SNPMiner Trials: Clinical Trial Report
Report for Clinical Trial NCT01497834
Developed by Shray Alag, 2019.
SNP Clinical Trial Gene
The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032
combination therapy in Japanese subjects.
Name: BMS-790052 (Daclatasvir)
Description: Tablets, Oral, 60mg, Once daily, 24 weeksType: Drug
Daclatasvir + Asunaprevir
Name: BMS-650032 (Asunaprevir)
Description: Capsules, Oral, 100mg, Twice daily, 24 weeksType: Drug
Daclatasvir + Asunaprevir
Primary Outcomes
Description: SVR24 - sustained virologic response at follow-up Week 24 (after end of treatment)
Measure: Antiviral activity, as determined by the proportion of subjects with SVR24
Time: After 24 weeks of the last dose
Secondary Outcomes
Measure: Antiviral activity, as determined by the proportion of subjects who achieve Hepatitis C virus (HCV) ribonucleic acid (RNA) below lower limit of quantitation (LLOQ) target detected or not detected
Time: Weeks 1, 2, 4, 6, 8, 10 and 12; Weeks 4 and 12; End of treatment (EOT), or post treatment Week 12
Measure: Antiviral activity, as determined by the proportion of subjects who achieve HCV RNA below LLOQ, target not detected
Time: Weeks 1, 2, 4, 6, 8, 10 and 12; Weeks 4 and 12; EOT, or post treatment Week 12, post treatment Week 24
Measure: Safety, as measured by the frequency of serious adverse events (SAEs), discontinuations due to adverse events (AEs), AEs by intensity and laboratory abnormalities by toxicity grade
Time: End of treatment plus 7 days
Measure: Proportion of subjects with SVR24 by IL28B status [CC, CT, or TT genotype at the IL28B rs12979860 single nucleotide polymorphisms (SNP)]
Time: Follow-up Week 24
Purpose: Treatment
Single Group Assignment
There is one SNP
SNPs
Proportion of subjects with SVR24 by IL28B status [CC, CT, or TT genotype at the IL28B rs12979860 single nucleotide polymorphisms (SNP)].
HPO Nodes