Short Term Treatment With BI 201335, Peginterferon-alpha 2a and Ribavirin in Hepatitis c Virus Genotype-1 Treatment-naïve Patients (SILEN-C3)
NCT ID: NCT00984620
Last Updated: 2015-09-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
160 participants
INTERVENTIONAL
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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short arm
patients to receive BI201335 with PegIFN/RBV for 12 wks followed by 12 weeks PegIFN/RBV with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 NA 3 days after first administration of PegIFN/RBV)
BI 201335
BI 201335
Pegylated Interferon-alpha (IFN)
Pegylated Interferon-alpha
Ribavirin (RBV)
Ribavirin (RBV)
long arm
patients to receive BI201335 with PegIFN/RBV for 24 wks with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 NA 3 days after first administration of PegIFN/RBV)
BI 201335
BI 201335
Pegylated Interferon-alpha (IFN)
Pegylated Interferon-alpha
Ribavirin (RBV)
Ribavirin (RBV)
Interventions
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BI 201335
BI 201335
BI 201335
BI 201335
Pegylated Interferon-alpha (IFN)
Pegylated Interferon-alpha
Ribavirin (RBV)
Ribavirin (RBV)
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
70 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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1220.40.002 Boehringer Ingelheim Investigational Site
Tulepo, Mississippi, United States
1220.40.007 Boehringer Ingelheim Investigational Site
New York, New York, United States
1220.40.006 Boehringer Ingelheim Investigational Site
Germantown, Tennessee, United States
1220.40.004 Boehringer Ingelheim Investigational Site
Jackson, Tennessee, United States
1220.40.003 Boehringer Ingelheim Investigational Site
Nashville, Tennessee, United States
1220.40.005 Boehringer Ingelheim Investigational Site
Austin, Texas, United States
1220.40.4303 Boehringer Ingelheim Investigational Site
Linz, , Austria
1220.40.4301 Boehringer Ingelheim Investigational Site
Vienna, , Austria
1220.40.1004 Boehringer Ingelheim Investigational Site
Calgary, Alberta, Canada
1220.40.1001 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia, Canada
1220.40.1002 Boehringer Ingelheim Investigational Site
Ottawa, Ontario, Canada
1220.40.1003 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
1220.40.1005 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
1220.40.3303A Boehringer Ingelheim Investigational Site
Clichy, , France
1220.40.3305A Boehringer Ingelheim Investigational Site
Lille, , France
1220.40.3301A Boehringer Ingelheim Investigational Site
Marseille, , France
1220.40.3306A Boehringer Ingelheim Investigational Site
Montpellier, , France
1220.40.3302A Boehringer Ingelheim Investigational Site
Paris, , France
1220.40.3304A Boehringer Ingelheim Investigational Site
Rennes, , France
1220.40.4902 Boehringer Ingelheim Investigational Site
Berlin, , Germany
1220.40.4909 Boehringer Ingelheim Investigational Site
Berlin, , Germany
1220.40.4906 Boehringer Ingelheim Investigational Site
Düsseldorf, , Germany
1220.40.4908 Boehringer Ingelheim Investigational Site
Düsseldorf, , Germany
1220.40.4904 Boehringer Ingelheim Investigational Site
Hamburg, , Germany
1220.40.4905 Boehringer Ingelheim Investigational Site
Mainz, , Germany
1220.40.4001 Boehringer Ingelheim Investigational Site
Bucharest, , Romania
1220.40.4002 Boehringer Ingelheim Investigational Site
Bucharest, , Romania
1220.40.4003 Boehringer Ingelheim Investigational Site
Bucharest, , Romania
Countries
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References
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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.
Other Identifiers
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1220.40
Identifier Type: -
Identifier Source: org_study_id
2009-012579-90
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
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