E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10002724 |
E.1.2 | Term | Anti-HCV positive |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019183 |
E.1.2 | Term | HCV |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019752 |
E.1.2 | Term | Hepatitis C virus (HCV) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To compare the antiviral effect of 12 weeks versus 24 weeks of treatment with 120 mg of BI 201335 NA soft gelatin capsules given once daily in combination with 24 or 48 weeks of pegylated interferon-α 2a and ribavirin (PegIFN/RBV) in HCV genotype 1 infected treatment-naïve patients. |
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E.2.2 | Secondary objectives of the trial |
To compare the safety of 12 weeks versus 24 weeks of treatment with 120 mg of BI 201335 NA soft gelatin capsules given once daily in combination with 24 or 48 weeks of pegylated interferon-α 2a and ribavirin (PegIFN/RBV) in HCV genotype 1 infected treatment-naïve patients. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Chronic hepatitis C infection of genotype 1 (1a, 1b or mixed 1a/1b) confirmed by genotypic testing at screening
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
7) Female patients who are infertile or who are of childbearing potential with a negative pregnancy test and agreeing to abstain from intercourse or to use one accepted method of birth control in addition to the use of a condom or Male patients who are sterile, or who agree to abstain from intercourse or who use a condom while their female partners use one medically accepted method of birth control 8) Signed informed consent form prior to trial participation
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E.4 | Principal exclusion criteria |
1) Hepatitis C infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening.
2) Patients who have been previously treated with at least one dose of any protease inhibitor for acute or chronic hepatitis C infection
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 based on presence of HBs-Ag
6) Decompensated liver disease, or history of decompensated liver disease
7) Active or suspected 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 m2/kg.
10) Usage of any investigational drugs within 30 days prior to enrolment
11) Alpha fetoprotein value >100ng/mL at screening; if > 20ng/mL and ≤ 100ng/mL, if liver cancer is excluded
12) Total bilirubin > 1.5 x ULN with ratio of direct/indirect > 1.
13) ALT or AST level > 10 x ULN
14) TSH and T4 outside normal limits and not adequately controlled thyroid function;
15) Poorly controlled diabetes mellitus as evidenced by HbA1c > 7.5%
16) History of moderate, severe or uncontrolled psychiatric disease, especially depression, including a history of hospitalisation or prior suicidal attempt;
17) Active autoimmune disease, including autoimmune hepatitis
18) Received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 30 days prior to enrolment
19) Received silymarin (milk thistle) or glycyrrhizin or Sho-saiko-to (SST) within 30 days prior to enrolment
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E.5 End points |
E.5.1 | Primary end point(s) |
Virological response at week 28 (W28VR): - i.e. virological response sustained for 4 weeks after end of all treatment for patients with viral load BLQ at week 4 and below lower limit of detection (BLD) at weeks 8-12 - i.e. virological response 4 weeks after end of treatment with BI 201335 NA, but on continued treatment with PegIFN/RBV for patients not achieving a VL BLQ at week 4 and a VL BLD at weeks 8-12
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 14 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 0 |