Hepatitis C, Chronic Clinical Trial
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
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.
| Status | Completed |
| Enrollment | 496 |
| Est. completion date | January 2015 |
| Est. primary completion date | February 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | 1241.36.61005 Boehringer Ingelheim Investigational Site | Camperdown | New South Wales |
| Australia | 1241.36.61004 Boehringer Ingelheim Investigational Site | Clayton | Victoria |
| Australia | 1241.36.61001 Boehringer Ingelheim Investigational Site | Darlinghurst | Victoria |
| Australia | 1241.36.61008 Boehringer Ingelheim Investigational Site | Heidelberg | Victoria |
| Australia | 1241.36.61002 Boehringer Ingelheim Investigational Site | Herston | Queensland |
| Australia | 1241.36.61010 Boehringer Ingelheim Investigational Site | Kogarah | New South Wales |
| Australia | 1241.36.61006 Boehringer Ingelheim Investigational Site | Melbourne | Victoria |
| Australia | 1241.36.61009 Boehringer Ingelheim Investigational Site | New Lambton | New South Wales |
| Australia | 1241.36.61007 Boehringer Ingelheim Investigational Site | Randwick | New South Wales |
| Belgium | 1241.36.32006 Boehringer Ingelheim Investigational Site | Antwerpen | |
| Belgium | 1241.36.32001 Boehringer Ingelheim Investigational Site | Bruxelles | |
| Belgium | 1241.36.32004 Boehringer Ingelheim Investigational Site | Edegem | |
| Belgium | 1241.36.32005 Boehringer Ingelheim Investigational Site | Gent | |
| Belgium | 1241.36.32002 Boehringer Ingelheim Investigational Site | Leuven | |
| Belgium | 1241.36.32003 Boehringer Ingelheim Investigational Site | Liège | |
| Belgium | 1241.36.32007 Boehringer Ingelheim Investigational Site | Roeselare | |
| Canada | 1241.36.01005 Boehringer Ingelheim Investigational Site | Calgary | Alberta |
| Canada | 1241.36.01003 Boehringer Ingelheim Investigational Site | London | Ontario |
| Canada | 1241.36.01001 Boehringer Ingelheim Investigational Site | Ottawa | Ontario |
| Canada | 1241.36.01004 Boehringer Ingelheim Investigational Site | Toronto | Ontario |
| Canada | 1241.36.01007 Boehringer Ingelheim Investigational Site | Toronto | Ontario |
| Canada | 1241.36.01006 Boehringer Ingelheim Investigational Site | Vancouver | British Columbia |
| Canada | 1241.36.01002 Boehringer Ingelheim Investigational Site | Winnipeg | Manitoba |
| France | 1241.36.33001 Boehringer Ingelheim Investigational Site | Clichy Cedex | |
| France | 1241.36.33004 Boehringer Ingelheim Investigational Site | Creteil | |
| France | 1241.36.33002 Boehringer Ingelheim Investigational Site | Grenoble Cedex 9 | |
| France | 1241.36.33008 Boehringer Ingelheim Investigational Site | Paris | |
| France | 1241.36.33003 Boehringer Ingelheim Investigational Site | Paris Cedex 20 | |
| France | 1241.36.33006 Boehringer Ingelheim Investigational Site | Saint Laurent du Var Cedex | |
| France | 1241.36.33005 Boehringer Ingelheim Investigational Site | Toulouse | |
| France | 1241.36.33007 Boehringer Ingelheim Investigational Site | Villejuif Cedex | |
| Germany | 1241.36.49011 Boehringer Ingelheim Investigational Site | Aachen | |
| Germany | 1241.36.49001 Boehringer Ingelheim Investigational Site | Berlin | |
| Germany | 1241.36.49012 Boehringer Ingelheim Investigational Site | Dortmund | |
| Germany | 1241.36.49004 Boehringer Ingelheim Investigational Site | Düsseldorf | |
| Germany | 1241.36.49008 Boehringer Ingelheim Investigational Site | Erlangen | |
| Germany | 1241.36.49009 Boehringer Ingelheim Investigational Site | Esslingen | |
| Germany | 1241.36.49014 Boehringer Ingelheim Investigational Site | Freiburg | |
| Germany | 1241.36.49002 Boehringer Ingelheim Investigational Site | Hamburg | |
| Germany | 1241.36.49007 Boehringer Ingelheim Investigational Site | Mainz | |
| Germany | 1241.36.49013 Boehringer Ingelheim Investigational Site | Tübingen | |
| Greece | 1241.36.30001 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1241.36.30002 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1241.36.30003 Boehringer Ingelheim Investigational Site | Patras | |
| Greece | 1241.36.30004 Boehringer Ingelheim Investigational Site | Rhodes | |
| Italy | 1241.36.39025 Boehringer Ingelheim Investigational Site | Antella (fi) | |
| Italy | 1241.36.39023 Boehringer Ingelheim Investigational Site | Bisceglie (bat) | |
| Italy | 1241.36.39021 Boehringer Ingelheim Investigational Site | Bologna | |
| Italy | 1241.36.39022 Boehringer Ingelheim Investigational Site | Milano | |
| Italy | 1241.36.39020 Boehringer Ingelheim Investigational Site | Palermo | |
| Italy | 1241.36.39026 Boehringer Ingelheim Investigational Site | Pavia | |
| Italy | 1241.36.39028 Boehringer Ingelheim Investigational Site | Pescara | |
| Italy | 1241.36.39029 Boehringer Ingelheim Investigational Site | Roma | |
| Italy | 1241.36.39024 Boehringer Ingelheim Investigational Site | San Giovanni Rotondo (fg) | |
| New Zealand | 1241.36.64001 Boehringer Ingelheim Investigational Site | Auckland NZ | |
| New Zealand | 1241.36.64002 Boehringer Ingelheim Investigational Site | Hamilton | |
| Portugal | 1241.36.35103 Boehringer Ingelheim Investigational Site | Barreiro | |
| Portugal | 1241.36.35104 Boehringer Ingelheim Investigational Site | Coimbra | |
| Portugal | 1241.36.35101 Boehringer Ingelheim Investigational Site | Lisboa | |
| Spain | 1241.36.34006 Boehringer Ingelheim Investigational Site | Badalona (Barcelona) | |
| Spain | 1241.36.34002 Boehringer Ingelheim Investigational Site | Barcelona | |
| Spain | 1241.36.34004 Boehringer Ingelheim Investigational Site | Barcelona | |
| Spain | 1241.36.34001 Boehringer Ingelheim Investigational Site | L'Hospitalet Llobregat (BCN) | |
| Spain | 1241.36.34005 Boehringer Ingelheim Investigational Site | Madrid | |
| Spain | 1241.36.34008 Boehringer Ingelheim Investigational Site | Malaga | |
| Spain | 1241.36.34003 Boehringer Ingelheim Investigational Site | Sevilla | |
| Spain | 1241.36.34007 Boehringer Ingelheim Investigational Site | Vigo (Pontevedra) | |
| United Kingdom | 1241.36.44003 Boehringer Ingelheim Investigational Site | Birmingham | |
| United Kingdom | 1241.36.44006 Boehringer Ingelheim Investigational Site | Edinburgh | |
| United Kingdom | 1241.36.44011 Boehringer Ingelheim Investigational Site | Hull | |
| United Kingdom | 1241.36.44013 Boehringer Ingelheim Investigational Site | Leeds | |
| United Kingdom | 1241.36.44008 Boehringer Ingelheim Investigational Site | Leicester | |
| United Kingdom | 1241.36.44001 Boehringer Ingelheim Investigational Site | London | |
| United Kingdom | 1241.36.44005 Boehringer Ingelheim Investigational Site | London | |
| United Kingdom | 1241.36.44007 Boehringer Ingelheim Investigational Site | Manchester | |
| United Kingdom | 1241.36.44010 Boehringer Ingelheim Investigational Site | Newcastle upon Tyne | |
| United Kingdom | 1241.36.44002 Boehringer Ingelheim Investigational Site | Oxford | |
| United Kingdom | 1241.36.44004 Boehringer Ingelheim Investigational Site | Plymouth | |
| United States | 1241.36.00020 Boehringer Ingelheim Investigational Site | Anaheim | California |
| United States | 1241.36.00002 Boehringer Ingelheim Investigational Site | Arlington | Texas |
| United States | 1241.36.00027 Boehringer Ingelheim Investigational Site | Atlanta | Georgia |
| United States | 1241.36.00039 Boehringer Ingelheim Investigational Site | Austin | Texas |
| United States | 1241.36.00005 Boehringer Ingelheim Investigational Site | Bakersfield | California |
| United States | 1241.36.00017 Boehringer Ingelheim Investigational Site | Baton Rouge | Louisiana |
| United States | 1241.36.00022 Boehringer Ingelheim Investigational Site | Bradenton | Florida |
| United States | 1241.36.00026 Boehringer Ingelheim Investigational Site | Charlottesville | Virginia |
| United States | 1241.36.00033 Boehringer Ingelheim Investigational Site | Chicago | Illinois |
| United States | 1241.36.00031 Boehringer Ingelheim Investigational Site | Dallas | Texas |
| United States | 1241.36.00004 Boehringer Ingelheim Investigational Site | Deland | Florida |
| United States | 1241.36.00006 Boehringer Ingelheim Investigational Site | Fort Lauderdale | Florida |
| United States | 1241.36.00003 Boehringer Ingelheim Investigational Site | Gainesville | Florida |
| United States | 1241.36.00032 Boehringer Ingelheim Investigational Site | Hillsborough | New Jersey |
| United States | 1241.36.00043 Boehringer Ingelheim Investigational Site | Kansas City | Missouri |
| United States | 1241.36.00009 Boehringer Ingelheim Investigational Site | La Jolla | California |
| United States | 1241.36.00007 Boehringer Ingelheim Investigational Site | Los Angeles | California |
| United States | 1241.36.00008 Boehringer Ingelheim Investigational Site | Murray | Utah |
| United States | 1241.36.00044 Boehringer Ingelheim Investigational Site | Newport News | Virginia |
| United States | 1241.36.00015 Boehringer Ingelheim Investigational Site | Norfolk | Virginia |
| United States | 1241.36.00016 Boehringer Ingelheim Investigational Site | North Little Rock | Arkansas |
| United States | 1241.36.00013 Boehringer Ingelheim Investigational Site | Oceanside | California |
| United States | 1241.36.00010 Boehringer Ingelheim Investigational Site | Orlando | Florida |
| United States | 1241.36.00024 Boehringer Ingelheim Investigational Site | Palm Harbor | Florida |
| United States | 1241.36.00029 Boehringer Ingelheim Investigational Site | Richmond | Virginia |
| United States | 1241.36.00019 Boehringer Ingelheim Investigational Site | San Diego | California |
| United States | 1241.36.00034 Boehringer Ingelheim Investigational Site | San Francisco | California |
| United States | 1241.36.00035 Boehringer Ingelheim Investigational Site | Springfield | Illinois |
| United States | 1241.36.00018 Boehringer Ingelheim Investigational Site | Tupelo | Mississippi |
| United States | 1241.36.00001 Boehringer Ingelheim Investigational Site | Valparaiso | Indiana |
| United States | 1241.36.00030 Boehringer Ingelheim Investigational Site | Zephyrhills | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
United States, Australia, Belgium, Canada, France, Germany, Greece, Italy, New Zealand, Portugal, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | SVR12 Rates With Historical Control | Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus (HCV) RNA level <25 IU/mL at 12 weeks after end of Treatment (EOT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This is the primary analyses of the primary endpoint. The number of participants analyzed are actually adjusted number of participant analyzed. |
12 Week (post-treatment) | No |
| Primary | Comparisons of SVR12 Rates Across Treatment Arms | Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint. | 12 Week (post-treatment) | No |
| Secondary | SVR4: Plasma HCV RNA Level <25 IU/mL at 4 Weeks After EOT. | Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4): Plasma HCV RNA level <25 IU/mL at 4 weeks after EOT. | 4 weeks (after End Of Treatment) | No |
| Secondary | SVR24: Plasma HCV RNA Level <25 IU/mL at 24 Weeks After EOT. | Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24): Plasma HCV RNA level <25 IU/mL at 24 weeks after EOT. | 4 weeks (after End Of Treatment) | No |
| Secondary | Prognostic Value of SVR12 Predicting SVR24 | The positive predictive value of SVR12 predicting SVR24 are the patients with an SVR12 (=YES) and the SVR24 was assessed. | 24 Week (post-treatment) | No |
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