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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

NCT ID: NCT01728324

Last Updated: 2016-02-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

496 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2015-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatitis C, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Randomised 24-week arm

BI 207127 in combination with FDV and RBV for 24 weeks (randomised)

Group Type EXPERIMENTAL

BI 207127: 24-week treatment

Intervention Type DRUG

24 weeks of active treatment

Faldaprevir: 24-week treatment

Intervention Type DRUG

24 weeks of active treatment

RBV: 24-week treatment

Intervention Type DRUG

24 weeks of active treatment

Randomised 16-week arm

BI 207127-placebo, FDV-placebo and RBV-placebo for 8 weeks followed by BI 207127 in combination with FDV and RBV for 16 weeks (randomised)

Group Type EXPERIMENTAL

BI 207127-placebo: 8-week treatment

Intervention Type DRUG

8 weeks of placebo treatment

Ribavirin-placebo: 8-week treatment

Intervention Type DRUG

8 weeks of placebo treatment

Faldaprevir-placebo: 8-week treatment

Intervention Type DRUG

8 weeks of placebo treatment

Faldaprevir: 16-week treatment

Intervention Type DRUG

16 weeks of active treatment

Ribavirin: 16-week treatment

Intervention Type DRUG

16 weeks of active treatment

BI 207127: 16-week treatment

Intervention Type DRUG

16 weeks of active treatment

Allocated 24-week arm

BI 207127 in combination with FDV and RBV for 24 weeks (allocated to patients with compensated cirrhosis)

Group Type EXPERIMENTAL

Ribavirin: 24-week treatment

Intervention Type DRUG

24 weeks of active treatment

Faldaprevir: 24-week treatment

Intervention Type DRUG

24 weeks of active treatment

BI 207127: 24-week treatment

Intervention Type DRUG

24 weeks of active treatment

Interventions

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BI 207127-placebo: 8-week treatment

8 weeks of placebo treatment

Intervention Type DRUG

Ribavirin: 24-week treatment

24 weeks of active treatment

Intervention Type DRUG

BI 207127: 24-week treatment

24 weeks of active treatment

Intervention Type DRUG

Faldaprevir: 24-week treatment

24 weeks of active treatment

Intervention Type DRUG

Faldaprevir: 24-week treatment

24 weeks of active treatment

Intervention Type DRUG

Ribavirin-placebo: 8-week treatment

8 weeks of placebo treatment

Intervention Type DRUG

BI 207127: 24-week treatment

24 weeks of active treatment

Intervention Type DRUG

Faldaprevir-placebo: 8-week treatment

8 weeks of placebo treatment

Intervention Type DRUG

Faldaprevir: 16-week treatment

16 weeks of active treatment

Intervention Type DRUG

Ribavirin: 16-week treatment

16 weeks of active treatment

Intervention Type DRUG

RBV: 24-week treatment

24 weeks of active treatment

Intervention Type DRUG

BI 207127: 16-week treatment

16 weeks of active treatment

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1241.36.00016 Boehringer Ingelheim Investigational Site

North Little Rock, Arkansas, United States

Site Status

1241.36.00020 Boehringer Ingelheim Investigational Site

Anaheim, California, United States

Site Status

1241.36.00005 Boehringer Ingelheim Investigational Site

Bakersfield, California, United States

Site Status

1241.36.00009 Boehringer Ingelheim Investigational Site

La Jolla, California, United States

Site Status

1241.36.00007 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Site Status

1241.36.00013 Boehringer Ingelheim Investigational Site

Oceanside, California, United States

Site Status

1241.36.00019 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Site Status

1241.36.00034 Boehringer Ingelheim Investigational Site

San Francisco, California, United States

Site Status

1241.36.00022 Boehringer Ingelheim Investigational Site

Bradenton, Florida, United States

Site Status

1241.36.00004 Boehringer Ingelheim Investigational Site

DeLand, Florida, United States

Site Status

1241.36.00006 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

Site Status

1241.36.00003 Boehringer Ingelheim Investigational Site

Gainesville, Florida, United States

Site Status

1241.36.00010 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

Site Status

1241.36.00024 Boehringer Ingelheim Investigational Site

Palm Harbor, Florida, United States

Site Status

1241.36.00030 Boehringer Ingelheim Investigational Site

Zephyrhills, Florida, United States

Site Status

1241.36.00027 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

Site Status

1241.36.00033 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Site Status

1241.36.00035 Boehringer Ingelheim Investigational Site

Springfield, Illinois, United States

Site Status

1241.36.00001 Boehringer Ingelheim Investigational Site

Valparaiso, Indiana, United States

Site Status

1241.36.00017 Boehringer Ingelheim Investigational Site

Baton Rouge, Louisiana, United States

Site Status

1241.36.00018 Boehringer Ingelheim Investigational Site

Tupelo, Mississippi, United States

Site Status

1241.36.00043 Boehringer Ingelheim Investigational Site

Kansas City, Missouri, United States

Site Status

1241.36.00032 Boehringer Ingelheim Investigational Site

Hillsborough, New Jersey, United States

Site Status

1241.36.00002 Boehringer Ingelheim Investigational Site

Arlington, Texas, United States

Site Status

1241.36.00039 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

Site Status

1241.36.00031 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

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1241.36.00008 Boehringer Ingelheim Investigational Site

Murray, Utah, United States

Site Status

1241.36.00026 Boehringer Ingelheim Investigational Site

Charlottesville, Virginia, United States

Site Status

1241.36.00044 Boehringer Ingelheim Investigational Site

Newport News, Virginia, United States

Site Status

1241.36.00015 Boehringer Ingelheim Investigational Site

Norfolk, Virginia, United States

Site Status

1241.36.00029 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Site Status

1241.36.61005 Boehringer Ingelheim Investigational Site

Camperdown, New South Wales, Australia

Site Status

1241.36.61010 Boehringer Ingelheim Investigational Site

Kogarah, New South Wales, Australia

Site Status

1241.36.61009 Boehringer Ingelheim Investigational Site

New Lambton, New South Wales, Australia

Site Status

1241.36.61007 Boehringer Ingelheim Investigational Site

Randwick, New South Wales, Australia

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1241.36.61002 Boehringer Ingelheim Investigational Site

Herston, Queensland, Australia

Site Status

1241.36.61004 Boehringer Ingelheim Investigational Site

Clayton, Victoria, Australia

Site Status

1241.36.61001 Boehringer Ingelheim Investigational Site

Darlinghurst, Victoria, Australia

Site Status

1241.36.61008 Boehringer Ingelheim Investigational Site

Heidelberg, Victoria, Australia

Site Status

1241.36.61006 Boehringer Ingelheim Investigational Site

Melbourne, Victoria, Australia

Site Status

1241.36.32006 Boehringer Ingelheim Investigational Site

Antwerp, , Belgium

Site Status

1241.36.32001 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

Site Status

1241.36.32004 Boehringer Ingelheim Investigational Site

Edegem, , Belgium

Site Status

1241.36.32005 Boehringer Ingelheim Investigational Site

Ghent, , Belgium

Site Status

1241.36.32002 Boehringer Ingelheim Investigational Site

Leuven, , Belgium

Site Status

1241.36.32003 Boehringer Ingelheim Investigational Site

Liège, , Belgium

Site Status

1241.36.32007 Boehringer Ingelheim Investigational Site

Roeselare, , Belgium

Site Status

1241.36.01005 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Site Status

1241.36.01006 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Site Status

1241.36.01002 Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

Site Status

1241.36.01003 Boehringer Ingelheim Investigational Site

London, Ontario, Canada

Site Status

1241.36.01001 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

Site Status

1241.36.01004 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Site Status

1241.36.01007 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Site Status

1241.36.33001 Boehringer Ingelheim Investigational Site

Clichy, , France

Site Status

1241.36.33004 Boehringer Ingelheim Investigational Site

Créteil, , France

Site Status

1241.36.33002 Boehringer Ingelheim Investigational Site

Grenoble, , France

Site Status

1241.36.33003 Boehringer Ingelheim Investigational Site

Paris, , France

Site Status

1241.36.33008 Boehringer Ingelheim Investigational Site

Paris, , France

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1241.36.33006 Boehringer Ingelheim Investigational Site

Saint-Laurent-du-Var, , France

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1241.36.33005 Boehringer Ingelheim Investigational Site

Toulouse, , France

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1241.36.33007 Boehringer Ingelheim Investigational Site

Villejuif, , France

Site Status

1241.36.49011 Boehringer Ingelheim Investigational Site

Aachen, , Germany

Site Status

1241.36.49001 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1241.36.49012 Boehringer Ingelheim Investigational Site

Dortmund, , Germany

Site Status

1241.36.49004 Boehringer Ingelheim Investigational Site

Düsseldorf, , Germany

Site Status

1241.36.49008 Boehringer Ingelheim Investigational Site

Erlangen, , Germany

Site Status

1241.36.49009 Boehringer Ingelheim Investigational Site

Esslingen am Neckar, , Germany

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1241.36.49014 Boehringer Ingelheim Investigational Site

Freiburg im Breisgau, , Germany

Site Status

1241.36.49002 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

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1241.36.49007 Boehringer Ingelheim Investigational Site

Mainz, , Germany

Site Status

1241.36.49013 Boehringer Ingelheim Investigational Site

Tübingen, , Germany

Site Status

1241.36.30001 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1241.36.30002 Boehringer Ingelheim Investigational Site

Athens, , Greece

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1241.36.30003 Boehringer Ingelheim Investigational Site

Pátrai, , Greece

Site Status

1241.36.30004 Boehringer Ingelheim Investigational Site

Rhodes, , Greece

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1241.36.39025 Boehringer Ingelheim Investigational Site

Antella (fi), , Italy

Site Status

1241.36.39023 Boehringer Ingelheim Investigational Site

Bisceglie (bat), , Italy

Site Status

1241.36.39021 Boehringer Ingelheim Investigational Site

Bologna, , Italy

Site Status

1241.36.39022 Boehringer Ingelheim Investigational Site

Milan, , Italy

Site Status

1241.36.39020 Boehringer Ingelheim Investigational Site

Palermo, , Italy

Site Status

1241.36.39026 Boehringer Ingelheim Investigational Site

Pavia, , Italy

Site Status

1241.36.39028 Boehringer Ingelheim Investigational Site

Pescara, , Italy

Site Status

1241.36.39029 Boehringer Ingelheim Investigational Site

Roma, , Italy

Site Status

1241.36.39024 Boehringer Ingelheim Investigational Site

San Giovanni Rotondo (fg), , Italy

Site Status

1241.36.64001 Boehringer Ingelheim Investigational Site

Auckland NZ, , New Zealand

Site Status

1241.36.64002 Boehringer Ingelheim Investigational Site

Hamilton, , New Zealand

Site Status

1241.36.35103 Boehringer Ingelheim Investigational Site

Barreiro, , Portugal

Site Status

1241.36.35104 Boehringer Ingelheim Investigational Site

Coimbra, , Portugal

Site Status

1241.36.35101 Boehringer Ingelheim Investigational Site

Lisbon, , Portugal

Site Status

1241.36.34006 Boehringer Ingelheim Investigational Site

Badalona (Barcelona), , Spain

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1241.36.34002 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1241.36.34004 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1241.36.34001 Boehringer Ingelheim Investigational Site

L'Hospitalet Llobregat (bcn), , Spain

Site Status

1241.36.34005 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1241.36.34008 Boehringer Ingelheim Investigational Site

Málaga, , Spain

Site Status

1241.36.34003 Boehringer Ingelheim Investigational Site

Seville, , Spain

Site Status

1241.36.34007 Boehringer Ingelheim Investigational Site

Vigo (Pontevedra), , Spain

Site Status

1241.36.44003 Boehringer Ingelheim Investigational Site

Birmingham, , United Kingdom

Site Status

1241.36.44006 Boehringer Ingelheim Investigational Site

Edinburgh, , United Kingdom

Site Status

1241.36.44011 Boehringer Ingelheim Investigational Site

Hull, , United Kingdom

Site Status

1241.36.44013 Boehringer Ingelheim Investigational Site

Leeds, , United Kingdom

Site Status

1241.36.44008 Boehringer Ingelheim Investigational Site

Leicester, , United Kingdom

Site Status

1241.36.44001 Boehringer Ingelheim Investigational Site

London, , United Kingdom

Site Status

1241.36.44005 Boehringer Ingelheim Investigational Site

London, , United Kingdom

Site Status

1241.36.44007 Boehringer Ingelheim Investigational Site

Manchester, , United Kingdom

Site Status

1241.36.44010 Boehringer Ingelheim Investigational Site

Newcastle upon Tyne, , United Kingdom

Site Status

1241.36.44002 Boehringer Ingelheim Investigational Site

Oxford, , United Kingdom

Site Status

1241.36.44004 Boehringer Ingelheim Investigational Site

Plymouth, , United Kingdom

Site Status

Countries

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United States Australia Belgium Canada France Germany Greece Italy New Zealand Portugal Spain United Kingdom

References

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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.

Reference Type DERIVED
PMID: 27920566 (View on PubMed)

Other Identifiers

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2012-003535-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1241.36

Identifier Type: -

Identifier Source: org_study_id

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