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Completed

NCT Number: NCT00984620

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

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

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

1220.40.4303 Boehringer Ingelheim Investigational Site, Linz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BI 201335

Drug

BI 201335

Pegylated Interferon-alpha (IFN)

Drug

Pegylated Interferon-alpha

ribavirin (RBV)

Drug

Ribavirin (RBV)

Primary outcomes

  1. Virological Response at Week 28 (W28VR)

    Time frame: 28 weeks

    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 outcomes

  1. Rapid Virological Response at Week 4 (RVR)

    Time frame: 4 weeks

    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.

  2. Virological Response at Week 24 (W24VR)

    Time frame: 24 weeks

    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.

  3. Virological Response at Week 36 (W36VR)

    Time frame: 36 weeks

    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.

  4. End of Treatment Response (ETR)

    Time frame: up to 48 weeks

    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.

  5. Sustained Virological Response (SVR24) at 24 Weeks After Completion of All Therapy

    Time frame: 72 weeks

    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.

  6. Viral Load (HCV RNA) at All Visits During Treatment and Follow-up

    Time frame: From baseline to 72 weeks

    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.

  7. Time to Reach a Plasma HCV RNA Level BLD While on Treatment

    Time frame: 48 weeks

    Time to reach a plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) level below the lower limit of detection (BLD) while on treatment

  8. Laboratory Test Abnormalities and Study Medication Tolerabilities

    Time frame: 48 weeks

    Participants with possible clinically significant laboratory test abnormalities observed in functional groups: Haematology, Coagulation, Electrolytes, Enzymes, Substrates and Differentials, automatic.

  9. Number of Participants With Clinically Relevant Abnormalities Vital Signs, and Physical Examination

    Time frame: 48 weeks

    No number of participants with clinically relevant abnormalities in vital signs and physical examination.

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

    Time frame: baseline and 48 weeks

    Change from baseline (CFB) in Red blood cells.

  11. Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)

    Time frame: baseline and 48 weeks

    Change from baseline (CFB) in haematocrit and Eosinophils.

  12. Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)

    Time frame: baseline and 48 weeks

    Change from baseline (CFB) in Platelets and white blood cells.

  13. Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)

    Time frame: baseline and 48 weeks

    Change from baseline (CFB) in Sodium, Bicarbonate, Cholesterol total, Triglyceride, and Glucose.

  14. Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)

    Time frame: baseline and 48 weeks

    Change from baseline (CFB) in AST/GOT, ALT/GPT, Alka. phosphatase, GGT, Creatine kinase, Lipase, and Amylase.

  15. Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)

    Time frame: baseline and 48 weeks

    Change from baseline (CFB) in PT-INR (ratio).

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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)

Important dates

Study start
2009
Primary completion
2011
First posted
Sep 25, 2009
Registry last updated
Sep 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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