Safety, Antiviral Activity and PK of MRD of BI 201335 in Chronic Hepatitis C Patients Both Treatment Naive and -Experienced
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
This study will investigate safety, antiviral activity, and pharmacokinetics of BI 201335 NA in HCV genotype 1 infected patients treated for 14 days monotherapy followed by BI 201335 NA combination therapy with PegIFN/RBV for an additional 14 days for treatment-naïve patients; or for 28 days as BI 201335 NA combination therapy with PegIFN/RBV for treatment-experienced patients.
A secondary objective is to investigate antiviral activity, potential drug-drug interactions and safety of combination therapy of BI 201335 NA and PegIFN/RBV up to 28 days for treatment-naïve patients.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
1a. For treatment-naïve patients: no prior therapy with interferon, peginterferon, or ribavirin for acute or chronic hepatitis C infection
1b. For treatment-experienced patients: confirmed virological failure during or after combination treatment with an approved dose of alfa-2a or alfa-2b peginterferon combined with ribavirin; such patients must have received at least 12 weeks of therapy with a 90 day washout period prior to screening and must have documentation of medical history prior to enrolment in 1220.2 2. Age 18 years or older 3. Signed informed consent form prior to trial participation 4. Male or female with documented hysterectomy or menopausal female with last menstrual period at least 6 months prior to screening 5. Chronic hepatitis C infection of genotype 1, diagnosed by positive HCV serology test (HCV Ab positive) or detectable HCV RNA at least 6 months prior to screening 6. HCV viral load >= 100,000 IU/mL at screening 7. TSH and T4 within normal limits or adequately controlled thyroid function 8. Histological evidence within 36 months prior to study enrolment of any degree of chronic necroinflammatory activity or the presence of fibrosis (Ishak Grade 1-4 or Metavir Grade 1-3)
Exclusion criteria
- Patients who have been previously treated with at least one dose of any protease inhibitor for acute or chronic hepatitis C infection
- Evidence of liver disease due to causes other than chronic HCV infection
- Positive ELISA for HIV-1 or HIV-2
- Hepatitis B virus (HBV) infection based on presence of Hbs Ag or HBV DNA
- Any previous liver biopsy consistent with cirrhosis
- Decompensated liver diseases as evidenced by ascites, portal hypertension, jaundice or hepatic encephalopathy
- Haemophilia
- Hemoglobinopathy (e.g., thalassemia major or sickle cell anemia)
- Severe pre-existing psychiatric disease
- Poorly controlled diabetes mellitus
- Ischaemic heart disease
- Chronic obstructive airway disease
- Autoimmune disease; including autoimmune hepatitis
- History of alcohol abuse within the past 12 months
- Hyperbilirubinemia (conjugated bilirubin) >1.5x ULN
- Alkaline phosphatase >1.5x ULN
- ALT and AST levels >= 5 x ULN
- Hemoglobin < 12.0 g/dL for women and < 13.0 g/dL for men
- White blood cell count < 2000 cells/mm3
- Absolute Neutrophil Count < 1500 cells/mm3
- Platelet count < 100,000 cells/mm3
- Prothrombin time INR (Institutional Normalized Ratio) prolonged to > 1.5 x ULN
- Usage of any investigational drug within 30 days prior to enrolment; or the planned usage of an investigational drug during the course of the current study
- Known hypersensitivity to study drugs
Trial design
Primary purpose
Allocation
Interventional model
Masking
96 participants in 5 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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