IFN-free Combination Therapy in HCV-infected Patients Treatment-naive:HCVerso1

Phase 3

Completed

Conditions: Hepatitis C, Chronic

Interventions: Drug: BI 201335 (Faldaprevir)
Drug: Ribavirin (RBV)
Drug: BI 207127
Drug: Faldaprevir (BI 201335)

Registration Number: NCT01732796

Lead Sponsor: Boehringer Ingelheim

Brief Summary: The aim of the study is to confirm efficacy of treatment for 16 and 24 weeks in chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 470

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Allocated 24 weeks BI 207127 + BI 201335	BI 201335 (Faldaprevir)	24 weeks of BI 207127 and BI 201335 in combination with Ribavirin
Allocated 24 weeks BI 207127 + BI 201335	BI 207127	24 weeks of BI 207127 and BI 201335 in combination with Ribavirin
Randomized 16 weeks BI 7127+BI1335 + RBV	BI 201335 (Faldaprevir)	16 weeks of BI 207127 and QD BI 201335 RBV, followed by additional 8 weeks of placebo BI 207127+ placebo BI 201335 in combination with placebo RBV
Randomized 16 weeks BI 7127+BI1335 + RBV	Ribavirin (RBV)	16 weeks of BI 207127 and QD BI 201335 RBV, followed by additional 8 weeks of placebo BI 207127+ placebo BI 201335 in combination with placebo RBV
Randomized 16 weeks BI 7127+BI1335 + RBV	BI 207127	16 weeks of BI 207127 and QD BI 201335 RBV, followed by additional 8 weeks of placebo BI 207127+ placebo BI 201335 in combination with placebo RBV
Allocated 24 weeks BI 207127 + BI 201335	Ribavirin (RBV)	24 weeks of BI 207127 and BI 201335 in combination with Ribavirin
Randomized 24weeks BI 7127+ BI1335 + RBV	BI 207127	24 weeks of BI 207127and BI 201335 in combination with RBV
Randomized 24weeks BI 7127+ BI1335 + RBV	Faldaprevir (BI 201335)	24 weeks of BI 207127and BI 201335 in combination with RBV
Randomized 24weeks BI 7127+ BI1335 + RBV	Ribavirin (RBV)	24 weeks of BI 207127and BI 201335 in combination with RBV

Primary Outcome Measures

Name	Time	Method
SVR12 Rates With Historical Control	12 Week (post-treatment)	Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C Virus ribonucleic acid (HCV RNA) level \<25 international units/millilitre (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
Comparisons of SVR12 Rates Across Treatment Arms	12 Week (post-treatment)	Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint.

Secondary Outcome Measures

Name	Time	Method
SVR4	4 Week (post-treatment)	Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4).
SVR24	24 Week (post-treatment)	Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24).

Trial Locations

Locations (101): 1241.20.00002 Boehringer Ingelheim Investigational Site
🇺🇸
Chevy Chase, Maryland, United States
1241.20.00012 Boehringer Ingelheim Investigational Site
🇺🇸
Houston, Texas, United States
1241.20.01008 Boehringer Ingelheim Investigational Site
🇨🇦
Vancouver, British Columbia, Canada
1241.20.01010 Boehringer Ingelheim Investigational Site
🇨🇦
Vancouver, British Columbia, Canada
1241.20.35102 Boehringer Ingelheim Investigational Site
🇵🇹
Porto, Portugal
1241.20.35302 Boehringer Ingelheim Investigational Site
🇮🇪
Dublin, Ireland
1241.20.01001 Boehringer Ingelheim Investigational Site
🇨🇦
Vancouver, British Columbia, Canada
1241.20.39008 Boehringer Ingelheim Investigational Site
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Milano, Italy
1241.20.33007 Boehringer Ingelheim Investigational Site
🇫🇷
Paris, France
1241.20.33008 Boehringer Ingelheim Investigational Site
🇫🇷
Vandoeuvre Cedex, France
1241.20.33009 Boehringer Ingelheim Investigational Site
🇫🇷
Rennes Cedex 09, France
1241.20.00004 Boehringer Ingelheim Investigational Site
🇺🇸
Maitland, Florida, United States
1241.20.00010 Boehringer Ingelheim Investigational Site
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Decatur, Georgia, United States
1241.20.00003 Boehringer Ingelheim Investigational Site
🇺🇸
Oceanside, California, United States
1241.20.00024 Boehringer Ingelheim Investigational Site
🇺🇸
Tulsa, Oklahoma, United States
1241.20.00032 Boehringer Ingelheim Investigational Site
🇺🇸
Springfield, Massachusetts, United States
1241.20.00016 Boehringer Ingelheim Investigational Site
🇺🇸
New York, New York, United States
1241.20.00019 Boehringer Ingelheim Investigational Site
🇺🇸
Rochester, New York, United States
1241.20.00008 Boehringer Ingelheim Investigational Site
🇺🇸
Poway, California, United States
1241.20.00013 Boehringer Ingelheim Investigational Site
🇺🇸
Portland, Oregon, United States
1241.20.00031 Boehringer Ingelheim Investigational Site
🇺🇸
New York, New York, United States
1241.20.01003 Boehringer Ingelheim Investigational Site
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Victoria, British Columbia, Canada
1241.20.43003 Boehringer Ingelheim Investigational Site
🇦🇹
Graz, Austria
1241.20.01002 Boehringer Ingelheim Investigational Site
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Toronto, Ontario, Canada
1241.20.00022 Boehringer Ingelheim Investigational Site
🇺🇸
Houston, Texas, United States
1241.20.01007 Boehringer Ingelheim Investigational Site
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Montreal, Quebec, Canada
1241.20.33005 Boehringer Ingelheim Investigational Site
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Nice Cedex 3, France
1241.20.01006 Boehringer Ingelheim Investigational Site
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Hamilton, Ontario, Canada
1241.20.33003 Boehringer Ingelheim Investigational Site
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Clermont-Ferrand Cedex, France
1241.20.33006 Boehringer Ingelheim Investigational Site
🇫🇷
Marseille Cedex 08, France
1241.20.49012 Boehringer Ingelheim Investigational Site
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Bonn, Germany
1241.20.33004 Boehringer Ingelheim Investigational Site
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Lyon, France
1241.20.36001 Boehringer Ingelheim Investigational Site
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Budapest, Hungary
1241.20.49006 Boehringer Ingelheim Investigational Site
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Magdeburg, Germany
1241.20.33002 Boehringer Ingelheim Investigational Site
🇫🇷
Pessac Cedex, France
1241.20.49001 Boehringer Ingelheim Investigational Site
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Frankfurt am Main, Germany
1241.20.49008 Boehringer Ingelheim Investigational Site
🇩🇪
Kiel, Germany
1241.20.35303 Boehringer Ingelheim Investigational Site
🇮🇪
Dublin 8, Ireland
1241.20.49013 Boehringer Ingelheim Investigational Site
🇩🇪
Köln, Germany
1241.20.36002 Boehringer Ingelheim Investigational Site
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Kaposvar, Hungary
1241.20.39007 Boehringer Ingelheim Investigational Site
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Ancona, Italy
1241.20.39003 Boehringer Ingelheim Investigational Site
🇮🇹
Brescia, Italy
1241.20.39002 Boehringer Ingelheim Investigational Site
🇮🇹
Milano, Italy
1241.20.39005 Boehringer Ingelheim Investigational Site
🇮🇹
Pavia, Italy
1241.20.35103 Boehringer Ingelheim Investigational Site
🇵🇹
Aveiro, Portugal
1241.20.35104 Boehringer Ingelheim Investigational Site
🇵🇹
Coimbra, Portugal
1241.20.70004 Boehringer Ingelheim Investigational Site
🇷🇺
St. Petersburg, Russian Federation
1241.20.34003 Boehringer Ingelheim Investigational Site
🇪🇸
Madrid, Spain
1241.20.34002 Boehringer Ingelheim Investigational Site
🇪🇸
Barcelona, Spain
1241.20.70002 Boehringer Ingelheim Investigational Site
🇷🇺
Chelyabinsk, Russian Federation
1241.20.44002 Boehringer Ingelheim Investigational Site
🇬🇧
London, United Kingdom
1241.20.44007 Boehringer Ingelheim Investigational Site
🇬🇧
Liverpool, United Kingdom
1241.20.34004 Boehringer Ingelheim Investigational Site
🇪🇸
Alicante, Spain
1241.20.40003 Boehringer Ingelheim Investigational Site
🇷🇴
Bucharest, Romania
1241.20.31006 Boehringer Ingelheim Investigational Site
🇳🇱
Den Haag, Netherlands
1241.20.34006 Boehringer Ingelheim Investigational Site
🇪🇸
Valencia, Spain
1241.20.44005 Boehringer Ingelheim Investigational Site
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Bristol, United Kingdom
1241.20.35101 Boehringer Ingelheim Investigational Site
🇵🇹
Lisboa, Portugal
1241.20.35105 Boehringer Ingelheim Investigational Site
🇵🇹
Vila Real, Portugal
1241.20.40002 Boehringer Ingelheim Investigational Site
🇷🇴
Bucharest, Romania
1241.20.34001 Boehringer Ingelheim Investigational Site
🇪🇸
Majadahonda, Madrid, Spain
1241.20.34007 Boehringer Ingelheim Investigational Site
🇪🇸
A Coruña, Spain
1241.20.44001 Boehringer Ingelheim Investigational Site
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London, United Kingdom
1241.20.00015 Boehringer Ingelheim Investigational Site
🇺🇸
Fort Lauderdale, Florida, United States
1241.20.00033 Boehringer Ingelheim Investigational Site
🇺🇸
Chula Vista, California, United States
1241.20.00006 Boehringer Ingelheim Investigational Site
🇺🇸
La Mesa, California, United States
1241.20.49011 Boehringer Ingelheim Investigational Site
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Leipzig, Germany
1241.20.49003 Boehringer Ingelheim Investigational Site
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München, Germany
1241.20.49005 Boehringer Ingelheim Investigational Site
🇩🇪
Ulm, Germany
1241.20.00014 Boehringer Ingelheim Investigational Site
🇺🇸
Fort Pierce, Florida, United States
1241.20.00026 Boehringer Ingelheim Investigational Site
🇺🇸
Dothan, Alabama, United States
1241.20.00018 Boehringer Ingelheim Investigational Site
🇺🇸
Baltimore, Maryland, United States
1241.20.00009 Boehringer Ingelheim Investigational Site
🇺🇸
Las Vegas, Nevada, United States
1241.20.00017 Boehringer Ingelheim Investigational Site
🇺🇸
Dallas, Texas, United States
1241.20.01005 Boehringer Ingelheim Investigational Site
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Whitby, Ontario, Canada
1241.20.49009 Boehringer Ingelheim Investigational Site
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Herne, Germany
1241.20.33001 Boehringer Ingelheim Investigational Site
🇫🇷
Montpellier Cedex 5, France
1241.20.49002 Boehringer Ingelheim Investigational Site
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Berlin, Germany
1241.20.49004 Boehringer Ingelheim Investigational Site
🇩🇪
Berlin, Germany
1241.20.49014 Boehringer Ingelheim Investigational Site
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Hamburg, Germany
1241.20.35301 Boehringer Ingelheim Investigational Site
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Dublin, Ireland
1241.20.49007 Boehringer Ingelheim Investigational Site
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Würzburg, Germany
1241.20.49010 Boehringer Ingelheim Investigational Site
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Oberhausen, Germany
1241.20.31003 Boehringer Ingelheim Investigational Site
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Amsterdam, Netherlands
1241.20.31001 Boehringer Ingelheim Investigational Site
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Amsterdam, Netherlands
1241.20.39006 Boehringer Ingelheim Investigational Site
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Napoli, Italy
1241.20.31004 Boehringer Ingelheim Investigational Site
🇳🇱
Amsterdam, Netherlands
1241.20.39001 Boehringer Ingelheim Investigational Site
🇮🇹
Torino, Italy
1241.20.39004 Boehringer Ingelheim Investigational Site
🇮🇹
Torino, Italy
1241.20.31005 Boehringer Ingelheim Investigational Site
🇳🇱
Groningen, Netherlands
1241.20.40001 Boehringer Ingelheim Investigational Site
🇷🇴
Bucharest, Romania
1241.20.70001 Boehringer Ingelheim Investigational Site
🇷🇺
Moscow, Russian Federation
1241.20.70005 Boehringer Ingelheim Investigational Site
🇷🇺
St. Petersburg, Russian Federation
1241.20.34005 Boehringer Ingelheim Investigational Site
🇪🇸
Barcelona, Spain
1241.20.34008 Boehringer Ingelheim Investigational Site
🇪🇸
Santander, Spain
1241.20.44006 Boehringer Ingelheim Investigational Site
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London, United Kingdom
1241.20.44004 Boehringer Ingelheim Investigational Site
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Nottingham, United Kingdom
1241.20.44003 Boehringer Ingelheim Investigational Site
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Southampton, United Kingdom
1241.20.00001 Boehringer Ingelheim Investigational Site
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New Orleans, Louisiana, United States
1241.20.00005 Boehringer Ingelheim Investigational Site
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Austin, Texas, United States
1241.20.00020 Boehringer Ingelheim Investigational Site
🇺🇸
Richmond, Virginia, United States

IFN-free Combination Therapy in HCV-infected Patients Treatment-naive:HCVerso1

Recruitment & Eligibility

Study & Design

Trial Locations

Instant Trial Alerts

Instant Trial Alerts