Antiviral effect, safety and pharmacokinetics of once daily BI 201335 NA in hepatitis C virus genotype 1 infected treatment-naive patients for 24 weeks as combination therapy with pegylated interferon-a 2a and ribavirin (double-blinded, randomised, placebo-controlled, Phase II)
- Conditions
- chronic hepatitis C infection of genotype 1MedDRA version: 9.1Level: LLTClassification code 10008912Term: Chronic hepatitis C
- Registration Number
- EUCTR2008-003538-11-NL
- Lead Sponsor
- Boehringer Ingelheim bv
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 420
1)Chronic hepatitis C infection, diagnosed by seropositivity for anti-HCV antibodies or detectable HCV RNA at least 6 months prior to screening
2)HCV infection of genotype 1(1a, 1b or mixed 1a/1b) diagnosed by genotypic testing or screening
3)Therapy-naive to interferon (including any experimental or investigational interferon products as monotherapy or in combination with any other agents), pegylated interferon, or ribavirin for acute or chronic hepatitis C infection
4)HCV viral load>=100.000 IU/mL at screening
5) Liver biopsy within 24 months prior to study enrolment that provides histological evidence of any degree of chronic necroinflammatory activity or the presence of fibrosis (Ishak grade 1-4 or Metavir Grade 1-3)
6)Normal finding on fundoscopy within 6 months prior to Day 1
6) Age 18 to 65
7) Female patients (a)with documented hysterectomy, or (b) who have had both ovaries removed, or (c) with documented tubal ligation, or (d) who are post-menopausal with last menstrual period at least 12 months prior to screening, or
(e) childbearing potential with a negative serum pregnancy test at screening and on Day 1 (Visit 2) that either agree to abstain from intercourse, or agree to use one of the appropriate medically accepted methods of birth control (see below) from the date of screening until 6 months after the last dose of ribavirin in addition to the consistent and correct use of a condom, and that are not breast-feeding or nursing or plan to nurse at any time from the date of screening until 6 months after the last dose of ribavirin.
Note : Pregnancy tests must be performed every 4 weeks after screening until 6 months after the last dose of ribavirin for females of childbearing potential. Note: Medically accepted methods of contraception for females in this trial are ethinyl estradiol containing contraceptives, diaphragm with spermicide substance, and cervical cap.
8)Male patients (a) who are documented to be sterile, or (b) who agree to abstain from intercourse from the date of screening until 6 months after the last dose of ribavirin, or (c) who consistently and correctly use a condom while their female partners (if applicable) agree to use one of the appropriate medically accepted methods of birth control (see below) from the date of screening until 6 months after the last dose of ribavirin, and (d) without pregnant female partners. It is in the responsibility of the male patient to ensure that his partner (or partners) is not pregnant prior to entry into the study or becomes pregnant during the treatment and follow-up phase. Female partners of childbearing potential must agree to perform a monthly pregnancy test from the date of screening until 6 months after the last dose of ribavirin
9) Signed informed consent from prior to trial participation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1) Hepatitis C infection of mixed genotype 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 ELISA for HIV-1 or HIV-2
5) Hepatitis B virus (HBV) infection based on presence of HBs-Ag
6) Decompensated liver disease, or history of decompensated liver disease, as evidenced by ascites, portal hypertension, jaundice or hepatic encephalopathy, coagulopathy, varices, history of variceal bleeding, or any other clincial evidence of decompensation
7) Active or suspected malignancy or history of malignancy within the last 5 years (with the exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix)
8) History of alcohol or drug abuse within the past 12 months. Patients with documented drug and alcohol addiction free history of at least 12 months who are, in the opinion of the investigator, unlikely to relapse, may be enrolled in the study.
Note: Patients with a positive drug screen other than cannabis at time of screening will be excluded from the trial.
9)Usage of any investigational drugs within 30 days prior to enrolment, or 5 half-lives, whichever is longer; or the planned usage of an investigational drug during the course of the current study
10) Known hypersensitivity to any ingredient of the study drug
11)A condition that is defined as one which in the opinion of the investigator may either put the patient at risk because of participation in the study or may influence the results of the study or the patient's ability to participate in the study
12)Alpha fetoprotein value>100ng/mL at screening; if >20ng/mL and <=100ng/mL, patients can be included if there is no evidence of liver cancer in two congruent imaging studies (e.g., ultrasound, CT scan, MRI) within 6 months of Day 1
13) Total bilirubin >1.5xULN with ratio of direct/indirect > 1. (Patients with Gilbert's polymorphism are not excluded.)
14) ALT or AST levels >5xULN
15) INR prolonged to >1.5xULN
16) Hemoglobin<12g/dL for women and <13g/dL for men
17) White blood cell count <2000cells/mm3
18) Absolute neutrophil count <1500cells/mm3
19) Platelet count<100.000cells/mm3
20) TSH and T4 outside normal limits and not adequately controlled thyroid function; patients with TSH below the lower limit of normal my be enrolled if free T4 is normal and there is no clinical evidence of hyperthyroidism or hypothyroidism
21) Poorly controlled diabetes mellitus as evidenced by HbA1c>7.5%
22) Patients who are at risk for bleeding (NSAIDs therapy, anticoagulant therapy, vitamin K deficiency, known coagulopathy, hemophilia)
23) Hemoglobinopathy (e.g. thalassemia major or sickle cell anemia)
24) History of moderate, severe or uncontrolled psychiatric disease, especially depression.
25) Clinical evidence of chronic cardiac disease
26) Clinically significant abnormalities on screening ECG
27) Clinical evidence of chronic pulmonary disease (e.g., chronic obstructive pulmonary disease) associated with functional impairment
28) Active autoimmune disease, including autoimmune hepatitis
29) Evidence of acute or chronic renal disease
30) Organ transplant history, other than cornea or hair
31) Active seizure disorder within the past 2 years; patients may be enrolled if on stable medication and seizures have not been experienced for more than 2 year
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method