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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00984620
First received: September 24, 2009
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Hepatitis C
Drug: BI 201335
Drug: BI201335
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Virological response at week 28 (W28VR): [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Virological response at weeks 4, 24, 36, 48 and 72 [ Time Frame: 4-72 weeks ] [ Designated as safety issue: No ]
  • Adverse Events (AEs,)Tolerability, vital signs and physical examination and laboratory test abnormalities [ Time Frame: 4-72 weeks ] [ Designated as safety issue: No ]
  • Rapid virological response at week 4 (RVR) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • End of Treatment Response (ETR) [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
  • Sustained Virological Response (SVR24) at 24 weeks after completion of all therapy [ Time Frame: up to 72 weeks ] [ Designated as safety issue: No ]
  • Viral load (HCV RNA) at all visits during treatment and follow-up [ Time Frame: up to 60 week ] [ Designated as safety issue: No ]
  • Time to reach a plasma HCV RNA level below the lower limit of detection [ Time Frame: week 24 ] [ Designated as safety issue: No ]

Enrollment: 160
Study Start Date: September 2009
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Drug: BI201335
12 wks with PegIFN/RBV followed by 12 weeks PegIFN/RBV with a 3 days lead-in phase of PegIFN/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)
Drug: BI 201335
12 wks with PegIFN/RBV followed by 12 weeks PegIFN/RBV with a 3 days lead-in phase of PegIFN/RBV

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00984620

  Show 28 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00984620     History of Changes
Other Study ID Numbers: 1220.40, 2009-012579-90
Study First Received: September 24, 2009
Last Updated: March 27, 2014
Health Authority: Austria: Federal Office for Safety in Health Care
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Romania: National Medicines Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014