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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00984620
First received: September 24, 2009
Last updated: October 19, 2011
Last verified: October 2011
History of Changes
  Purpose

The objective of this trial is to investigate antiviral effect and safety of treatment with 240mg once daily of BI 201335 NA with a 3-day lead-in with pegylated interferon/ribavirin in hepatitis c virus genotype 1 infected treatment-naïve patients for 12 or 24 weeks in combination with 24 or 48 weeks of pegylated interferon-alpha 2a and ribavirin.


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:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

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) [ Time Frame: 4-72 weeks ] [ Designated as safety issue: Yes ]

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

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

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00984620     History of Changes
Other Study ID Numbers: 1220.40, 2009-012579-90
Study First Received: September 24, 2009
Last Updated: October 19, 2011
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
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
 Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013