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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01358864
First received: May 23, 2011
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: BI 201335
Drug: placebo/PegIFN/RBV
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase III, Randomised, Double-blind and Placebo Controlled Study of Once Daily BI 201335, 240 mg for 12 or 24 Weeks in Combination With Pegylated interferon-a (PegIFNa) and Ribavirin (RBV) in Patients With Genotype 1 Chronic Hepatitis C Infection Who Failed a Prior PegIFN/RBV Treatment

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Sustained Virological Response (SVR12): Plasma HCV RNA level <25 IU/mL, undetected 12 weeks after the originally planned treatment duration. [ Time Frame: week 72 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Virological response after 24 weeks of treatment discontinuation (SVR24): Plasma HCV RNA level <25 IU/mL (undetected) 24 weeks after the originally planned treatment duration, [ Time Frame: week 60 ] [ Designated as safety issue: No ]
  • Early Treatment Success (ETS): Plasma HCV RNA level <25 IU/mL (undetected or detected) at Week 4 and <25 IU/mL (undetected) at Week 8, [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • ALT/AST normalisation: ALT/AST in normal range at end of tretament and post treatment [ Time Frame: week 72 ] [ Designated as safety issue: No ]

Enrollment: 678
Study Start Date: June 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Placebo/PegIFN/RBV
patient to receive two capsules identical to those containing BI201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks
Drug: placebo/PegIFN/RBV
PegIFN/RBV for 48 weeks
Experimental: BI201335 12 weeks
patient to receive two capsules containing BI 201335 once a day for 12 weeks and PegIFN/RBV for 48 weeks
Drug: BI 201335
BI 201335 once a day (QD) for 12 weeks
Experimental: BI201335 24 weeks
patient to receive two capsules containing BI 201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks
Drug: BI 201335
BI 201335 once a day (QD) for 24 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

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

Exclusion criteria:

  1. HCV infection of mixed genotype; Hepatitis B Virus (HBV) or Human Immunodeficiency Virus (HIV) co-infection
  2. Evidence of acute or chronic liver disease due to causes other than chronic HCV infection,
  3. Decompensated liver disease, or history of decompensated liver disease,
  4. Body weight < 40 or > 125 kg,
  5. Clinical evidence of significant or unstable cardiovascular disease, chronic pulmonary disease, history or evidence of retinopathy or clinically significant ophthalmological disorder
  6. Pre-existing psychiatric condition that could interfere with the subject's participation in and completion of the study
  7. Laboratory parameters disorders (thalassemia major, sickle cell anemia or G6PD deficit)
  8. Hemoglobin < 12 g/dL for women and < 13 g/dL for men
  9. 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,
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01358864

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Locations
United States, Arkansas
1220.7.0091 Boehringer Ingelheim Investigational Site
North Little Rock, Arkansas, United States
United States, Colorado
1220.7.0082 Boehringer Ingelheim Investigational Site
Englewood, Colorado, United States
United States, Florida
1220.7.0095 Boehringer Ingelheim Investigational Site
Palm Harbor, Florida, United States
United States, Georgia
1220.7.0039 Boehringer Ingelheim Investigational Site
Columbus, Georgia, United States
United States, Illinois
1220.7.0013 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
United States, Indiana
1220.7.0062 Boehringer Ingelheim Investigational Site
Vaiparaiso, Indiana, United States
United States, Louisiana
1220.7.0085 Boehringer Ingelheim Investigational Site
Baton Rouge, Louisiana, United States
1220.7.0087 Boehringer Ingelheim Investigational Site
Baton Rouge, Louisiana, United States
1220.7.0101 Boehringer Ingelheim Investigational Site
New Orleans, Louisiana, United States
United States, Massachusetts
1220.7.0027 Boehringer Ingelheim Investigational Site
Framingham, Massachusetts, United States
United States, New York
1220.7.0012 Boehringer Ingelheim Investigational Site
New York, New York, United States
United States, North Carolina
1220.7.0077 Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina, United States
United States, Oregon
1220.7.0058 Boehringer Ingelheim Investigational Site
Portland, Oregon, United States
United States, Texas
1220.7.0063 Boehringer Ingelheim Investigational Site
Arlington, Texas, United States
1220.7.0029 Boehringer Ingelheim Investigational Site
Austin, Texas, United States
1220.7.0071 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
1220.7.0009 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
1220.7.0016 Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
Austria
1220.7.4303 Boehringer Ingelheim Investigational Site
Linz, Austria
1220.7.4301 Boehringer Ingelheim Investigational Site
Wien, Austria
1220.7.4302 Boehringer Ingelheim Investigational Site
Wien, Austria
Belgium
1220.7.3207 Boehringer Ingelheim Investigational Site
Bruxelles, Belgium
1220.7.3201 Boehringer Ingelheim Investigational Site
Bruxelles, Belgium
1220.7.3204 Boehringer Ingelheim Investigational Site
Edegem, Belgium
1220.7.3205 Boehringer Ingelheim Investigational Site
Gent, Belgium
1220.7.3206 Boehringer Ingelheim Investigational Site
Jette, Belgium
1220.7.3202 Boehringer Ingelheim Investigational Site
Leuven, Belgium
1220.7.3203 Boehringer Ingelheim Investigational Site
Liège, Belgium
Canada, Alberta
1220.7.1011 Boehringer Ingelheim Investigational Site
Calgary, Alberta, Canada
1220.7.1012 Boehringer Ingelheim Investigational Site
Edmonton, Alberta, Canada
Canada, British Columbia
1220.7.1016 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia, Canada
1220.7.1003 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia, Canada
1220.7.1007 Boehringer Ingelheim Investigational Site
Victoria, British Columbia, Canada
Canada, Ontario
1220.7.1004 Boehringer Ingelheim Investigational Site
Ottawa, Ontario, Canada
1220.7.1006 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
Canada, Quebec
1220.7.1010 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
1220.7.1014 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
France
1220.7.3301 Boehringer Ingelheim Investigational Site
Clichy, France
1220.7.3311 Boehringer Ingelheim Investigational Site
Lille, France
1220.7.3303 Boehringer Ingelheim Investigational Site
Marseille, France
1220.7.3304 Boehringer Ingelheim Investigational Site
Montpellier, France
1220.7.3305 Boehringer Ingelheim Investigational Site
Nice Cedex 3, France
1220.7.3310 Boehringer Ingelheim Investigational Site
Paris, France
1220.7.3302 Boehringer Ingelheim Investigational Site
Paris, France
1220.7.3316 Boehringer Ingelheim Investigational Site
Pessac Cedex, France
1220.7.3317 Boehringer Ingelheim Investigational Site
Reims, France
1220.7.3315 Boehringer Ingelheim Investigational Site
Rennes Cedex 09, France
1220.7.3318 Boehringer Ingelheim Investigational Site
Strasbourg, France
1220.7.3308 Boehringer Ingelheim Investigational Site
Vandoeuvre Cedex, France
Germany
1220.7.4902 Boehringer Ingelheim Investigational Site
Berlin, Germany
1220.7.4904 Boehringer Ingelheim Investigational Site
Berlin, Germany
1220.7.4913 Boehringer Ingelheim Investigational Site
Dortmund, Germany
1220.7.4906 Boehringer Ingelheim Investigational Site
Düsseldorf, Germany
1220.7.4901 Boehringer Ingelheim Investigational Site
Frankfurt am Main, Germany
1220.7.4908 Boehringer Ingelheim Investigational Site
Hamburg, Germany
1220.7.4918 Boehringer Ingelheim Investigational Site
Hannover, Germany
1220.7.4907 Boehringer Ingelheim Investigational Site
Herne, Germany
1220.7.4903 Boehringer Ingelheim Investigational Site
Leipzig, Germany
1220.7.4911 Boehringer Ingelheim Investigational Site
Mainz, Germany
1220.7.4905 Boehringer Ingelheim Investigational Site
München, Germany
Japan
1220.7.8106 Boehringer Ingelheim Investigational Site
Chiba, Chiba, Japan
1220.7.8111 Boehringer Ingelheim Investigational Site
Gifu, Gifu, Japan
1220.7.8107 Boehringer Ingelheim Investigational Site
Itabashi-ku, Tokyo, Japan
1220.7.8112 Boehringer Ingelheim Investigational Site
Izunokuni, Shizuoka, Japan
1220.7.8108 Boehringer Ingelheim Investigational Site
Kamakura, Kanagawa, Japan
1220.7.8117 Boehringer Ingelheim Investigational Site
Kita-gun, Kagawa, Japan
1220.7.8109 Boehringer Ingelheim Investigational Site
Kofu, Yamanashi, Japan
1220.7.8116 Boehringer Ingelheim Investigational Site
Kurashiki, Okayama, Japan
1220.7.8118 Boehringer Ingelheim Investigational Site
Kurume, Fukuoka, Japan
1220.7.8110 Boehringer Ingelheim Investigational Site
Matsumoto, Nagano, Japan
1220.7.8124 Boehringer Ingelheim Investigational Site
Matsuyama, Ehime, Japan
1220.7.8113 Boehringer Ingelheim Investigational Site
Nagoya, Aichi, Japan
1220.7.8105 Boehringer Ingelheim Investigational Site
Namegata, Ibaraki, Japan
1220.7.8114 Boehringer Ingelheim Investigational Site
Nishinomiya, Hyogo, Japan
1220.7.8125 Boehringer Ingelheim Investigational Site
Ogaki, Gifu, Japan
1220.7.8119 Boehringer Ingelheim Investigational Site
Omura, Nagasaki, Japan
1220.7.8122 Boehringer Ingelheim Investigational Site
Omuta, Fukuoka, Japan
1220.7.8121 Boehringer Ingelheim Investigational Site
Osaka, Osaka, Japan
1220.7.8101 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan
1220.7.8102 Boehringer Ingelheim Investigational Site
Sendai, Miyagi, Japan
1220.7.8115 Boehringer Ingelheim Investigational Site
Tanabe, Wakayama, Japan
1220.7.8123 Boehringer Ingelheim Investigational Site
Toyama,Toyama, Japan
1220.7.8126 Boehringer Ingelheim Investigational Site
Tsu, Mie, Japan
1220.7.8104 Boehringer Ingelheim Investigational Site
Tsuchiura, Ibaraki, Japan
Portugal
1220.7.3503 Boehringer Ingelheim Investigational Site
Aveiro, Portugal
1220.7.3509 Boehringer Ingelheim Investigational Site
Barreiro, Portugal
1220.7.3506 Boehringer Ingelheim Investigational Site
Coimbra, Portugal
1220.7.3505 Boehringer Ingelheim Investigational Site
Lisboa, Portugal
1220.7.3501 Boehringer Ingelheim Investigational Site
Lisboa, Portugal
1220.7.3502 Boehringer Ingelheim Investigational Site
Porto, Portugal
Puerto Rico
1220.7.0034 Boehringer Ingelheim Investigational Site
San Juan, Puerto Rico
Spain
1220.7.3406 Boehringer Ingelheim Investigational Site
A Coruña, Spain
1220.7.3404 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1220.7.3412 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1220.7.3402 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1220.7.3411 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1220.7.3409 Boehringer Ingelheim Investigational Site
Madrid, Spain
1220.7.3405 Boehringer Ingelheim Investigational Site
Madrid, Spain
1220.7.3410 Boehringer Ingelheim Investigational Site
Majadahonda-Madrid, Spain
1220.7.3408 Boehringer Ingelheim Investigational Site
Santander, Spain
1220.7.3403 Boehringer Ingelheim Investigational Site
Sevilla, Spain
1220.7.3401 Boehringer Ingelheim Investigational Site
Valencia, Spain
1220.7.3407 Boehringer Ingelheim Investigational Site
Vigo (Pontevedra), Spain
Switzerland
1220.7.4106 Boehringer Ingelheim Investigational Site
Bern, Switzerland
1220.7.4103 Boehringer Ingelheim Investigational Site
La Chaux-de-Fonds, Switzerland
1220.7.4107 Boehringer Ingelheim Investigational Site
Lugano, Switzerland
1220.7.4108 Boehringer Ingelheim Investigational Site
St. Gallen, Switzerland
1220.7.4101 Boehringer Ingelheim Investigational Site
Zürich, Switzerland
United Kingdom
1220.7.4405 Boehringer Ingelheim Investigational Site
Bristol, United Kingdom
1220.7.4409 Boehringer Ingelheim Investigational Site
London, United Kingdom
1220.7.4404 Boehringer Ingelheim Investigational Site
London, United Kingdom
1220.7.4410 Boehringer Ingelheim Investigational Site
London, United Kingdom
1220.7.4401 Boehringer Ingelheim Investigational Site
Manchester, United Kingdom
1220.7.4408 Boehringer Ingelheim Investigational Site
Nottingham, United Kingdom
1220.7.4407 Boehringer Ingelheim Investigational Site
Oxford, United Kingdom
1220.7.4403 Boehringer Ingelheim Investigational Site
Southampton, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01358864     History of Changes
Other Study ID Numbers: 1220.7, 2010-021715-17
Study First Received: May 23, 2011
Last Updated: May 19, 2014
Health Authority: Austria: Medicines and Medical Devices Agency
Belgium: Federal Agency for Medicinal and Health Products
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Japan: Ministry of Health, Labor and Welfare
Portugal: National Pharmacy and Medicines Institute
Spain: Spanish Agency of Medicines
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Interferons
Ribavirin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014