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Trial record 17 of 50 for:    BI 201335 OR faldaprevir

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)

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ClinicalTrials.gov Identifier: NCT01358864
Recruitment Status : Completed
First Posted : May 24, 2011
Results First Posted : October 28, 2015
Last Update Posted : August 29, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE May 23, 2011
First Posted Date  ICMJE May 24, 2011
Results First Submitted Date  ICMJE July 3, 2015
Results First Posted Date  ICMJE October 28, 2015
Last Update Posted Date August 29, 2016
Study Start Date  ICMJE June 2011
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 23, 2011)
Sustained Virological Response (SVR): Plasma HCV RNA level <25 IU/mL, undetected 24 weeks after the originally planned treatment duration.
Change History Complete list of historical versions of study NCT01358864 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2015)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2011)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C, Chronic
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 30, 2012)
678
Original Estimated Enrollment  ICMJE
 (submitted: May 23, 2011)
625
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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,
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Canada,   France,   Germany,   Japan,   Portugal,   Puerto Rico,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries Romania
 
Administrative Information
NCT Number  ICMJE NCT01358864
Other Study ID Numbers  ICMJE 1220.7
2010-021715-17 ( EudraCT Number: EudraCT )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date July 2016

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