.4405 Boehringer Ingelheim Investigational Site	Bristol
United Kingdom	1220.7.4404 Boehringer Ingelheim Investigational Site	London
United Kingdom	1220.7.4409 Boehringer Ingelheim Investigational Site	London
United Kingdom	1220.7.4410 Boehringer Ingelheim Investigational Site	London
United Kingdom	1220.7.4401 Boehringer Ingelheim Investigational Site	Manchester
United Kingdom	1220.7.4408 Boehringer Ingelheim Investigational Site	Nottingham
United Kingdom	1220.7.4407 Boehringer Ingelheim Investigational Site	Oxford
United Kingdom	1220.7.4403 Boehringer Ingelheim Investigational Site	Southampton
United States	1220.7.0063 Boehringer Ingelheim Investigational Site	Arlington	Texas
United States	1220.7.0029 Boehringer Ingelheim Investigational Site	Austin	Texas
United States	1220.7.0085 Boehringer Ingelheim Investigational Site	Baton Rouge	Louisiana
United States	1220.7.0087 Boehringer Ingelheim Investigational Site	Baton Rouge	Louisiana
United States	1220.7.0013 Boehringer Ingelheim Investigational Site	Chicago	Illinois
United States	1220.7.0039 Boehringer Ingelheim Investigational Site	Columbus	Georgia
United States	1220.7.0071 Boehringer Ingelheim Investigational Site	Dallas	Texas
United States	1220.7.0082 Boehringer Ingelheim Investigational Site	Englewood	Colorado
United States	1220.7.0027 Boehringer Ingelheim Investigational Site	Framingham	Massachusetts
United States	1220.7.0009 Boehringer Ingelheim Investigational Site	Houston	Texas
United States	1220.7.0101 Boehringer Ingelheim Investigational Site	New Orleans	Louisiana
United States	1220.7.0012 Boehringer Ingelheim Investigational Site	New York	New York
United States	1220.7.0091 Boehringer Ingelheim Investigational Site	North Little Rock	Arkansas
United States	1220.7.0095 Boehringer Ingelheim Investigational Site	Palm Harbor	Florida
United States	1220.7.0058 Boehringer Ingelheim Investigational Site	Portland	Oregon
United States	1220.7.0016 Boehringer Ingelheim Investigational Site	San Antonio	Texas
United States	1220.7.0062 Boehringer Ingelheim Investigational Site	Vaiparaiso	Indiana
United States	1220.7.0077 Boehringer Ingelheim Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  France,  Germany,  Japan,  Portugal,  Puerto Rico,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained Virological Response 12 Weeks Post Treatment (SVR12)	Percentage of participants with sustained virological response (SVR12) 12 weeks post treatment defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.	12 weeks post treatment, up to 60 weeks	No
Secondary	Virological Response After 24 Weeks of Treatment Discontinuation (SVR24)	Percentage of participants with virological response after 24 weeks of treatment discontinuation (SVR24) defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.	24 weeks post treatment, up to 72 weeks	No
Secondary	Early Treatment Success (ETS)	Percentage of participants with early Treatment Success (ETS) defined as a plasma HCV RNA level <25 IU/mL (undetected or detected) at Week 4 and <25 IU/mL (undetected) at Week 8.	Week 4 and Week 8	No
Secondary	ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO	The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment (EoT) when patients do not have sustained virological response 12 weeks post treatment. BL=baseline	End of treatment, up to 48 weeks	No
Secondary	ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES	The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline	End of treatment, up to 48 weeks	No
Secondary	AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO	The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline	End of treatment, up to 48 weeks	No
Secondary	AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES	The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment (EoT) when patients have sustained virological response 12 weeks post treatment. BL=baseline	End of treatment, up to 48 weeks	No
Secondary	ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO	The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline	12 weeks post treatment, up to 60 weeks	No
Secondary	ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES	The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline	12 weeks post treatment, up to 60 weeks	No
Secondary	AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO	The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline	12 weeks post treatment, up to 60 weeks	No
Secondary	AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES	The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline	12 weeks post treatment, up to 60 weeks	No

External Links

•   Link