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: September 22, 2015
Last verified: September 2015
  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: Pegylated Interferon-alpha (IFN)
Drug: Ribavirin (RBV)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
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 12 Weeks Post Treatment (SVR12) [ Time Frame: 12 weeks post treatment, up to 60 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Virological Response After 24 Weeks of Treatment Discontinuation (SVR24) [ Time Frame: 24 weeks post treatment, up to 72 weeks ] [ Designated as safety issue: No ]
    Percentage of participants with virological response after 24 weeks of treatment discontinuation (SVR24) defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.

  • Early Treatment Success (ETS) [ Time Frame: Week 4 and Week 8 ] [ Designated as safety issue: No ]
    Percentage of participants with early Treatment Success (ETS) defined as a plasma HCV RNA level <25 IU/mL (undetected or detected) at Week 4 and <25 IU/mL (undetected) at Week 8.

  • ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO [ Time Frame: End of treatment, up to 48 weeks ] [ Designated as safety issue: No ]
    The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment (EoT) when patients do not have sustained virological response 12 weeks post treatment. BL=baseline

  • ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES [ Time Frame: End of treatment, up to 48 weeks ] [ Designated as safety issue: No ]
    The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline

  • AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO [ Time Frame: End of treatment, up to 48 weeks ] [ Designated as safety issue: No ]
    The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline

  • AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES [ Time Frame: End of treatment, up to 48 weeks ] [ Designated as safety issue: No ]
    The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment (EoT) when patients have sustained virological response 12 weeks post treatment. BL=baseline

  • ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO [ Time Frame: 12 weeks post treatment, up to 60 weeks ] [ Designated as safety issue: No ]
    The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline

  • ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES [ Time Frame: 12 weeks post treatment, up to 60 weeks ] [ Designated as safety issue: No ]
    The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline

  • AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO [ Time Frame: 12 weeks post treatment, up to 60 weeks ] [ Designated as safety issue: No ]
    The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline

  • AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES [ Time Frame: 12 weeks post treatment, up to 60 weeks ] [ Designated as safety issue: No ]
    The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline


Enrollment: 678
Study Start Date: June 2011
Study Completion Date: May 2014
Primary Completion Date: February 2013 (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: Pegylated Interferon-alpha (IFN)
Pegylated Interferon-alpha for 48 weeks
Drug: Ribavirin (RBV)
Ribavirin (RBV) for 24 or 48 weeks
Drug: Placebo
Placebo to BI201335 for 24 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 24 weeks
Drug: Pegylated Interferon-alpha (IFN)
Pegylated Interferon-alpha for 48 weeks
Drug: Ribavirin (RBV)
Ribavirin (RBV) for 24 or 48 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
Drug: Pegylated Interferon-alpha (IFN)
Pegylated Interferon-alpha for 48 weeks
Drug: Ribavirin (RBV)
Ribavirin (RBV) for 24 or 48 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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

  Show 116 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
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
Results First Received: July 3, 2015
Last Updated: September 22, 2015
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
Interferon-alpha
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 25, 2016