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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:
ClinicalTrials.gov Identifier:
NCT01358864
First Posted: May 24, 2011
Last Update Posted: August 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
May 23, 2011
May 24, 2011
July 3, 2015
October 28, 2015
August 29, 2016
June 2011
February 2013   (Final data collection date for primary outcome measure)
Sustained Virological Response 12 Weeks Post Treatment (SVR12) [ Time Frame: 12 weeks post treatment, up to 60 weeks ]
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.
Sustained Virological Response (SVR): Plasma HCV RNA level <25 IU/mL, undetected 24 weeks after the originally planned treatment duration.
Complete list of historical versions of study NCT01358864 on ClinicalTrials.gov Archive Site
  • Virological Response After 24 Weeks of Treatment Discontinuation (SVR24) [ Time Frame: 24 weeks post treatment, up to 72 weeks ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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
  • Virological response after 12 weeks of treatment discontinuation (SVR12): Plasma HCV RNA level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration,
  • 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,
  • Alanine transaminase (ALT) normalisation: ALT in normal range 24 weeks after end of the originally planned treatment duration.
Not Provided
Not Provided
 
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)
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Hepatitis C, Chronic
  • 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
  • Drug: Placebo
    Placebo to BI201335 for 24 weeks
  • 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
    Interventions:
    • Drug: Pegylated Interferon-alpha (IFN)
    • Drug: Ribavirin (RBV)
    • Drug: Placebo
  • Experimental: BI201335 12 weeks
    patient to receive two capsules containing BI 201335 once a day for 12 weeks and PegIFN/RBV for 48 weeks
    Interventions:
    • Drug: BI 201335
    • Drug: Pegylated Interferon-alpha (IFN)
    • Drug: Ribavirin (RBV)
  • Experimental: BI201335 24 weeks
    patient to receive two capsules containing BI 201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks
    Interventions:
    • Drug: BI 201335
    • Drug: Pegylated Interferon-alpha (IFN)
    • Drug: Ribavirin (RBV)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
678
May 2014
February 2013   (Final data collection date for primary outcome measure)

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,
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Canada,   France,   Germany,   Japan,   Portugal,   Puerto Rico,   Spain,   Switzerland,   United Kingdom,   United States
Romania
 
NCT01358864
1220.7
2010-021715-17 ( EudraCT Number: EudraCT )
Not Provided
Not Provided
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP