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

Boehringer Ingelheim160 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

160

Conditions

Hepatitis C

Interventions

BI 201335DRUG

BI 201335

BI 201335DRUG

BI 201335

Pegylated Interferon-alpha (IFN)DRUG

Pegylated Interferon-alpha

Ribavirin (RBV)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (28)

Outcomes

Primary Outcomes

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.

Time frame: 28 weeks

Secondary Outcomes

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.

Time frame: 4 weeks

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.

Time frame: 24 weeks

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.

Time frame: 36 weeks

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.

Time frame: up to 48 weeks

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.

Data from ClinicalTrials.gov

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1220.40.002 Boehringer Ingelheim Investigational Site

Tulepo, Mississippi, United States

1220.40.007 Boehringer Ingelheim Investigational Site

New York, New York, 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

1220.40.005 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

1220.40.4303 Boehringer Ingelheim Investigational Site

Linz, Austria

1220.40.4301 Boehringer Ingelheim Investigational Site

Vienna, Austria

1220.40.1004 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

1220.40.1001 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

...and 18 more locations

Time frame: 72 weeks

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 frame: From baseline to 72 weeks

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

Time frame: 48 weeks

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.

Time frame: 48 weeks

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.

Time frame: 48 weeks

Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)

Change from baseline (CFB) in Red blood cells.