Clareo Health | Safety, Antiviral Effect and PK of BI 207127 + BI 201335 +/- RBV for 4 up to 40 Weeks in Patients With Chronic HCV Genotype 1 Infection
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Chronic hepatitis C virus (HCV) infection of genotype (GT) 1
Parts 1-3:Treatment naive to Interferon -alfa (IFN), Pegylated interferon -alfa (PegIFN), ribavirin (RBV), and any direct acting antiviral agent for chronic hepatitis C
Part 4: Treatment experienced with confirmed prior virological failure to an approved dose of PegIFN/RBV (null-response)
HCV RNA \>=10,000 IU/mL at screening
Liver biopsy within two years or fibroscan within six months prior to baseline
Liver biopsy within two years or fibroscan within 6 months prior to screening
Age 18-75 years
You may not be if
Hepatitis C virus (HCV) infection of mixed genotype
Evidence of liver disease due to causes other than chronic HCV infection
Positive ELISA for human immunodeficiency virus (HIV)
Hepatitis B virus (HBV) infection
Decompensated liver disease or history of decompensated liver disease
Active or suspected malignancy within the last 5 years
Ongoing or historical photosensitivity or recurrent rash
History of alcohol or drug abuse (except cannabis) within the past 12 months
Body mass index (BMI)I \<18 or \> 35 kg/m2
Usage of any investigational drugs within 30 days prior to enrolment, or 5 half-lives, whichever is longer; o the planned usage of an investigational drug during the course of the current study
Known hypersensitivity to any ingredient of the study drugs
A condition that is defined as one which in the opinion of the investigator may interfere with the patient's capability for participation in the trial or may influence the results of the trial
Alpha fetoprotein \>100ng/mL at screening; if \>20ng/mL and \<=100ng/mL, patients can be included if there is no evidence of liver cancer in an appropriate imaging study within 6 months prior to randomisation
Total bilirubin \> 2 mg/dL with ratio of direct/indirect \> 1
AST or ALT \>5xULN
INR prolonged to \>1.7xULN
Requirement for chronic systemic corticosteroids
Received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 30 days prior to enrolment or 5 half-lives, whichever is longer
Received silymarin or glycyrrhizin or Sho-saiko-to within 30 days prior to enrolment
