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

Completed · Phase 1 · Has a placebo group

Conditions studied: Hepatitis C, Chronic

In brief

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.

Key facts

Study ID

NCT00793793

Run by

Boehringer Ingelheim

People needed

96

Starts

2007-09-01

Expected to finish

2011-01-25

Last updated by the study team

2018-09-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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