SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT01497834

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 3 Japanese Study of BMS-790052 Plus BMS-650032 Combination Therapy in Chronic Hepatitis C Genotype 1b Infected Subjects Who Are Non Response to Interferon Plus Ribavirin and Interferon Based Therapy Ineligible Naive/Intolerant

The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032 combination therapy in Japanese subjects.

NCT01497834 Hepatitis C
MeSH:Hepatitis A Hepatitis C Hepatitis
HPO:Hepatitis

2 Interventions

Name: BMS-790052 (Daclatasvir)

Description: Tablets, Oral, 60mg, Once daily, 24 weeks
Type: Drug
Group Labels: 1

Daclatasvir + Asunaprevir

Name: BMS-650032 (Asunaprevir)

Description: Capsules, Oral, 100mg, Twice daily, 24 weeks
Type: Drug
Group Labels: 1

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

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 rs12979860

Proportion of subjects with SVR24 by IL28B status [CC, CT, or TT genotype at the IL28B rs12979860 single nucleotide polymorphisms (SNP)].



HPO Nodes


HPO: