Clinical trial NCT00984620: Short Term Treatment With BI 201335, Peginterferon-alpha 2a and Ribavirin in Hepatitis c Virus Genotype-1 Treatment-naïve Patients (SILEN-C3)
Official title: Antiviral Effect and Safety of Once Daily BI 201335 NA in Hepatitis C Virus Genotype 1 Infected Treatment-naive Patients for 12 or 24 Weeks as Combination Therapy With Pegylated Interferon-alpha 2a and Ribavirin (Randomised, Open Label, Phase II)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2009-09-25
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the antiviral efficacy and safety of a 12-week with a 24-week treatment of BI 201335 at a dose of 120 mg once daily, with a 24-week background of pegylated interferon-alpha 2a (PegIFN) plus ribavirin (RBV), in treatment-naïve patients infected with hepatitis C virus (HCV) genotype 1


Eligibility criteria: Inclusion criteria:

1. Chronic hepatitis C infection of genotype 1
2. Therapy-naïve to interferon, pegylated interferon, and ribavirin
3. HCV viral load \> 100.000 IU/ml at screening
4. Liver biopsy or fibroscan within two years prior to screening that provides evidence of any degree of fibrosis or cirrhosis
5. Normal retinal finding on fundoscopy within 6 months prior to Day 1
6. Age 18 to 70 years

Exclusion criteria:

1. HCV of mixed genotype (1/2, 1/3, and 1/4) .
2. Patients who have been previously treated with at least one dose of any protease inhibitor
3. Evidence of liver disease due to causes other than chronic HCV infection
4. Positive for HIV-1 or HIV-2 antibodies
5. Hepatitis B virus (HBV) infection
6. Decompensated liver disease, or history of decompensated liver disease
7. Active malignancy or history of malignancy within the last 5 years
8. History of alcohol or drug abuse (except cannabis) within the past 12 months.
9. Body Mass Index \< 18 or \> 35 kg/m2.
10. Usage of any investigational drugs within 30 days prior to enrolment
11. Alpha fetoprotein value \>100ng/mL at screening;
12. Total bilirubin \> 1.5 x ULN with ratio of direct/indirect \> 1.
13. ALT or AST level \> 10 x ULN

Primary outcomes:
measure: Virological Response at Week 28 (W28VR)
timeFrame: 28 weeks
Secondary outcomes:
measure: Rapid Virological Response at Week 4 (RVR)
timeFrame: 4 weeks
measure: Virological Response at Week 24 (W24VR)
timeFrame: 24 weeks
measure: Virological Response at Week 36 (W36VR)
timeFrame: 36 weeks
measure: End of Treatment Response (ETR)
timeFrame: up to 48 weeks
measure: Sustained Virological Response (SVR24) at 24 Weeks After Completion of All Therapy
timeFrame: 72 weeks
measure: Viral Load (HCV RNA) at All Visits During Treatment and Follow-up
timeFrame: From baseline to 72 weeks
measure: Time to Reach a Plasma HCV RNA Level BLD While on Treatment
timeFrame: 48 weeks
measure: Laboratory Test Abnormalities and Study Medication Tolerabilities
timeFrame: 48 weeks
measure: Number of Participants With Clinically Relevant Abnormalities Vital Signs, and Physical Examination
timeFrame: 48 weeks
measure: Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)
timeFrame: baseline and 48 weeks
measure: Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)
timeFrame: baseline and 48 weeks
measure: Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)
timeFrame: baseline and 48 weeks
measure: Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)
timeFrame: baseline and 48 weeks
measure: Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)
timeFrame: baseline and 48 weeks
measure: Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)
timeFrame: baseline and 48 weeks
Other outcomes:
Locations:
city: Tulepo
country: United States
facility: 1220.40.002 Boehringer Ingelheim Investigational Site
state: Mississippi
city: New York
country: United States
facility: 1220.40.007 Boehringer Ingelheim Investigational Site
state: New York
city: Germantown
country: United States
facility: 1220.40.006 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Jackson
country: United States
facility: 1220.40.004 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: 1220.40.003 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Austin
country: United States
facility: 1220.40.005 Boehringer Ingelheim Investigational Site
state: Texas
city: Linz
country: Austria
facility: 1220.40.4303 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 1220.40.4301 Boehringer Ingelheim Investigational Site
city: Calgary
country: Canada
facility: 1220.40.1004 Boehringer Ingelheim Investigational Site
state: Alberta
city: Vancouver
country: Canada
facility: 1220.40.1001 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Ottawa
country: Canada
facility: 1220.40.1002 Boehringer Ingelheim Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: 1220.40.1003 Boehringer Ingelheim Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: 1220.40.1005 Boehringer Ingelheim Investigational Site
state: Quebec
city: Clichy
country: France
facility: 1220.40.3303A Boehringer Ingelheim Investigational Site
city: Lille
country: France
facility: 1220.40.3305A Boehringer Ingelheim Investigational Site
city: Marseille
country: France
facility: 1220.40.3301A Boehringer Ingelheim Investigational Site
city: Montpellier
country: France
facility: 1220.40.3306A Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: 1220.40.3302A Boehringer Ingelheim Investigational Site
city: Rennes Cedex 09
country: France
facility: 1220.40.3304A Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1220.40.4902 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1220.40.4909 Boehringer Ingelheim Investigational Site
city: Düsseldorf
country: Germany
facility: 1220.40.4906 Boehringer Ingelheim Investigational Site
city: Düsseldorf
country: Germany
facility: 1220.40.4908 Boehringer Ingelheim Investigational Site
city: Hamburg
country: Germany
facility: 1220.40.4904 Boehringer Ingelheim Investigational Site
city: Mainz
country: Germany
facility: 1220.40.4905 Boehringer Ingelheim Investigational Site
city: Bucharest
country: Romania
facility: 1220.40.4001 Boehringer Ingelheim Investigational Site
city: Bucharest
country: Romania
facility: 1220.40.4002 Boehringer Ingelheim Investigational Site
city: Bucharest
country: Romania
facility: 1220.40.4003 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Dieterich D, Asselah T, Guyader D, Berg T, Schuchmann M, Mauss S, Ratziu V, Ferenci P, Larrey D, Maieron A, Stern JO, Ozan M, Datsenko Y, Bocher WO, Steinmann G. SILEN-C3, a phase 2 randomized trial with faldaprevir plus pegylated interferon alpha-2a and ribavirin in treatment-naive hepatitis C virus genotype 1-infected patients. Antimicrob Agents Chemother. 2014 Jun;58(6):3429-36. doi: 10.1128/AAC.02497-13. Epub 2014 Apr 7.