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

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

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,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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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