Status:
COMPLETED
Drug Drug Interaction Study Between BI 201335 and BI 207127 in Chronic Hepatitis C Infected Patients
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
To evaluate the drug-drug interactions between BI 201335 and BI 207127 as well as their combined effect on CYP probe drug substrates and on tenofovir and raltegravir in treatment naive or prior treatm...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Chronic hepatitis C genotype 1 infection, diagnosed at least 6 months prior to screening
- Treatment naive or confirmed prior treatment relapse or partial response following treatment with interferon and ribavirin
- Age 18 to 70 years
- HCV RNA (Hepatitis C Virus RiboNucleic Acid) = 1,000 IU/mL at screening
- Liver biopsy or fibroscan to exclude cirrhosis
- Exclusion criteria:
- Hepatitis C Virus (HCV) infection of mixed genotype; Hepatitis B Virus (HBV) or Human Immunodeficiency Virus (HIV) co-infection
- Evidence of acute or chronic liver disease due to causes other than chronic HCV infection,
- Decompensated liver disease, or history of decompensated liver disease,
- Body weight \< 40 or \> 125 kg,
- Clinical evidence of significant or unstable cardiovascular disease, chronic pulmonary disease, history or evidence of retinopathy or clinically significant ophthalmological disorder
- Pre-existing psychiatric condition that could interfere with the subject's participation in and completion of the study
- Laboratory parameters disorders (thalassemia major, sickle cell anemia or glucose 6 phosphate dehydrogenase deficit)
- Hemoglobin \< 12 g/dL for women and \< 13 g/dL for men
- Patients who have been previously treated with at least one dose of any antiviral or immunomodulatory drug other than interferon alfa or ribavirin for acute or chronic HCV infection
Exclusion
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT01525628
Start Date
April 1 2012
End Date
October 1 2014
Last Update
June 10 2016
Active Locations (16)
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1
1241.27.0006 Boehringer Ingelheim Investigational Site
La Mesa, California, United States
2
1241.27.0005 Boehringer Ingelheim Investigational Site
Rockville, Maryland, United States
3
1241.27.0004 Boehringer Ingelheim Investigational Site
Marlton, New Jersey, United States
4
1241.27.0003 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States