Hepatitis C
Conditions
Interventions
investigational material(s)
Generic name etc : BMS-790052, BMS-650032
INN of investigational material :
Therapeutic category code : 625 Anti-virus agents
Dosage and Administration for Investigational
Sponsors
Bristol-Myers K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects chronically infected with HCV Genotype 1 HCV RNA viral load of more than 5logIU/mL (100,000 IU/mL) at screening
Exclusion criteria
Exclusion criteria: Subjects with evidence of liver cirrhosis Evidence of HCC Co-infection with hepatitis B virus, HIV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess safety and tolerability, as measured by related serious adverse events (SAEs) and discontinuations due to related AEs. To determine the proportion of subjects who achieve SVR12. | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects who achieve RVR The proportion of subjects with extended rapid virologic response The proportion of subjects who achieve SVR24 Resistant variants associated with clinical failure | — |
Outcome results
None listed