A Safety and Effectiveness Study of TMC435 in Chronic, Genotype 1, Hepatitis C Patients Who Failed to Previous Standard Treatment (ASPIRE)
Hepatitis C
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis C, Peginterferon alpha-2a, PegIFNalpha-2a, RBV, Ribavirin, Placebo, TMC435-TIDP16-C206, TMC435-C206, TMC435, HCV
Eligibility Criteria
Inclusion Criteria:
- Must have chronic hepatitis C infection as evidenced by liver biopsy, anti-hepatitis C virus (HCV) and HCV RNA positive
- Must have chronic hepatitis C infection (genotype 1) with HCV RNA level greater than10000 IU/mL
- Patient must have failed at least 1 prior course of peg interferon (Peg-IFN-alfa-2a)/ribavirin (RBV) therapy (standard treatment)
- Must be willing to use 2 effective methods of birth control for up to 7 months after last dose of study medication
Exclusion Criteria:
- Has an evidence of decompensated liver disease
- Co-infection with any other Hepatitis C virus genotype or co-infection with the human immunodeficiency virus (HIV)
- Has a medical condition which is a contraindication to Peg-INF or RBV therapy
- Have had history of, or any current medical condition which could impact the safety of the patient in the study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
TMC435 100 mg 12 Wks + PR48
TMC435 100 mg 24 Wks + PR48
TMC435 100 mg 48 Wks + PR48
TMC435 150 mg 12 Wks + PR48
TMC435 150 mg 24 Wks + PR48
TMC435 150 mg 48 Wks + PR48
Placebo 48 Wks + PR48
Participants will receive TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
Participants willl receive TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
Participants will receive TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
Participants will receive TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
Participants will receive TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
Participants will receive TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
Participants will receive Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.