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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:
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

May 23, 2011
May 19, 2014
June 2011
May 2014   (final data collection date for primary outcome measure)
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 ]
Sustained Virological Response (SVR): Plasma HCV RNA level <25 IU/mL, undetected 24 weeks after the originally planned treatment duration. [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01358864 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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, [ 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, [ Designated as safety issue: No ]
  • Alanine transaminase (ALT) normalisation: ALT in normal range 24 weeks after end of the originally planned treatment duration. [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Hepatitis C, Chronic
  • Drug: BI 201335
    BI 201335 once a day (QD) for 24 weeks
  • Drug: BI 201335
    BI 201335 once a day (QD) for 12 weeks
  • Drug: placebo/PegIFN/RBV
    PegIFN/RBV for 48 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
    Intervention: Drug: placebo/PegIFN/RBV
  • Experimental: BI201335 12 weeks
    patient to receive two capsules containing BI 201335 once a day for 12 weeks and PegIFN/RBV for 48 weeks
    Intervention: Drug: BI 201335
  • Experimental: BI201335 24 weeks
    patient to receive two capsules containing BI 201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks
    Intervention: Drug: BI 201335
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
May 2014   (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,
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Belgium,   Canada,   France,   Germany,   Japan,   Portugal,   Puerto Rico,   Spain,   Switzerland,   United Kingdom
 
NCT01358864
1220.7, 2010-021715-17
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
May 2014

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