Status:
COMPLETED
Safety, Antiviral Activity and PK of MRD of BI 201335 in Chronic Hepatitis C Patients Both Treatment Naive and -Experienced
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 th...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2011
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00793793
Start Date
September 1 2007
End Date
January 25 2011
Last Update
September 5 2018
Active Locations (16)
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1
1220.2.10 Boehringer Ingelheim Investigational Site
San Francisco, California, United States
2
1220.2.15 Boehringer Ingelheim Investigational Site
San Francisco, California, United States
3
1220.2.17 Boehringer Ingelheim Investigational Site
Baltimore, Maryland, United States
4
1220.2.11 Boehringer Ingelheim Investigational Site
New York, New York, United States