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

NCT01728324 | Completed Phase 3 Results

• 2 other identifiers: 1241.362012-003535-27
• Study Type: interventional
• Target: 496
• Locations: 12 countries
• Sites: 109

Brief Summary

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.

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Secondary Outcomes (3)

• SVR4: Plasma HCV RNA Level <25 IU/mL at 4 Weeks After EOT.

  4 weeks (after End Of Treatment)

• SVR24: Plasma HCV RNA Level <25 IU/mL at 24 Weeks After EOT.

  4 weeks (after End Of Treatment)

• Prognostic Value of SVR12 Predicting SVR24

  24 Week (post-treatment)

Study Arms (3)

Randomised 24-week arm

EXPERIMENTAL

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

Drug: BI 207127: 24-week treatment; Drug: Faldaprevir: 24-week treatment; Drug: RBV: 24-week treatment

Randomised 16-week arm

EXPERIMENTAL

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)

Drug: BI 207127-placebo: 8-week treatment; Drug: Ribavirin-placebo: 8-week treatment; Drug: Faldaprevir-placebo: 8-week treatment; Drug: Faldaprevir: 16-week treatment; Drug: Ribavirin: 16-week treatment; Drug: BI 207127: 16-week treatment

Allocated 24-week arm

EXPERIMENTAL

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

Drug: Ribavirin: 24-week treatment; Drug: Faldaprevir: 24-week treatment; Drug: BI 207127: 24-week treatment

Interventions

BI 207127-placebo: 8-week treatment DRUG

8 weeks of placebo treatment

Randomised 16-week arm

Ribavirin: 24-week treatment DRUG

24 weeks of active treatment

Allocated 24-week arm

BI 207127: 24-week treatment DRUG

24 weeks of active treatment

Randomised 24-week arm

Faldaprevir: 24-week treatment DRUG

24 weeks of active treatment

Allocated 24-week arm

Ribavirin-placebo: 8-week treatment DRUG

8 weeks of placebo treatment

Randomised 16-week arm

Faldaprevir-placebo: 8-week treatment DRUG

8 weeks of placebo treatment

Randomised 16-week arm

Faldaprevir: 16-week treatment DRUG

16 weeks of active treatment

Randomised 16-week arm

Ribavirin: 16-week treatment DRUG

16 weeks of active treatment

Randomised 16-week arm

RBV: 24-week treatment DRUG

24 weeks of active treatment

Randomised 24-week arm

BI 207127: 16-week treatment DRUG

16 weeks of active treatment

Randomised 16-week arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic hepatitis C infection, diagnosed by positive anti-HCV antibodies and detected HCV RNA at screening
• HCV infection of sub-GT1b confirmed by genotypic testing at screening.
• HCV viral load =1,000 IU/mL at randomisation.
• Patients who have never been previously treated with any other HCV treatment regimen.

You may not qualify if:

• HCV infection of mixed GT (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening.
• HCV infection of sub-GT1a, mixed GT1a/1b, or undefined GT1.
• Liver disease due to causes other than chronic HCV infection.
• HIV infection.
• Hepatitis B virus infection based on presence of HBs-Ag.
• Confirmed or suspected active malignancy or history of malignancy within the last 5 years prior to screening.
• History of illicit drug abuse other than cannabis or chronic alcohol abuse within 12 months prior to randomisation.
• 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).
• Decompensated liver disease, or history of decompensated liver disease.
• Clinical evidence of unstable cardiovascular disease which may further decompensate due to anemia.
• Red blood cell disorders.
• Body weight \<40 kg or \>125 kg.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (109)

1241.36.00016 Boehringer Ingelheim Investigational Site

North Little Rock, Arkansas, United States

Location

1241.36.00020 Boehringer Ingelheim Investigational Site

Anaheim, California, United States

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1241.36.00005 Boehringer Ingelheim Investigational Site

Bakersfield, California, United States

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1241.36.00009 Boehringer Ingelheim Investigational Site

La Jolla, California, United States

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1241.36.00007 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

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1241.36.00013 Boehringer Ingelheim Investigational Site

Oceanside, California, United States

Location

1241.36.00019 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Location

1241.36.00034 Boehringer Ingelheim Investigational Site

San Francisco, California, United States

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1241.36.00022 Boehringer Ingelheim Investigational Site

Bradenton, Florida, United States

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1241.36.00004 Boehringer Ingelheim Investigational Site

DeLand, Florida, United States

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1241.36.00006 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

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1241.36.00003 Boehringer Ingelheim Investigational Site

Gainesville, Florida, United States

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1241.36.00010 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

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1241.36.00024 Boehringer Ingelheim Investigational Site

Palm Harbor, Florida, United States

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1241.36.00030 Boehringer Ingelheim Investigational Site

Zephyrhills, Florida, United States

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1241.36.00027 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

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1241.36.00033 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

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1241.36.00035 Boehringer Ingelheim Investigational Site

Springfield, Illinois, United States

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1241.36.00001 Boehringer Ingelheim Investigational Site

Valparaiso, Indiana, United States

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1241.36.00017 Boehringer Ingelheim Investigational Site

Baton Rouge, Louisiana, United States

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1241.36.00018 Boehringer Ingelheim Investigational Site

Tupelo, Mississippi, United States

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1241.36.00043 Boehringer Ingelheim Investigational Site

Kansas City, Missouri, United States

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1241.36.00032 Boehringer Ingelheim Investigational Site

Hillsborough, New Jersey, United States

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1241.36.00002 Boehringer Ingelheim Investigational Site

Arlington, Texas, United States

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1241.36.00039 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

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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

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1241.36.00026 Boehringer Ingelheim Investigational Site

Charlottesville, Virginia, United States

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1241.36.00044 Boehringer Ingelheim Investigational Site

Newport News, Virginia, United States

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1241.36.00015 Boehringer Ingelheim Investigational Site

Norfolk, Virginia, United States

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1241.36.00029 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Location

1241.36.61005 Boehringer Ingelheim Investigational Site

Camperdown, New South Wales, Australia

Location

1241.36.61010 Boehringer Ingelheim Investigational Site

Kogarah, New South Wales, Australia

Location

1241.36.61009 Boehringer Ingelheim Investigational Site

New Lambton, New South Wales, Australia

Location

1241.36.61007 Boehringer Ingelheim Investigational Site

Randwick, New South Wales, Australia

Location

1241.36.61002 Boehringer Ingelheim Investigational Site

Herston, Queensland, Australia

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1241.36.61004 Boehringer Ingelheim Investigational Site

Clayton, Victoria, Australia

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1241.36.61001 Boehringer Ingelheim Investigational Site

Darlinghurst, Victoria, Australia

Location

1241.36.61008 Boehringer Ingelheim Investigational Site

Heidelberg, Victoria, Australia

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1241.36.61006 Boehringer Ingelheim Investigational Site

Melbourne, Victoria, Australia

Location

1241.36.32006 Boehringer Ingelheim Investigational Site

Antwerp, Belgium

Location

1241.36.32001 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1241.36.32004 Boehringer Ingelheim Investigational Site

Edegem, Belgium

Location

1241.36.32005 Boehringer Ingelheim Investigational Site

Ghent, Belgium

Location

1241.36.32002 Boehringer Ingelheim Investigational Site

Leuven, Belgium

Location

1241.36.32003 Boehringer Ingelheim Investigational Site

Liège, Belgium

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1241.36.32007 Boehringer Ingelheim Investigational Site

Roeselare, Belgium

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1241.36.01005 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

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1241.36.01006 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

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1241.36.01002 Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

Location

1241.36.01003 Boehringer Ingelheim Investigational Site

London, Ontario, Canada

Location

1241.36.01001 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

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1241.36.01004 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

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1241.36.01007 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

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1241.36.33001 Boehringer Ingelheim Investigational Site

Clichy, France

Location

1241.36.33004 Boehringer Ingelheim Investigational Site

Créteil, France

Location

1241.36.33002 Boehringer Ingelheim Investigational Site

Grenoble, France

Location

1241.36.33003 Boehringer Ingelheim Investigational Site

Paris, France

Location

1241.36.33008 Boehringer Ingelheim Investigational Site

Paris, France

Location

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

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1241.36.49011 Boehringer Ingelheim Investigational Site

Aachen, Germany

Location

1241.36.49001 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1241.36.49012 Boehringer Ingelheim Investigational Site

Dortmund, Germany

Location

1241.36.49004 Boehringer Ingelheim Investigational Site

Düsseldorf, Germany

Location

1241.36.49008 Boehringer Ingelheim Investigational Site

Erlangen, Germany

Location

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

Location

1241.36.49002 Boehringer Ingelheim Investigational Site

Hamburg, Germany

Location

1241.36.49007 Boehringer Ingelheim Investigational Site

Mainz, Germany

Location

1241.36.49013 Boehringer Ingelheim Investigational Site

Tübingen, Germany

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1241.36.30001 Boehringer Ingelheim Investigational Site

Athens, Greece

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1241.36.30002 Boehringer Ingelheim Investigational Site

Athens, Greece

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1241.36.30003 Boehringer Ingelheim Investigational Site

Pátrai, Greece

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1241.36.30004 Boehringer Ingelheim Investigational Site

Rhodes, Greece

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1241.36.39025 Boehringer Ingelheim Investigational Site

Antella (fi), Italy

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1241.36.39023 Boehringer Ingelheim Investigational Site

Bisceglie (bat), Italy

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1241.36.39021 Boehringer Ingelheim Investigational Site

Bologna, Italy

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1241.36.39022 Boehringer Ingelheim Investigational Site

Milan, Italy

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1241.36.39020 Boehringer Ingelheim Investigational Site

Palermo, Italy

Location

1241.36.39026 Boehringer Ingelheim Investigational Site

Pavia, Italy

Location

1241.36.39028 Boehringer Ingelheim Investigational Site

Pescara, Italy

Location

1241.36.39029 Boehringer Ingelheim Investigational Site

Roma, Italy

Location

1241.36.39024 Boehringer Ingelheim Investigational Site

San Giovanni Rotondo (fg), Italy

Location

1241.36.64001 Boehringer Ingelheim Investigational Site

Auckland NZ, New Zealand

Location

1241.36.64002 Boehringer Ingelheim Investigational Site

Hamilton, New Zealand

Location

1241.36.35103 Boehringer Ingelheim Investigational Site

Barreiro, Portugal

Location

1241.36.35104 Boehringer Ingelheim Investigational Site

Coimbra, Portugal

Location

1241.36.35101 Boehringer Ingelheim Investigational Site

Lisbon, Portugal

Location

1241.36.34006 Boehringer Ingelheim Investigational Site

Badalona (Barcelona), Spain

Location

1241.36.34002 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1241.36.34004 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1241.36.34001 Boehringer Ingelheim Investigational Site

L'Hospitalet Llobregat (bcn), Spain

Location

1241.36.34005 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1241.36.34008 Boehringer Ingelheim Investigational Site

Málaga, Spain

Location

1241.36.34003 Boehringer Ingelheim Investigational Site

Seville, Spain

Location

1241.36.34007 Boehringer Ingelheim Investigational Site

Vigo (Pontevedra), Spain

Location

1241.36.44003 Boehringer Ingelheim Investigational Site

Birmingham, United Kingdom

Location

1241.36.44006 Boehringer Ingelheim Investigational Site

Edinburgh, United Kingdom

Location

1241.36.44011 Boehringer Ingelheim Investigational Site

Hull, United Kingdom

Location

1241.36.44013 Boehringer Ingelheim Investigational Site

Leeds, United Kingdom

Location

1241.36.44008 Boehringer Ingelheim Investigational Site

Leicester, United Kingdom

Location

1241.36.44001 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1241.36.44005 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1241.36.44007 Boehringer Ingelheim Investigational Site

Manchester, United Kingdom

Location

1241.36.44010 Boehringer Ingelheim Investigational Site

Newcastle upon Tyne, United Kingdom

Location

1241.36.44002 Boehringer Ingelheim Investigational Site

Oxford, United Kingdom

Location

1241.36.44004 Boehringer Ingelheim Investigational Site

Plymouth, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 27920566 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Therapeutics; Ribavirin; deleobuvir; faldaprevir

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2012
• First Posted: November 19, 2012
• Study Start: November 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: January 1, 2015
• Last Updated: February 12, 2016
• Results First Posted: February 12, 2016

Record last verified: 2016-01

Locations

US (31); GR (4); PT (3); NZ (2); FR (8); CA (7); DE (10); AU (9); ES (8); GB (11); BE (7); IT (9)