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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)

Primary Purpose

Hepatitis C

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BI 201335
BI 201335
Pegylated Interferon-alpha (IFN)
Ribavirin (RBV)
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 1220.40.002 Boehringer Ingelheim Investigational Site
  • 1220.40.007 Boehringer Ingelheim Investigational Site
  • 1220.40.006 Boehringer Ingelheim Investigational Site
  • 1220.40.004 Boehringer Ingelheim Investigational Site
  • 1220.40.003 Boehringer Ingelheim Investigational Site
  • 1220.40.005 Boehringer Ingelheim Investigational Site
  • 1220.40.4303 Boehringer Ingelheim Investigational Site
  • 1220.40.4301 Boehringer Ingelheim Investigational Site
  • 1220.40.1004 Boehringer Ingelheim Investigational Site
  • 1220.40.1001 Boehringer Ingelheim Investigational Site
  • 1220.40.1002 Boehringer Ingelheim Investigational Site
  • 1220.40.1003 Boehringer Ingelheim Investigational Site
  • 1220.40.1005 Boehringer Ingelheim Investigational Site
  • 1220.40.3303A Boehringer Ingelheim Investigational Site
  • 1220.40.3305A Boehringer Ingelheim Investigational Site
  • 1220.40.3301A Boehringer Ingelheim Investigational Site
  • 1220.40.3306A Boehringer Ingelheim Investigational Site
  • 1220.40.3302A Boehringer Ingelheim Investigational Site
  • 1220.40.3304A Boehringer Ingelheim Investigational Site
  • 1220.40.4902 Boehringer Ingelheim Investigational Site
  • 1220.40.4909 Boehringer Ingelheim Investigational Site
  • 1220.40.4906 Boehringer Ingelheim Investigational Site
  • 1220.40.4908 Boehringer Ingelheim Investigational Site
  • 1220.40.4904 Boehringer Ingelheim Investigational Site
  • 1220.40.4905 Boehringer Ingelheim Investigational Site
  • 1220.40.4001 Boehringer Ingelheim Investigational Site
  • 1220.40.4002 Boehringer Ingelheim Investigational Site
  • 1220.40.4003 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

short arm

long arm

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Virological Response at Week 28 (W28VR)
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

Rapid Virological Response at Week 4 (RVR)
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)
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)
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)
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
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
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 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
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
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)
Change from baseline (CFB) in Red blood cells.
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)
Change from baseline (CFB) in haematocrit and Eosinophils.
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)
Change from baseline (CFB) in Platelets and white blood cells.
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)
Change from baseline (CFB) in Sodium, Bicarbonate, Cholesterol total, Triglyceride, and Glucose.
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)
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)
Change from baseline (CFB) in PT-INR (ratio).

Full Information

First Posted
September 24, 2009
Last Updated
August 7, 2015
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00984620
Brief Title
Short Term Treatment With BI 201335, Peginterferon-alpha 2a and Ribavirin in Hepatitis c Virus Genotype-1 Treatment-naïve Patients (SILEN-C3)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
short arm
Arm Type
Experimental
Arm Description
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)
Arm Title
long arm
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
BI 201335
Intervention Description
BI 201335
Intervention Type
Drug
Intervention Name(s)
BI 201335
Intervention Description
BI 201335
Intervention Type
Drug
Intervention Name(s)
Pegylated Interferon-alpha (IFN)
Intervention Description
Pegylated Interferon-alpha
Intervention Type
Drug
Intervention Name(s)
Ribavirin (RBV)
Intervention Description
Ribavirin (RBV)
Primary Outcome Measure Information:
Title
Virological Response at Week 28 (W28VR)
Description
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.
Time Frame
28 weeks
Secondary Outcome Measure Information:
Title
Rapid Virological Response at Week 4 (RVR)
Description
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.
Time Frame
4 weeks
Title
Virological Response at Week 24 (W24VR)
Description
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.
Time Frame
24 weeks
Title
Virological Response at Week 36 (W36VR)
Description
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.
Time Frame
36 weeks
Title
End of Treatment Response (ETR)
Description
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.
Time Frame
up to 48 weeks
Title
Sustained Virological Response (SVR24) at 24 Weeks After Completion of All Therapy
Description
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.
Time Frame
72 weeks
Title
Viral Load (HCV RNA) at All Visits During Treatment and Follow-up
Description
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 Frame
From baseline to 72 weeks
Title
Time to Reach a Plasma HCV RNA Level BLD While on Treatment
Description
Time to reach a plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) level below the lower limit of detection (BLD) while on treatment
Time Frame
48 weeks
Title
Laboratory Test Abnormalities and Study Medication Tolerabilities
Description
Participants with possible clinically significant laboratory test abnormalities observed in functional groups: Haematology, Coagulation, Electrolytes, Enzymes, Substrates and Differentials, automatic.
Time Frame
48 weeks
Title
Number of Participants With Clinically Relevant Abnormalities Vital Signs, and Physical Examination
Description
No number of participants with clinically relevant abnormalities in vital signs and physical examination.
Time Frame
48 weeks
Title
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)
Description
Change from baseline (CFB) in Red blood cells.
Time Frame
baseline and 48 weeks
Title
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)
Description
Change from baseline (CFB) in haematocrit and Eosinophils.
Time Frame
baseline and 48 weeks
Title
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)
Description
Change from baseline (CFB) in Platelets and white blood cells.
Time Frame
baseline and 48 weeks
Title
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)
Description
Change from baseline (CFB) in Sodium, Bicarbonate, Cholesterol total, Triglyceride, and Glucose.
Time Frame
baseline and 48 weeks
Title
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)
Description
Change from baseline (CFB) in AST/GOT, ALT/GPT, Alka. phosphatase, GGT, Creatine kinase, Lipase, and Amylase.
Time Frame
baseline and 48 weeks
Title
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)
Description
Change from baseline (CFB) in PT-INR (ratio).
Time Frame
baseline and 48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Chronic hepatitis C infection of genotype 1 Therapy-naïve to interferon, pegylated interferon, and ribavirin HCV viral load > 100.000 IU/ml at screening Liver biopsy or fibroscan within two years prior to screening that provides evidence of any degree of fibrosis or cirrhosis Normal retinal finding on fundoscopy within 6 months prior to Day 1 Age 18 to 70 years Exclusion criteria: HCV of mixed genotype (1/2, 1/3, and 1/4) . Patients who have been previously treated with at least one dose of any protease inhibitor Evidence of liver disease due to causes other than chronic HCV infection Positive for HIV-1 or HIV-2 antibodies Hepatitis B virus (HBV) infection Decompensated liver disease, or history of decompensated liver disease Active malignancy or history of malignancy within the last 5 years History of alcohol or drug abuse (except cannabis) within the past 12 months. Body Mass Index < 18 or > 35 kg/m2. Usage of any investigational drugs within 30 days prior to enrolment Alpha fetoprotein value >100ng/mL at screening; Total bilirubin > 1.5 x ULN with ratio of direct/indirect > 1. ALT or AST level > 10 x ULN
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1220.40.002 Boehringer Ingelheim Investigational Site
City
Tulepo
State/Province
Mississippi
Country
United States
Facility Name
1220.40.007 Boehringer Ingelheim Investigational Site
City
New York
State/Province
New York
Country
United States
Facility Name
1220.40.006 Boehringer Ingelheim Investigational Site
City
Germantown
State/Province
Tennessee
Country
United States
Facility Name
1220.40.004 Boehringer Ingelheim Investigational Site
City
Jackson
State/Province
Tennessee
Country
United States
Facility Name
1220.40.003 Boehringer Ingelheim Investigational Site
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
1220.40.005 Boehringer Ingelheim Investigational Site
City
Austin
State/Province
Texas
Country
United States
Facility Name
1220.40.4303 Boehringer Ingelheim Investigational Site
City
Linz
Country
Austria
Facility Name
1220.40.4301 Boehringer Ingelheim Investigational Site
City
Wien
Country
Austria
Facility Name
1220.40.1004 Boehringer Ingelheim Investigational Site
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
1220.40.1001 Boehringer Ingelheim Investigational Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
1220.40.1002 Boehringer Ingelheim Investigational Site
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
1220.40.1003 Boehringer Ingelheim Investigational Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
1220.40.1005 Boehringer Ingelheim Investigational Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
1220.40.3303A Boehringer Ingelheim Investigational Site
City
Clichy
Country
France
Facility Name
1220.40.3305A Boehringer Ingelheim Investigational Site
City
Lille
Country
France
Facility Name
1220.40.3301A Boehringer Ingelheim Investigational Site
City
Marseille
Country
France
Facility Name
1220.40.3306A Boehringer Ingelheim Investigational Site
City
Montpellier
Country
France
Facility Name
1220.40.3302A Boehringer Ingelheim Investigational Site
City
Paris
Country
France
Facility Name
1220.40.3304A Boehringer Ingelheim Investigational Site
City
Rennes Cedex 09
Country
France
Facility Name
1220.40.4902 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1220.40.4909 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1220.40.4906 Boehringer Ingelheim Investigational Site
City
Düsseldorf
Country
Germany
Facility Name
1220.40.4908 Boehringer Ingelheim Investigational Site
City
Düsseldorf
Country
Germany
Facility Name
1220.40.4904 Boehringer Ingelheim Investigational Site
City
Hamburg
Country
Germany
Facility Name
1220.40.4905 Boehringer Ingelheim Investigational Site
City
Mainz
Country
Germany
Facility Name
1220.40.4001 Boehringer Ingelheim Investigational Site
City
Bucharest
Country
Romania
Facility Name
1220.40.4002 Boehringer Ingelheim Investigational Site
City
Bucharest
Country
Romania
Facility Name
1220.40.4003 Boehringer Ingelheim Investigational Site
City
Bucharest
Country
Romania

12. IPD Sharing Statement

Citations:
PubMed Identifier
24709256
Citation
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.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/
Description
Related Info

Learn more about this trial

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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