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)

Boehringer Ingelheim logo

Boehringer Ingelheim

Status and phase

Completed
Phase 3

Conditions

Hepatitis C, Chronic

Treatments

Drug: Placebo
Drug: BI 201335
Drug: Pegylated Interferon-alpha (IFN)
Drug: Ribavirin (RBV)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01358864
2010-021715-17 (EudraCT Number)
1220.7

Details and patient eligibility

About

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.

Enrollment

678 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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,

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

678 participants in 3 patient groups

Placebo/PegIFN/RBV
Active Comparator group
Description:
patient to receive two capsules identical to those containing BI201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks
Treatment:
Drug: Ribavirin (RBV)
Drug: Pegylated Interferon-alpha (IFN)
Drug: Placebo
BI201335 12 weeks
Experimental group
Description:
patient to receive two capsules containing BI 201335 once a day for 12 weeks and PegIFN/RBV for 48 weeks
Treatment:
Drug: Ribavirin (RBV)
Drug: Pegylated Interferon-alpha (IFN)
Drug: BI 201335
BI201335 24 weeks
Experimental group
Description:
patient to receive two capsules containing BI 201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks
Treatment:
Drug: Ribavirin (RBV)
Drug: Pegylated Interferon-alpha (IFN)
Drug: BI 201335

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems