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Completed

NCT Number: NCT01358864

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)

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.

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1220.7.4303 Boehringer Ingelheim Investigational Site, Linz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • HCV infection of mixed genotype; Hepatitis B Virus (HBV) or Human Immunodeficiency Virus (HIV) co-infection
  • Evidence of acute or chronic liver disease due to causes other than chronic HCV infection,
  • Decompensated liver disease, or history of decompensated liver disease,
  • Body weight < 40 or > 125 kg,
  • Clinical evidence of significant or unstable cardiovascular disease, chronic pulmonary disease, history or evidence of retinopathy or clinically significant ophthalmological disorder
  • Pre-existing psychiatric condition that could interfere with the subject's participation in and completion of the study
  • Laboratory parameters disorders (thalassemia major, sickle cell anemia or G6PD deficit)
  • Hemoglobin < 12 g/dL for women and < 13 g/dL for men
  • 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,

Treatment and study plan

BI 201335

Drug

BI 201335 once a day (QD) for 24 weeks

Pegylated Interferon-alpha (IFN)

Drug

Pegylated Interferon-alpha for 48 weeks

ribavirin (RBV)

Drug

Ribavirin (RBV) for 24 or 48 weeks

Placebo

Drug

Placebo to BI201335 for 24 weeks

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
May 24, 2011
Registry last updated
Aug 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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