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)

Completed · Phase 3 · Has a placebo group

Conditions studied: Hepatitis C, Chronic

In brief

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.

Key facts

Study ID

NCT01358864

Run by

Boehringer Ingelheim

People needed

678

Starts

2011-06-01

Expected to finish

2014-05-01

Last updated by the study team

2016-08-29

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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,

You may not qualify if…

• 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,

Where it is running

• 1220.7.0082 Boehringer Ingelheim Investigational Site — Englewood, Colorado, United States
• 1220.7.0095 Boehringer Ingelheim Investigational Site — Palm Harbor, Florida, United States
• 1220.7.0039 Boehringer Ingelheim Investigational Site — Columbus, Georgia, United States
• 1220.7.0013 Boehringer Ingelheim Investigational Site — Chicago, Illinois, United States
• 1220.7.0062 Boehringer Ingelheim Investigational Site — Vaiparaiso, Indiana, United States
• 1220.7.0085 Boehringer Ingelheim Investigational Site — Baton Rouge, Louisiana, United States
• 1220.7.0087 Boehringer Ingelheim Investigational Site — Baton Rouge, Louisiana, United States
• 1220.7.0101 Boehringer Ingelheim Investigational Site — New Orleans, Louisiana, United States
• 1220.7.0027 Boehringer Ingelheim Investigational Site — Framingham, Massachusetts, United States
• 1220.7.0012 Boehringer Ingelheim Investigational Site — New York, New York, United States
• 1220.7.0077 Boehringer Ingelheim Investigational Site — Winston-Salem, North Carolina, United States
• 1220.7.0058 Boehringer Ingelheim Investigational Site — Portland, Oregon, United States
• 1220.7.0063 Boehringer Ingelheim Investigational Site — Arlington, Texas, United States
• 1220.7.0029 Boehringer Ingelheim Investigational Site — Austin, Texas, United States
• 1220.7.0071 Boehringer Ingelheim Investigational Site — Dallas, Texas, United States
• 1220.7.0009 Boehringer Ingelheim Investigational Site — Houston, Texas, United States
• 1220.7.0016 Boehringer Ingelheim Investigational Site — San Antonio, Texas, United States
• 1220.7.4303 Boehringer Ingelheim Investigational Site — Linz, Austria
• 1220.7.4301 Boehringer Ingelheim Investigational Site — Vienna, Austria
• 1220.7.4302 Boehringer Ingelheim Investigational Site — Vienna, Austria
• 1220.7.3201 Boehringer Ingelheim Investigational Site — Brussels, Belgium
• 1220.7.3207 Boehringer Ingelheim Investigational Site — Brussels, Belgium
• 1220.7.3204 Boehringer Ingelheim Investigational Site — Edegem, Belgium
• 1220.7.3205 Boehringer Ingelheim Investigational Site — Ghent, Belgium
• 1220.7.0091 Boehringer Ingelheim Investigational Site — North Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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