Short Term Treatment With BI 201335, Peginterferon-alpha 2a and Ribavirin in Hepatitis c Virus Genotype-1 Treatment-naïve Patients (SILEN-C3)
- Conditions
- Hepatitis C
- Interventions
- Registration Number
- NCT00984620
- Lead Sponsor
- Boehringer Ingelheim
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description short arm Pegylated Interferon-alpha (IFN) 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) long arm Pegylated Interferon-alpha (IFN) 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) long arm Ribavirin (RBV) 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) short arm BI 201335 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) short arm Ribavirin (RBV) 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) long arm BI 201335 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)
- Primary Outcome Measures
Name Time Method Virological Response at Week 28 (W28VR) 28 weeks Virological response at Week 28: The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at Week 28.
- Secondary Outcome Measures
Name Time Method Rapid Virological Response at Week 4 (RVR) 4 weeks Rapid virological response at week 4 (RVR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 4.
Virological Response at Week 24 (W24VR) 24 weeks virological response at week 24 (W24VR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 24.
Virological Response at Week 36 (W36VR) 36 weeks Virological response at week 36 (W36VR): the patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 36.
End of Treatment Response (ETR) up to 48 weeks End of Treatment Response (ETR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at end of all therapy.
Sustained Virological Response (SVR24) at 24 Weeks After Completion of All Therapy 72 weeks Sustained Virological Response (SVR24) at 24 weeks: The patients who reached plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at 24 weeks after completion of all Hepatitis C virus (HCV) therapy.
Viral Load (HCV RNA) at All Visits During Treatment and Follow-up From baseline to 72 weeks Viral load of Hepatitis C virus Ribonucleic acid (HCV RNA) at all visits during treatment (TRT) and follow-up, ie. change from baseline viral load at all visits.
Time to Reach a Plasma HCV RNA Level BLD While on Treatment 48 weeks Time to reach a plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) level below the lower limit of detection (BLD) while on treatment
Laboratory Test Abnormalities and Study Medication Tolerabilities 48 weeks Participants with possible clinically significant laboratory test abnormalities observed in functional groups: Haematology, Coagulation, Electrolytes, Enzymes, Substrates and Differentials, automatic.
Number of Participants With Clinically Relevant Abnormalities Vital Signs, and Physical Examination 48 weeks No number of participants with clinically relevant abnormalities in vital signs and physical examination.
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1) baseline and 48 weeks Change from baseline (CFB) in Red blood cells.
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2) baseline and 48 weeks Change from baseline (CFB) in haematocrit and Eosinophils.
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3) baseline and 48 weeks Change from baseline (CFB) in Platelets and white blood cells.
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) baseline and 48 weeks Change from baseline (CFB) in Sodium, Bicarbonate, Cholesterol total, Triglyceride, and Glucose.
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) baseline and 48 weeks Change from baseline (CFB) in AST/GOT, ALT/GPT, Alka. phosphatase, GGT, Creatine kinase, Lipase, and Amylase.
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6) baseline and 48 weeks Change from baseline (CFB) in PT-INR (ratio).
Trial Locations
- Locations (28)
1220.40.006 Boehringer Ingelheim Investigational Site
🇺🇸Germantown, Tennessee, United States
1220.40.4301 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
1220.40.003 Boehringer Ingelheim Investigational Site
🇺🇸Nashville, Tennessee, United States
1220.40.4001 Boehringer Ingelheim Investigational Site
🇷🇴Bucharest, Romania
1220.40.002 Boehringer Ingelheim Investigational Site
🇺🇸Tulepo, Mississippi, United States
1220.40.007 Boehringer Ingelheim Investigational Site
🇺🇸New York, New York, United States
1220.40.005 Boehringer Ingelheim Investigational Site
🇺🇸Austin, Texas, United States
1220.40.4303 Boehringer Ingelheim Investigational Site
🇦🇹Linz, Austria
1220.40.1004 Boehringer Ingelheim Investigational Site
🇨🇦Calgary, Alberta, Canada
1220.40.1003 Boehringer Ingelheim Investigational Site
🇨🇦Montreal, Quebec, Canada
1220.40.1001 Boehringer Ingelheim Investigational Site
🇨🇦Vancouver, British Columbia, Canada
1220.40.3303A Boehringer Ingelheim Investigational Site
🇫🇷Clichy, France
1220.40.1005 Boehringer Ingelheim Investigational Site
🇨🇦Montreal, Quebec, Canada
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
1220.40.3304A Boehringer Ingelheim Investigational Site
🇫🇷Rennes Cedex 09, France
1220.40.4902 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
1220.40.4908 Boehringer Ingelheim Investigational Site
🇩🇪Düsseldorf, Germany
1220.40.4909 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
1220.40.4906 Boehringer Ingelheim Investigational Site
🇩🇪Düsseldorf, Germany
1220.40.4904 Boehringer Ingelheim Investigational Site
🇩🇪Hamburg, Germany
1220.40.4905 Boehringer Ingelheim Investigational Site
🇩🇪Mainz, Germany
1220.40.4002 Boehringer Ingelheim Investigational Site
🇷🇴Bucharest, Romania
1220.40.4003 Boehringer Ingelheim Investigational Site
🇷🇴Bucharest, Romania
1220.40.3302A Boehringer Ingelheim Investigational Site
🇫🇷Paris, France
1220.40.004 Boehringer Ingelheim Investigational Site
🇺🇸Jackson, Tennessee, United States
1220.40.1002 Boehringer Ingelheim Investigational Site
🇨🇦Ottawa, Ontario, Canada