Safety, Antiviral Activity and PK of MRD of BI 201335 in Chronic Hepatitis C Patients Both Treatment Naive and -Experienced

• Status: Completed
• Trial end date: 2011-01-25
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Antiviral Agents; Pharmaceutical Solutions

Criteria

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:

1. Patients who have been previously treated with at least one dose of any protease inhibitor for acute or chronic hepatitis C infection

2. Evidence of liver disease due to causes other than chronic HCV infection

3. Positive ELISA for HIV-1 or HIV-2

4. Hepatitis B virus (HBV) infection based on presence of Hbs Ag or HBV DNA

5. Any previous liver biopsy consistent with cirrhosis

6. Decompensated liver diseases as evidenced by ascites, portal hypertension, jaundice or hepatic encephalopathy

7. Haemophilia

8. Hemoglobinopathy (e.g., thalassemia major or sickle cell anemia)

9. Severe pre-existing psychiatric disease

10. Poorly controlled diabetes mellitus

11. Ischaemic heart disease

12. Chronic obstructive airway disease

13. Autoimmune disease; including autoimmune hepatitis

14. History of alcohol abuse within the past 12 months

15. Hyperbilirubinemia (conjugated bilirubin) >1.5x ULN

16. Alkaline phosphatase >1.5x ULN

17. ALT and AST levels >= 5 x ULN

18. Hemoglobin < 12.0 g/dL for women and < 13.0 g/dL for men

19. White blood cell count < 2000 cells/mm3

20. Absolute Neutrophil Count < 1500 cells/mm3

21. Platelet count < 100,000 cells/mm3

22. Prothrombin time INR (Institutional Normalized Ratio) prolonged to > 1.5 x ULN

23. 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

24. Known hypersensitivity to study drugs