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Trial record 6 of 28 for:    RNA | BI 201335 OR faldaprevir

Short Term Treatment With BI 201335, Peginterferon-alpha 2a and Ribavirin in Hepatitis c Virus Genotype-1 Treatment-naïve Patients (SILEN-C3)

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ClinicalTrials.gov Identifier: NCT00984620
Recruitment Status : Completed
First Posted : September 25, 2009
Results First Posted : September 7, 2015
Last Update Posted : September 7, 2015
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE September 24, 2009
First Posted Date  ICMJE September 25, 2009
Results First Submitted Date  ICMJE July 3, 2015
Results First Posted Date  ICMJE September 7, 2015
Last Update Posted Date September 7, 2015
Study Start Date  ICMJE September 2009
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2015)
Virological Response at Week 28 (W28VR) [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 24, 2009)
Virological response at week 28 (W28VR): [ Time Frame: 28 weeks ]
Change History Complete list of historical versions of study NCT00984620 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2015)
  • Rapid Virological Response at Week 4 (RVR) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: baseline and 48 weeks ]
    Change from baseline (CFB) in Red blood cells.
  • Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2) [ Time Frame: baseline and 48 weeks ]
    Change from baseline (CFB) in haematocrit and Eosinophils.
  • Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: baseline and 48 weeks ]
    Change from baseline (CFB) in PT-INR (ratio).
Original Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2009)
RVR, EVR, SVR [ Time Frame: 72 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Short Term Treatment With BI 201335, Peginterferon-alpha 2a and Ribavirin in Hepatitis c Virus Genotype-1 Treatment-naïve Patients (SILEN-C3)
Official Title  ICMJE 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)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C
Intervention  ICMJE
  • Drug: BI 201335
    BI 201335
  • Drug: Pegylated Interferon-alpha (IFN)
    Pegylated Interferon-alpha
  • Drug: Ribavirin (RBV)
    Ribavirin (RBV)
Study Arms  ICMJE
  • Experimental: 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)
    Interventions:
    • Drug: BI 201335
    • Drug: Pegylated Interferon-alpha (IFN)
    • Drug: Ribavirin (RBV)
  • Experimental: 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)
    Interventions:
    • Drug: BI 201335
    • Drug: Pegylated Interferon-alpha (IFN)
    • Drug: Ribavirin (RBV)
Publications * 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, Böcher WO, Steinmann G. SILEN-C3, a phase 2 randomized trial with faldaprevir plus pegylated interferon α-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 27, 2011)
160
Original Estimated Enrollment  ICMJE
 (submitted: September 24, 2009)
140
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Canada,   France,   Germany,   Romania,   United States
Removed Location Countries Taiwan
 
Administrative Information
NCT Number  ICMJE NCT00984620
Other Study ID Numbers  ICMJE 1220.40
2009-012579-90 ( EudraCT Number: EudraCT )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP