Safety, Antiviral Activity and PK of MRD of BI 201335 in Chronic Hepatitis C Patients Both Treatment Naive and -Experienced
NCT ID: NCT00793793
Last Updated: 2018-09-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
96 participants
INTERVENTIONAL
2007-09-30
2011-01-25
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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20mg
patient to receive 20mg solution BI201335 qd +/- PegIFN/RBV fore 28 days
BI201335
patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV fore 28 days
48mg
patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV fore 28 days
BI201335
patient to receive rising doses of BI201335 solution qd +/- PegIFN/RBV fore 28 days
120mg
patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV fore 28 days
BI201335
patient to receive rising doses of BI201335 solution qd +/- PegIFN/RBV fore 28 days
240mg
patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV fore 28 days
BI201335
patient to receive rising doses of BI201335 solution qd +/- PegIFN/RBV fore 28 days
Placebo
Placebo
Interventions
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BI201335
patient to receive rising doses of BI201335 solution qd +/- PegIFN/RBV fore 28 days
BI201335
patient to receive rising doses of BI201335 solution qd +/- PegIFN/RBV fore 28 days
BI201335
patient to receive rising doses of BI201335 solution qd +/- PegIFN/RBV fore 28 days
BI201335
patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV fore 28 days
Placebo
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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1220.2.10 Boehringer Ingelheim Investigational Site
San Francisco, California, United States
1220.2.15 Boehringer Ingelheim Investigational Site
San Francisco, California, United States
1220.2.17 Boehringer Ingelheim Investigational Site
Baltimore, Maryland, United States
1220.2.11 Boehringer Ingelheim Investigational Site
New York, New York, United States
1220.2.12 Boehringer Ingelheim Investigational Site
New York, New York, United States
1220.2.14 Boehringer Ingelheim Investigational Site
Austin, Texas, United States
1220.2.3304A Boehringer Ingelheim Investigational Site
Lyon, , France
1220.2.3303A Boehringer Ingelheim Investigational Site
Marseille, , France
1220.2.3301A Boehringer Ingelheim Investigational Site
Paris, , France
1220.2.3302A Boehringer Ingelheim Investigational Site
Paris, , France
1220.2.49002 Boehringer Ingelheim Investigational Site
Berlin, , Germany
1220.2.49005 Boehringer Ingelheim Investigational Site
Düsseldorf, , Germany
1220.2.49006 Boehringer Ingelheim Investigational Site
Hanover, , Germany
1220.2.49004 Boehringer Ingelheim Investigational Site
Kiel, , Germany
1220.2.49003 Boehringer Ingelheim Investigational Site
Mainz, , Germany
1220.2.34001 Boehringer Ingelheim Investigational Site
Madrid, , Spain
Countries
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References
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Berger KL, Lagace L, Triki I, Cartier M, Marquis M, Lawetz C, Bethell R, Scherer J, Kukolj G. Viral resistance in hepatitis C virus genotype 1-infected patients receiving the NS3 protease inhibitor Faldaprevir (BI 201335) in a phase 1b multiple-rising-dose study. Antimicrob Agents Chemother. 2013 Oct;57(10):4928-36. doi: 10.1128/AAC.00822-13. Epub 2013 Jul 22.
Manns MP, Bourliere M, Benhamou Y, Pol S, Bonacini M, Trepo C, Wright D, Berg T, Calleja JL, White PW, Stern JO, Steinmann G, Yong CL, Kukolj G, Scherer J, Boecher WO. Potency, safety, and pharmacokinetics of the NS3/4A protease inhibitor BI201335 in patients with chronic HCV genotype-1 infection. J Hepatol. 2011 Jun;54(6):1114-22. doi: 10.1016/j.jhep.2010.08.040. Epub 2010 Nov 11.
Other Identifiers
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2007-001158-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1220.2
Identifier Type: -
Identifier Source: org_study_id
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