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)

NCT01358864 | Completed Phase 3 Results

• 2 other identifiers: 1220.72010-021715-17
• Study Type: interventional
• Target: 678
• Locations: 12 countries
• Sites: 116

Brief 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.

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Virological Response After 24 Weeks of Treatment Discontinuation (SVR24)

  24 weeks post treatment, up to 72 weeks

• Early Treatment Success (ETS)

  Week 4 and Week 8

• ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO

  End of treatment, up to 48 weeks

• ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES

  End of treatment, up to 48 weeks

• AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO

  End of treatment, up to 48 weeks

Study Arms (3)

Placebo/PegIFN/RBV

ACTIVE COMPARATOR

patient to receive two capsules identical to those containing BI201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks

Drug: Pegylated Interferon-alpha (IFN); Drug: Ribavirin (RBV); Drug: Placebo

BI201335 12 weeks

EXPERIMENTAL

patient to receive two capsules containing BI 201335 once a day for 12 weeks and PegIFN/RBV for 48 weeks

Drug: BI 201335; Drug: Pegylated Interferon-alpha (IFN); Drug: Ribavirin (RBV)

BI201335 24 weeks

EXPERIMENTAL

patient to receive two capsules containing BI 201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks

Drug: BI 201335; Drug: Pegylated Interferon-alpha (IFN); Drug: Ribavirin (RBV)

Interventions

BI 201335 DRUG

BI 201335 once a day (QD) for 24 weeks

BI201335 12 weeks; BI201335 24 weeks

Pegylated Interferon-alpha (IFN) DRUG

Pegylated Interferon-alpha for 48 weeks

BI201335 12 weeks; BI201335 24 weeks; Placebo/PegIFN/RBV

Ribavirin (RBV) DRUG

Ribavirin (RBV) for 24 or 48 weeks

BI201335 12 weeks; BI201335 24 weeks; Placebo/PegIFN/RBV

Placebo DRUG

Placebo to BI201335 for 24 weeks

Placebo/PegIFN/RBV

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic hepatitis C genotype 1 infection, diagnosed at least 6 months prior to screening
• Confirmed prior virological failure with an approved dose of PegIFN/RBV
• Age 18 to 70 years,
• HCV RNA (RiboNucleic Acid) = 1,000 IU/mL at screening,

You may not qualify if:

• HCV infection of mixed genotype; Hepatitis B Virus (HBV) or Human Immunodeficiency Virus (HIV) co-infection
• Evidence of acute or chronic liver disease due to causes other than chronic HCV infection,
• Decompensated liver disease, or history of decompensated liver disease,
• Body weight \< 40 or \> 125 kg,
• Clinical evidence of significant or unstable cardiovascular disease, chronic pulmonary disease, history or evidence of retinopathy or clinically significant ophthalmological disorder
• Pre-existing psychiatric condition that could interfere with the subject's participation in and completion of the study
• Laboratory parameters disorders (thalassemia major, sickle cell anemia or G6PD deficit)
• Hemoglobin \< 12 g/dL for women and \< 13 g/dL for men
• 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,

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (116)

1220.7.0091 Boehringer Ingelheim Investigational Site

North Little Rock, Arkansas, United States

Location

1220.7.0082 Boehringer Ingelheim Investigational Site

Englewood, Colorado, United States

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1220.7.0095 Boehringer Ingelheim Investigational Site

Palm Harbor, Florida, United States

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1220.7.0039 Boehringer Ingelheim Investigational Site

Columbus, Georgia, United States

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1220.7.0013 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

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1220.7.0062 Boehringer Ingelheim Investigational Site

Vaiparaiso, Indiana, United States

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1220.7.0085 Boehringer Ingelheim Investigational Site

Baton Rouge, Louisiana, United States

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1220.7.0087 Boehringer Ingelheim Investigational Site

Baton Rouge, Louisiana, United States

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1220.7.0101 Boehringer Ingelheim Investigational Site

New Orleans, Louisiana, United States

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1220.7.0027 Boehringer Ingelheim Investigational Site

Framingham, Massachusetts, United States

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1220.7.0012 Boehringer Ingelheim Investigational Site

New York, New York, United States

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1220.7.0077 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

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1220.7.0058 Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

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1220.7.0063 Boehringer Ingelheim Investigational Site

Arlington, Texas, United States

Location

1220.7.0029 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

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1220.7.0071 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

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1220.7.0009 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

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1220.7.0016 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

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1220.7.4303 Boehringer Ingelheim Investigational Site

Linz, Austria

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1220.7.4301 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1220.7.4302 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1220.7.3201 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1220.7.3207 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1220.7.3204 Boehringer Ingelheim Investigational Site

Edegem, Belgium

Location

1220.7.3205 Boehringer Ingelheim Investigational Site

Ghent, Belgium

Location

1220.7.3206 Boehringer Ingelheim Investigational Site

Jette, Belgium

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1220.7.3202 Boehringer Ingelheim Investigational Site

Leuven, Belgium

Location

1220.7.3203 Boehringer Ingelheim Investigational Site

Liège, Belgium

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1220.7.1011 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

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1220.7.1012 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

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1220.7.1003 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

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1220.7.1016 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

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1220.7.1007 Boehringer Ingelheim Investigational Site

Victoria, British Columbia, Canada

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1220.7.1004 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

Location

1220.7.1006 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

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1220.7.1010 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1220.7.1014 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

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1220.7.3301 Boehringer Ingelheim Investigational Site

Clichy, France

Location

1220.7.3311 Boehringer Ingelheim Investigational Site

Lille, France

Location

1220.7.3303 Boehringer Ingelheim Investigational Site

Marseille, France

Location

1220.7.3304 Boehringer Ingelheim Investigational Site

Montpellier, France

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1220.7.3305 Boehringer Ingelheim Investigational Site

Nice, France

Location

1220.7.3302 Boehringer Ingelheim Investigational Site

Paris, France

Location

1220.7.3310 Boehringer Ingelheim Investigational Site

Paris, France

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1220.7.3316 Boehringer Ingelheim Investigational Site

Pessac, France

Location

1220.7.3317 Boehringer Ingelheim Investigational Site

Reims, France

Location

1220.7.3315 Boehringer Ingelheim Investigational Site

Rennes, France

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1220.7.3318 Boehringer Ingelheim Investigational Site

Strasbourg, France

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1220.7.3308 Boehringer Ingelheim Investigational Site

Vandœuvre-lès-Nancy, France

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1220.7.4902 Boehringer Ingelheim Investigational Site

Berlin, Germany

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1220.7.4904 Boehringer Ingelheim Investigational Site

Berlin, Germany

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1220.7.4913 Boehringer Ingelheim Investigational Site

Dortmund, Germany

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1220.7.4906 Boehringer Ingelheim Investigational Site

Düsseldorf, Germany

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1220.7.4901 Boehringer Ingelheim Investigational Site

Frankfurt am Main, Germany

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1220.7.4908 Boehringer Ingelheim Investigational Site

Hamburg, Germany

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1220.7.4918 Boehringer Ingelheim Investigational Site

Hanover, Germany

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1220.7.4907 Boehringer Ingelheim Investigational Site

Herne, Germany

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1220.7.4903 Boehringer Ingelheim Investigational Site

Leipzig, Germany

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1220.7.4911 Boehringer Ingelheim Investigational Site

Mainz, Germany

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1220.7.4905 Boehringer Ingelheim Investigational Site

München, Germany

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1220.7.8106 Boehringer Ingelheim Investigational Site

Chiba, Chiba, Japan

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1220.7.8111 Boehringer Ingelheim Investigational Site

Gifu, Gifu, Japan

Location

1220.7.8107 Boehringer Ingelheim Investigational Site

Itabashi-ku, Tokyo, Japan

Location

1220.7.8112 Boehringer Ingelheim Investigational Site

Izunokuni, Shizuoka, Japan

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1220.7.8108 Boehringer Ingelheim Investigational Site

Kamakura, Kanagawa, Japan

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1220.7.8117 Boehringer Ingelheim Investigational Site

Kita-gun, Kagawa, Japan

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1220.7.8109 Boehringer Ingelheim Investigational Site

Kofu, Yamanashi, Japan

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1220.7.8116 Boehringer Ingelheim Investigational Site

Kurashiki, Okayama, Japan

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1220.7.8118 Boehringer Ingelheim Investigational Site

Kurume, Fukuoka, Japan

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1220.7.8110 Boehringer Ingelheim Investigational Site

Matsumoto, Nagano, Japan

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1220.7.8124 Boehringer Ingelheim Investigational Site

Matsuyama, Ehime, Japan

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1220.7.8113 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, Japan

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1220.7.8105 Boehringer Ingelheim Investigational Site

Namegata, Ibaraki, Japan

Location

1220.7.8114 Boehringer Ingelheim Investigational Site

Nishinomiya, Hyogo, Japan

Location

1220.7.8125 Boehringer Ingelheim Investigational Site

Ogaki, Gifu, Japan

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1220.7.8119 Boehringer Ingelheim Investigational Site

Omura, Nagasaki, Japan

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1220.7.8122 Boehringer Ingelheim Investigational Site

Omuta, Fukuoka, Japan

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1220.7.8121 Boehringer Ingelheim Investigational Site

Osaka, Osaka, Japan

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1220.7.8101 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, Japan

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1220.7.8102 Boehringer Ingelheim Investigational Site

Sendai, Miyagi, Japan

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1220.7.8115 Boehringer Ingelheim Investigational Site

Tanabe, Wakayama, Japan

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1220.7.8123 Boehringer Ingelheim Investigational Site

Toyama,Toyama, Japan

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1220.7.8126 Boehringer Ingelheim Investigational Site

Tsu, Mie, Japan

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1220.7.8104 Boehringer Ingelheim Investigational Site

Tsuchiura, Ibaraki, Japan

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1220.7.3503 Boehringer Ingelheim Investigational Site

Aveiro, Portugal

Location

1220.7.3509 Boehringer Ingelheim Investigational Site

Barreiro, Portugal

Location

1220.7.3506 Boehringer Ingelheim Investigational Site

Coimbra, Portugal

Location

1220.7.3501 Boehringer Ingelheim Investigational Site

Lisbon, Portugal

Location

1220.7.3505 Boehringer Ingelheim Investigational Site

Lisbon, Portugal

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1220.7.3502 Boehringer Ingelheim Investigational Site

Porto, Portugal

Location

1220.7.0034 Boehringer Ingelheim Investigational Site

San Juan, Puerto Rico

Location

1220.7.3406 Boehringer Ingelheim Investigational Site

A Coruña, Spain

Location

1220.7.3402 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1220.7.3404 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1220.7.3411 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1220.7.3412 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1220.7.3405 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1220.7.3409 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1220.7.3410 Boehringer Ingelheim Investigational Site

Majadahonda-Madrid, Spain

Location

1220.7.3408 Boehringer Ingelheim Investigational Site

Santander, Spain

Location

1220.7.3403 Boehringer Ingelheim Investigational Site

Seville, Spain

Location

1220.7.3401 Boehringer Ingelheim Investigational Site

Valencia, Spain

Location

1220.7.3407 Boehringer Ingelheim Investigational Site

Vigo (Pontevedra), Spain

Location

1220.7.4106 Boehringer Ingelheim Investigational Site

Bern, Switzerland

Location

1220.7.4103 Boehringer Ingelheim Investigational Site

La Chaux-de-Fonds, Switzerland

Location

1220.7.4107 Boehringer Ingelheim Investigational Site

Lugano, Switzerland

Location

1220.7.4108 Boehringer Ingelheim Investigational Site

Sankt Gallen, Switzerland

Location

1220.7.4101 Boehringer Ingelheim Investigational Site

Zurich, Switzerland

Location

1220.7.4405 Boehringer Ingelheim Investigational Site

Bristol, United Kingdom

Location

1220.7.4404 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1220.7.4409 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1220.7.4410 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1220.7.4401 Boehringer Ingelheim Investigational Site

Manchester, United Kingdom

Location

1220.7.4408 Boehringer Ingelheim Investigational Site

Nottingham, United Kingdom

Location

1220.7.4407 Boehringer Ingelheim Investigational Site

Oxford, United Kingdom

Location

1220.7.4403 Boehringer Ingelheim Investigational Site

Southampton, United Kingdom

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

faldaprevir; Ribavirin

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
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2011
• First Posted: May 24, 2011
• Study Start: June 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: May 1, 2014
• Last Updated: August 29, 2016
• Results First Posted: October 28, 2015

Record last verified: 2016-07

Locations

US (18); AU (3); BE (7); GB (8); DE (11); JP (24); PR (1); ES (12); CA (9); PT (6); FR (12); CH (5)