Overview

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)

Status:
Completed
Trial end date:
2014-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Boehringer Ingelheim
Treatments:
Interferon-alpha
Interferons
Ribavirin
Criteria
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,