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

Hepatitis C Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00984620
• Other study ID #: 1220.40
• Secondary ID: 2009-012579-90
• Status: Completed
• Phase: Phase 2
• First received: September 24, 2009
• Last updated: August 7, 2015
• Start date: September 2009

Study information

• Verified date: August 2015
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health CareCanada: Health CanadaFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesRomania: National Medicines AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• BI 201335
BI 201335
• BI 201335
BI 201335
• Pegylated Interferon-alpha (IFN)
Pegylated Interferon-alpha
• Ribavirin (RBV)
Ribavirin (RBV)

Locations

Country	Name	City	State
Austria	1220.40.4303 Boehringer Ingelheim Investigational Site	Linz
Austria	1220.40.4301 Boehringer Ingelheim Investigational Site	Wien
Canada	1220.40.1004 Boehringer Ingelheim Investigational Site	Calgary	Alberta
Canada	1220.40.1003 Boehringer Ingelheim Investigational Site	Montreal	Quebec
Canada	1220.40.1005 Boehringer Ingelheim Investigational Site	Montreal	Quebec
Canada	1220.40.1002 Boehringer Ingelheim Investigational Site	Ottawa	Ontario
Canada	1220.40.1001 Boehringer Ingelheim Investigational Site	Vancouver	British Columbia
France	1220.40.3303A Boehringer Ingelheim Investigational Site	Clichy
France	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	1220.40.3302A Boehringer Ingelheim Investigational Site	Paris
France	1220.40.3304A Boehringer Ingelheim Investigational Site	Rennes Cedex 09
Germany	1220.40.4902 Boehringer Ingelheim Investigational Site	Berlin
Germany	1220.40.4909 Boehringer Ingelheim Investigational Site	Berlin
Germany	1220.40.4906 Boehringer Ingelheim Investigational Site	Düsseldorf
Germany	1220.40.4908 Boehringer Ingelheim Investigational Site	Düsseldorf
Germany	1220.40.4904 Boehringer Ingelheim Investigational Site	Hamburg
Germany	1220.40.4905 Boehringer Ingelheim Investigational Site	Mainz
Romania	1220.40.4001 Boehringer Ingelheim Investigational Site	Bucharest
Romania	1220.40.4002 Boehringer Ingelheim Investigational Site	Bucharest
Romania	1220.40.4003 Boehringer Ingelheim Investigational Site	Bucharest
United States	1220.40.005 Boehringer Ingelheim Investigational Site	Austin	Texas
United States	1220.40.006 Boehringer Ingelheim Investigational Site	Germantown	Tennessee
United States	1220.40.004 Boehringer Ingelheim Investigational Site	Jackson	Tennessee
United States	1220.40.003 Boehringer Ingelheim Investigational Site	Nashville	Tennessee
United States	1220.40.007 Boehringer Ingelheim Investigational Site	New York	New York
United States	1220.40.002 Boehringer Ingelheim Investigational Site	Tulepo	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Austria,  Canada,  France,  Germany,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	28 weeks	No
Secondary	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.	4 weeks	No
Secondary	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.	24 weeks	No
Secondary	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.	36 weeks	No
Secondary	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.	up to 48 weeks	No
Secondary	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.	72 weeks	No
Secondary	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.	From baseline to 72 weeks	No
Secondary	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	48 weeks	No
Secondary	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.	48 weeks	No
Secondary	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.	48 weeks	No
Secondary	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)	Change from baseline (CFB) in Red blood cells.	baseline and 48 weeks	No
Secondary	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)	Change from baseline (CFB) in haematocrit and Eosinophils.	baseline and 48 weeks	No
Secondary	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)	Change from baseline (CFB) in Platelets and white blood cells.	baseline and 48 weeks	No
Secondary	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)	Change from baseline (CFB) in Sodium, Bicarbonate, Cholesterol total, Triglyceride, and Glucose.	baseline and 48 weeks	No
Secondary	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.	baseline and 48 weeks	No
Secondary	Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)	Change from baseline (CFB) in PT-INR (ratio).	baseline and 48 weeks	No

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